HPV vaccine-injury stories are making headlines all over the world, most recently in Ireland, the U.K., Japan, France, Spain, Denmark, India, Australia, and Colombia. In contrast, not one mainstream media outlet in the U.S. has covered this recurring, consistent global trend. The pattern appears to be that one day these girls are healthy, and shortly after receiving the vaccine things start to deteriorate. In some cases the reaction is immediate, with headaches and fainting, in others, the onset is later and more devastating, with autoimmune disorders or POTS-like symptoms. The most tragic cases have resulted in death. Injuries in the U.S. appear to be similar in nature to those around the world, yet there remains a media blackout.
I’m going to focus on Ireland as they have had recent press coverage and I have a particular interest there as my nickname may suggest. Five years ago, the press was even more open than today with a precautionary piece in the Irish examiner detailing a stern warning from one of the safety researchers on Gardasil, Dr. Diane Harper. However, that piece was published on the last day of summer, and Ireland had adopted the vaccine a few months before. There was little time for busy moms to read it before their kids would go back to school and receive the vaccine for the first time.
My main concerns about the HPV vaccine program stem from the problems I see with the vaccine program itself. Ireland is one of the few countries in Europe that does not have a no-fault vaccine-injury compensation program, while at the same time having one of the most aggressive vaccine schedules. A baby in Ireland will receive 30 doses of 14 vaccines before she reaches 13 months old if you include the much-hyped flu shot. Vaccines are not mandatory, but there is immense pressure to conform to the schedule, which is rarely questioned. In Ireland, the HSE (equivalent to our CDC) financially compensates doctors for each vaccine administered. They are also given a bonus if patients complete the entire schedule. Unlike the United States, citizens of Ireland are far less litigious and not likely to sue the manufacturer or the government for damages due to the vaccines they were pressured into giving their children, partly because the cost of doing so is exorbitant.
A steering committee was set up to look into the possibility of establishing a no-fault compensation scheme in Ireland, acknowledging that vaccines come with inherent risks. In 2009, the committee issued a recommendation to the government in favor of its implementation, but so far nothing has been done. The committee noted “The State, through many call and recall programs, exerts considerable influence on families to immunize their children with a view to achieving the social benefits for the community in general referred to earlier. It is against this background that the very small number of cases of children who suffer serious adverse reactions to some vaccines need to be considered . . . . The State should acknowledge that and make arrangements for a payment scheme . . . .” I can see why the government might be reluctant to act. It can get expensive. Despite being very unpopular because it has not turned out to be the easy “no-fault” program it was envisioned as, and is instead remarkably slow and adversarial, the vaccine-injury compensation scheme in the U.S. has paid out almost $3.5 billion to victims since its inception and has a huge backlog of cases to review. When you pressure people to get repeated doses of something that is bound to harm a percentage of them and you take financial responsibility for that harm, it can get very expensive indeed.
So what about the HPV vaccine program in Ireland? Gardasil was adopted as the vaccine of choice in 2010, and teenagers were given three shots over three visits. In 2014, it was changed to two shots over two visits. The HSE calls it a “Blitz and Mop” campaign which they describe in detail on page 7 in this HPV instructional document for schools. The first Blitz has a Tdap booster complement and the second, a MenC booster.
Why only two shots in Europe when three are given in the U.S.? For some reason a “new marketing authorization” was issued from the makers of Gardasil and Ceravix in 2014, who decided — arbitrarily? — that there is a strict cutoff at 13 years and 364 days old, after which a child in Europe will then need an extra dose if she hasn’t already received two shots. Try as I might, I could not locate a scientific reason for this distinction. Rather, it appears to be a 33.3% cost reduction incentive for European countries where uptake has historically been inconsistent. The U.K. and Ireland have rates well over 80% in school-aged girls, whereas, other countries’ rates vary widely from 17% to 81%. With rates in the U.S. hovering around 30%, I think we might expect to see a similar incentive here once the two-dose experiment plays out over the pond. Although vaccine mandates appear to be the preferred tactic to increase uptake in the U.S. In fact, Rhode Island recently mandated it for boys.
