Vaccination and Cancer
Insight: New doubts about prostate-cancer vaccine Provenge
Prostate cancer vaccine Provenge has long incited passions unlike any other cancer therapy.
Doctors who raised doubts about it received death threats. Health regulators and lawmakers faced loud protests at their offices. A physician at the American Cancer Society was so intimidated by Provenge partisans that he yanked a skeptical discussion of it from his blog.
The vitriol dissipated in April 2010, when the U.S. Food and Drug Administration approved Provenge for advanced prostate cancer, satisfying investors in manufacturer Dendreon and patients who for years had demanded it be put on the market.
But the bell on Round Two sounded when Marie Huber, a trained scientist and former hedge-fund analyst, made it her mission in the last year to analyze what she believes are deadly flaws in the studies that led to the approval of Provenge by the FDA.
She argues that the main reason Provenge seemed to extend survival - a crucial factor in the FDA's decision - was that older men in the study who did not receive Provenge died months sooner than similar patients in other studies.
She raises the possibility the "placebo" they received was actually harmful and made Provenge, known scientifically as sipuleucel-T, look better by comparison.
As Huber gains traction, most notably with a February paper in the prestigious Journal of the National Cancer Institute, she, too, is receiving threats. One post on an investors' message board last month suggested that "somebody smack her with a rubber hose." An email said "don't think you will be unscathed in this battle you waged on Provenge."
Provenge is Dendreon's only product and the company's stature with investors has waned with disappointing sales. In 2011, product revenues totaled $213.5 million, far from the $400 million Dendreon initially projected.
The company insists Huber's analysis is flawed and that Provenge has helped thousands of men with prostate cancer.
"I'm looking forward to getting this to patients around the world," said President and Chief Executive John Johnson.
FIRST CANCER VACCINE
Since it won FDA approval two years ago, Provenge has been Exhibit A for the idea that a patient's immune system can control or cure cancer. The first therapeutic cancer vaccine to reach the market, Provenge tries to engineer white blood cells, part of the immune system, to vanquish prostate cancer, which killed an estimated 33,720 men in the United States last year.
I
ts path to approval has all the features of a heavyweight healthcare fight - desperate patients demanding access to a promising therapy, a very expensive drug that extends life only a few months and efficacy data open to interpretation.
The FDA declined to approve the drug in 2007, when a clinical trial failed to show it slowed tumor growth. That incited protests, lawsuits and death threats against physicians on the FDA advisory panel who did not recommend approval, breaking with the 13-4 majority in favor.
"Provenge came along when we didn't have much to offer for prostate cancer," said Dr. Len Lichtenfeld of the ACS. "The advocacy community was bursting at the seams for something that worked. When you have that situation, it inflames passions and that can overtake the science."
In the pivotal trial called IMPACT, published in July 2010, but shared with the FDA months earlier, Provenge extended median survival by 4.1 months to 25.8 months from 21.7 months. That was sufficient for FDA approval. The vaccine costs $93,000 and patients also incur physician and other charges. Medicare agreed to cover Provenge last year, as have private insurers, but doctors initially balked at a long wait for reimbursement.
Huber had long been "utterly intrigued" by Provenge and its "huge promise of harnessing the immune system to battle cancer," she said in an interview.
In documents JNCI requires authors to sign, she declared no financial conflicts of interest. Neither she nor her former firm nor anyone else she is connected to stands to benefit financially from her analysis, she said.
Instead, she says she is motivated to help "vulnerable and desperate patients" - so much so that she gave up her job, salary and health insurance. Arguing that Provenge is harming these men,
She called "the whole thing utterly horrific. The company got away with hiding data and doctors making $7,000 per prescription won't even engage in discussion" about whether it helps their patients.
After receiving degrees in biochemistry and bioscience enterprise from Cambridge University, Huber began working as an analyst for a hedge fund in 2007. A Thomson Reuters analysis of securities filings confirmed her former firm has not held any positions in Dendreon.
