Risks of HPV vaccine may outweigh benefits

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A female student getting an HPV vaccine.  Photo: Bronwyn Scott
A female student getting an HPV vaccine. Photo: Bronwyn Scott

New studies suggest that the human papillomavirus vaccine (HPV), administered to Grade 6 girls across B.C. and offered for free at Langara, may cause more harm than good.

Two teenagers, 14 and 19, died after suffering similar neurological symptoms after immunization, which included migraines, speech problems, dizziness, chest pain, inability to walk and confusion, according to a study co-authored by neuroscientist Christopher Shaw.

Shaw said that his intention is not to scare people off, but rather to remind them that everything comes with risks and to make sure young people understand enough to make informed decisions.

“I just want them to have that piece of the story,” he said.

Not all are convinced that the vaccine causes more harm than good

A causal connection between the vaccine and adverse reactions, however, cannot be determined and these incidents are rare.

“There will be side effects to anything that you have in this world, whether . . . it’s an injection or . . . driving a car,” said Dr. Ashleigh Stelzer-Chilton, a family doctor in Vancouver.   “Nothing is 100 per cent.”

“I’ve worked in Africa and all over the place where vaccines are not available for a whole bunch of different reasons . . . but people die all the time for things that we’ve got protection from here,” said Stelzer-Chilton.  “I think sometimes we focus on the wrong thing.”

According to Stelzer-Chilton, the statistics for the vaccine are “excellent.”

Another article Shaw co-authored, however, suggests the vaccine clinical trials were inadequate and claims of a 70 per cent reduction in cervical cancer are unfounded.

“What we do is evaluate the science,” said Shaw, who stressed he wasn’t offering a medical opinion but indicated that his publications are “heavily reviewed by other scientists in reputable journals.”

Despite being lauded by the media and health-care professionals, Shaw warned that “adverse reactions … [can be] horrific.”

Some of the facts about HPV

According to the Society of Obstetricians and Gynaecologists of Canada, 10 to 30 per cent of Canada’s adult population has HPV.

The virus is common among teenagers and young adults. Men can also be infected.

Using condoms and having fewer sexual partners reduces the risk of infection and regular Pap tests detect early infection. Symptoms may not be apparent and HPV is easily passed to a sexual partner.

If left undetected HPV can develop into cervical cancer, the second most common cancer for women in Canada aged 20 to 44.

Cervarix and Gardasil prevent two strains that account for most cervical cancers and the latter also prevents most strains of genital warts.

HPV is transmitted sexually and the injections, administered three times over six months, are given to young girls before they contract the virus. The vaccine is also free for those born in 1991-93.

Reported by Bronwyn Scott

In this podcast, Bronwyn Scott talks to Dr. Ashleigh Stelzer-Chilton about the HPV vaccine.

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  1. Patrick McKnight says

    Once again, The Voice is promoting needless fear based on speculation and bad science. Had The Voice done it’s job, they would know that Christopher Shaw has a shady reputation.
    How many people have already died because of anti-vaxxer fear mongering? How many will die solely because of this article?

  2. Nienke van Houten, Ph.D. says

    The title of this article does not accurately represent this issue. It suggests that the risks to HPV vaccination outweigh the potential benefits and provides a study by Tomljenovich and Shaw, published in Pharmaceutical Regulatory Affairs: Open Access, as supporting data. This study is flawed in several respects: it lacks many controls, investigates only two cases, does not provide any clear causal connection to the HPV vaccine and misuses data from the VAERS database.

    There simply is not enough evidence in this paper to make these assertions about safety, especially when there is a wealth of information from controlled clinical trials conducted in tens of thousands of woman that support the use of the HPV vaccine. For example, here is a link to a meta-analysis of 7 different clinical trials in a total of over 44,000 women. Adverse events did not differ significantly between vaccine and control groups. I selected this article because its open access and thus available to everyone.

    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3034689/

  3. Chris Shaw says

    “Anti-vaxxer fear mongering” and “a shady reputation”? Honestly, Patrick time to learn that ad hominem insults are logical fallacies and that you need to read the literature a bit more closely. Also, if there is a shady reputation at stake it is more likely to be in the trials conducted by the pharma. As for number of women saved so far by HPV vaccines: 0. Hence your statement that anti- vaxxer fear mongering has killed people does not apply in this case and, indeed, I doubt if you can document with real numbers the number who have been so affected in any disease. Just because you think so doesn’t make it so. Ante up or shut up.

