Post Gardasil Syndrome

Orac at Respectful Insolence has a post about the invented condition Post Gardasil Syndrome. Norma at Sanevax, one of the anti-vaccine sites, is pushing the creation of this syndrome. In order to do that, she uses a couple of anecdotes about things that happened following the Gardasil HPV vaccine. (It is very telling that a web search for Post-Gardasil syndrome shows only alt-med and anti-vaccine sites but no actual credible medical sites.)

I just took a minute and tabulated the components of Post-Gardasil Syndrome:

Brittany from Ohio, Camille from Quebec, and Iraida Ruiz  from Spain suffer from the following symptoms:

peripheral neurological disorder, abnormal pupillary function and dilation, peripheral neuropathy in both legs, decreased endocrine activity and function, idiopathic epilepsy, liver function suppression, GI tract disorders, chronic Guillain-Barre-like symptoms, and hormone problems, fever, rash, fainting, fatigue, weakness, headaches, stomach pains, urinary infection, and abscesses in her mouth, vision impairment and oral Candida, Bad headache and bad pain in her right ear, deafness in this ear, blurred vision on the right eye, deviation of the mouth towards the right side, lost feeling and  sensitivity in her right arm and in both legs. She cannot walk and she is in a wheelchair.

Wendy’s daughter suffered from a rude doctor and lack of injection.

What an amazing drug. Perhaps it should be further developed as a form of biological warfare.

There are probably more symptoms that could be added, at least in her mind. This is not how syndromes are named. The primary reason for calling something a syndrome is an association between several symptoms that are clinically related. Preferably, there should also be a plausible biological rationale that connects the symptoms, although, admittedly, that is often not determined.

She goes on further:

Consider the serious adverse reactions reported after Gardasil injections. Steven Rubin posted disturbing data on the MedAlerts Blog (http://medalerts.org/analysis/archi…), sponsored by NVIC, regarding reports filed with VAERS. Refer to the chart in the blog for reference.

Number of Serious Events Reported to VAERS by Disease:
The chart clearly illustrates serious HPV vaccine injury reports filed were more than double the number of similar events reported for other ‘CDC-recommended vaccines’ administered in the 7-18 age group despite the fact that Gardasil is not yet the most widely used vaccine in that cohort.
Any VAERS report that indicates hospitalization, permanent disability, life-threatening illness, congenital anomaly or death is classified as serious.
Of the 75 FDA-approved vaccines, two HPV vaccines account for 16% of the entire VAERS database.

The Vaccine Adverse Effects Reporting System (VAERS) is a mechanism of the CDC to collect adverse effects from vaccines. In addition to VAERS, there are two other reporting  systems in place in the US.

From the CDC report from VAERS on Gardasil, is prefaced by the following statement.

VAERS data cannot be used to prove a causal association between the vaccine and the adverse event. The only association between the adverse event and vaccination is temporal, meaning that the adverse event occurred sometime after vaccination. Therefore, the adverse event may be coincidental or it may have been caused by vaccination, however we cannot make any conclusions that the events reported to VAERS were caused by the vaccine.

It is this concept of temporal correlation as being differentiated that anti-vaxers have the most difficulty explaining.  Although I suspect at least some must be wilfully ignorant and continue to ignore the difference in order to further their propaganda.

In addition, they are not above twisting the data. Again from the CDC Gardasil site.

The vast majority (92%) of the adverse events reports following Gardasil® vaccination were mild and included, pain and swelling at the injection site (the arm), fever, dizziness, nausea, and fainting. Syncope (fainting) is common after injections and vaccinations, especially in adolescents. Falls after fainting may sometimes cause serious injuries, such as head injuries, which can be prevented by closely observing the person for 15 minutes after vaccination.

For the serious effects, the numbers tell a different story from Norma’s.

  • Guillain-Barré Syndrome (GBS) Guillain-Barré syndrome (GBS) has been reported after vaccination with Gardasil® . GBS is a rare neurologic disorder that causes muscle weakness. It occurs in 1-2 out of every 100,000 people in their teens. A number of infections have been associated with GBS. There has been no indication that Gardasil® increases the rate of GBS above the rate expected in the general population, whether or not they were vaccinated.
  • Blood Clots There have been some reports of blood clots in females after receiving Gardasil®. These clots have occurred in the heart, lungs, and legs. Most of these people had a risk of getting blood clots, such as taking oral contraceptives (the birth control pill), smoking, obesity, and other risk factors.
  • Deaths As of September 15, 2011, there have been a total 71 VAERS reports of death among those who have received Gardasil®. There were 57 reports among females, 3 were among males, and 11 were reports of unknown gender. Thirty four of the total death reports have been confirmed and 37 remain unconfirmed due to no identifiable patient information in the report such as a name and contact information to confirm the report. A death report is confirmed (verified) after a medical doctor reviews the report and any associated records. In the 34 reports confirmed, there was no unusual pattern or clustering to the deaths that would suggest that they were caused by the vaccine and some reports indicated a cause of death unrelated to vaccination.

An important note about the VAERS system is that it accepts reports from both health care providers, parents, and others. I think it is a fair question to ask how many of the adverse effects, especially the serious ones, are sent in by people who are anti-vaccine to begin with.

The latest numbers on the prevalence of HPV in the US are from 2010:

The overall HPV prevalence of high- and low-risk types was 42.5% (95% confidence interval [CI]: 40.3–44.7) among U.S. females aged 14–59 years.HPV vaccine-preventable types 6 or 11 (low-risk types) or 16 or 18 (high-risk types) were detected in 8.8% of female participants: HPV-6 in 2.8% (95% CI: 2.2–3.6), HPV-11 in 0.3% (95% CI: 0.2–0.7), HPV-16 in 4.7% (95% CI: 4.0–5.5), and HPV-18 in 1.9% (95% CI: 1.4–2.5).

The incidence of cancers related to HPV is not trivial.