LACK OF EVIDENCE
Each dose of Provenge is custom-made. A nurse or technician withdraws white blood cells from a man's arm in a three-to-four hour procedure called leukapheresis.
The cells are shipped to a Dendreon manufacturing facility, where for two days they are incubated with a "fusion protein:" One protein that stimulates the cells' growth and maturation and another called PAP, or prostatic acid phosphatase. PAP is an antigen that studs prostate cancer cells like antennae, pieces of it sticking out of the cells' surfaces.
Dendreon says the patients' white blood cells take up the antigen and within hours their surfaces bristle with fragments of the telltale molecule. The cells are then shipped back to the physician and infused into the patient. A full treatment includes three such procedures, two weeks apart.
Back inside the body, Dendreon claims the modified cells trigger the immune system to produce T cells that kill any cell sporting the PAP antigen — namely, prostate cancer cells.
In principle, that should eliminate the cancer, but Provenge does not shrink either the primary tumor or metastases.
Steven Rosenberg of the National Cancer Institute, a leading tumor immunologist, says that raises doubts over whether Provenge helps patients live longer, as the IMPACT trial reported.
"We have a lot of data that supports the idea that the product works the way it was designed to," said Dr. Mark Frohlich, Dendreon's chief medical officer. "We're seeing evidence of immune-system activation. The only question is whether the T cells are killing the tumor."
The FDA acknowledges that data supporting Provenge's approval did not show the drug shrank tumors, but says the overall survival benefit was enough to bring it to market. Spokeswoman Rita Chapelle, citing data submitted by Dendreon, said there is a "lack of evidence of anti-tumor activity," the reason for which "is unclear."
SUSPICIONS OVER SURVIVAL BENEFIT
Huber's analysis comes from data showing that men who received the placebo had very different survival times based on their age. Men older than 65 lived 17.3 months on placebo and 23 months with Provenge. Men younger than 65 lived 28 months after receiving placebo and 29 months after Provenge.
Other studies have shown that age generally does not affect how long a man survives with this form of prostate cancer, says Peter Iversen, a urologist and prostate-cancer surgeon at the University of Copenhagen and co-author of the paper with Huber.
Combining these findings led to the new paper's conclusion: The four-month edge in median survival from Provenge for all patients was due to longer survival among older men who got the vaccine.
"There is no efficacy in the younger patients, the primary group where you would expect it," said Huber.
Since the immune system weakens with age, an immune-based therapy should work better in younger men.
Some experts agree.
"If it was really a vaccine, you'd think younger men would show more response, since they are more immunocompetent," said NCI's Rosenberg.
On that basis, Huber and her co-authors, including two prostate-cancer specialists, argue the placebo used in the trial may have harmed the older men, cutting months off their lives and inadvertently making Provenge seem beneficial.
One way that could have occurred was through leukapheresis. That process removed about 90 percent of certain kinds of circulating white blood cells, according to calculations by immunologist Laura Haynes of the Trudeau Institute, a co-author of the JNCI paper.
The Provenge men got back about 32 percent of those cells, which had been stored at body temperature. The placebo men got back 12 percent, which had been incubated at near-freezing temperatures. Cold storage has been reported to kill "most, if not all, of those cells," notes the JNCI paper. Moreover, said Haynes, "if you return dead and dying cells to older men you are likely to cause inflammation," which can stoke the growth of cancerous cells.
Younger men were better able to replace the lost white blood cells, argued Iversen. Older men could not, resulting in early death.
"These cells are very specialized and there is research suggesting that removing them can harm older men," he said.
Earlier this month, DynaMed, an online database used by physicians, added to its Provenge entry a note on the JNCI paper, but calls the concern "not substantiated." ACS's Lichtenfeld says the analysis "might inhibit some patients and doctors from going ahead with a very expensive drug."
Huber says she plans to approach European regulators as they consider Dendreon's application to approve Provenge.
Investor message boards have lit up in response to the new paper. In February, an anonymous commentator on InvestorVillage.com warned that Huber's work was about to be published "a few days before our earnings. Her agenda is obvious."