    Nienke, sorry: aluminum adjuvants are not placebo controls and never will be. See Chris Exley’s letter in Vaccine. And, yes, we do know that there are no controls in this study: it’s a case study, no more, no less and designed to report on clinical findings. Anytime you want to come into our lab and examine the postmortem samples you are more than welcome to do so.

  4. Nienke van Houten, Ph.D. says

    Chris, I agree that Patrick’s comment on your reputation is inappropriate, especially in a public discussion board. As you know, I prefer to engage in civil discourse and avoid polemics. My main problem in this context is not with your work, but rather that this article is disproportionately biased towards it and suggests conclusions that are not represented by your study – as you acknowledge.

    With respect to my own comments, I do think that aluminum adjuvants are appropriate controls in vaccine trials. I have also reviewed a lot of Chris Exley’s work, including the vaccine letter. I don’t find the basis for his ‘aluminum body burden hypothesis’ that convincing.

    I would be very intrigued to learn about your staining protocols. How did you control for false positives? How did you titer your antibodies? Its not that clear to me from your methods. It would also be very interesting to compare the ‘gardasil’ brains with control brains from healthy vaccinated and unvaccinated people. But then you need to find the brains, which I imagine is a bit of a challenge. I see that we have more to discuss on this issue.
    Best,
    N.

    1. Asep says

      I agree that they have not tested this vaccnie enough, and even though I had cervical pre-cancer myself, I don’t think I’d want my 10 yr old daughter getting one just yet. My older daughter, (who is in the USAF), has already gotten one…because it was recommended by the AF doctor. She had the vaccnie after my grandson, not sure if it will affect her fertility in the future.First of all though, calling it a “cervical cancer vaccnie” is a misnomer; it is really an HPV vaccnie. Boys get HPV too, and pass it on to girls, who may or may not get cervical cancer, but the majority of women who get it…also have HPV. So, from that standpoint, if they make it mandatory for girls…it should be for boys too, to stop the spread of the virus.Also, I am part of a study that is being done to see if some people are genetically predisposed to cervical cancer, so I hope they don’t jump the gun here and make it mandatory for anyone just yet.

  5. Lucija Tomljenovic says

    Nienke,

    Regarding the meta-analysis you mention, I am quoting here directly from our paper published in Annals of Medicine last year:

    http://www.ncbi.nlm.nih.gov/pubmed/22188159

    In a recent meta-analysis of safety and efficacy of HPV vaccines, seven trials enrolling a total of 44,142 females were evaluated (83). Two main populations of women were defined in these trials: those who received three doses of the HPV vaccine or the aluminum containing
    placebo within a year (denoted as the per-protocol population (PPP)), and those who received at least one injection of the vaccine or the placebo within the same period (intention-to-treat population (ITT)). While HPV vaccine efficacy was evaluated in both PPP and ITT cohorts, vaccine safety was primarily evaluated in the ITT cohort (83). Although ITT analysis is ‘conservative’ for assessment of treatment benefits (since dropouts may occur), it is ‘anti-conservative’ for assessment of adverse reactions (ADRs), because ADRs will occur less frequently if fewer doses of the vaccine are administered. Thus, such a selection procedure may explain why the meta-analysis found the risk-to-benefit ratio to be in favour of the HPV vaccines (83).

    The seven trials included in the meta-analysis were all sponsored by the vaccine manufacturers (14,15,20,65 – 69). In a lengthy report of potential conflicts of interests of the FUTURE II trial study group (15), the majority of authors declared ‘receiving lecture fees from Merck, Sanofi Pasteur, and Merck Sharp & Dohme’. In addition, ‘Indiana University and Merck have a confidential agreement that pays the university on the basis of certain landmarks regarding the HPV vaccine.’

    In the 2009 JAMA editorial (11), Haug noted that ‘When weighing evidence about risks and benefits, it is also appropriate to ask who takes the risk, and who gets the benefit. Patients and the public logically expect that only medical and scientific evidence is put on the balance. If other matters weigh in, such as profit for a company or financial or professional gains for physicians or groups of physicians, the balance is easily skewed. The balance will also tilt if the adverse events are not calculated correctly.’