Persistent HPV infections are now recognized as the cause of essentially all cervical cancers, as well as most cases of anal cancer. In 2011, more than 12,000 women in the United States are expected to be diagnosed with cervical cancer and more than 4,000 are expected to die from it . Cervical cancer is diagnosed in nearly half a million women each year worldwide, claiming a quarter of a million lives annually.

Although anal cancer is uncommon, more than 5,000 men and women in the United States are expected to be diagnosed with the disease in 2011, and 770 people are expected die from it .

Genital HPV infection also causes some cancers of the vulva, vagina, and penis (3). In addition, oral HPV infection causes some cancers of the oropharynx (the middle part of the throat, including the soft palate, the base of the tongue, and the tonsils).

It has been estimated that HPV infection accounts for approximately 5 percent of all cancers worldwide.

These are the numbers that need to be publicized. What we call cancer is many diseases and in many cases there is no definitive causality. With HPV we have that causality and in Gardasil and other vaccines, we have a preventative weapon. The anti-vaccine crowd spreads fear, uncertainty, and doubt that undermines that effort.

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67 Responses to Post Gardasil Syndrome

  1. Dan Kegel says:

    Sadly, it’s a lot easier to spread fear and hysteria than to get people to pay attention to the data.

    I hadn’t heard of VSD and CISA yet, thanks, I’ll link to them.

    • I am all for a Gardasil vaccine, or any vaccine for that matter, that doesn’t have the range of side effects (and harmful or fatal) ones EVEN REMOTELY described on a package insert. To me one death from cervical cancer is no more righteous than one death from a vaccine.

      • Bre Alsobrook says:

        I am for many vaccines but I have Post Gardasil Syndrome. I have had major health issues ever since I got my first shot and I have had a migraine 24/7 since March 4th and NOTHING helps. This has effected my education because I can’t go to school anymore because my migraine is so severe. I also want to state that I was forced to get the shot because Perry said that if I didn’t get it then I couldn’t go to school. Before this started I had planned to go to TAMS at UNT now because of the vaccine I can’t go. This shot has literally ruined my educational future. Also, I haven’t slept more than 2 hours a night since about a week after I got my first shot, that was 4 years ago. Honestly there are only about 12,000 people a year in the US that get diagnosed with cervical cancer. There are thousands of girls that are having severe side affects of this shot and some girls that are still getting cervial cancer- even after the shot.

      • Dan Kegel says:

        Bre wrote:
        “There are thousands of girls that are having severe side affects of this shot and some girls that are still getting cervial cancer- even after the shot.”

        From what I can see, the number of severe side effects is extremely small. When I reviewed the VAERS data (see http://kegel.com/hpv/safety/vaers.html ) there were only 22 reports of death that were not obviously explained by preexisting conditions, and that’s small enough that the apparent link to the vaccine might have been coincidence in some of them.

        Also, the vaccine only addresses the most common two strains, but that’s no reason not to take it; those two strains account for most cervical cancer. An upcoming vaccine (the nonavalent hpv vaccine) will add more strains, providing more complete protection.

      • Bre – I am truly sorry that you are suffering. However, as I pointed out earlier, the connection the timing of your suffering and the vaccine is almost surely to be coincidental.

  2. Mary says:

    My daughter has suffered terribly since receiving her first Gardasil vaccine in 2009. I am not anti-vaccine and can not say for certain that the vaccine was the cause of her illness. My gut tells me what many are finding out-the vaccine combined with a family history of auto-immune disorders can create a very toxic reaction. I am all for protecting my daughter from cervical cancer-it’s why I consented to the vaccine. I do not agree with those who respond hysterically without the facts-from either side. As I said, I can’t prove what has caused my daughter’s illness but would be an idiot not to note the timing. I am one of many trying to ask the right questions, that is all.

    • Mary, you are perhaps on the right track. The one thing that many people overlook (and the scientists especially) is that the adjuvants used in the making of the vaccine are, by themselves, toxic. For example, Vitamin E and Polysorbate (which was the adjuvant system used in the H1N1 vaccine) is responsible for rheumatoid arthritis and is toxic to the brain of rats. Aluminum is used to bind the antigens which is readily taken up by immune cells called APC’s (or antigen presenting cells) which express the bits of the virus on their outsides so that other immune cells can recognize it and produce antibodies – this is how our immune system works. So imagine if these same APC’s express parts of adjuvant (vitamin E, Polysorbate 80 or L-Histidine) as an antigen, then the antibodies to that will be developed. Where the science gets tricky is that the body often has biomolecules that are similar in structure (the human body already contains L-Histidine) so if we introduce FOREIGN L-Histidine what do you suppose the reaction will be? Anaphylaxis. Now, new information has surfaced (thanks to Sanevax) that shows that the Gardasil vaccine (13 lots taken from other countries as well as the US) contains HPV DNA strains 11 and 18 tightly bound to the aluminum in the adjuvant. When this aluminum is taken up by the APC’s, the DNA will be expressed, but because DNA in a virus, bacteria, fungi, plant or animal is the same (Adenine, Guanine, Thimine, Cysteine) we now will develop antibodies to these nucleic acids. As well, if the DNA enters a non-immunogenic cell (because of the positive charge of the cell and the negative charge of the DNA and the presence of cell membrane disruptors like Polysorbate 80 and L-histidine) that DNA can be incorporated into the inside of a human cell where it could become part of the host DNA and cause the cell to become cancerous. So, in summation, there are many things that we don’t know about the effect of that 0,5 mL of vaccine being injected into us. Each person will respond differently, as you have said, and so I feel that the range of reactions experienced are a reflection of the complexity of the biological processes and so the term ‘syndrome’ is appropriate.

    • Mary, if you are Canadian and needing support, visit http://www.canadiangardasilawarenessnetwork.com.