Parents in Ireland are asked for their consent before the school administers vaccines, but some have reported that not enough information is given as to the side effects of the vaccines. The PIL (patient information leaflet) should be given with each vaccine as per the manufacturers’ recommendations. However, the HSE specifically instructs the local health authorities NOT to give a PIL for Gardasil. (Page 10 on this slide show). The PIL is important because not only does it outline the risks and contraindications, it also gives details on the ingredients (HPV Types 6, 11, 16, and 18, amorphous aluminum hydroxyphosphate sulfate, yeast protein, sodium chloride, L-histidine, polysorbate 80, sodium borate) and how to file a report if there are any adverse reactions. For example, if the teenager (or any woman) is pregnant, Gardasil can harm the fetus. This is extremely important information. So I was very curious to find out why the HSE would want to conceal this from the public and deny a generation of teenagers their right to have informed consent. What I found was shocking to say the least. In relation to the PIL, the HSE says on page 22 here that: “. . . about 1 in 4 Irish adults have literacy problems. Many adults therefore would have difficulty understanding the technical details in the Patient Information Leaflet.” Please read that last sentence again, and tell me if you are not wondering what century we are living in? While I am sure that literacy in some categories is weak, the overall literacy rate in Ireland is 99%, the same as the United States. Are we really penalizing 99% of parents (and their daughters) because 1% “would have difficulty understanding the technical details”?
In other words, I think Irish parents could read a PIL if the health of their children depended on it — and it does. The government has already acknowledged that vaccine injury is something to be considered; so it is very worrying that the PIL would be deliberately withheld. It puts so many children at risk, especially since 80-90% of Irish school-attending teenagers have been vaccinated with Gardasil.
What IS given to the teenagers is an information “packet” that is supposed to go home with the consent form. This “packet” is really a marketing brochure with fun graphics aimed specifically at schoolchildren. It is not a PIL as key facts and risk information are missing. This is surely contrary to the specific instructions of the Irish Medical Organisation’s recommendations regarding the advertising code of ethics when marketing ‘health related products’ to children. The marketing material uses language that is clearly coercive as it makes exaggerated and untrue claims. For example, the claim that “HPV vaccine protects us from cervical cancer” is not one made by Merck, the manufacturers of Gardasil. In fact, they cannot currently and most likely will never prove that Gardasil protects from cervical cancer. The FDA, who authorized the fast-track approval of Gardasil, does not require it. It may be safe to say that without a Patient Information Leaflet, the patient cannot have true informed consent. And vaccination is a medical procedure that requires informed consent.
This has led a group of parents who claim to have Gardasil-injured teenagers to set up the support group called R.E.G.R.E.T. to bring attention to their complaints. The support group has only been active for a few weeks, but already they are receiving many emails citing similar stories of reactions to this vaccine that is heavily marketed to teenagers. The primary goal of R.E.G.R.E.T. is to get help for their daughters who have been injured by the HPV vaccine. These girls, like many around the world, are unable to live normal lives and need lots of help and support. Just as important to these moms is raising awareness among Irish parents about the safety issues surrounding the HPV vaccine, in the hope that when those parents have to decide on this vaccine they will be in a position to make a truly informed decision. The group feels that the information provided by the HSE is incomplete and biased and is downplaying the safety issues while exaggerating Gardasil’s effectiveness. R.E.G.R.E.T. hopes that by sharing their stories, the truth will out itself, a belief which we share at the Thinking Moms’ Revolution.