IFFY STATISTICS
Critics of the new analysis argue the number of cells removed is too small to suppress the immune system. Charles Drake, an oncologist and immunologist at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, said there is no evidence the placebo men in IMPACT suffered more infections or other effects of a depleted immune system than the Provenge men.
The scientist who led IMPACT, oncologist Philip Kantoff of Dana Farber Cancer Center, said colleagues in immunology "dismissed as nonsense the idea that leukapheresis could hurt individuals."
He takes issue, too, with the statistics. Dividing the men by whether they are older or younger than 65, he said, is "arbitrary" and to pick apart data retrospectively is a statistical no-no.
Dendreon's Frohlich also criticizes the statistics: "If you do enough of these (post-hoc analyses) then by chance alone you'd expect to get one positive finding."
In other words, it is almost always possible to find a subset of patients who do better than others.
When Dendreon divided the men by whether they were older or younger than about 71, he added, they found no red flags.
The FDA agrees that such post-hoc statistical analyses "are exploratory" and their results "must be interpreted with caution, as acknowledged by the authors." Yet a paid consultant to Dendreon before the IMPACT trial agreed with many of Huber's concerns.
"The control vaccine used in IMPACT and in the predecessor trial had never been used anywhere for anything and may well have been detrimental to patients," said Donald Berry of MD Anderson Cancer Center, a leading biostatistician. "Here's a great way to get your drug approved: Kill the control patients."
Despite the heated rhetoric, Provenge may go out with a whimper more than a bang. Promising new agents for advanced prostate cancer include an oral drug from Medivation Inc called enzalutamide, in the final phase of clinical trials, and Zytiga from Johnson & Johnson, which won FDA approval in 2011. A vaccine that targets PSA, from Bavarian Nordic Immunotherapy, is in late-stage trials.
Dendreon does not disclose how many patients have been prescribed Provenge. CEO Johnson said that about 70 percent of its Provenge revenue comes from sales to community hospitals and doctors and 30 percent from academic medical centers. Some of the latter decline to use Provenge, deterred by lingering concerns over whether it provides a meaningful benefit.
Three such facilities in the Midwest, contacted at random by Reuters, confirmed they do not recommend Provenge. All asked not to be named for fear of receiving threats.
"It is my policy not to make public comments about this drug," said one oncologist. Patients who ask for it "are referred to another facility."
Source : Reuters
Link to Source
60 Lab Studies Now Confirm Cancer Link to a Vaccine You Probably Had as a Child
Dr. Maurice Hilleman made astounding revelations in an interview that was cut from The Health Century — the admission that Merck drug company vaccines had been injecting dangerous viruses into people worldwide.
Bear in mind that Dr. Hilleman was the developer of Merck’s vaccine program. He developed over three dozen vaccines, more than any other scientist in history. He was a member of the U.S. National Academy of Science, the Institute of Medicine, the American Academy of Arts and Sciences, and the American Philosophical Society. He received a special lifetime achievement award from the World Health Organization. Hilleman was one of the early vaccine pioneers to warn about the possibility that simian viruses might contaminate vaccines.
The video above has circulated for awhile, and some of you may
already have seen it. But I think it’s important to revisit and remember
history when it comes to vaccines, especially in light of current
developments.
For starters, the HPV vaccine Gardasil, which is being vigorously pushed on unsuspecting young girls and women to theoretically guard against cervical cancer still has never been proven to actually prevent cancer. On the contrary, evidence suggests that under certain circumstances the vaccine increases your risk of precancerous lesions by nearly 45 percent, and an ever increasing number of girls are being seriously injured by this unnecessary vaccine.
As of December 13, 2010, 20,915 adverse reactions had been reported in the United States alone, including 89 deaths, 297 miscarriages or stillbirths, and 370 reports of abnormal pap smears post vaccination.
All of this from a vaccine that has only been on the market for four years!
Making matters worse, as of 2009 the US FDA approved Gardasil for use on young boys as well, and the first male death has also been reported. In September of last year, a young boy died just eight days after being vaccinated with Gardasil.
