Issue 13 / 11 April 2016

THE quadrivalent human papillomavirus (HPV) vaccine is now in its tenth year of use in Australia’s national immunisation program. HPV vaccines are now included in national programs in over 65 countries around the world and more than 200 million doses of the vaccine have been given.

It is fair to say that they are among the most well studied and scrutinised vaccines ever and that they are more effective than we would have dared to hope. Australia has led the world in observing dramatic declines in HPV infection, genital warts and precancerous cervical lesions.

The Global Advisory Committee on Vaccine Safety of the World Health Organization has reviewed the safety of HPV vaccines six times now and every time has concluded that they are safe. In following up possible concerns from routine surveillance systems for adverse events following immunisation, analytical and population-based studies have not confirmed that any illness – not one – occurs more frequently in vaccinated than in unvaccinated girls.

So why do parents still come to us scared of this vaccine and worried it is somehow different to all the others? And how do we convey this incredible depth of scientific knowledge that supports the remarkable safety and efficacy of the HPV vaccines?

The issue seems to be that bad news, scary news and anything shocking, travels fast, and faster than ever and with wider reach in this age of social media.

While in the past it was perhaps reasonable to ignore unscientific anti-vaccination claims spread by pamphlet and newsletter, for fear of giving them oxygen, it is now a reality that anti-vaccination messages are already out there. They have a wide reach and, if not refuted by trusted sources, can continue to spread and erode trust in vaccines, no matter how outlandish the claims made.

Recent research shows that bad news is more likely to be shared, that well intentioned searches for information on the internet can easily produce skewed and negative results (McDermott T, Hawkes D, Benhamu J. The role of pejorative search terms and professional anti-vaccine advocates on search engine results for Human Papillomavirus Vaccine. Journal of Adolescent Health 2016. In press), and that once a myth is heard it is very difficult to remove the seed of doubt that has been planted.

An example of a frightening rumour currently doing the social media rounds is concerns about HPV vaccines and premature ovarian failure, also called primary ovarian insufficiency (POI).

This has been prompted by a statement for more research into this issue released (and then widely reported by anti-vaccination groups) by the deceptively named American College of Pediatrics (ACP), a small group of conservative clinicians who split off from the esteemed American Academy of Pediatrics in 2002 over ideological disagreement about same-sex adoption. The ACP has strong religiously based views across a number of policy areas including homosexuality, abortion and drug regulation.

Globally there are six cases of POI, with inconsistent temporal associations to vaccination, published by clinicians known to have conservative religious agendas or anti-vaccination beliefs. One case series described three cases of POI, which included cases in two sisters, but it was later revealed that the senior author on that study was acting as a witness in a legal case brought by the two sisters, which was still in active litigation at the time of the article’s publication.

POI fits the classic type of illness for which vaccines are blamed – rare, serious and of unknown cause. There is no evidence from a decade of HPV vaccine safety surveillance and analysis globally that the vaccine causes reproductive problems in women. Claims of infertility caused by vaccination are surely chapter one in the anti-vaccine campaigner’s handbook for derailing immunisation programs (eg, polio vaccine campaigns).

So, how can we as doctors and health care professionals respond?

We suggest a need to listen, understand and acknowledge parental concerns, be informed about the latest anti-vaccine rumours or know where you can go to find out (eg, the excellent Skeptical Raptor blog maintains a page updating circulating HPV vaccine rumours and providing evidence about vaccine safety), and know where you can access reliable information about vaccines.

The reality is that scientific facts about vaccines alone won’t necessarily remove all doubts – but explaining why there is misinformation online about vaccines and that it is ideologically driven rather than scientifically based may well help parents to understand that the “community” they see on line is not representative of either the vast majority of the parent community or the scientific community.

There are also some excellent parent communities online which are supportive of vaccines, evidence-based and non-judgmental about legitimate questions about vaccine safety (eg, The Vaccine Page on Facebook).

The reality may be that, in this day and age of clickbait, predatory journals and celebrities giving medical advice, we all need to step up with confidence as advocates for science, for medicine, and for prevention of disease.

Associate Professor Julia Brotherton, is medical director of the National HPV Vaccination Program Register. Dr David Hawkes is an honorary fellow at the Department of Pharmacology and Therapeutics at the University of Melbourne. Associate Professor Marion Saville is executive director of the Victorian Cytology Service.

29 thoughts on “Vaccination questions need patient response

  1. Elizabeth Hart says:

    Why is there no conflict of interest statement on this article promoting HPV vaccination?  The authors’ associations with any pharmaceutical companies, and any other potential conflicts of interest, should be clearly disclosed.