    As for the safety of aluminum adjuvants, please check out the link below, to the 8th International Congress on Autoimmunity 2012 in Granada, which was organized by Prof Yehuda Shoenfeld who is the world’s leading authority in autoimmune diseases. Yehuda is the head of the Department of Medicine at the Tel Aviv University since 1984 (age 36). He has founded and is heading the Center for Autoimmune Diseases since 1985 – at the largest hospital in Israel- the Sheba Medical Center. He has authored more than 1500 papers in his career and is currently on the editorial board of 43 journals in the field of Rheumatology, and Autoimmunity. Much of the focus of his work has been on the toxic mechanisms by which vaccine adjuvants induce autoimmune diseases in humans.

    Shoenfeld coined the term ASIA: “autoimmune/inflammatory syndrome induced by adjuvants”, which encompasses several adjuvant-triggered medical conditions that are characterized by a misregulated immune response.

    This year the Congress had a special focus on ASIA and the role on vaccine adjuvants in ASIA:

    http://www2.kenes.com/AUTOIMMUNITY/SCI/Pages/2ndInternationalSymposiumonVaccines.aspx

    Early this year I have received an invite by Professor Victor Preedy (PhD DSc FRSPH FRCPath) from the Kings College London to contribute a chapter to “The Comprehensive Guide to Autism”. This new book aims to be the most comprehensive book on autism to date. It will be
    published by Springer (in Oct 2013), one of the world’s leading academic book publisher. The Editors and Editorial Advisors are based at leading universities or institutions, including King’s College London, University of Westminster and University of the West of Scotland. Together, the Editors have published over 40 books and volumes in the biomedical sciences including 7 multi-chapter works of 120 chapters or more.

    I have been asked to write a chapter on Autism spectrum disorders and aluminium vaccine adjuvants.

    What all this suggests is that concerns regarding the safety of alum adjuvants and vaccinations in general have been underestimated by the relevant authorities, and that there is now a growing acceptance in the wider scientific community that vaccines and adjuvants in the amounts given to children today may be a risk factor for neurodevelopmental disorders.

  6. Lucija Tomljenovic says

    As for our study in Pharma Regulatory Affairs, regarding negative controls, please note that no staining was observed with HPV-18L1 antibodies using the identical method (one photo is show in the paper). I can show you all the photos from all brain areas from both girls, all were negative for HPV-18L1. We also diluted the anti-HPV-16L1 to 1:200 and we initially used the 1:100 dilution. Both times the results were the same.
    There was also no staining on the samples incubated only with the 2dary antibody.

    If you have other specific suggestions on how to improve our methods, please send me an email because I appreciate constructive criticism.

    We are now working on a larger study which will include controls sourced probably from the Harvard Brain Bank Resource Center.

    We are also planning to do a study in animal models.

  7. Nienke van Houten, Ph.D. says

    Thanks Lucija,
    I will take my time to look at the references that you have suggested. I have looked at some of Shoenfeld’s papers in the past and listened to him give a seminar on Youtube.

    If I have questions and/or suggestions I will email you. I am very tempted by Chris’ offer to visit your lab.
    Best wishes,
    N.

  8. Nienke van Houten, Ph.D. says

    I would like to clarify that when Schoenfeld refers to ASIA syndrome, it refers to a broad spectrum of etiologies and is not limited to adjuvants used in vaccines. For example, he categorizes silicon from breast implants into this group.

  9. Patrick McKnight says

    “I am pleased that your reporter Gail Johnson included my comments about the benefits of the human papillomavirus vaccine in her article [‘Researchers advocate HPV vaccine scrutiny’, November 1-8].

    “I want to provide some new information that confirms my concerns about the research methods used by Lucija Tomljenovic and Chris Shaw for their paper regarding the deaths of two young women who had received the HPV vaccine. This paper has now been reviewed by the U.S. Clinical Immunization Safety Assessment (CISA) network, which is a Centers for Disease Control-funded network established in 2001 with six participating medical research centres involved in immunization-safety assessment.

    “The CISA has concluded that there are a number of methodological flaws with the publication and that it lacks the evidence to support the authors’ conclusions. This assessment is available on the Centers for Disease Control website at http://www.dbd.gov/ under ‘vaccine safety technical reports’.

    “Numerous credible studies have shown that both HPV vaccines used in Canada are safe and highly effective. The vaccine is estimated to prevent about 70 percent of cancers to the cervix.

    “I encourage all girls eligible for the school program who are in grades 6 through 12 in B.C. and young women born in 1991, 1992, and 1993 to get vaccinated against HPV infection.”

    Dr. Monika Naus / Medical Director, Immunization, B.C. Centre for Disease Control

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