So what’s going on here?
Is it possible that vaccines sold by drugmakers like Merck are causing lethal disease? Judging by history, the answer may be yes.
Contaminated Polio Vaccine Responsible for Human Cancer Cases In 2002, the journal Lancet published compelling evidence that contaminated polio vaccine was responsible for up to half of the 55,000 non-Hodgkin’s lymphoma cases that were occurring each year.
What was it contaminated with?
SV40, a cancer-causing monkey virus. The puzzle began in 1994, when Dr. Michele Carbone, a Loyola University researcher, found the virus SV40, which had never before been detected in humans, in half of the human lung tumors he was studying. Since then, 60 different lab studies have confirmed the results, and SV40 has been found in a variety of human cancers, including lung-, brain-, bone-, and lymphatic cancer.
At first no one could fathom how the virus had been transmitted into the human population.
But in the censored interview with Dr. Maurice Hilleman above, Hilleman admits Merck’s responsibility in unleashing this virus via their polio vaccine, as well as the likelihood that there was an importing and spreading the AIDS virus in the same manner.
Just Who is Dr. Maurice Hilleman? Now, for those of you who may think Dr. Hilleman was just another crackpot (he passed away in 2005), think again. He was, and still is, the leading vaccine pioneer in the history of vaccines. He developed more than three dozen vaccines—more than any other scientist in history—and was the developer of Merck’s vaccine program.
He was a member of the U.S. National Academy of Science, the Institute of Medicine, the American Academy of Arts and Sciences, and the American Philosophical Society, and received a special lifetime achievement award from the World Health Organization.
When he was chief of the Department of Respiratory Diseases with what’s now the Walter Reed Army Institute of Research, he discovered the genetic changes that occur when the influenza virus mutates, known as shift and drift. He was also one of the early vaccine pioneers to warn about the possibility that simian viruses might contaminate vaccines.So Dr. Hilleman knew what he was talking about. And in his own words, “vaccines have to be considered the bargain basement technology for the 20th Century.”
Vaccines Can Cause the Very Disease They’re Meant to Prevent, and Worse For years, researchers suggested that millions of vials of polio vaccine, contaminated with SV40, infected individuals between 1953 and 1963 and caused human tumors, and by 1999, molecular evidence of SV40 infections were showing up in children born after 1982. Some experts now suggest the virus may have remained in the polio vaccine until as late as 1999.
Still, the FDA and health authorities turned a blind eye.
In addition, just like Gardasil may well increase your risk of cervical cancer rather than reduce it, the live polio vaccine has also been found to cause polio. And, in rare instances the virus in the vaccine has even been known to mutate into a much deadlier version. As reported by MSN News in 2009, genetic analysis has proven such mutated viruses have caused at least seven separate outbreaks in Nigeria.
According to the CDC the last case of wild polio in the US—meaning polio caused naturally and not due to the live polio vaccine—occurred in 1979. From 1980 through 1999, there were NO wild polio cases in the US. Instead we had 144 cases of vaccine-associated paralytic polio (VAPP) caused by live oral polio vaccine.
Polio outbreaks in Haiti and the Dominican Republic in 2002 were also traced back to a strain of oral polio vaccine (OPV) that mutated back to virulence.
According to a report by Neil Z. Miller of the Global Vaccine Institute, the live polio virus from the vaccine can remain in your throat for one to two weeks and in your feces for up to two months. So not only is the vaccine recipient at risk, but he or she can potentially spread the disease to others.
In 1999, the Advisory Committee on Immunization Practices (ACIP) recommended that the United States replace the live-virus vaccine with an inactivated “killed” virus vaccine, which is what remains in use today. However, the inactivated polio virus vaccine has not been without its share of serious side effects either.
Rotavirus Vaccine Contaminated with Pig Virus Last year, the US FDA suspended the rotavirus vaccine Rotarix after an independent lab discovered it was contaminated with “a substantial amount” of DNA from the porcine circovirus. In pigs, this virus causes poor growth, weight loss, weakness, enlarged lymph nodes, skin rashes, difficulty breathing, jaundice, stomach ulcers, and sudden death.
