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Clinical trial investigators dismissed most of the 102 serious adverse events including 17 deaths that occurred in the clinical trials as unrelated to the study. But given the reactivity profile of aluminium, can we really say that for sure?
Nearly 90 percent of all Gardasil recipients and 85 percent of those who received the "placebo" reported one or more adverse events within 15 days of vaccination. Pain and swelling at the site of injection affected approximately 83 percent of Gardasil recipients and 73 percent of those who received the aluminium placebo. About 60 percent of those who received either the vaccine or the placebo had systemic adverse events including headache, fever, nausea, dizziness, vomiting, diarrhoea and myalgia. Those who received the vaccine reported even more serious adverse events such as gastroenteritis, appendicitis, pelvic inflammatory disease, asthma, bronchospasm and arthritis.
In a never before done study, scientists recently found a link between aluminium in vaccines and symptoms associated with Parkinson's, amyotrophic lateral sclerosis (ALS, or Lou Gehrig's disease) and Alzheimer's.
"This is suspicious," neuroscientist Chris Shaw told the Georgia Straight, Canada's largest urban weekly. "Either this [link] is known by industry and it was never made public, or industry was never made to do these studies by Health Canada. I'm not sure which is scarier."
Shaw said there could be 10,000 studies showing aluminium hydroxide is safe to be injected, but that he hasn't been able to find one study that looked beyond the first few weeks of injection. The reason this is significant, according to Shaw, is that neurological damage can take years to manifest.
Indeed, this is what we see time and again in vaccine studies. Either the placebo itself contains aluminium, which doesn't much allow us to learn the reactivity profile of the experimental vaccine, or the participants are only monitored for safety issues for a small frame of time, or, as in the case of Gardasil, both.
What Shaw and his colleagues found was neuron death. That's no small thing, as it's implicated in hundreds of medical conditions. If someone has a controlled, long-term study that shows aluminium hydroxide is safe, he said, please "put it on the table. That's how you do science."
Participants in the Gardasil studies were monitored for, at most, four years and many for a considerably shorter time frame. The largest trial is scheduled to be ended early and the people who were given a placebo now will be given the vaccine, meaning it's no longer possible to study long-term differences in health between those who received the vaccine and those who received the placebo.
In terms of long-term safety, one sentence in the FDA's insert is particularly revealing. "Gardasil has not been evaluated for the potential to cause carcinogenicity or genotoxicity," according to the insert. Yes, carcinogenicity means the ability to cause cancer. It's also not known whether the vaccine can cause chromosomal damage. We don't know because researchers didn't look. The trials were not set up to examine that question.
The vaccine is approved for use in girls as young as nine. The rationale for doing so is that the vaccine is only effective prior to exposure to HPV and actually leads to increased risk of precursors to cervical cancer in those previously infected, so it's best to catch girls as early as possible. Yet only 100 9-year-olds received Gardasil in trials, adding to the unknowns about administering a vaccine on still developing bodies. Those children have only been followed for 18 months.
If this vaccine turns out to have safety issues are we even going to know? Or will it remain on the childhood vaccinations schedule long after many girls suffer serious side effects or worse?
Even more terrifying is the idea -- being put forth by some HPV vaccine proponents -- of giving the vaccine to toddlers so as to weaken the possible connection between a vaccine for a sexually transmitted disease and "promiscuous" behaviour by youngsters.
Dr. Anne Szarewski, a consultant for Cancer Research UK who worked on the vaccine trials, told The Telegraph that giving the shot to young children was a good idea, provided that its efficacy could be proved to last into adulthood.
"There is an argument to giving it to toddlers, because you get away from any links between sexual activity and the whole ethical question that it poses," Szarewski said.
Even entertaining the idea of giving the vaccine to 2- and 4-year-olds is ludicrous at this stage give that the trials have thus far lasted well short of a decade, and we have no idea how a toddler's immune system would cope.
We do know generally that vaccines stimulate qualitatively inferior immunity than natural exposure, and for this reason most vaccines are "boosted" periodically during childhood or adolescence. Naturally acquired immunity lasts much longer, perhaps even a lifetime. The vast, vast majority of people who contract HPV pass the virus without symptoms.
Even if we're talking about vaccinating 9- to 12-year-olds, we still have no reason to believe at this point that the duration of immunity would last that long or until their first sexual encounter.
Dr. Clayton Young, a board-certified obstetrician gynaecologist in Texas, outlined his objections this way: "Vaccinating these children against HPV with a vaccine that is of unknown duration of efficacy will only postpone their exposure to an age which they are less likely [to] clear the infection on their own and be subject to more severe disease.
"The study of the vaccine in children and adolescents is limited to only measuring the development of antibodies to the HPV subtypes in the vaccine," Young continued. "There is absolutely no evidence that the vaccine prevents anything when administered at this young age. Merck expects you to extrapolate their adult data to the immune response in children. If they were really interested in vaccine efficacy in children, should it not be studied properly in children?"
Sanofi Pasteur and Merck have an enormous amount at stake in the universal administration of the shots.(GEE-WHAT A COINCIDENCE, MERCK SUBSIDIZED THE STUDIES) A place on the childhood vaccination schedule means a steady and exponentially larger revenue stream. Financial analysts predict Gardasil could be Merck's most important pipeline contributor to top-line growth, with peak sales of at least $2 billion -- revenue Merck badly needs after the Vioxx scandals. That revenue figure assumes that Gardasil will be required for school admittance.
"It's a stockholders dream," said Barbara Loe Fisher, president of the NVIC, a U.S. non-profit organisation that promotes the right to informed consent on vaccine decisions. Fisher sat on the FDA's committee that reviews vaccines in 2001, when the vaccine underwent early reviews.
Fisher went on to explain that Merck did not reveal in public documents exactly how many 9- to 15-year-old girls were in the clinical trials and how many of them had serious adverse events after being injected with Gardasil or the aluminium-containing placebo. "For example, if there were fewer than 1,000 little girls actually injected with three doses of Gardasil, it is important to know how many had serious adverse events and how long they were followed for chronic health problems, such as juvenile arthritis.
"This has nothing to do with kids and whether they are going to have sex," Fisher added. "It has to do with whether they are going to be set up for chronic inflammatory disease" from yet another vaccine being added to the litany of those they already receive. "I would want more data on long-term effects of autoimmunity on certain genotypes," she said in an interview, "and whether this vaccine is going to harm far more girls than it is going to protect."
Dr. Jacqueline Laing, a specialist in medical ethics at London Metropolitan University, was equally as critical: "Diseases associated with promiscuity will never be eradicated by universal state vaccination," she told The Telegraph. "The interests of the vaccine manufacturers should not take precedence over the rights and safety of children."
Suzanne Nelson is a freelance journalist and writer living in New Orleans. She spent five years covering the U.S. Congress for Roll Call Newspaper in Washington, D.C., and now focuses on subjects pertaining to health. She also maintains a health blog at honesthuman.com.