James Lyons-Weiler and the HPV ad controversy

Have you heard of the appeal to authority logical fallacy? It refers to an appeal from a someone based on his or her presumed expertise merely by being a self-described authority.  Authority or not, all contentions should be proven, particularly when one is not actually an authority in a given topic.

Such is the case of James Lyons-Weiler, PhD  when it comes HPV vaccines. Who is Dr Lyons-Weiler? That is a difficult question to answer because he has moved through a variety of areas of study. Looking at his Linkedin account, he has a Master’s in zoology, with a focus on paeloecology, a PhD in ecology and biology, where he studied wild flowers and computational statistics, and he did postdoctoral work in computational molecular biology related to evolutionary genetics. Since then, he has worked on a variety of data analysis and modelling projects, including lung cancer gene expression and protein evolution.  He has been on the faculty at three different universities, most recently the University of Pittsburgh, where he directed the Bioinformatics Analysis Core.  In the past few years, he has written several books. One is about ebola, another about autism, and the third about how he believes medicine is more motivated by profit than cures. Most recently, he founded something called The Institute for pure and applied knowledge and he has begun to be a voice in the antivaccine movement. He even has Mary Holland, famous antivax advocate and attorney, on his advisory board. He has several current projects, including the CDC Accountability Project and the FTC petition re: HPV tv ad.

The appeal to authority I am concerned with is his issue with the HPV ad, which centers around a television ad for Merck’s HPV vaccine. The ad was created by BBDO Worldwide and can be watched here, on ispot dot tv. The gist of the commercial is a man and a woman discussing that they have cancer caused by the human papillomavirus (HPV) and wouldn’t it have been nice if they could have done something as teens to prevent that virus. The point made is that the HPV vaccine can prevent HPV which then can protect the person from getting cancers associated with the virus. The viewer is directed to www.hpv.com for more information.

 

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As part of the Vaxxed film tour, producer Del Bigtree has been posting periscope videos (made with handheld smart phones) with people all over the country. He recently sat down with James Lyons-Weiler to discuss the FTC petition and the ad. You can watch their conversation here (thank you to Karen Halabura for helping me get the video off Facebook). Dr Lyons-Weiler tells Bigtree that the ad is emotionally manipulative and makes claims not supported by science. You can view the petition and transcript of the tv ad here. Lyons-Weiler thinks the ad is false advertising and the Federal Trade Commission should remove it because of seven errors he feels Merck makes in the ad, all of which point to false advertising. The video, as of writing of this blog, has 22,000 views and nearly 800 shares.  I feel it is worthwhile pointing out the mistakes Lyons-Weiler makes in this contentions because his assertions are influential enough that they are now showing up in online discussions about HPV vaccines.

Italicized points are from Lyons-Weiler while bold are from me.

(a) the knowledge that HPV vaccination does not protect against all HPV types, which could lead vaccinated consumers to act as though they are in fact protected from HPV infection in general, when, in reality, they are not;  As per the provider information for Gardasil 9, the most recently available HPV vaccine in USA, it protects against HPV types 6, 11, 16, 18, 31, 33, 45, 52, and, 58. These represent 81% of the viruses that cause cervical cancer, 74% of the other HPV-associated cancers, and 90% of the HPV types which cause anogenital warts. The ad clearly uses the word ‘could’ when they postulate that the person ‘could’ have protected from HPV back at age 11 or 12. Therefore, no false advertising.

(b) the knowledge that has resulted from numerous studies that indicate that HPV vaccination using any of the available HPV vaccines only provides partial protection against 2, 4 or 9 types of HPV, when in reality there are at least 100 HPV viral types that can replace those that the vaccination removes from an individual or from the population; Gardasil 9 offers protection from most of the HPV types that cause cancer.  Therefore, no false advertising.

(c) the knowledge that women should continue to get Pap smears after HPV vaccination to screen for infection (as expected given type replacement); The Merck ad is aimed at both men and women, boys and girls, and states that everyone should talk to their doctor. The implication is the doctor will tell the patient the benefit of yearly exams, both for men and women. The ad does not imply nor state that the vaccine should replace yearly wellness exams. Therefore, no false advertising.

(d) the knowledge that HPV vaccine has been found to fail to lead to a decrease in overall HPV infection rates, according to study by the US Centers for Disease Control and Prevention (Markowitz et al., 2016); Strangely, Lyons-Weiler’s own source proves him wrong. Markowitz, et al, concluded that, 6 years after vaccine introduction, there was a 64% decrease in 4xHPV type prevalence in females aged 14 to 19. Therefore, no false advertising.

(e) the knowledge of side effects of HPV vaccination, including death, paralysis, premature ovarian failure, seizures and blindness; There have been many large studies of HPV vaccine safety, in various countries, and none have found any significant relationship between the vaccine and serious adverse events. As the ad clearly states to get more information from your doctor, and you get a vaccine information sheet with reach vaccine which clearly outlines risks and benefits, then again, There is no false advertising.

(f) the knowledge of alternatives to the vaccines for protection against HPV; Del and Lyons-Weiler spend a great deal of time talking about safe sex in the interview. Lyons-Weiler stays that HPV is a lifestyle disease and practicing unsafe sex is what needs to change. Since 95% of women clear the virus in the first two years, and there is a drug, according to him, in clinical trials that will completely cure the virus, there is no need to vaccinate. He does not seem to notice his statements are contradictory. He wants women to abstain from sex but then he also wants women not to worry about the virus because there is a cure for it coming soon. Del claims that pap smears stop HPV in it’s tracks, which is completely untrue. A pap smear can only (hopefully) detect if you have cancer or not. It is not a cure nor a treatment for cancer. They both routinely fail to tell their audience how this virus also affects men and they fail to inform that nearly all sexually active people will, at some point in their life, usually in early adulthood, acquire HPV infection. Yes, HPV is passed as a sexually transmitted infection but you can pass it via oral, anal, or vaginal sex or even just contact with sexual fluids (what my mother’s generation called heavy petting). Condoms do not prevent HPV as it can infect areas a condom does not cover. The only way to guarantee you will never get HPV is to never engage in any sexual activity with anyone other than the one partner you will have and keep for your entire life, assuming they also have only had one partner their entire life. As this is not a reasonable goal for most people, and sex is a natural, biological function, this vaccine is an important part of having a HEALTHY life. Vaccination is one key part of staying healthy. The only alternative to vaccination is abstinence and that is not a valid choice for all. Furthermore, human papillomaviruses can also cause oral and anal cancers, none of which are detectable by pap smears.  Therefore,  no false advertising.

(g) the knowledge that indiscriminate use of HPV vaccination in a population not screened for HPV infection may increase (double) the risk of HPV-associated cancer. Lyons-Weiler does not qualify this statement with any details so one must conclude this allegation is false. In the film interview with Bigtree, Lyons-Weiler states he believes that getting the HPV vaccine while already infected may be a problem but he, again, does not qualify this statement with any supporting evidence. Therefore, no false advertising.

The conversation between Del Bigtree and James Lyons-Weiler, regarding HPV vaccine, is rife with dangerous myths about both human papillomaviruses and the HPV vaccine. In just the few days since it first aired, I have noticed comments online being made that bear striking resemblance to those of Lyons-Weiler. He has influenced people. This vaccine already has so many dangerous myths associated with it that it is a shame to now have more. As a person who lost a lovely cousin to cervical cancer, a cousin who did have yearly pap smears, I know that Bigtree and Lyons-Weiler are doing is going to cost lives that could have been prevented. My own children are or will be protected with this vaccine. Like tens of millions world-wide, they have had no serious side effects to any vaccine, ever, in their lives.

Why is Lyons-Weiler engaged in this battle against HPV vaccine? On his website, he discusses a great many different projects, including several related to vaccines. It is troubling to me that he is spreading myths and lies about vaccines while, at the same time, asking for donations for his multiple projects. Usually, scientists with his level of education work for a research institute or university and they write grants to fund their projects. I have no real idea why Lyons-Weiler is no longer involved in the standard type of research, but I find it deeply troubling that he is stirring up vaccine waters.

As always, be sure to think for yourself!

 

 

Kathy

 

My sources for information and facts on HPV vaccine and cancers related to HPV.

 

  1. Gardasil 9 – provider information sheet
  2. Pink Book chapter on Human Papillomavirus
  3. Gardasil Myths debunked at Skeptical Raptor blog
  4. Prevalence of HPV After Introduction of the Vaccination
  5. CDC page on human papillomavirus information
  6. Ways to prevent HPV infection

 

 

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129 thoughts on “James Lyons-Weiler and the HPV ad controversy

  1. Thank you for the notice of your blog article. I look forward to filling the in blanks. First, I point you to the Merck data provided to the FDA (Vaccines and Related Biological Products Advisory Committee (VRBPAC)) in 2006 showing increased risk of CIN or cancer if the HPV vaccine is given to individuals who are already infected. Here is the link (hard to provide links in the interview w/Del):

    http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

    You will find the increase in CIN for cases of prior exposure on the bottom of page 13. Merck told the FDA that women are at a 44.6% increased risk for precancerous lesions or full blown cervical cancer after vaccination if they already have or had HPV infection prior to being vaccinated.