As expected, both the FDA and GlaxoSmithKline spokespeople stated that the contaminated Rotarix vaccine carried no known human health risks. However, this is easy to say since there are no studies to confirm or deny a link between these viruses and human disease.
In the case of the polio vaccine, the link between the SV40 virus and human cancer wasn’t discovered until 40 years later! It is actually surprisingly common for vaccines to contain various animal matter, including foreign animal tissues containing genetic material (DNA/RNA).
Once the Rotarix contamination was discovered, new technology was used to test eight infectious attenuated viral vaccines, and in addition to Rotarix, two others contained “unexpected viral sequences”:
HPV Vaccine Now Routine for Boys as Well… So far, very few parents have voluntarily lined up their sons for the HPV vaccine, but that may soon change. As reported by Paging Dr. Gupta, the American Academy of Pediatrics’ 2011 schedule of recommended routine vaccines for children and teens now includes the HPV vaccine for boys aged 9-18 as well.
Folks, this is a disaster in the making. I shudder to think about the statistics we’ll see in a few years if parents fall for this nonsense.
I urge you to consider the risks already revealed in the four short years since Gardasil came on the market. Already, there are close to 21,000 reported incidents of adverse effects and death, despite the fact that only two out of every 10 women in the approved age group have gotten the vaccine so far.
Add to this the fact that an estimated 90 to 99 percent of all adverse effects are never reported, and the abnormally large risks of the HPV vaccine compared to other vaccines should give most people reason to pause.
Although the FDA ultimately dismisses all side effects, including deaths, as being within the norm, even they have stated that:
“In VAERS, a higher proportion of Gardasil reports were of syncope [fainting] and VTEs [venous thromboembolic events] compared with other vaccines.”
And according to the National Vaccine Information Center, the incidents of miscarriage and still birth events from Gardasil supersede the same event from all other vaccinations.
According to a recent Sane Vax press release on PR Log:
“There is no doubt the vaccine’s safety and efficacy has not been thoroughly investigated. And independent investigation on the safety and efficacy of the HPV vaccines, Gardasil and Cervarix must be conducted before there are more injuries and deaths.”
What’s most frustrating about this is that not a single one of these 21,000 children and young women needed to be harmed or die.
Why?
There are still outstanding questions about whether HPV is or is not the direct cause of cervical cancer. The FDA knows there are many other co-factors involved with the development of cervical cancer, and as of 2003 acknowledged that “most infections (by HPV) are short-lived and not associated with cervical cancer.” The same news release also states that “with proper screening, cervical cancer is avoidable, and if caught early, curable.”
In essence, three years before the HPV vaccine came upon the scene, they knew that what was needed—if anything—was simply improved screening methods, such as regular pap smear testing for girls and women that are far less risky than getting an HPV shot.
Interestingly, and disturbingly, routine pap smears have DECLINED, coinciding neatly with the release of the HPV vaccine. Between 2007 and 2010, cervical cancer screening rates declined by nearly 7 percent, the New York Times reported in December of last year.
When you consider that the HPV vaccine increases your risk of cancer if you’re already infected with certain types of HPV, this is a double-whammy of bad news since rarely, if ever, are girls and women given HPV pap screening before they get an HPV shot.
Source : International Medical Council on Vaccination
Link to Source
It’s all madness! Not only is the HPV vaccine is one of the most unnecessary vaccines on the market, it is also the most dangerous! And now they want to unleash it on young boys, and they’re trying to get it approved for older women as well.
Weighing Benefits versus Risks Even without a potential contamination scare, there are serious risks to every vaccine. The HPV vaccine is a perfect example. So before vaccinating you really need to be certain that the benefits will outweigh those risks.