  3. Jane says:

    @ Mary: Unfortunately you won’t get any more intelligent response out of rabidly ‘pro-science’ people than you will out of rabid ‘anti-vaxxers.’ If it’s in a medical/science journal they believe it, despite all the various revelations of malfeasance.

    Fortunately there ARE some smart, incurably curious scientists and doctors out there. Make sure that those people have access to your data so that IF there is a link, they will be able to find it. There are a lot of questions regarding autoimmune disease and some interesting research. Meanwhile, I hope very much that your daughter recovers.

    • Jane, may of the “anti-vaccine”ers are scientists too. We cannot hope to fight against a vaccine that is dangerous if we don’t research ACTUAL journal articles. We are not a bunch of uneducated hacks as you might have been led to believe.

      • Jane says:

        Heather, my comment was directed towards the rabid people on both side of the great divide that is, unfortunately, the vaccination debate. There are many non-rabid, intelligent people who can look at the pros and cons with an open mind and who understand that sometimes we just don’t know–but we can work towards finding out. There has been some fascinating, responsible research into aluminum adjuvants that has been, to the best of my knowledge, completely ignored by the FDA, and I find that troubling. But I’ve read some crazy fear-mongering on the part of the anti-vaccine camp and I am as apt to dismiss that as I am the arrogant nonsense spouted by Orac, referenced in this article, who I no longer bother to read. Be nice to see a bit of middle ground.

      • Unfortunately, there is no middle ground. You can only vaccinate or not vaccinate. As far as I know from the epidemiological and review articles I have seen, there is no correlation between most disorders and vaccines beyond the temporal.

        Yes, Orac can be somewhat over the top, but it is very difficult to find fault with his science. Another area to look up plain langguage resources on Vaccines and other health issues is SScience Based Medicine. where the language is less extreme, but the science is solid.

        As I have said before, all of the research points to vaccines being much safer than the diseases they prevent.

      • Jane says:

        @PEI: Nonsense. Sure there is middle ground. It consists of people who can assess the pros and cons of each vaccine separately–not treating ALL vaccines as if they were equal–and take an honest look at potential pitfalls; people who are capable of acknowledging that science is only what we know so far. Middle ground scientists keep investigating, and middle ground parents look at each vaccine’s pros and cons.

      • As far as each vaccine is concerned, they research tells us that there are individuals who should not be vaccinated. It is through the examination of individual medical histories that this information is gleaned. Virtually everyone I have heard who decides not to vaccinate downplays the seriousness of the diseases that the vaccines prevent.

    • Jane says:

      Virtually every pro ALL vaccine person downplays the potential consequences of vaccines, emphasizes the risks of disease–most childhood diseases are perfectly manageable in healthy kids who don’t swill soda etc., although I’m all for vaccinating against the more serious ones–and completely ignores the rising rates of autoimmune disease. Your point?

      • I think you need to do some more reading on the risks of these diseases, and then compare the relative risk of the disease against that of the vaccine. Chicken Pox, measles and mumps have and continue to kill and cripple children in vastly more numbers that the small numbers that are affected vaccines.

      • “I have said all the way through that for certain people, the risk of vaccine increases and there are certain people who should not get those vaccines. That is what the research has told us. For teh general population, the relative risk is very different.”

        Which certain people would those be??? Would you know them simply by looking at them? Of course not, it is not something that is obvious on the outside, right. The same is for the thousands of girls who now have chest pains, seizures, inflammation in the joints, sudden neurogenic shock, neuropathy, muscle pain, etc.. etc.. where there were none before. Causation for the scientist means having someone with an egg allergy who receives a vaccine with egg protein who goes into anaphylactic shock. When those kinds of reactions first showed up, doctors were dumbfounded too and dismissed the connection. Now that we know more about how vaccines work in the body, those connections are becoming clearer. PEI, how would YOU explain the numerous Healthy, Active and Vibrant teenaged girls who fall ill with the list of ailments I gave above after as little as one of the shots. Can you not concede that there is perhaps something unique about these girls that WHEN IN COMBINATION WITH the immunogenic compounds (adjuvants are specifically added to elicit an enhanced immune reaction) alters a persons biochemical mechanisms and immune system function? There is research that proves this, if you just know where to look.

      • The issues you list above are many of those listed in my original article and so far researchers have found no causal relationship, only a temporal one. That’s how I explain them.

        As far as who should not get a vaccine, the list is here:
        http://www.cdc.gov/vaccines/vpd-vac/should-not-vacc.htm. It is a considerably longer list than egg allergies.

      • Dan Kegel says:

        Hi Jane/Heather,
        I’m trying to understand the key qualms people have about HPV vaccination.
        (By “key qualms”, I mean what first and most strongly makes them oppose it,
        as opposed to secondary qualms that come later or are more in support of
        the original, key anti-vaccination position.) I’ve started off with morals and
        abstinence-related arguments, but will cover others as I start understanding them.
        Can you have a look and see if your single core anti-Gardasil argument is
        there yet? It’s at http://kegel.com/hpv/qualms/
        Thanks!

  4. Dan Kegel says:

    Mary, have you filed a VAERS report yet? And have you looked into filing a claim with the National Vaccine Injury Compensation Program? It’s a bit late, but you’ll be happy to hear that the CDC seems to be looking into whether and how a family history of autoimmune disease is associated with adverse effects from vaccination; see Family History Risk Study of Siblings at http://www.cdc.gov/vaccinesafety/Activities/cisa/cisa_studies.html

    Jane, I’ve yet to meet a rabid scientist. They tend towards the skeptical. Which malfeasance in particular are you referring to?

    • Jane says:

      @ Dan: Yes, the rabidly skeptical to the point of stupidity–making pronouncements on the side of current science about things that they actually know very little about. Knee-jerk ‘skepticism,’ I suppose.

      Goodness, if you’re not up on pharma corporate malfeasance, I hardly know where to start. Medical journal high jinks would be a good place for you to look.