    These data are from Merck’s own Gardasil safety trials. Unfortunately, the FDA did not require HPV screening prior to vaccination with Gardasil, and no warning on the package insert exists.

    The ad does not provide this important information to consumers, and therefore it is, in my opinion, and the opinion of many others, very misleading to science-naive consumers. Under US truth in advertising laws, manufacturers of products cannot make a claim that a product “could” do something if it also “could” have the opposite effect without being forthright about the negative effect.

    Consumers don’t know the details of the science and have to rely on the manufacturers and their doctors being forthright on risks to enjoy their right to informed consent.

    I will provide more information soon about why the ad is misleading on efficacy, and how you are reading the CDC study wrong re: “could have” prevented HPV infection. I will point the specific studies that the ad ignores (what is referred to in the petition as “the totality of the evidence in the scientific literature”).

    Liked by 1 person

    • That points to the importance of giving the vaccine to boys and girls before they become sexually active, a point underscored in the ad by mentioning the age of 11 or 12 as ideal. Also, you are referring to one trial, which is cherry picking. Cherry picking does not a valid medical claim make.

      The ad points you to the hpv.com website and your doctor for more information. The ad was not meant to convey all the science to consumers.

      The ad is not lying by telling people to go to the website or their own doctor for the full facts.

      Maybe you can also comment why you read the one study incorrectly? Markowitz, et al.

      Like

      • Actually I am considering the totality of the science. Their failure to disclose the failure of the product by not reporting Markowitz’s finding of no net change in overall infection rates before and after the vaccine came to market leads to the unwarranted claim that the vaccine could have prevented HPV infection.

        For other studies that also show that the vaccine leads to type replacement, leaving vaccinated individuals at continued risk of HPV infection, see https://jameslyonsweiler.com/2016/06/29/high-risk-hpv-type-replacement-follows-hpv-vaccination/

        Liked by 1 person

      • I find it interesting that you do not find a 44% increase in the risk of CIN or cancer due to vaccination of women infected with HPV to be a health concern. There are at least five studies that demonstrate type replacement after HPV infection, two of which that conclude that the rarer types are dangerous, and likely more dangerous, than the common types (Guo et al., University of Texas study and Fisher et al., the study from Germany). Five studies is hardly cherry-picking. And the specific results you pulled that showed efficacy of HPV-4 from Markowitz et al. are nice, but I’ve never questioned whether the vaccine-targeted types are cleared. All studies show that Gardisil is fairly effective at clearing the targeted types, that is not debated. The problem is that the vaccine cannot be said to potential prevent “HPV infection”. The relevant result is the 58.1vs. 54.4 aPR 1.00, and the 56.7 vs. Prevaccine Era (1.01) results that apply to claims that the HPV vaccine could have prevented “HPV infection”. It can be said to prevent infection by some types of HPV, but prevention of 2, 4 or 9 “HPV types” is not protection from “HPV infection”. Consumers that do not know the science are easily misled by such generalization – and the claim is nowhere supported by any study. The claim that HPV vaccine could have prevented a patient’s cancer is also not supported by any study. CIN lesions, yes. Cancer, no. There has not been enough time for that endpoint to be demonstrated. The misleading effects of the advertisement are seen in comments by doctors, who say wild things like “this vaccine could eradicate HPV” and in the behavior of some of the vaccinated, who assume they are protected from “HPV infection” when clearly they are not, leading to the type replacement conclusions of Guo et al.:

        ““The prevalence of high-risk nonvaccine types was higher among vaccinated women than unvaccinated women (52.1% vs 40.4%, prevalence ratio 1.29, 95% CI 1.06–1.57), but this difference was attenuated after adjusting for sexual behavior variables (adjusted prevalence ratio 1.19, 95% CI 0.99–1.43). HPV vaccination was effective against all 4 vaccine types in young women vaccinated after age 12. However, vaccinated women had a higher prevalence of high-risk nonvaccine types, suggesting that they may benefit from newer vaccines covering additional types.”

        and Fisher et al. (2016), who found that high-risk HPV types replacing the vaccine-targeted types. They wrote “the percentage of non-vaccine HR-HPV types was higher than expected, considering that eight HPV types formerly classified as ‘low-risk’ or ‘probably high-risk’ are in fact HR-HPV types.”

        Fischer et al 2016: Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccination. Oncol Lett. 12(1):601-610.

        Regarding the rest of the post, I’m happy to let my contribution to the bodies of knowledge that I’ve made speak from themselves. I’m proud of the wide diversity of biomedical research studies that I’ve been lucky enough to be a part of. I directed the data analysis for many of the studies I’ve been on, and they have afforded me the opportunity to apply my knowledge of biostatistics, high-dimensional data analysis, study design principles, genetic, genomics, proteomics and bioinformatics in many areas of biomedical research: http://bit.ly/29UhHNc

        You may be interested to know that “Cures vs. Profits” has a subtitle “Successes in Translational Research” because I set out to find the most brilliant examples of successes in biomedical research that have occurred in spite of the tension between the drive for Profits and the need for Cures. And no, I’m not convinced that medical researchers and corporations always put profits before cures. Some do, some don’t.

        I can arrange for you to receive a review copy if you would like to have a closer look at the book

        Finally, much to the chagrin of many true-blue antivaccination people, I am 100% pro immunization safety. Both of my sons are vaccinated – but not for HPV. I do not wish to contribute to the rise of rarer, more dangerous types of HPV. That’s because I understand evolutionary principles, population genetics, selective sweeps, and the current HPV vaccines are hard selection against the common types. The rare types are rare for a reason. The use of the vaccine is an uncontrolled experiment that could lead to increased rates of all types of cancer. So every argument for HPV vaccination to reduce cancer rates is a valid argument against incomplete immunization.

        BTW, you may be interested in the journal I created as Founding Editor-in-Chief: Cancer Informatics. It’s a legacy to my mom, who died from breast cancer in the early 1970’s. http://www.la-press.com/journal-cancer-informatics-j10

        Thanks for the invitation and the opportunity to clarify.

        Liked by 2 people

      • it’s not quite fair to say the commentator did not find an increase concerning. What was pointed out was that there is no real evidence of an increase: it was observed in a small sub group, explained clearly, and not found in large scale studies. I’d say the insistence of repeatedly using that sub-result in contradiction of the data is what is concerning.

        Liked by 1 person

      • There was no such finding in larger studies. Showing the increase to have been a spurious sub result because of the problematic nature of the sub-group.

        The explanation was not one of power but one of confounders. There were other factors at play.

        Liked by 1 person

      • They suggested an explanation. Which is the usual way scientists deal with results that appear to be spurious, if you look at studies. And the larger studies confirmed that this was spurious.

        As was repeatedly said, continuing to latch onto a small, spurious sub result is disingenuous. A scientist should know better.

        Liked by 1 person

    • On page 14 of the document you provided it said this.

      “This demonstrated a limitation of the evaluation of small subgroups, where subgroups might have imbalances in baseline demographic characteristics. In this case, it appeared that subjects in this subgroup of study 013 who received GardasilTM might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients. In study 015, the applicant conducted a subgroup primary efficacy analyses for HPV 16/18. Here, the evaluation of this subgroup did not raise a concern about enhancement of cervical disease due to HPV:”

      I think it’s disingenuous to neglect that further analysis did not raise a concern about enhancement of cervical disease due to HPV, especially when stating it does causes unnecessary fears of the vaccine and parents will fail to protect their children from cancers caused by HPV.

      Liked by 2 people

      • It’s not disingenuous, I simply accept the data as consistent with other data in the field. A positive finding of an increase should be of concern – and certainly worthy of at least required pap smears before vaccinating! If I had a daughter who wanted to be vaccinated who had already been sexually active, I would certainly have her tested for HPV infection prior to vaccination. Further, vertical transmission (from infected mothers to babies) is more common than is realized. I shudder to think what proposed studies on babies will bring if these safety data do, in fact, point to increased risk. FDA turned a blind eye to an important finding. I’m faulting them for finding it insufficient grounds for concern. We should not rely on post-marketing surveillance to find out if they were right. They should have demanded more studies on these issues.

        Liked by 1 person

      • Exactly. Contrary to the claim below, the speaker’s claim is not consistent with other data with the field. You are completely correct: presenting a small sub result as the actual finding, ignoring caveats and nuances, is incorrect. From a lay person, it would be an error. From someone with a science background it’s disingenuous. Even if it’s the result of deep bias rather than intentional misrepresentation, a professional should know better.

        Liked by 1 person

      • More data is exactly what larger scale trials provided. It did not support the result. Since it has been disproven, repeating it is disingenuous, as was pointed out.

        Liked by 1 person

      • You’re operating from the premise that no further analysis was performed when on the very next page it disputed your claim. You also haven’t provided the literature that’s consistent with your evaluation and expect me to take your word for it? No, that’s not how it works and I’m certain you know better. You’ve made the claim, the burden of proof is on you.

        A Pap smear is not recommended before vaccinating as its given to children before they engage in sexual activity however by age 21, routine Pap smears are recommended. Your use of emotive language and the slippery slope fallacy based on conjecture and “feels” is inconsistent with objectivity and scientific methodology. Interesting.