In the case of Rotarix, along with RotaTeq (a similar vaccine made by Merck), the benefits are very questionable, especially if you live in the United States or another developed country. Typically, when a child in the United States contracts rotavirus, and most do in infancy and early childhood, all that is required is lots of rest, good nutrition and plenty of fluids to prevent dehydration from diarrhea. This infection also provides natural immunity that will protect your child for life.
Along with showing little benefit for a disease that is typically entirely treatable with fluids and rest, a recent drug review by the FDA found that Rotarix is associated with an increase in pneumonia-related deaths in children, compared to a placebo.
So with this particular vaccine, children living in developed countries like the US are potentially taking on serious risks with what appears to be very little benefit — and that was before the contamination was uncovered.
In the case of the HPV vaccine (Gardasil and Cervarix) the choice is clear. It has a high rate of risk and the potential benefits are unproven:
The moral of the story?
Do your homework before subjecting your children to any vaccine. A great way to get started is to simply use the Search Feature at the top of each of my Web pages and search my site as it contains a litany of research on vaccine safety, and the lack thereof. The National Vaccine Information Center (NVIC) also provides well-referenced information on vaccines and diseases, such as HPV, rotavirus and polio.
Source : International Medical Council on Vaccination via Dr. Mercola
Link to Source
For starters, the HPV vaccine Gardasil, which is being vigorously pushed on unsuspecting young girls and women to theoretically guard against cervical cancer still has never been proven to actually prevent cancer. On the contrary, evidence suggests that under certain circumstances the vaccine increases your risk of precancerous lesions by nearly 45 percent, and an ever increasing number of girls are being seriously injured by this unnecessary vaccine.
As of December 13, 2010, 20,915 adverse reactions had been reported in the United States alone, including 89 deaths, 297 miscarriages or stillbirths, and 370 reports of abnormal pap smears post vaccination.
All of this from a vaccine that has only been on the market for four years!
Making matters worse, as of 2009 the US FDA approved Gardasil for use on young boys as well, and the first male death has also been reported. In September of last year, a young boy died just eight days after being vaccinated with Gardasil.
So what’s going on here?
Is it possible that vaccines sold by drugmakers like Merck are causing lethal disease? Judging by history, the answer may be yes.
Contaminated Polio Vaccine Responsible for Human Cancer Cases In 2002, the journal Lancet published compelling evidence that contaminated polio vaccine was responsible for up to half of the 55,000 non-Hodgkin’s lymphoma cases that were occurring each year.
What was it contaminated with?
SV40, a cancer-causing monkey virus. The puzzle began in 1994, when Dr. Michele Carbone, a Loyola University researcher, found the virus SV40, which had never before been detected in humans, in half of the human lung tumors he was studying. Since then, 60 different lab studies have confirmed the results, and SV40 has been found in a variety of human cancers, including lung-, brain-, bone-, and lymphatic cancer.
At first no one could fathom how the virus had been transmitted into the human population.
But in the censored interview with Dr. Maurice Hilleman above, Hilleman admits Merck’s responsibility in unleashing this virus via their polio vaccine, as well as the likelihood that there was an importing and spreading the AIDS virus in the same manner.
Just Who is Dr. Maurice Hilleman? Now, for those of you who may think Dr. Hilleman was just another crackpot (he passed away in 2005), think again. He was, and still is, the leading vaccine pioneer in the history of vaccines. He developed more than three dozen vaccines—more than any other scientist in history—and was the developer of Merck’s vaccine program.
He was a member of the U.S. National Academy of Science, the Institute of Medicine, the American Academy of Arts and Sciences, and the American Philosophical Society, and received a special lifetime achievement award from the World Health Organization.
When he was chief of the Department of Respiratory Diseases with what’s now the Walter Reed Army Institute of Research, he discovered the genetic changes that occur when the influenza virus mutates, known as shift and drift. He was also one of the early vaccine pioneers to warn about the possibility that simian viruses might contaminate vaccines.So Dr. Hilleman knew what he was talking about. And in his own words, “vaccines have to be considered the bargain basement technology for the 20th Century.”