  5. Interesting how you provide no Canadian data. I wonder if you had tried to find out the number of young women in this country who have reported the same serious side effects you would have a hard time in getting them. I know, because I have tried and It is not an easy process to get information out of Health Canada; and the information you DO get is hardly complete. For example, I was able to obtain the numbers of reports placed by each year starting in 2006 with a colored bar graph showing the ration of mild to serious events, but no actual numbers. As well, I am unable to obtain info on how these reports relate to the number of doses given. There is a specialized process by which I could apply to access this information (not under the FOI route) and only if I qualify. As well, you readily discount the accounts parents give of their childrens suffering. Anecdotal or not, what other method of accounting for their childrens symptoms post-Gardasil do you suggest they use? And of course the CDC, FDA and Health Canada are going to deny causation…. they always do until a class action lawsuit against the drug company is filed. If you had bothered to read through the rest of Sanevax.orgs website you would have also discovered (but likely not reported) that the vaccine is contaminated with the same cancer causing strain of HPV DNA (18). Conveniently, you choose to focus on the paranoia of the parents and of Sanevax in daring to call a spade a spade. I guarantee you that you WILL see an increase in autoimmune disorders, clotting disorders, girls who drop dead out of nowhere the longer this vaccine remains declared “SAFE AND EFFECTIVE”.

  6. Dan Kegel says:

    Heather, the DNA found in Gardasil corresponds to the L1 gene which produces the outer coat, whereas the genes associated with carcinogenesis are the E6 and E7 genes are not found in Gardasil. The good folks at sanevax.org are erring on the side of extreme caution here; there is no reason to believe that their fears about the DNA being carcinogenic.

    Really, the prevailing ethos at sanevax.org seems to be “we’ll print any little scrap of information that hints that vaccines are dangerous, without regard to proof”. Medical journals like the Lancet, on the other hand, have an ethos closer to “it has to be repeatably measurable to be trusted as evidence”. This is why I trust the Lancet far more than I trust Sanevax: there is a sanity filter in place at the Lancet lacking at sanevax. This is not to say there isn’t good information at sanevax; it’s just that the atmosphere there propagates bad information along with the good.

    • lia costa says:

      ohhh i do have proof, i have a living proof, my daughter sitting in front of me, today just fell 6 times, (been a good day though) she is breathing, but again not eating, but she is still alive, and i just pray to God to keep her alive, because she is a living proof how twisted and insane some minds are, we will proof, then i would like to know your comments, Listen there are too many, how can you/they ignore or pretend they dont exist. (its the next generation, the future of the world) Money/Power blinds many people.

      • Dan Kegel says:

        Lia, have you filed a VAERS report? I’d like to see a copy if possible.
        Without knowing the details, it’s hard to say whether the vaccine caused your daughter’s problems.

      • Dan, You assume that E6 or E7 fragments would NOT be included. According to patents for the manufacture of HPV vaccines, ambiguous wording exists that allows for the inclusion of E6 and E7 proteins (some vaccines for HPV are manufactured using these proteins). “In a further preferred embodiment the vaccine of the invention may be formulated with HPV early antigens such as E1, E2, E3, E4, E5, E6,E7, E8 or immunologically active derivatives thereof. When delivered in chimaeric form it is preferable to utilise an immunogenic fragment of about 30 60 amino acids of the early antigen. Early proteins may have the wild type sequence or comprise suitable mutations, for example, to prevent transforming activity.” U.S. Patent 7205125. The characterization of the recently discovered DNA needs to be performed in order to confirm or deny the allegations by Sanevax. I am also curious as to why the presence of DNA is now being confirmed by the FDA and yet no characterization or testing of any kind has been done by the FDA. They state that it is to be expected, yet Mercks own monographs state it contains NO DNA… which is the truth? I think that the patent reveals a lot. It corroborates the FDA’s statement of Oct 21, but does little to renew my confidence that the vaccine should not be considered a DNA vaccine.

  7. Pingback: Help! The anti-vaxxers have broken into the Strategic National Stupid Reserve! | Mama Mara

  8. Lia – I am sorry for the suffering of your daughter, I really am. I have raised three children, one of them with a number of aliments who spent considerable time in the hospital when he was younger. I know how the search for answers works, I have done it. However, I found that it was the scientific research that lead to the treatments that have minimize the long term, effects.

    As a parent, ‘knowing in my gut’ seems like a reasonable approach, however, as an adult I realize that my personal concept of knowing about medical issues is not the same as the experts knowledge. For example, last year I talked to a nurse about my sore chest muscles from working on my car the day before and how it was compounded by gas pains. I am over fifty and aches and pains are a normal part of life. My gut feeling was very wrong, as my two heart stents can prove.

    Heather – perhaps you can tell me which vaccinations you do consider to be safe. I have yet to have any acknowledgement of any safe vaccines from the anti-vaccine side. The research is entirely on the side of vaccines that are much safer than the diseases they prevent, to suggest otherwise is totally misleading.

    Perhaps you should read something like this instead of relying on the writing of people who are, in principle, against vaccines.
    http://scienceblogs.com/insolence/2011/09/oh_no_theres_dna_in_my_gardasil.php

    • Which vaccines do I find safe? Not many these days. I believe adjuvants are responsible for many of the ailments we are seeing related to vaccines. How do I come by this information? Chris Exley, a leading researcher in the field of aluminum adjuvants believes that aluminum adjuvants should not be used as placebo’s in vaccine trials. Aluminum elicits an immune response on it’s own and therefore is not considered a true independant variable. This is a principle learned in High School science class.

      I am suspicious of corporations like Bayer that knowingly sell HIV contaminated drugs to hemophiliacs and can’t explain how it contaminated rice with GM genes.

      Why do so many drug company CEO’s end up in government? How did Rumsfeld go from Searle to Defence department? Why do drug companies spend so much in contributions during elections?

      How did Baxter almost spread live bird flu in a vaccine destined for all of Europe?