        Liked by 1 person

      • “A Pap smear is not recommended before vaccinating as its given to children before they engage in sexual activity however by age 21, routine Pap smears are recommended. ”

        Just because the CDC recommends that it be given to 11- and 12- year olds does not mean that it is given to 11- and 12- year olds. Uptake of this vaccine is very low (around 60% girls, 40% boys), and for good reason. The policy does not match the culture in which 11- and 12- year olds are not seen as their parents to need to be protected against infection.

        You can’t do a pap smear on and 11 or 12 year old as pelvic exams are not allowed. Great. So we’ll just pretend that there are no 11 and 12 -year olds who are already infected, and ignore the potential consequences of vaccinating infected individuals, and then we’ll pretend that their adverse events had nothing to do with the vaccine.

        Like

      • They cleared all HPV-positive patients of HPV via surgery in the intention-to-treat group in the larger study, and therefore the additional risk that could have manifested was minimized. While it is certainly a great thing that the lesions found were cleared, the larger study is completely irrelevant for a population whose HPV status is unknown prior to vaccination.

        I hope you can now see that I am not disingenuous, but rather informed and knowledgeable of the limits of knowledge claims that are possible from a given study.

        Liked by 1 person

      • No. Insisting on sticking to s spurious sub result that was explained in the face of much more robust conflicting data does not make you informed. And is disingenuous.

        Like

    • From a 2011 systematic review and meta-analysis of the efficacy and safety of the HPV vaccine.

      “In conclusion, our review demonstrated that VLP-based prophylactic HPV vaccines are highly efficacious in pre- venting persistent infection and cervical diseases asso- ciated with vaccine HPV types among young female adults. The vaccines were safe and generally well toler- ated. Vaccination of adolescent girls prior to sexual debut appeared to be the most effective public health measure for prevention of cervical diseases and cancer. Questions related to long-term efficacy and safety have yet to be addressed.”

      Liked by 2 people

    • Actually, that’s incorrect. This claim – that those infected are more prone to to having precancerous lesions – is based on only one of the small subgroups of
      women involved in the trial, as addressed in detail here: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

      In this group the women were PCR positive and seropositive
      for relevant HPV types at day 1 (6/11/16/18). That means they were still
      infected (PCR positive).

      As explained in the document: “This demonstrated a limitation of the evaluation of small subgroups, where subgroups might have imbalances in baseline demographic characteristics. In this case, it appeared that subjects in this subgroup of study 013 who received Gardasil might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients.”

      In other word, this specific small group was biased in ways that increased the chances of development of pre cancerous lesions independent of the vaccine: it wasn’t the vaccine. It was their other factors. Other small groups did not show the same findings – for example, see Table 20 which had more than twice the enrollment of study 013. “Here, the evaluation of this subgroup did not raise a concern about enhancement of cervical disease due to HPV” (in fact the placebo group had a 5% higher rate in CIN2/3).

      In the larger study of over 17,000 women enrolled, no such concern was seen: Munoz et al (2010) http://www.ncbi.nlm.nih.gov/pubmed/20139221

      There, there is no exacerbation of disease in infected individuals, in fact ALL the placebos had higher rates.

      So what we have is one badly composed small group, made of women already at risk of lesions, that had those. This result was countered in
      the large trial. The balance of the evidence does not support the claim that
      being infected with HPV before the vaccine is a risk factor – in fact, it goes
      the other way. That’s why it is not mentioned in the Pink Book: “Ideally,
      vaccine should be administered before potential exposure to HPV through sexual contact; however, persons who may have already been exposed to HPV should be vaccinated.” http://www.cdc.gov/vaccines/pubs/pinkbook/hpv.html

      So this claim is badly based, and as presented, misleading, as are the other claims in the video.

      Liked by 1 person

      • No, I’m sorry you find this hard to understand. I am saying that the trial explained the result: it was because of confounding factors, a spurious sub result. It was not ignored.

        Later and larger studies examined the question. And supported the fact that the result was spurious.

        In other words, you are repeating a result that never held weight, and that has since been disproving. You are in the wrong when you repeat it as valid. I hope that’s clearer.

        Liked by 1 person

      • It is not I that do not understand, it is you. Here is the text – they did not determine, as you claim, that the result WAS due to confounding variable- they SPECULATED that is might have been due to difference at baseline. BIG difference: ” In this case, it appeared that subjects in this subgroup of study 013 who received Gardasil™ ****might have had enhanced risk factors**** for development of CIN 2/3 or worse compared to placebo recipients. ”

        Sloppy, not something to base vaccination of millions of infected people upon.

        Like

      • Suggesting an explanation of why a result is spurious is what serious scientists do in this situation. Other data confirmed that this result was, in fact, spurious. Other data that your statements ignore. Inappropriately.

        So again, we have a small sub-result, explained as most likely spurious, an explanation confirmed by larger trials which found no such association. As was pointed out, latching onto the small sub result and presenting it as fact, as the end all, is disingenuous.

        Liked by 1 person

      • “We examined the concurrence of multiple human papillomavirus (HPV) infections in 47,617 women who underwent cervical screening in New Mexico between December 2007 and April 2009 using the LINEAR ARRAY HPV Genotyping Test (Roche Diagnostics, Indianapolis, Indiana), which detects 37 different types of HPV. Our primary goal was to examine the distributions of multiple HPV types with a special interest in negative interactions, which could signal the possibility of type replacement associated with a common niche if some HPV types were prevented by vaccination. Multiple infections were found to be more common than expected under independence, but this could largely be accounted for by a woman-specific latent heterogeneity parameter which was found to be dependent on age and cytological grade. While multiple infections were more common in young women and in those with abnormal cytology, greater heterogeneity was seen in older women and in those with normal cytology, possibly reflecting greater variability in exposure due to current or past HPV exposure or due to heterogeneity in related HPV reactivation or in immune responses to HPV infection or persistence. A negative interaction was found between HPV 16 and several other HPV types for women with abnormal cytology but not for those with normal cytology, suggesting that type replacement in women vaccinated against HPV 16 is unlikely to be an issue for the general population.”

        http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4239798/

        Liked by 2 people

      • Interesting that’s all you have to say about a large cohort study that refutes your claims. Type replacement is not at all definitive at this time as you claim.

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      • I restrict my comments to those that are relevant to the topic at hand. For example, I don’t shift the discussion to efficacy whilst discussing safety. That is all I had to say because it refutes your claim that the study somehow refutes the original data from Merck to the FDA that indicated higher risk of cervical lesions and cancer in those already infected after vaccination.

        If you want to say that there may be cohort effect, because those patients were further along in their infection, and that the HPV vaccine was not efficacious in those already infected, fine. That matches the low efficacy for infecteds found by everyone else and it is widely accepted HPV vaccine is not curative. But that’s EFFICACY.

        On safety, the concerns remain.

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      • I don’t comment on blogs much and the cohort study results I posted would have been better off in a separate thread but it doesn’t change the results of study that shows your claims of type replacement are not in fact, definitive at all.

        I believe I posted 4 other studies down thread that further show type replacement is not definitive and not being seen at the population level but will continue to be monitored.

        Making extraordinary claims not supported by extraordinary evidence shows a lack of scientific rigor and calls into question your credibility as a scientist. That you would influence gullible parents to not vaccinate their children on such flimsy grounds and assign unnecessary risks on their health is unconscionable.

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    • People who are pro-immunization safety value accuracy. They include, for example, serious researchers doing serious science actually examining HPV issues – and so far, there really isn’t any good evidence, for example, of type replacement.

      The Fischer study, for example, suggested a “maybe”. There may be a shift. At some point. It alerted us to the chance of continued monitoring. It also emphasized the importance of protecting against the types covered by the vaccine, high risk types that are the most common.

      In other words, parents choosing to deny their children protection from the current, most common types are doing that, and that alone so far. They are not protecting their children from the more common cancer causing types. Doing that out of a hypothetical concern about the more rare types is a little strange.

      Liked by 1 person

    • When I have time I will need to look at these articles on their entirety, as a clinical researcher just having a few sentences does nothing. As a provider I don’t see a correlation with what you are claiming and what I am seeing. I can say that after watching the video of you and Del I was saddened by that misinformation regarding cervical cytology screening that was presented as it was erroneous. Since you have no clinical background in women’s health I am confused as to why you were even used as a type of expert on this subject.

      Liked by 2 people

    • Moller et al (2014) discusses the replacement of low risk HPV types in vaccinates subjects. Am I missing something here?
      Also this is a direct quite from the conclusion, why did you not mention this?:

      “Our findings are compatible with the working hypothesis that HPV transmission
      dynamics from 1 type are largely independent of other types, supporting the view that, at present, there is no reason to suspect detrimental consequences of vaccination against a limited
      set of HPV types.”

      Can you explain why those of us that are actually Women’s Health Providers are seeing a DECREASE in cervical cancer precursors in vaccinated women? Can you tell me what work you have done in women’s health that makes you feel you can speak up and discourage a vaccination that is backed by ACOG and the ASCCP?

      Can you PLEASE tell me what I can do to get Del Bigtree to STOP acting like he is an expert in medicine and leave medicine to the experts.

      I am seeing where you taking bits and pieces of a study that you either don’t understand or that you just want to get on the Wakefield/Bigtree bandwagon and spew nonsense. Please for the sake of women’s health stick to whatever your field is which is NOT this. I beg you.