So just how safe is Gardasil? And how safe is it to combine it with Tdap and MenC? Could these girls’ stories be true? If there are even a handful of reported serious post-vaccination reactions, then Sanevax’s dire prediction from that Irish Examiner article almost five years ago would now be a reality. Every vaccine is “unavoidably unsafe” according to the U.S. Supreme Court; therefore, the answer to how “safe” is in the fine print. For this we need to look at the package insert where Merck provides excerpts from its clinical trials. You will note that throughout Merck’s clinical trial data Gardasil is compared to a placebo which contains an aluminum adjuvant, an ingredient already found in Gardasil. The gold standard of medicine is to test new drugs against an inert substance like a saline placebo. The aluminum adjuvant primes the immune system to mount a response to the antigen (the HPV virus in this case) and therefore, by definition, is anything but inert. There was one small cohort study conducted with an inert saline solution. When you compare adverse events from this cohort to Gardasil, the results are staggering in their contrast. See page 5 of the package insert for examples. After that point in the insert, Merck combines the saline and the aluminum “placebo” results together in one comparison group in order to present a more streamlined — and less jarring — comparison. (This sort of practice is highlighted in TMR’s blog “Critical Thinking 201: ‘Vaccine Science’.”) This is the data that the world relies on when assessing the “safety” of Gardasil.
When healthy children are given preventive medicine, the precautionary principle should hold sway. When reports of adverse events outnumber the cases of illness the drug is meant to prevent, the prudent thing to do is halt the administration of that drug until further studies have been done. In the case of the HPV vaccine, we may never know if or how many cases of cancer this drug will prevent because it is not possible to calculate for at least another 25 years, as the mean age for cervical cancer is 50 years. (This theme is explored in detail in TMR’s blog “The Evidence on Gardasil: Modern Miracle or Dangerous Scam?“ The number of cases of cervical cancer in teenagers is close to zero. Therefore, considering the number of reported adverse events among these teenagers, what would be the prudent thing to do?
Ever since the end of the last century, patients’ reactions to vaccines have been routinely dismissed as if the victims were raving lunatics who needed to pipe down because there isn’t a triple-blind placebo-controlled study to back up their claims. The medical profession is supposed to be practicing evidence-based medicine (EBM), which is a modern concept developed in the 1980s. The idea behind EBM is sound, except in cases where you have illnesses doctors can’t explain since it takes a long time to formulate and produce the evidence that provides the basis of EBM. In such cases, patients’ anecdotes may our best guides while the good doctors are figuring it all out.
Facebook is turning into a triage center for vaccine injuries, autoimmune disorders and every other 21st century medical emergency that seems to be dismissed as “normal” by the medical establishment. If it doesn’t fit the pharmaceutical “medical” paradigm, then it either doesn’t exist or it is a psychosomatic illness and the sufferer should just have a lie down and stop complaining. Heck, it is even suggested that we should embrace “autism” as if it were some kind of quirky personality trait that we have only just noticed — we just never realized that it was here all along. “It’s better diagnosing; so stop talking about it as if it is iatrogenic and debilitating in nature. Love your kids and embrace it.” Completely ignoring the fact that all the recent research shows a huge environmental component in the development of autism.
This is not about vaccine injury alone. It is about a system of practiced cognitive dissonance so widely accepted as to be ingrained in the medical establishment, with many doctors unaware that they are active participants. We are living in an age where research is being compromised in favor of the status quo and the truth is being stifled in favor of a promotion or a paycheck.
So please pay attention to what is happening overseas as it seems to be the only place where the press is free to report both sides of the subject. I will be keeping a close eye on events in Ireland with the hope that the government will hold true to its promise to protect those most vulnerable to the side effects of vaccines, and in particular Gardasil. More worrying is that Gardasil 9 is just around the corner, and the same kids will be given this new vaccine on top of the old. My fear is that we will see a whole new wave of adverse events being reported to VAERS and a lot more emails being sent to R.E.G.R.E.T. in Ireland. When will it end? When is enough, enough (for Merck)?
Read the package insert and #BeOneLessGardasilInjury.
For more by ShamROCK, click here.