Vaccines Can Cause the Very Disease They’re Meant to Prevent, and Worse For years, researchers suggested that millions of vials of polio vaccine, contaminated with SV40, infected individuals between 1953 and 1963 and caused human tumors, and by 1999, molecular evidence of SV40 infections were showing up in children born after 1982. Some experts now suggest the virus may have remained in the polio vaccine until as late as 1999.
Still, the FDA and health authorities turned a blind eye.
In addition, just like Gardasil may well increase your risk of cervical cancer rather than reduce it, the live polio vaccine has also been found to cause polio. And, in rare instances the virus in the vaccine has even been known to mutate into a much deadlier version. As reported by MSN News in 2009, genetic analysis has proven such mutated viruses have caused at least seven separate outbreaks in Nigeria.
According to the CDC the last case of wild polio in the US—meaning polio caused naturally and not due to the live polio vaccine—occurred in 1979. From 1980 through 1999, there were NO wild polio cases in the US. Instead we had 144 cases of vaccine-associated paralytic polio (VAPP) caused by live oral polio vaccine.
Polio outbreaks in Haiti and the Dominican Republic in 2002 were also traced back to a strain of oral polio vaccine (OPV) that mutated back to virulence.
According to a report by Neil Z. Miller of the Global Vaccine Institute, the live polio virus from the vaccine can remain in your throat for one to two weeks and in your feces for up to two months. So not only is the vaccine recipient at risk, but he or she can potentially spread the disease to others.
In 1999, the Advisory Committee on Immunization Practices (ACIP) recommended that the United States replace the live-virus vaccine with an inactivated “killed” virus vaccine, which is what remains in use today. However, the inactivated polio virus vaccine has not been without its share of serious side effects either.
Rotavirus Vaccine Contaminated with Pig Virus Last year, the US FDA suspended the rotavirus vaccine Rotarix after an independent lab discovered it was contaminated with “a substantial amount” of DNA from the porcine circovirus. In pigs, this virus causes poor growth, weight loss, weakness, enlarged lymph nodes, skin rashes, difficulty breathing, jaundice, stomach ulcers, and sudden death.
As expected, both the FDA and GlaxoSmithKline spokespeople stated that the contaminated Rotarix vaccine carried no known human health risks. However, this is easy to say since there are no studies to confirm or deny a link between these viruses and human disease.
In the case of the polio vaccine, the link between the SV40 virus and human cancer wasn’t discovered until 40 years later! It is actually surprisingly common for vaccines to contain various animal matter, including foreign animal tissues containing genetic material (DNA/RNA).
Once the Rotarix contamination was discovered, new technology was used to test eight infectious attenuated viral vaccines, and in addition to Rotarix, two others contained “unexpected viral sequences”:
- A measles vaccine was found to contain low levels of the retrovirus avian leukosis (AVL) virus—a virus known to cause cancer in chickens. This despite the fact that vaccine manufacturers have been required to use eggs from leucosis-free stocks for over 40 years.
- Rotateq, Merck’s rotavirus vaccine, was found to contain a virus similar to simian (monkey) retrovirus—the SV40 virus previously linked to human cancer.
HPV Vaccine Now Routine for Boys as Well… So far, very few parents have voluntarily lined up their sons for the HPV vaccine, but that may soon change. As reported by Paging Dr. Gupta, the American Academy of Pediatrics’ 2011 schedule of recommended routine vaccines for children and teens now includes the HPV vaccine for boys aged 9-18 as well.
Folks, this is a disaster in the making. I shudder to think about the statistics we’ll see in a few years if parents fall for this nonsense.
I urge you to consider the risks already revealed in the four short years since Gardasil came on the market. Already, there are close to 21,000 reported incidents of adverse effects and death, despite the fact that only two out of every 10 women in the approved age group have gotten the vaccine so far.
Add to this the fact that an estimated 90 to 99 percent of all adverse effects are never reported, and the abnormally large risks of the HPV vaccine compared to other vaccines should give most people reason to pause.