      Liked by 2 people

    • So you are saying they should do like you and latch onto the one small study that shows a correlation and ignore all others that don’t? In the very link you gave it says that the other studies considered in that document didn’t show the same correlation. And I quote from your link:

      “Therefore, while the subgroup from study 013 remains a concern of the clinical review team, there is some evidence that this represented an unbalanced subgroup where GardasilTM recipients at baseline had more risk factors for development of CIN 2/3 or worse. Furthermore, when the subgroups from three studies are combined, these groups appear to be more similar. Finally, there is compelling evidence that the vaccine lacks therapeutic efficacy among women who have had prior exposure to HPV and have not cleared previous infection (PCR positive and seropositive), which represented approximately 6% of the overall study populations.”.

      Did you notice the size of the subgroup in study 013? What are the results of the research done since the publication of that document 10 years ago?

      And all of it is irrelevant to the point that “talk to your doctor” covers it.

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    • Even if your assertion is correct (which I don’t believe) that this finding is significant and should be listed as a warning, what you are doing is far beyond the pale. Aligning yourself with someone who holds out all vaccines as an anti-God abomination of the devil full of deadly poisons and part of an evil conspiracy doesn’t make me or anyone with any scientific sense view you with any legitimacy.

      All you’ve done is add to the anti-vaccine, a it-science industry that is killing people all over the world.

      Like

    • You are right, James Lyons-Weiker. I am sorry this guy feels the need to tear you apart and this piece is weak and full of mistruths. I am disgusted by the same old rhetoric that vaccines are safe and effective. Thank you for speaking out!

      So, naysayers, please hear me out. BBC did a similar story and this news story is also a blatant lie. I do want to trust the BBC. See my comments below.

      http://www.bbc.com/news/world-australia-37211349

      First, it doesn’t appear that cervical cancer rates have reduced by half since 2006 (when vaccine introduced in US) or 2007 (when campaign began in Australia). Here’s Australia’s data:

      US vaccine introduced in 2006. Here’s US data:

      http://seer.cancer.gov/statfacts/html/cervix.html

      According to this source, “But over the last 40 years, the cervical cancer death rate has gone down by more than 50%. The main reason for this change was the increased use of the Pap test.”

      http://www.cancer.org/cancer/cervicalcancer/detailedguide/cervical-cancer-key-statistics

      Supposing that cervical cancer did halve since the introduction of the vaccine, how could the vaccine take credit? Young girls are recommended for the shots (age 9-13), yet the median age of cervical cancer is 49. It would take decades of this vaccine for any reduction in mortality to occur. Keep in mind that the vaccine needs a booster every 5-10 years. Hmm… and now they want to give this vaccine to newborns.

      Australian vaccination campaign started in 2007. Australian data:

      Like

      • No one is giving HPV vax to newborns except one clinical study and that is for a respiratory infection that does not affect all babies. The vaccine is being tested as a treatment. It would not be for all babies.

        Pap smears do not prevent HPV. They just try to catch it.

        Like

  2. From a 2015 overview of the quadrivalent HPV vaccine.

    “summary, the data presented here, reflecting experiences with the HPV4 vaccine in hundreds of thousands of recipients, and the reviews by global health experts and organizations, reinforce the favorable safety profile of the vaccine. The HPV4 vaccine has also been shown to be highly effective at the population level, with marked reductions in the prevalence of HPV vaccine-type-related infection and disease.66–84 The extensive information presented here can be used by healthcare providers to help address questions regarding the safety of the HPV4 vaccine and improve vaccination rates so that patients may benefit from the protection afforded by the vaccine.”

    http://mobile.journals.lww.com/pidj/_layouts/15/oaks.journals.mobile/articleviewer.aspx?year=2015&issue=09000&article=00017

    Liked by 2 people

    • Yes, the HPV vaccines clear the vaccine-targeted types. However, the safety concerns are becoming increasingly apparent. There are also concerns over the integrity and usefulness of the safety studies themselves. HPV-4 was studied vs. aluminum placebo, not saline, and HPV-9 was compared to HPV-4. The public now bears the burden of being the population upon which the safety profiles are being learned. The vaccines have never been tested on males, nor directly on 11- and 12-year olds. The FDA may be lax on the science, but the FTC requires accuracy in advertising. It will be interesting to see what they say about Merck’s false claims.

      Like

      • The review cited above directly addressed the safety concerns. Studies in over a million showed no serious safety problems. The clinical trials included 11-12 years old, so the claim above is also untrue.

        Accuracy in advertising is important. But the claims about this ad range from badly supported to outright untrue.

        Liked by 1 person

      • It must get tiring moving those goalposts around and from the two systematic reviews and meta-analyses I’ve already posted your claims of safety concerns fall flat. Evidence, not claims from someone arguing from authority who seems less than objective, engages in logical fallacies and shows grave bias carries zero weight.

        Also, your evidence the advertisement was somehow untruthful doesn’t support your claims

        Liked by 1 person

    • I’ve already agreed that the vaccines clear those that they target, not an issue. But efficacy of the targeted types does not reassure at all when it comes to unqualified claims of efficacy that disregard type replacement. Which is, according to Guo et al. rapid.

      Like

      • “The number of studies that show that partial immunization via available HPV (human papillomavirus) vaccines is not only insufficient at reducing overall HPV infection rates; the vaccines actually cause rarer, more lethal types of HPV to sweep in and the net effect could be devastating increases in HPV-related cancers.

        Here I review the biomedical research studies that show that type replacement is real, and that vaccination against the more common types may be, sadly and ironically, expected to cause INCREASES in HPV-related cancer.

        The first study is CDC’s own study, in which they show no net change in HPV infection rate (considering all types) after HPV vaccines were introduced medical practice:

        MARKOVITZ (1)

        Markowitz LE et al., 2016 Prevalence of HPV After Introduction of the Vaccination Program in the United States. Pediatrics. 2016 Feb 22. pii: peds.2015-1968.

        That study concluded that type replacement did not occur because their univariate analysis of individual types showed no individual type with a significant increase. However, because the vaccines do clear the vaccine-targeted types, the lack of change in overall infection rate shows that type replacement must be occurring.

        The second study is by Fisher et al. (2016), which specifically found that high-risk HPV types replacing the vaccine-targeted types. They wrote “the percentage of non-vaccine HR-HPV types was higher than expected, considering that eight HPV types formerly classified as ‘low-risk’ or ‘probably high-risk’ are in fact HR-HPV types.

        Fischer et al 2016: Shift in prevalence of HPV types in cervical cytology specimens in the era of HPV vaccination. Oncol Lett. 12(1):601-610.

        A third study is that by Guo et al., (2015) that also clearly found evidence of type replacement occurring as a result of HPV vaccination:

        “The prevalence of high-risk nonvaccine types was higher among vaccinated women than unvaccinated women (52.1% vs 40.4%, prevalence ratio 1.29, 95% CI 1.06–1.57), but this difference was attenuated after adjusting for sexual behavior variables (adjusted prevalence ratio 1.19, 95% CI 0.99–1.43). HPV vaccination was effective against all 4 vaccine types in young women vaccinated after age 12. However, vaccinated women had a higher prevalence of high-risk nonvaccine types, suggesting that they may benefit from newer vaccines covering additional types.”

        Guo et al., 2015. Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20-26 years) American Association for Cancer Research Meeting, Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; 2015. Abstract nr 844

        A fourth study is that by Mollers et al., who wrote

        “…our findings do suggest that clustering differs among HPV types and varies across risk groups.”
        and
        “The ecological niche could also be taken through type replacement, which refers to the possibility that elimination of HPV16 and HPV18 could lead to an increased transmission of nonvaccine types. For this to occur, antagonistic interactions are required between vaccine types and those not included in the vaccine (8, 9). Type replacement has been observed following vaccination against other pathogens (e.g., Streptococcus pneumoniae) (10) and is plausible whenever genotypically diverse pathogen strains compete for the same hosts.”
        Mollers M et al., 2014. Population- and type-specific clustering of multiple HPV types across diverse risk populations in the Netherlands. Am J Epidemiol. 179(10):1236-46. doi: 10.1093/aje/kwu038.
        A study of Italian women also found evidence of type replacement and who wrote that “an accurate post-vaccine surveillance is necessary to early detect a possible genotype replacement”
        Giambi C et al., 2013. A cross-sectional study to estimate high-risk human papillomavirus prevalence and type distribution in Italian women aged 18-26 years. BMC Infect Dis. 13:74. doi: 10.1186/1471-2334-13-74.
        There are other studies that show type replacement. While some studies may show no type replacement, negative results do not take precedence over positive results. At best, one could say that the science is unsettled. However, CDC’s own study showed no net change in HPV infection rate, and studies now from the US, Germany, Italy and the Netherlands all support the same conclusions: there is evidence for grave concern over the adequacy of HPV vaccines: while the vaccine-targeted types are cleared, the hundred or so that can replace them across the sexually active population includes pathogenic types that may be more lethal than those targeted by the vaccines.
        The statistics on the types that are said to be known to cause the most cancers are potentially misleading, because there is an inverse relationship between the ability of pathogen to cause disease (morbidity) and death (mortality). If you count numbers of cases, yes, HPV-16 appears to be high-risk. But the low-frequency types may be even HIGHER risk – which would explain why they are low-frequency.
        The study from Germany (Fisher et al., 2016) is definitive, and we have our answer: HPV type replacement is real, and is caused by partial vaccination against an oncogenic virus group.”