      How much influence did Stephen Harpers friend and ex-campaign manager who was working for Hill and Knowlton have on Health Canada’s approval of Gardasil and the 300 million dollar contract to Merck Frosst Canada? I’ve had my flu shot this year, but only because it contains no adjuvant….
      I am just wondering why you trust vaccines so much?????

      • Anyone who has a modicum of understanding of statistics or epidemiology understands that any risk from the use of vaccines is far outweighed by the risk of NOT vaccinating. I agree one death from a cancer outweighs one death from a vaccine. However, we are not talking about a one to one ration in Gardasil or any other vaccine. There is just no way to compare the numbers who have been spared by vaccinations against the number who have been harmed. No would would suggest either, that vaccine safety should not be monitored and improved where possible, this is why the VAERS databese was established, and what it has accomplished over the years.

        In one instance, VAERS detected reports for intussusception over that what would be expected to occur by chance alone after the RotaShield rotavirus vaccine in 1999. Epidemiologic studies confirmed an increased risk, and these data contributed to the product’s removal from the US market. In another example, VAERS determined that there may be a potential for a small increase in risk for Guillain-Barre’ syndrome (GBS) after the meningococcal conjugate vaccine, Menactra. As a result of this finding, a history of GBS became a contraindication to the vaccine and further controlled studies are currently underway to research this issue.

        Individual anecdotes are the basis for further investigation. It is the examination of the medical details of these instances and the accumulation of a large amount of data that reveals a causative relationship. For example, anaphylaxis has resulted in about 1 out of 1,000,000 vaccines, and has not caused any deaths in recent years. It is one of the reasons why vaccines re given by professionals.

      • Please consider the work of Dr. Chris Exley on Aluminum adjuvants: http://youtu.be/JKfbkeQyw84. Nearly ALL vaccines contain this adjuvant. Science will continue to ignore the epidemic of acute neurological disorders, thank goodness people ARE asking questions and sharing anecdotal information. Dr. Exley is living proof that the Science is NOT CLEAR!

      • All we can do is follow the best evidence that is provided, and so far, the evidence does not support Dr. Exley. He seems to be of the opinion that aluminium is a major contributor to Alzheimer’s Disease, a contribution that has been discarded by other researchers. The talk you linked to was given at a conference that brought together the cream of the anti-vaccination crowd including Andrew Wakefield. I cannot say that Exley is wrong, but his credibility is affected by the company he keeps.

      • I find it interesting that a small group of scientists who meet to discuss the dangers and adverse effects that vaccines have (or anti-vaccine group as you put it) is somehow dispicable compared to a large group of scientists who meet to discuss the benefits of vaccines which you deem as laudable. Why is one group better than another. That is like having a House of Commons with 100% Conservatives in it with no Opposition. Do you really want to live in that world PEI? And by the way, who were their sponsors? Certainly not BigPharma, unlike most of the scientists who conduct research nowadays. As well, until you argue the scientific points proving Dr. Exley is wrong, I guess I’ll just lump you in with those “pro-vaccine people”.

      • There isn’t a lot of solid science in that group, again, the presence of Wakefield is especially troubling. Another discussion of aluminium adjuvants can be found here. In general, to be pro-vaccine is to be pro-science as virtually all research has demonstrated conclusively that the ‘pro’ side for vaccination far outweighs the ‘con’ side.

        A post here describes the backers of the conference as being decidedly anti-vaccine. As near as I can tell, most of the speakers at the conference brought a very anti-vaccine approach along with them.

      • Dan Kegel says:

        A better reference for questions about the safety of aluminum adjuvants might be http://www.ncbi.nlm.nih.gov/pubmed/15479434 “Vaccine adjuvants: current state and future trends”. (Immunol Cell Biol. 2004 Oct;82(5):488-96) It says:
        “With few exceptions, alum remains the sole adjuvant approved for human use in the majority of countries worldwide. … alum has the potential to cause severe local and systemic side-effects including sterile abscesses, eosinophilia and myofascitis, although fortunately most of the more serious side-effects are relatively rare.”

        An animal model of problems with aluminum adjuvants was published recently, http://www.ncbi.nlm.nih.gov/pubmed/19740540 “Aluminum hydroxide injections lead to motor deficits and motor neuron degeneration”. I don’t know whether these results have been reproduced yet.

        So: some adjuvant is needed to make the vaccine work; aluminum is almost the only game in town; it has very rare side effects; and research is going on to find new adjuvants that reduce the risk further.

        This is rather like the situation with thiomersal (thin evidence for real harm, but maybe worth getting rid of just to be safe), except it’s harder to find a substitute.

      • CA Shaw is a proponent of the imaginary vaccine-autism link, a link that has been proven to not exist. Full Stop.

      • Jane says:

        @ Dan: that’s the study I was talking about. Because the FDA and MOD wouldn’t acknowledge it, Dr Shaw and team ended up trying to replicate the study themselves. The results were worse second time around, and certainly couldn’t be considered trivial. None of the team vaccinates their kids any more (at all). I find it truly disturbing that no-one is apparently interested in proving or disproving the study.

      • Jane says:

        @PEI: Well, if Shaw thinks vaccines are risky, then OF COURSE you should completely discredit a valid, scientifically-conducted study out of a university without ever having tried to replicate it yourself. Duh. That’s how modern medical science works, right?

      • Again, there is no connection between autism and vaccination. That is a valid point as virtually all major studies have shown that. I don;t need to replicate them myself, I can look to Health Canada, WHO, FDA, and others to make that statement. For a researcher today to make that claim, puts him or her in the area of ideology rather than science.

      • Jane says:

        “Again, there is no connection between autism and vaccination. That is a valid point as virtually all major studies have shown that. I don;t need to replicate them myself, I can look to Health Canada, WHO, FDA, and others to make that statement. For a researcher today to make that claim, puts him or her in the area of ideology rather than science.”