Although the FDA ultimately dismisses all side effects, including deaths, as being within the norm, even they have stated that:
“In VAERS, a higher proportion of Gardasil reports were of syncope [fainting] and VTEs [venous thromboembolic events] compared with other vaccines.”
And according to the National Vaccine Information Center, the incidents of miscarriage and still birth events from Gardasil supersede the same event from all other vaccinations.
According to a recent Sane Vax press release on PR Log:
“There is no doubt the vaccine’s safety and efficacy has not been thoroughly investigated. And independent investigation on the safety and efficacy of the HPV vaccines, Gardasil and Cervarix must be conducted before there are more injuries and deaths.”
What’s most frustrating about this is that not a single one of these 21,000 children and young women needed to be harmed or die.
Why?
There are still outstanding questions about whether HPV is or is not the direct cause of cervical cancer. The FDA knows there are many other co-factors involved with the development of cervical cancer, and as of 2003 acknowledged that “most infections (by HPV) are short-lived and not associated with cervical cancer.” The same news release also states that “with proper screening, cervical cancer is avoidable, and if caught early, curable.”
In essence, three years before the HPV vaccine came upon the scene, they knew that what was needed—if anything—was simply improved screening methods, such as regular pap smear testing for girls and women that are far less risky than getting an HPV shot.
Interestingly, and disturbingly, routine pap smears have DECLINED, coinciding neatly with the release of the HPV vaccine. Between 2007 and 2010, cervical cancer screening rates declined by nearly 7 percent, the New York Times reported in December of last year.
When you consider that the HPV vaccine increases your risk of cancer if you’re already infected with certain types of HPV, this is a double-whammy of bad news since rarely, if ever, are girls and women given HPV pap screening before they get an HPV shot.
Source : International Medical Council on Vaccination
Link to Source
It’s all madness! Not only is the HPV vaccine is one of the most unnecessary vaccines on the market, it is also the most dangerous! And now they want to unleash it on young boys, and they’re trying to get it approved for older women as well.
Weighing Benefits versus Risks Even without a potential contamination scare, there are serious risks to every vaccine. The HPV vaccine is a perfect example. So before vaccinating you really need to be certain that the benefits will outweigh those risks.
In the case of Rotarix, along with RotaTeq (a similar vaccine made by Merck), the benefits are very questionable, especially if you live in the United States or another developed country. Typically, when a child in the United States contracts rotavirus, and most do in infancy and early childhood, all that is required is lots of rest, good nutrition and plenty of fluids to prevent dehydration from diarrhea. This infection also provides natural immunity that will protect your child for life.
Along with showing little benefit for a disease that is typically entirely treatable with fluids and rest, a recent drug review by the FDA found that Rotarix is associated with an increase in pneumonia-related deaths in children, compared to a placebo.
So with this particular vaccine, children living in developed countries like the US are potentially taking on serious risks with what appears to be very little benefit — and that was before the contamination was uncovered.
In the case of the HPV vaccine (Gardasil and Cervarix) the choice is clear. It has a high rate of risk and the potential benefits are unproven:
- In more than 70 percent of cases, HPV clears up on its own within a few weeks or months. In over 90 percent of cases, it’s gone within two years, causing no symptoms or disease.
- Only about 26 percent of girls and women ages 14 to 59 have been exposed to any HPV strain at all; and
- Only 2 percent have been exposed to strains 16 or 18 – the two that Gardasil and Cervarix protect against – meaning this vaccine is completely unnecessary because HPV infection very rarely leads to cancer.
- Women whose partners wore condoms during vaginal intercourse are 70 percent less likely to become infected with HPV. That’s a FAR greater level of protection than you can get from this vaccine!
The moral of the story?
Do your homework before subjecting your children to any vaccine. A great way to get started is to simply use the Search Feature at the top of each of my Web pages and search my site as it contains a litany of research on vaccine safety, and the lack thereof. The National Vaccine Information Center (NVIC) also provides well-referenced information on vaccines and diseases, such as HPV, rotavirus and polio.
Source : International Medical Council on Vaccination via Dr. Mercola
Link to Source