        Like

      • yes lets look at Guo et al. First of all this study was done on women 20-26 years old. Anyone who understands the epidemiology of hrHPV understands the significance of this so I won’t waste my time explaining it.

        “The prevalence of high-risk nonvaccine types was higher among vaccinated women than unvaccinated women (52.1% vs 40.4%, prevalence ratio 1.29, 95% CI 1.06–1.57), but this difference was attenuated after adjusting for sexual behavior variables (adjusted prevalence ratio 1.19, 95% CI 0.99–1.43). HPV vaccination was effective against all 4 vaccine types in young women vaccinated after age 12. However, vaccinated women had a higher prevalence of high-risk nonvaccine types, suggesting that they may benefit from newer vaccines covering additional types.”

        What this says is that vaccinated women 20-26 showed a higher incidence of other high risk types (other than 16/18) and that women would BENEFIT FROM A VACCINE THAT COVERED MORE HIGH RISK TYPES. So this study advocated to the 9-valent HPV vaccine!!!!

        Feel free to copy and paste this info onto your site. You don’t even have to give me credit,

        Liked by 2 people

  3. “Consumers don’t know the details of the science and have to rely on the manufacturers and their doctors being forthright on risks to enjoy their right to informed consent.”

    Yes, consumers don’t understand the details of science so it’s problematic that you, someone who has some credentials and can influence gullible parents speaking from “authority”, purposely and deliberately mislead and misrepresent the vaccine and the science behind it.

    I have pointed out your misrepresentation from the document in your first link and provided two systematic reviews and meta-analyses showing the vaccines safety and efficacy. I will address your other claims in a following post.

    Liked by 2 people

      • In your opinion, perhaps. The funny thing about science – you can’t fool mother nature. If HPV vaccines cause an increase in cancer when people already infected are vaccinated, those cases will be attributed to incomplete vaccination and newer vaccines will be called for. Perhaps there will even be calls for more complete immunizations, targeting more types. We will know, of course, because we’ll be told that types that used to rare are now common. You can’t fool mother nature. I for one don’t want to wait for the outcome. I’d rather focus on stating the problem and generating solutions. Such as educating the public of the risks. People are still at risk of HPV infection after vaccination.

        Like

      • You base your premise on a spurious result that has been further studied that shows your premise to be faulty. I expect better from a scientist who has had the requisite education to know better.

        Liked by 1 person

      • The study that you say has refuted the spurious result is irrelevant to the population of unscreened women who do not know their HPV status. And no, 11- and 12- year olds have not been studied directly in the studies used for FDA approval in the US.

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      • If you couldn’t fool Mother Nature diabetics would not survive to adulthood and transplants wouldn’t work, nor would any vaccines.

        Science has been saving numerous lived by fooling other nature.

        Your use of this small sub result is incorrect, as has been explained. Clinging to the error does not make you less wrong.

        Liked by 1 person

  4. James Weiler….please re-read Moller et al (2014) I think you totally misunderstood what it said.

    “we did find differences in the tendency per HPV type to cluster together with other HPV types. For instance,HPV54 had a significantly lower affinity to be involved in a coinfection than HPV45”

    54 is a low risk type and 45 is high risk so this is discussing the tendency of types to “clump” or show up together. Why is Mr Weiler making an issue out of this? I have NO IDEA!!

    “The association in the occurrence of multiple HPV types likely depends on many factors, such as the risk heterogeneity of a population, the per-partnership transmission probability, differences in the persistence of lrHPV and hrHPV, and possibly immunological factors, such as ( partial) immunity
    against reinfection with the same HPV type or crossimmunity to other types”

    This all makes sense. When Mr Weiler is discussing “partial immunity” I don’t know what he is referring to but what the authors are talking about is when a patient is infected with the virus, then clear, but doesn’t acquire full immunity (think about a child that has a weak case of chicken pox, then gets it again a year later).
    According to Franceschi (2014) “if naturally acquired protection is absent or weak, vaccination of sexually active young women would be attractive because of the large fraction of them who may still be susceptible to HPV infection despite having been already infected and having cleared the infection in the past”.
    http://jid.oxfordjournals.org/content/early/2014/04/02/infdis.jiu143.full

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    • When I said you can’t fool Mother Nature, I was referring to the fact that if we see an increase in HPV Associated cancers due to type replacement, all of the argumentation same type replacement is not important will not matter.

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      • We’ve proven to you that type replacement is not a real health risk and is not causing cancer. The HPV vaccine is leading to a decrease in incidence of HPV and associated cancers. That you refuse to acknowledge you were wrong is deeply troublesome.

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      • So now we can prove things by simple denialist argumentation? That’s a neat trick. I usually rely on reproducibility of science and assessments of generalizability of estimates. Given the number of studies reporting type replacement, one has to wonder: if it’s not a health issue, as you say, then we don’t have to add more types to future HPV vaccines, right? So we’re good w/HPV-9? Because if there is no type replacement, or if it’s not an issue, one vaccination w/HPV-9 should be all anyone needs, right?

        At least no one has yet proposed that Type Replacement is good for us. Yet. I would not be at all surprised if someone tries to propose that gem.

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      • Since as has been demonstrated you have not provided good evidence of type replacement, I don’t think the denial is on the part of those pointing out your errors.

        We appear to be good with HPV9 because there’s no evidence of type replacement that suggests it’s not enough – and there is clear evidence it’s effective – and safe – http://pediatrics.aappublications.org/content/early/2016/07/14/peds.2015-4387 – in preventing a large number of cancers and deaths.

        Liked by 1 person

      • “So reissd predicts that Merck will never have to add another HPV type to their vaccine, because type replacement will not occur.”

        No, again you misunderstood.

        I am pointing out that there is no real evidence of type replacement yet. You are using that argument as an attack against the current vaccine, and that attack doesn’t hold water.

        Monitoring is continuing, as studies repeatedly said, because of the theoretical risk that it might, one day, happen. If it does, maybe there will be a need to add another type. But current evidence does not support it happening. So it’s not a reason not to use the current vaccine, as you repeatedly argued, and not a serious problem at this point.

        If – against current evidence – it happens, scientists will adjust. Again, that’s a poor argument against preventing tens of thousands of cancers.

        Liked by 1 person

      • So now there is something magical about HPV that causes type replacement to only MAYBE occur… when it’s know to occur in SOOO many other viruses with quasispecies and types… ok, well then you have to explain what’s so special about HPV that makes it so mysteriously different from other viruses that type replacement does not occur…

        Even under your model in which women who were at risk were already infected w/other types, prior to vaccination, they would then of course spread the rarer types not found in the vaccine if they had unprotected sex after the vaccine cleared the 2, 4 or 9 types…. so what do we call that phenomenon?

        The GUo study title is “Shifts in prevalence”… I can no longer take your comments seriously if you persist in concluding that the study did not show type replacement, especially since my communications w/Dr. Guo he specifically confirmed that type replacement is the correct interpretation.

        You may be suffering from wishful thinking?

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      • I think you are suffering wishful thinking. You have made up an argument that is not grounded in any facts at all. There is no issue with hpv type replacement. You have been proven utterly mistaken.

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      • In 2009, Gardisil researcher Dr. Diane Harper predicted that DUE TO MERCK’S AGGRESSIVE MARKETING, women might forgo pap smears, causing an increase in cervical cancer deaths:

        http://www.cbsnews.com/news/gardasil-researcher-speaks-out/

        Any increase in cervical cancer in a country in which HPV vaccine uptake is around 60% will be attributed to type replacement and changes in the behavior of the vaccinated due to misinformation from Merck and from ill-informed doctors.

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      • So, let’s make sure women don’t forego pap smears and everyone still practices safe sex.

        And are you wishing that cancer increases will be related to type replacement so you can prove you were right? Because there is zero evidence to support your claims and wishing for cancer rates to rise is vile and irrational.

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      • Fascinating, because I did just that. And communicated w/the lead author. Yep. Type replacement.

        You can repeat “no type replacement” in response to science all day and all night long. It won’t make these studies, nor the proper interpretation of them, go away.

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      • To remind you, adjusted results did not show type replacement.

        I can’t addressed undisclosed correspondence with an author, but the article doesn’t show what you claim. And the unadjusted result was explained in it.

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      • Well, the nice thing is you don’t have to take my word for it. Why don’t you write to Dr. Guo yourself and ask HIM how you should interpret the study?

        Readers, the article states “The underlying causes for the increased prevalence of high-risk nonvaccine types we observed among vaccinated women cannot be determined from these data.”

        Because the study is a cross-sectional study, one cannot RULE OUT type replacement as a potential cause of the increase in the rarer types.

        Other studies are more definitive.

        Guo et al. attribute, one way or the other, the increase rate of infection with non-vaccine types to riskier sexual behavior.

        Are we to presume that women engage in safer sexual behavior when they are vaccinated (Partially immunized) against HPV?

        I stand by my interpretation of HPV replacement as a contributor to these results. They are consistent with type replacement.