        I have absolutely no opinion about vaccines and autism; haven’t followed the debate at all. However, I’m not so stupid as to think that scientific knowledge is complete, or that if you don’t immediately drop dead of something it’s QED safe. Nor do I believe that a bona fide scientist who continues to look for answers is an idiot. You do. That is your privilege.

        I’m afraid that if you look to the FDA etc to make the statement about Shaw’s study on aluminum adjuvants and neurological damage, you are in for a long wait. As far as I know they have made no comment, pro or con, nor instigated a study to confirm or deny the results. As a taxpayer, that annoys me no end. I would love for them to expose the study as fake as my daughter is off to work in a medical clinic in Honduras and will have to have shots for everything from rabies to all the heps she hasn’t yet had (but not Gardasil, nor chicken pox, since she had the disease and–astonishingly–survived). Unfortunately, no one seems to want to question the status quo and the FDA has failed its bosses (the taxpayer).

      • No, I don’t think that a scientist who continues to look for answers is an idiot. I am a scientist and certainly not an idiot. I worked in Biotechnology and vaccine and pharmaceutical development and read plenty of journal articles…. some comprised of sound bona fide scientific reasoning and others that were published despite poor scientific reasoning. Case in point: An independant variable is one that produces no reaction (ie an immune or inflammatory reaction) so that it can be contrasted against something that you would expect to produce a reaction. The HPV trials used the vaccine as the positive control and the adjuvant (without HPV L1 VLP’s) as the placebo (and independant control). This is wrong, because the adjuvant produces it’s own immune system response. Why not use Normal Saline? It is after all, what already exists in the human body and so would be essentially inert. So the fact that several pages of data show the reaction rates between placebo groups and vaccine groups means nothing because the experimental design is flawed. I believe it is flawed purposely, to bolster the results of the vaccine and to downplay the reaction rates (which are nearly zero). Scientists CAN and DO skew their data to fit their hypothesis and Most of them get their work published…. Why? Because their study is funded by big pharmaceutical corporations. The little guy who proves that squalene causes CD8 T-cell proliferation in tissues like the brain, might get his work published in the Annals of Rat Cytology…..

      • If you haven’t been aware of the vaccine autism scares, you would not understand why Shaw’s association with them would discredit him. That non-existent link has been beat to death and is only supported now by people with an ideological axe to grind. Since Shaw obviously supports that link, he is not going to be taken seriously by others.

      • Dan Kegel says:

        @Jane For what it’s worth, the mice in pubmed 19740540′s behavioral experiment received 300 ug/kg, 18 times the aluminum in a course of Gardasil. It also may not have been a double-blind study, which makes it harder to rule out bias.

        I did find a study that compared vaccines with and without aluminum! pubmed 14871632, “Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence”, in Lancet Infect Dis., 2004. It reviewed all the available evidence (three randomised trials, four semi-randomised trials, and one cohort study), and though the data was said to be not very high quality, it found no effect and recommended no further research in that area.

        Pubmed 16044278 did describe 19 cases where patients vaccinated with Pentavac developed severe itching at the injection site that lasted for years, possibly related to the aluminum adjuvant. A VAERS search for injection/vaccination site pruritus related to HPV/HPV4 vaccine where the patient did not recover found only 42 hits, so this doesn’t seem to be common.

        I keep looking for solid evidence of non-rare harm due to aluminum adjuvant, but haven’t found it yet.

    • Jane says:

      @pei curmudgeon: Your assumption appears to be that the benefits always outweigh the risks and that the vaccine maker and the FDA, and an independent-minded pediatrician, will honestly assess these. In the case of Gardasil, even JAMA commented rather acidly about how Merck maximized the risks of the disease and minimized the risks of the vaccine. I tread a middle ground with vaccines. My kids have had most, including polio and meningitis–which are rare but pretty horrible–but not the chicken pox vaccine, which I thought at the time (and my pediatrician agreed) was stupid, and not Gardasil, which I believe may be right for some kids but not for others. The FDA and pediatricians are remarkably quiet about all the factors that put you at risk for persistent HPV infection and wave accusations of parental prudishness as a red herring. Appalling.

      Interestingly, about the same number of kids are at risk of suffering serious adverse effects from chicken pox as they are of suffering osteosarcoma as a result of fluoride ingestion; i.e. very few. Adverse effects of chicken pox warrant a nation-wide mandated vaccine program; osteosarcoma….oooh, let’s not mention that.

      • Dan Kegel says:

        Got a reference for those JAMA articles? I couldn’t find ‘em. All I could find were
        “Marketing and the HPV vaccine”,
        http://jama.ama-assn.org/content/302/7/781.abstract
        and “Postlicensure Safety Surveillance for Quadrivalent Human Papillomavirus Recombinant Vaccine”, http://jama.ama-assn.org/content/302/7/750.abstract
        both of which seemed to say the vaccine was both safe and effective. The safety
        paper did find some additional risk of fainting and blood clots, but no additional risk of anything else.

        You’re quite right that HPV vaccination is not for everyone. For instance, it’s not for people who will never have sex with anyone who has HPV. That category is, however, smaller than you might think, and it’s awfully hard to know if you’re in it.

      • I did look at the Varicella vaccine and the positive impact it has had.

        I cannot comment on the connection between osteosarcome and fluoride as I have done no research into the area. Besides it is irrelevant to the discussion here.

      • Jane says:

        @Dan: Apparently you didn’t read the actual article by the Rothmans, nor the editorial by Charlotte Haug.

        “You’re quite right that HPV vaccination is not for everyone. For instance, it’s not for people who will never have sex with anyone who has HPV. That category is, however, smaller than you might think, and it’s awfully hard to know if you’re in it.”

        Straight out of Merck’s playbook; “silly people….you’re just puritans.” You need to do some more research about exponential risk and why some people are more subject to persistent infections than those of us who ditch HPV infections fast.