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      • Guo et al., 2015. Comparison of HPV prevalence between HPV-vaccinated and non-vaccinated young adult women (20-26 years) American Association for Cancer Research Meeting, Apr 18-22; Philadelphia, PA. Philadelphia (PA): AACR; 2015. Abstract nr 844

        Guo states: “The prevalence of high-risk nonvaccine types was higher among vaccinated women than unvaccinated women (52.1% vs 40.4%, prevalence ratio 1.29, 95% CI 1.06–1.57), but this difference was attenuated after adjusting for sexual behavior variables (adjusted prevalence ratio 1.19, 95% CI 0.99–1.43). HPV vaccination was effective against all 4 vaccine types in young women vaccinated after age 12. However, vaccinated women had a higher prevalence of high-risk nonvaccine types, suggesting that they may benefit from newer vaccines covering additional types.”;

        In the body of Guo’s work, there is a chart showing prevalence of HPV types among vaccinated and unvaccinated.

        If you go down the chart, you see:

        Any HPV 70.7% among vaccinated, 56.1 unvaccinated

        High Risk HPV 63.6% among vaccinated, 44.5% among vaccinated

        Non vaccine type HPV 68.6% among vaccinated, 53.9% among vaccinated.

        Here is the source: http://www.tandfonline.com/doi/abs/10.1080/21645515.2015.1066948?journalCode=khvi20

        An accurate statement “HPV vaccine reduces vaccine strain HPV among teenage girls by 2/3. The prevalence of High Risk Type HPV is higher among vaccinated girls than unvaccinated girls.”

        2/3 efficacy.

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      • That is about Gardasil 4. Now we have 9. 9 covers 81% of strains that cause cancer. Hopefully, we will soon have a Gardasil that will cover all strains that cause cancer.

        Your type replacement point still invalidated.

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  5. How much is the US or world citizen for that matter going to end up paying for all this ecological shift and type replacement? From an economic point of view, this whole paradigm seems like costly tip toe into the water of knocking down a small set of HPV types…our collective resources could be better spent elsewhere and so long as there is no free market in this arena of American commerce-they are “our” taxpayer/social collective dollars that are funneled into this big medical machine. Free pap smears to the poorest of our nation’s women would have been and will continue to be a better use of dollars.

    Liked by 1 person

    • I would like to see all Americans have access to universal healthcare and free yearly wellness exams, including preventative testing measures like pap smears, colonoscopies, etc. However, as I pointed out in the blog post, pap smears do not prevent cancer. They can only detect it. They are no guarantee you will survive cancer. My own dear cousin died a few months after her regular yearly pap smear. The previous year, she had a clean pap. A year late, she had stage 4 cervical cancer and died within weeks. It was too far along to cure.

      As for type replacement, it is not an issue. Lyons-Weiler is wrong. It is not a health concern. He is cherry picking.

      Like

  6. As for my credentials, I have a master’s in zoology, an undergraduate in biology, a PhD in ecology Evolution and conservation biology, postdoctoral experience under an eight-piece Sloan Fellowship in computational molecular biology, 2 years teaching genetics as an assistant professor at the University of Massachusetts, and 14 years conducting biomedical research in cancer, including uterine cancer cervical cancer breast cancer, prostate cancer, colon cancer melanoma, lung cancer, and head and neck cancer. I also spent six years teaching research and study design at the University of Pittsburgh, computational analysis of high throughput genomics and proteomics data, both to graduate students and to clinicians, and I participated in over 100 research studies at the University of Pittsburgh of all various types and focus including many that involve them immunological research. You can question my credentials, but when Merck makes the claim that they have to add more types to their vaccine, that will be an admission that this vaccine provides partial an incomplete immunization. People claiming that the current HPV vaccine can eradicate the disease, or can prevent HPV infection, or can prevent HPV Associated cancers, completely ignore type replacement. So when they make the claim that this vaccine provides protection from HPV infection, without qualifiers, they are misleading the public.

    The director of the University of Pittsburgh Cancer Institute, and the dean of the school of medicine, and the chair of the Department of pathology, and a chair of the Department of biology, thought that I was credentialed enough to take hold of and be responsible for the research I was involved in. So I wonder why you think I don’t have the background, when you can clearly do a PubMed research and see all the research that I have been involved in. I won’t answer any more questions about my credentials, I have vast amount of experience in biomedical research, biomarker analysis, bioinformatics, genomics, proteomics, all of which are relevant to the topic of epidemiology of infectious diseases, and the application of medical procedures to a population. Now that you have brought my credentials up and brought them into question, I fully expect to be criticized for laying them out for you and some pathetic person who has to try to plea for my own credentials. I will not ever try to defend myself and my credentials, what I have done with them speaks for them sufficiently. Now let’s get back on topic, the point of this ad being misleading.

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    • I feel your lack of understanding of HPV and women’s health is important. I’ve already pointed out a couple errors in your interpretation of the studies and what I have read on type replacement discusses replacing a low risk type for a high risk type.
      So despite you bring impressed with your own credentials, what is your clinical background in women’s health?

      Liked by 1 person

    • Yes I outlined your credentials in the blog post upon which you are commenting. You are a well educated man and you probably are well trained to work in evolutionary biology. You have no training in cancer, immunizations, or viruses. You should stick to your training.

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  7. Concern has been raised that eradicating the most virulent HPV types, 16 and 18, could result in 1 or more of the types that are not targeted by the vaccine occupying the ecological niche created by the elimination of these types, referred to as type replacement. In this issue of the Journal, Yang et al. (Am J Epidemiol. 2014;180(11):1066-1075) report on concurrent infections with multiple HPV types in unvaccinated women who underwent cervical screening in New Mexico (December 2007-April 2009) to identify possible interactions between HPV types, which if present could suggest the possibility of type replacement. Consistent with previous reports, they show minimal type-specific interactions among women with normal cytology, which they consider an indication that type replacement of HPV 16/18 is unlikely to be an issue in the general population postvaccination. Type replacement may be of less concern with the introduction of multivalent vaccines that include most of the carcinogenic HPV types; continued surveillance postvaccination should improve our understanding of the impact of HPV vaccination on type distribution and screening performance.

    http://www.ncbi.nlm.nih.gov/pubmed/25355444

    Liked by 1 person

  8. What you don’t seem to understand is that Guo et al. concluded that the type replacement they observed was due to riskier sexual behavior (as demonstrated by the outcome of no significant type replacement after adjusting for sexual behavior-related risk factors).

    It is not I who does not know how to properly interpret the results of adjusting for a variable in multivariate linear models. When a plausible functional relationship exists between the dependent variable (type replacement) and an independent variable (sexual behavior), then the loss of significance after adjustment does not mean that type replacement does not occur. It means that its primary cause is likely the independent variable which, when adjusted, explains the variance in the dependent variable.

    Now I wonder why people who are vaccinated against HPV would feel that they are protected against HPV… and continue to or start to engage in riskier sexual behavior? Perhaps it’s because Merck, and their doctors, told them that they were protected “against HPV”.

    I’ve been in contact w/ Dr. Guo about his study and yes, of course, he and his colleague call for more types of HPV to be included. They realize that partial immunization is risky and can cause the rarer, more deadly types to replace the more common types.

    Each study conducted shows type replacement. It is only the commentators and author of this blog (whose affiliations we do not yet know) who have claimed that type replacement it is not “important”. That presumes a lot of knowledge on the pathogenicity of the 90-120 other HPV types that exist, even before their ability to cause disease in humans have been studied. I wish I could derive such knowledge out of thin air. Instead, I rely on all of published science.

    And as they continue to claim to know whether I know anything about cancer, virology, etc…. there is nothing more to said about my credentials. Ad-hominem attacks are used when you run out of valid criticism against the argument. My chapters on immunology don’t count, nor my chapter on vaccines, nor my chapter on cancer vaccines, nor my years of working with researchers who taught me cutting edge science in all of these areas. None of that matters to them. Can’t kill the message? Kill the messenger. Best of luck w/that agenda.

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    • Even if Guo et al did show what you claim – and they do not – that would not help your case, since multiple studies showed that HPV vaccine receipt does not lead to more adventurous sexual behavior. Trying to create a stigma against vaccine recipient is as much against the data as your other claims.

      But Guo et al did not claim that. They pointed out that vaccine recipients tended to be more sexually active. In other words, you have your causation arrow wrong: it’s not that the vaccine encouraged being active sexually, it’s that active women were more aware of the risk, and hence more likely to get vaccinated. So on this, too, you are in the wrong.

      The comments above have shown that the studies do not show what you claim – they do not show good evidence of type replacement. And studies you have ignored show none. So it’s not that people here are claiming type replacement is not important. It’s that you haven’t made a case that it’s happening. And you are using this non-case to deter people from protecting their children against an the risk of an infection that causes tens of thousands of cancers and thousands of deaths each year in the U.S..

      Like

      • Nor did anyone attack you personally. In fact, multiple commentators acknowledged that you have scientific credentials, even if they are not in women health, immunology, virology, or other vaccine-related areas. Those credentials make your counter-evidence claims even more troubling.

        Liked by 1 person

      • According to you, newer types of HPV in the Guo et al. study were found in higher frequencies among that vaccinated because they knew they were at risk and took to the vaccine. Don’t you think that if they were given the vaccine that they should have been told to avoid unsafe sex because the vaccine provided incomplete immunization???

        Sorry, I don’t buy it. Numerous MD’s I heard in the Allegheny County Courthouse claimed to the public that with the HPV-9 vaccine, we have a chance to ERADICATE HPV. FALSE.

        It’s all a matter of public record, the minutes are available online. They broadcast misinformation about the vaccine’s capability, just like the commercial does.

        In reality, HPV-9 only provides against >10% of the type of HPV virus, and therefore it is incorrect to say that it does, or could have, protected against “HPV infection”.

        Words carry meaning to the public, and they act according to the information provided to them. IN this case, the public is misled to believe they are protected against “HPV infection”, not “some types of HPV”, or more accurately “about 10% of known HPV types”.

        The has had it with vaccine misinformation, and they take it too far with HPV. No wonder why it’s mandated in only 48 states, and NO COUNTRY has mandated it. No wonder Japan and Denmark don’t want it for their populations.

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      • The prediction that Hpv vaccines can eliminate cervical cancer has been made by serious scientists based on the data, including the dramatic decline of precancer in Australia.

        You haven’t countered it.

        It’s not about eradicating hpv types that don’t cause cancer. It’s about preventing cancers and deaths. Human suffering. Something that’s important to those of us correcting your claims.

        Liked by 1 person

      • Now you claim to know that none of the other HPV types – all 90-120 of them – do not cause cancer. How do you know this?

        BTW, the definative study showing type replacement from Germany, Fisher et al. (2016), specifically found that high-risk HPV types replacing the vaccine-targeted types. “the percentage of non-vaccine HR-HPV types was higher than expected, considering that eight HPV types formerly classified as ‘low-risk’ or ‘probably high-risk’ are in fact HR-HPV types.

        ARE IN FACT.

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      • Which cancers are caused by HPV?

        High-risk HPVs cause several types of cancer.

        Cervical cancer: Virtually all cases of cervical cancer are caused by HPV, and just two HPV types, 16 and 18, are responsible for about 70 percent of all cases (7, 8).
        Anal cancer: About 95 percent of anal cancers are caused by HPV. Most of these are caused by HPV type 16.
        Oropharyngeal cancers (cancers of the middle part of the throat, including the soft palate, the base of the tongue, and the tonsils): About 70 percent of oropharyngeal cancers are caused by HPV. In the United States, more than half of cancers diagnosed in the oropharynx are linked to HPV type 16 (9).
        Rarer cancers: HPV causes about 65 percent of vaginal cancers, 50 percent of vulvar cancers, and 35 percent of penile cancers (10). Most of these are caused by HPV type 16.

        http://www.cancer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-fact-sheet

        Gardasil 9 protects against (HPV) Types 16, 18, 31, 33, 45, 52, and 58; precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

        https://www.merckvaccines.com/Products/Gardasil9

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      • The Fisher study is not definitive. It is one study. It also concluded this

        “Using an epidemiological approach, Tota et al (51) hypothesized that eradicating vaccine-targeted HPV16 and 18 enhances the chance of other HPV types not targeted by the vaccine to occupy the ecological niche created by the extinction of HPV16 and 18. Due to cross-protection against other HPV types with current vaccines and the upcoming implementation of novel multivalent vaccines against the majority of the HR-HPV types diminishes the risk of type replacement (52).”

        https://www.spandidos-publications.com/ol/12/1/601#b52-ol-0-0-4668

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    • Yes words carry meaning to the public. What do you honestly think “the public” will take from your words? That they should be tested for HPV before getting the vaccine? Umm nope. You put yourself squarely in the anti-vaccine camp whether you like it or not and they are holding you up as a hero. Why? Because words have meaning to the public.

      By your logic no one should ever claim that anything could ever prevent anything unless they can prove that that person is now 100% guaranteed not to get that disease. So nothing prevents heart disease or cancer or diabetes or artheroscoerosis. Nothing. Because if a doctor says it “can prevent” I might think I’ll never get heart disease! So I’ll stop getting physicals because my doctor told me what I’m doing can “prevent heart disease”.

      Do you even hear yourself?

      Liked by 2 people

      • We are not talking about ‘anything’. We are discussing a vaccine that cannot do what the ad claims it can do, and the aggressive marketing has the uninformed public and doctors believing that women vaccine are with current HPV vaccines are protected from HPV infection. This sets them up for infection with increase risk of infection with rarer, potentially more aggressive and lethal types of HPV. The fact that I have shared the science showing type replacement – all the studies I’ve shared – and that you and Dorit persist in spreading misinformation about type replacement despite the science betray your, and her, bias. Your article wonder why a an evolutionary biologist would bother with HPV vaccines, or with vaccines altogether. The reason is because I know. I did not ask to find the specific studies I looked for on type replacement, i found them because I wanted to know more. I wanted to know why the CDC’S study showed no net change in HPV infection before and after the vaccines came out. I wanted to understand Guo et al’s prevalence shift. I wanted to know whether other studies found type replacement. They sure do. And when I heAR a doc say that this vaccines could eradicate HPV with this vaccine when there is no chance or that hapening, as a person 2ho has dedicated my profession al life to reducing human pain and suffering through KNOWLEDGE, the duty to warn my fellow parents and Americans who being denied informed consent about the very real risks and consequences of HPV vaccination is sufficient reason. I don’t hear you or Dorit clamoring for vaccines that provide more complete immunity, nor for safer vaccines. I see you denying vaccine injuries occur. CDC uses VAERS data in their publications. It is utter nonsense to claim we cannot use VAERS to point to specific cases of HPV vaccination injury .. esp those for which a court of law found that the vaccine caused or contributed to the injury. I predict that we will see a change in vaccine law in the US. Government and corporate overreaches are being reined in all over the country. Thebreat of 2016 snd all of 2017 will be very iwnteresting. The families of vaccines injured people are not going away. They are in this to halt preventable harm, injuries and death in other people. And for their efforts they are disparaged, called names, and otherwise maligned by people like Dorit whose family owns stock in a vaccine company. AND they are denied compensation and justice. Times are changing, and there is no going back. Objectivity in science will return.

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      • A. As the post demonstrate, the ad is substantially accurate. There is abundant evidence to suggest that the vaccines could prevent most cervical cancer. That’s a lot – and these vaccines are very effective.

        I would add that you are not calling, or advancing, creating better vaccines. You are attacking the vaccine we have, that can prevent tens of thousands of cancers – and doing so based on incorrect claims.

        B. VAERs reports do not show causation. When CDC scholars use VAERS report they check medical records and use population data. When you use raw VAERS cases – no checking records, no examining background rates – you are misusing them, and misleading anyone who relies on your word. No, you cannot assume a VAERs case shows a vaccine injury. As a scientist, you should know better.
        When you are using raw VAERS data that directly counters safety studies in over a million women, you are going against the evidence and painting a false picture. Intentionally or not, you are promoting anti-vaccine claims by overstating the vaccine’s risk and understating its benefits. In that, you are acting to the detriment of those the vaccine can protect. You are directly working to cause harm. Whether or not that’s your intent.

        C. It’s sad that some people believe vaccines caused their harms, when there is no medical or scientific evidence of that, and studies show vaccines do not cause, for example, autoimmune diseases. It adds a layer of anger over their already existing pain from their suffering. This misplaced belief is bad for them, and reinforcing it isn’t doing them any favors. Worse: when you support these stories, you are, again, spreading fear that can scare people from protecting their children from the real risks of HPV infection. You are acting against the children left unimmunized.

        You are not working for vaccine safety. You are working against disease prevention. No gain from it. Just loss.

        Scientists who work on vaccines save lives. Scientists who spread unwarranted fears about vaccines prevent saving lives.

        I think you chose the wrong camp to be in.

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  9. So this blog doesn’t identify author or any financial ties to industry if any.
    Bottom line is there are 4times more reported adverse reactions to Gardasil then all other vaccines combined over a 6yr period, reported in VAERS- &with so many less kids getting it then the other vaccines on average– that is extremely significant point that many want to ignore or discredit. The CDC claims only 10%of reactions are even reported.
    The biggest problem with the TV ad is that it is targeted at young kids &to question parents about medical choices. That is NOT okay. Pharma marketing designed for minors is horrid, &no one should defend that.

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    • I have no financial ties to pharma or any medical industry nor do I have stock in any pharmaceutical company.

      Adverse events reported do not translate into issues actually caused by HPV vaccines. If you look at the reports, which I have, there are suicides, drug overdoses, heart attacks, heart viruses, strokes, lyme disease, and other events completely not related to HPV vaccine by anything other than timing. POTS and other nerve issues have also been examined and found not related to HPV vaccine. The link I posted in the article, link #3, will take you to more facts.

      This ad was not designed for minors. It was designed for parents.

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    • The cdc does not claim only 10% of reactions are reported. You will not find a source for that claim other than the founder of NVIC. I think she made it up. VAERS website states that severe adverse events are vastly overreported and minor ones are underreported. There is no specific statistic about the over and under reporting.