      • The evidence continues to come in about how prevalent HPV is and the various problems associated with infections (cervical, penile, anal, and throat cancers). It is often, but not exclusively spread by sexual contact. Those are facts, not just Merck’s ‘playbook’. So far, everything tells us that the risk of HPV is much greater than the risk from the vaccine. Mor eresearch will lead us to safer vaccines, but the ones we have now are all much safer than the alternative.

      • Jane says:

        @PEI: I’m not big on conspiracy theories, I don’t have any grudge against big business and I actually think that medical science has pulled off some real miracles. I bring up fluoride/chicken pox because it is remarkable to me how things can be slanted by money interests. A few kids with osteosarcoma? Osteoporosis increase? Nah, keep the fluoride flowing — we can save 0.5 fillings per person! A few kids seriously hurt by chicken pox? Oh my God. Vaccinate the whole population!

        Both scenarios result in a good cash flow. So no, I don’t think it’s irrelevant to the present discussion. But if you do, just ignore it. Most scientists do. Gotta get that funding somewhere.

      • You have just described two conspiracy theories. If there is a link between osteosarcoma and fluoride, it needs to be investigated on its own. It has nothing to do with vaccines. Those ‘few kids’ seriously hurt by chicken pox is a much higher number than ever were injured by the vaccine. By that argument, we should be vaccinate everyone.

      • Jane says:

        I know. Merck etc. are only thinking of us. You are quite right. We should never question the motivation behind the stuff we happily ingest.

      • Merck is primarily interested in profit and has done some despicable things, there is no question of that. However, the research also comes from independent researchers, the overwhelming number of whom have come done solidly on the side of the vaccines.

      • Jane says:

        “The evidence continues to come in about how prevalent HPV is and the various problems associated with infections (cervical, penile, anal, and throat cancers). It is often, but not exclusively spread by sexual contact. Those are facts, not just Merck’s ‘playbook’. So far, everything tells us that the risk of HPV is much greater than the risk from the vaccine. Mor eresearch will lead us to safer vaccines, but the ones we have now are all much safer than the alternative.”

        I am quite well aware of how HPV is spread. I am also aware of the factors that have made it increasingly an issue. I see, however, that you were not willing to comment on exponential risk or the factors that make people vulnerable to persistent infections. So I guess it boils down to: you vaccinate your kids; I will invite my kids to research HPV and tell me whether, with a family history of autoimmune disease, they want to get the shots or not. In fact, I already did. Life is good.

      • I have said all the way through that for certain people, the risk of vaccine increases and there are certain people who should not get those vaccines. That is what the research has told us. For teh general population, the relative risk is very different. As Dan asked in another comment, what exactly are you referring to as the exponential risk?

      • Dan Kegel says:

        Jane, got a reference for the exponential risk stuff? I can’t find anything obviously related to the current discussion in a quick search.

      • Jane says:

        ….apparently you have not followed the various revelations of skewed study reporting and failure to report conflicts of interest. I have. Interesting reading.

        Regardless, I am sure that the weight of current evidence comes down in favor of vaccines. In some cases I believe that vaccines are very imperfect in ways we don’t yet understand, but overall the best choice we have right now. I don’t believe that about Gardasil. You do. Again, your privilege.

      • I have no problem with further research at all. I am highly in favour of it. I have read a considerable amount on skewed studies. That is why I often rely on major review papers, or the opinions of experts in science based medicine to filter through the bs. I think that I trust them more than I trust myself in many of these issues.

      • Jane says:

        @PEI and Dan: There is tons of stuff out there about the exponential risk of multiple sex partners. Don’t have time to look right now, but I know there were some quite frightening stats–there was a really big study a year or two back. Of course, it is not popular to talk about this, because it makes you look like a moralist, God forbid. Having sex at a very young age, having multiple sex partners, smoking (that one’s HUGE), not eating vegetables etc. all put you at greater risk for persistent infections. Of course, you can have one partner and still get HPV, but if you eat and sleep well and get regular Paps your chances of getting cervical cancer virtually disappear.

        As one who cheerfully had my share of partners, although carefully, in my late teens/early 20s before marrying, I have no moral objection at all to multiple sex partners. But as the mother of several kids and house mother to many more, I believe it’s doing a disservice to kids to assume they’re too controlled by their hormones, and too stupid, to make decent decisions. HPV is far from the worst thing they can encounter sexually and there is so much focus on Gardasil that kids tend to think that if they’ve had it, they are no longer at risk for ANY STD. The conversations I’ve had would make your hair curl.

        However, I need to disengage here. Too much work.

      • Dan Kegel says:

        @jane, you wrote “there is so much focus on Gardasil that kids tend to think that if they’ve had it, they are no longer at risk for ANY STD.”

        Got any evidence to support that statement?
        A recently published study of a survey of 1200 girls,
        http://www.ajpmonline.org/webfiles/images/journals/amepre/AMEPRE_3270-stamped.pdf
        said “Among sexually active adolescents aged 15–19 years, those who received
        HPV vaccine were more likely to always wear a condom… No association was found between HPV vaccination and risky sexual behavior”.

        This discussion would be a lot shorter if everyone would support their statements with good references.

  9. Dan Kegel says:

    The FDA response is worth reading, too:
    “FDA Information on Gardasil – Presence of DNA Fragments Expected, No Safety Risk”
    http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm276859.htm

    • Dan, before you can expect someone to volunteer their private information, you probably have privacy laws prohibiting that. I am wondering what your background is and why you are interested in Lia’s report? Are you a physician?

  10. Dan Kegel says:

    Gardasil uses only the L1 gene; while hypothetically a vaccine against other genes might work against more varieties of HPV, Gardasil doesn’t use them.

    I’m not so much interested in any one person’s details – I’m mostly interested in encouraging people who have adverse effects to file VAERS reports. Without VAERS reports, it’s hard to tell how many people are having problems.

    My background is computer engineering; I also have a batchelor’s degree in biology, and grew up reading Scientific American (my Dad’s), and RN and AJN magazines (my Mom’s). I make my living writing software.

    Me, I trust vaccines which have been shown in clinical trials and aftermarket studies to be safe and effective. The polio, smallpox, and measles vaccines have been tremendously effective, and have saved many lives (see e.g. http://www.nytimes.com/2007/11/30/world/africa/30iht-measles.1.8539895.html for recent progress on measles). I do think it’s important to continue monitoring vaccine safety to guard against both quality problems (Murphy’s Law) and adverse effects that happen too seldom to detect in clinical trials. (As a famous person once said, “Trust — but verify.”) Hence my interest in encouraging everyone who has had problems to make sure their doctor files a VAERS report.

  11. lia costa says:

    Is mad ………… no words

    and they still say its a lie

    Monday, August 8, 2011, Chandigarh, India

    NEWS AND VIEWS
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    NATION
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    SPECIAL COVERAGE
    CHANDIGARH
    LUDHIANA

    DELHI

    THE TRIBUNE SPECIALS
    50 YEARS OF INDEPENDENCE

    TERCENTENARY CELEBRATIONS

    M A I N N E W S
    Indians sitting ducks as drug trials turn fatal
    In last 4 yrs, 1,725 persons have died in clinical trials; weak law compounds risks
    Aditi Tandon/TNS
    Tribune News Service

    New Delhi, August 7
    For the first time since 2010 when six tribal girls from Gujarat and Andhra Pradesh involved in the clinical trials of anti-cervical cancer HPV vaccine died, the government has admitted that 1,725 persons have lost their lives to drug trials in the last four years.
    The number of deaths has risen from 132 in 2007 and 288 in 2008 to 637 in 2009 and 668 last year, indicating the complete ineffectiveness of regulatory controls over the $400 million sector. Last year, the government gave compensation in just 22 cases out of the 668 that resulted in deaths due to “serious adverse events” during drug trials, Health Minister Ghulam Nabi Azad told Parliament this week.
    Currently, 1,868 clinical trials are going on as per the Clinical Trial Registry of India maintained by the office of the Drug Controller General of India (DCGI). Many of the drugs being tested are not even of specific relevance to the country and could have been tested anywhere. Equally shocking is the fact that the rules, under the Drugs and Cosmetics Act, entirely trust the trial investigator with the reason attributed for the death of a subject. This is resulting in gross under-reporting of actual deaths during clinical trials.
    Dr Chandra Gulhati, a leading medical practitioner, who led several clinical trials in the UK, says the number of deaths would be much more than we will ever know. “We have no system of independent auditors to investigate the cause of death of subjects involved in clinical trials. Whatever the investigator says is believed even if he attributes the death to a prior disease. Such investigators are always hired by the firm conducting the trial. How can we expect them to be objective all the time?”, he asks.
    Under the rules, a company interested in trial is supposed to approach the Drug Controller with a protocol to get approvals. But there has been evidence of weak monitoring of requests. “I just investigated a case where 800 pages of protocol were submitted to the DCGI for approval. The permission was granted in four days whereas even a clinician like me would require at least a month to understand the whole project. Clearly, people in the DCGI office are not vetting the requests properly,” said Gulhati, who is now investigating the cause of 81 deaths due to recent clinical trials in Indore.
    The rules further mandate the company conducting the trial to get consent forms signed from subjects. The idea is to have safeguards but it’s not working. In the HPV vaccine trial which was suspended after 6 deaths last year, the government inquiry concluded that consent forms had actually been signed by wardens of hostels where the girls resided and not by the girls themselves. In both Gujarat and Andhra, over 22 pc of the vaccinated girls were tribals even though our law bar trials on tribals unless the drug being tested is of specific benefit to them.
    Dr Amit Sengupta, who helped expose loopholes in the HPV trial conducted by the US NGO PATH, says India must drastically reduce the number of trials happening here. “Why should we allow trials of drugs for medical conditions that prevail elsewhere in the world? Trials for diarrhoea, malaria etc are understandable, but why should foreign firms come to us to test anti-cancer drugs? Cancer is prevalent in their countries also. Let them test there,” he says. The reason is: since the cost of testing in India is 80 per cent less than in the developed world, firms come here. Experts, meanwhile, also want the DCGI to frame rules to specify that trials will be allowed only in cases where the firm in question undertakes to make the drug available to Indians at affordable prices.
    Promoters of the HPV vaccine trial for instance wanted the vaccine included under India’s Universal Immunisation Programme even though it costs Rs 9000 per eligible girl (age 9 to 15 years). Vaccines for trial came free of cost from pharma giants GSK and MSD. Considering 1.25 crore girls enter the age group 9 to 15 years annually, the promoters could have made Rs 11, 250 crore per year had the government accepted public distribution of the HPV

  12. Dan Kegel says:

    Lia,
    (linking is probably better than pasting in the whole page.)
    The best source I’ve found for the result of the expert panel that looked into the HPV trial trouble you’re referring to is http://www.nature.com/news/2011/110622/full/474427a.html (including comments).
    The vaccine was already approved in India, and even according to Sama (a Womens’ Health group pressing for more investigation of the incident), in all likelihood not the cause of the deaths; the trials themselves had ethical problems that didn’t have anything to do with the vaccine per se.

    (The trial itself is described at http://www.path.org/news/an100422-hpv-india.php )

  13. david says:

    the Canadian government stopped testing food from Japan for radition because ther eis no money in it. here, eat this irradiated food which 100% you will die from but we will vaccinate you to protect you from something,less risky

    • This is pretty much a completely nonsensical statement. Do you any references to your statement that food with a 100% level of toxicity is coming in from japan? In every instance of a developed vaccine, the risks from contracting the original disease greatly outweigh the risks from the vaccine itself.

  14. Pingback: Catholic leaders promote death | PEI Curmudgeon's Blog

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