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      • It says it right on CDC website that is where I said it from. &Like I said people try to discredit. & I guess those observant and understanding of marketing notice the direct market at minors. It is apparent your opinions are based on your bias of promoting the vaccines. &Simply stating you have no ties is no proof of anything. If people want or don’t want the vaccine it is completely up to their family. This ad is over reaching & inappropriate. Pharma companies shouldn’t be allowed to market to consumers at all. This country is behind the eight ball on so many things.

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      • Please provide the link to the CDC page that says that. I have never seen that anywhere other than from Barbara Loe Fisher. And I have researched it’s origin.

        I do agree that pharma companies should not be allowed to run ads. They were not allowed until recently. I really hate the ads. But, that doesn’t make this one unethical or, as James contends, false.

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    • One of the most common adverse events is syncope and presyncope. POTS is also mentioned which shows up in adolescence often. I’m intimately involved with these conditions. I’ve never gotten any HPV vaccine. But when I was an adolescent is when I started experiencing presyncope with needles. My sister gets syncope and started earlier. She fainted and even stopped breathing at the pediatricians while being prepared for a tonsillectomy.

      Backed then they didn’t know a lot about autonomic disorders like they do now. And they still know so little. But, those of us that are of my generation weren’t diagnosed until older because it wasn’t known back then. Some kids just got dizzy or fainted when they got stuck with a needle, even though they never had before. We didn’t get vaccines at that age to blame it on.

      VAERS will never be a trustworthy indicator. That’s what actual scientific research is for. At best, it can indicate where new research should focus.

      Liked by 1 person

    • Also it may interest you to know that recently there has been a bill before congress trying to make advertising by pharmaceutical companies illegal again. The bill was sponsored by physicians.

      Liked by 1 person

  10. Calling James Lyons Weiler in effect, an underqualified murderer is beyond disingenuous, it’s a display of rabid ignorance. No-one, even the most qualified epidemiologists, cancer specialists or women’s health researchers can be certain about the co-morbidity of large scale public health programs. I’ve heard it said by doctors that whilst it appears that disease-prevention drugs like statins and anti-hypertensives reduce the numbers dying from a particular problem like heart disease life expectancy can still be reduced from an elevated risk of death from OTHER causes, to say nothing of loss of life quality. Those who accuse questioners of the vaccination consensus of ‘endangering lives’ need to have absolutely watertight evidence that the vaccine program itself is not a danger. That means closely examining the anomalies in sub groups, not displaying smug certitude whilst hoping the anomalies will evaporate when the data is treated in a slightly different way.

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    • Hm, wherein did anyone call Dr Lyons-Weiler ” an underqualified murderer is beyond disingenuous?” He has made terrible mistakes in reading HPV vaccine data and he has been corrected. That is all.

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      • ‘Murderer’ by virtue of – Misty: “All you’ve done is add to the anti-vaccine anti science industry that is killing people all over the world” and Reissd: “The natural conclusion being we should allow people to continue to get cancers and die because of this theoretical risk” and “scientists who spread unwarranted fears about vaccines prevent saving lives”

        ‘Underqualified’ by virtue of – . Catherine O’Brien: (rudely) “What is your degree in? I forgot”. And “You don’t know anything about women’s health do you?” and Vaccinesworkblog: “You have no training in cancer, immunisations or viruses. You should stick to your training”.

        Exactly which aspect of JLW’s experience DO you deem adequate to qualify him to engage in the subject of vaccine science?

        You, Vaccinesworkblog, start the by vehemently defending the Gardasil advert but along the way allow that consumers don’t understand the science and then later on agree that “pharma companies should not be allowed to run ads” Who’s been corrected?

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      • First of all, I do not believe pharmaceuticals should be allowed to run ads on television, radio, or in media. You should have to talk to your doctor about medicines.

        Secondly, the ad tells you to talk to your doctor to get more information, because consumers are not experts.

        Thirdly, the blog and comments stand true. James is not an expert in HPV and he does not understand it well. He has a tremendous bias, having a well-known antivax lawyer on his board. I believe he has been bought by the antivax side.

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      • Murderer implies someone intentionally killing. I don’t think Dr. Lyons-Weiler is a murderer. I do think that he is putting people at risk, and potentially at risk of death, by irresponsibly promoting anti-vaccine misinformation.

        I certainly did not attack his qualifications. But in my view, his qualifications make his behavior even more troubling. He should know better – and his qualifications may make lay people accept his incorrect claims at face value.

        There’s no contradiction in what Vaccines Work says. She said – and I agree – that ads by pharmaceutical companies are a bad thing. I also think it is. That doesn’t make this ad false, as Dr. Lyons-Weiler incorrectly said.

        Nor does the fact that many lay people don’t understand the science.

        You can oppose pharma advertising without supporting incorrect claims about a specific ads, and without supporting misinformation that can scare people – with no basis – about a life saving vaccine like the HPV vaccine.

        Liked by 1 person

  11. Thanks for the reply. You say “misinformation that can scare people”, referring to that from HPV skeptics. But it is also scary misinformation to say that ‘HPV causes cancer’. Cancer is a hugely complex multifactorial disease and is not ’caused’ per se by any ONE thing. There are combination risk factors, genetics and epigenetics, individual lifestyle, health history, psycho-bio-immunological states etc etc etc as well as viral load. Many people have HPV symptomlessly and rarely does it go on to cause pre cancerous lesions. If the same amount of time money and energy that is expended on a vast roll-out of a vaccine who’s protection wanes with time and damages some individuals was spent on simple and clear education and health promotion and monitoring there could well be a better outcome for all. It is, I suggest a matter of opinion whether the vaccine course is unassailably superior, and common sense is a perfectly adequate tool for discerning the best way forward. It has worked for thousands of years and continues to work, and it should not be just those with an abstrusely reductionist focus who get to make decisions about human health. Del Bigtree has a hell of a lot of common sense and to call him an uneducated fool shows a particular blindness to the true good he is doing by getting people to ASK QUESTIONS. I’m sure you started your science career asking questions, but I sense that there are some unaskable ones for you now. Like: “is it conceivable that vaccines could be anything other than perfect human health enhancers”?

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    • As with JLW, you seem to think that the solution to preventing HPV-related cancers is just to tell everyone not to engage in any sexual behavior ever. Since not even condoms prevent HPV, the only thing that can prevent is 100% abstinence. As I told JLW, that is not feasible for the average human nor should it be. We are sexual beings and should not have to be abstinent. What has worked for thousands of years? Letting people die of cancer and STDs? That has not worked too well for humanity. Better to have a vaccine that prevents the viruses.

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      • What has worked for thousands of years?
        Well it’s millions of years, billions even. That’s the immune system. It seems we don’t trust it any more. There’s this image I think of the human past being an unmitigated disease-ridden hell. I know we have records of plagues, but these are things that stick in the memory. there must have been plenty long eras of relative health and happiness otherwise we wouldn’t be here at all. You have only to look at the general robustness of animals to see that the vast majority survive very well by following instinctual drives and are well able to tolerate what would make modern humans quite sick. Dirt may be the answer! I wasn’t proposing sexual abstinence at all, just moderation of promiscuity, safe (er) sex, good health and rest – all the normal things that help ward off disease. And monitoring. And of course ploughing resources into development of better treatments IF a problem occurs.
        You say “letting people die of cancer and STD’s”. This sounds a very awful thing, like letting babies crawl out across the freeway. But if, in order to catch the 1 in in 10,000 who will be vulnerable to HPV-led cancer you have to vaccinate the other 9,999 needlessly this is a truly blunt instrument. Our inability to identify the 1 in 10,000 vulnerable person means we have to use the spread shot approach. This would be fine if it were certain that there was no downside to vaccination, but I think it is becoming clear that there is a down-side and it is being down-played! And the up-side exaggerated, as in the HPV advertisement. The couple who wish they’d done something to prevent their Cancer don’t KNOW that HPV vax would have saved them. It might, it might not. Surely the lesson of antibiotics should tell us that the more you try to corner pathogens the trickier they get. An ever increasing vaccine schedule will likely lead to a far more unstable viral population that we might wish with hindsight we hadn’t meddled with so much. If 50 years ago it had been impressed upon doctors that antibiotics should be held back for all but the most urgent cases and not handed out like sweets, we’d likely still have a useable range of effective antibiotics. We are now at that same moment (in medical history) where a cautious and considered reigning in of the excessive vaccine roll-out could save useful and important vaccines from becoming useless in the future.

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      • For as long as humans have been around, diseases have struck us down and occasionally wiped out whole populations. Even when people ate organic and drank clean water, measles and small pox wiped out whole tribes. When germ theory and hand washing were discovered, tremendous strides were made at keeping people alive and preventing diseases. But, until vaccines were invented, rates of all VPDs were still high and people were still dying and still suffering. Vaccines made huge strides for humanity and they continue to make huge strides.

        With HPV, 90% of infections clear on their own but we don’t know which people will clear and which will get cancer. So, if we vaccinate 1 million people, maybe one will have a severe reaction but all of them will have protection from 81% of the strains that cause these cancers. If we do not vaccinate those 1 million then 100,000 will get cancer. To me, it is a no brainer which choice is riskier.

        Like

  12. Pingback: The Truth about vaccines episode 5: HPV, Hep B, SIDS, and Shaken Baby Syndrome | vaccinesworkblog

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