    Julia Brotherton has been involved in the promotion of HPV vaccination in Australia for some years, at least since 2003. See for example: “Planning for human papillomavirus vaccines in Australia. Report of a research group meeting”. CDI Vol 28 No. 2 2004. In the acknowledgements of this report, co-authored by Julia Brotherton and Peter McIntyre, it is noted: “We would like to thank CSL Pharmaceuticals and GlaxoSmithKline for their support in facilitating this meeting…”

    It really concerns me that people such as Julia Brotherton, who have associations with industry, and who may also have an ideological and career interest in ‘proving’ the benefits of HPV vaccination, are also the ones evaluating the effectiveness of HPV vaccination.

    Personally, I have no confidence in Brotherton’s objectivity on this matter.  I also resent her use of ‘anti-vaccination’ rhetoric, a device which is often used to marginalise and discredit citizens who have legitimate concerns about the over-use of lucrative vaccine products.

     

  2. Elizabeth Hart says:

    David Hawkes is now clearly listed as an author on this article. 

    Hawkes is an administrator of the pro-vaccine lobby group SAVN.[1]   

    SAVN was given a platform to present its views at the public hearing re the No Jab, No Pay bill[1], a bill which was subsequently made law from January 2016. 

    In the interests of transparency, David Hawkes’ affiliation with the pro-vaccine lobby group SAVN should be disclosed on this article promoting HPV vaccination.

    Reference:

    1. See the Public Hearing transcript, accessible on the Social Services Legislation Amendment (No Jab, No Pay) Bill 2015 webpage: http://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Community

  3. Glenys Harrington says:

    Excellent summary of the issue/s and concerns. The additional information relating to keeping up with the rumors and where to refer parents and others to reliable online vaccination safety resources will be useful to the infection control and infectious diseases community. 

    Glenys Harrington, Consultant, Infection Control Consultancy (ICC), Melbourne, Victoria. E:infexion@ozemail.com.au 

     

  4. Elizabeth Hart says:

    The influence being exerted by publications such as MJA Insight, which is owned by the Australian Medical Association, must be subjected to scrutiny.  

    This is a critical political and ethical issue.  The continual censorship of questioning of vaccination policy by powerful elements in the medical and scientific establishment is undermining the rights of citizens in our democratic society.

  5. Stephen Tunley says:

    I was wondering, how this article is even modestly supported by scientific facts as disclosed by Merck disclosed in 2014 when seeking approval for Gardasil 9  there following in relation to Gardasil:

    ·       Serious adverse health events – 2.5%/100,000;

    ·       Systemic Auto immune disorders – 3.3% per 100,000; and

    ·       Spontaneous Abortions – 12.7 – 14.6%

    Refer: https://www.merck.com/product/usa/pi_circulars/g/gardasil_9/gardasil_9_pi.pdf

    Given this and the fact that cancer diagnosis rates in Australia are 7/100,000 how is this an acceptable safety outcome?

    I bring to your attention the following study https://clinicaltrials.gov/ct2/show/results/NCT01078220?sect=X30156&view=results#evnt that concluded…”Per protocol, non-serious adverse events and serious adverse events (SAEs) were not required to be captured as part of the study database, therefore, none were collected, and the number at risk is zero.” Is this an example of one of your safety studies?

    Are you comfortable that for every 100,000 vaccinated with Gardasil in Australia, there would be 2,500 serious adverse events. Compare this with the cervical cancer diagnosis rate in Australia of circa 7/100,000 –  and that’s diagnosis not death?

  6. Macquarie University Publishers Packages says:

    Elizabeth Hart, people in glass houses shouldn’t throw stones. 

    “I also resent her use of ‘anti-vaccination’ rhetoric, a device which is often used to marginalise and discredit citizens who have legitimate concerns about the over-use of lucrative vaccine products.” 

    Yet you yourself campaign about your perceived over-use of vaccine products. I have persoinally received unintelligelible rants from you following publication of evidence based vaccine articles. 

    So the question is, why have you not declared your COIs? 

    (In the interests of transparency and because I’m not a hypocrite, I am an admin of SAVN and have published many evidence based articles on vaccination).

  7. Chris Morgan says:

    It does read like an infomercial….

    If the vaccine is so great, why does ACT Health have notices in their lobby advising women to continue with their testing regime even if they have been vaccinated?

  8. Joanne Benhamu says:

    Stop the AVN is a Facebook Page which receives no funding so I am unclear on how you put this forward as a COI. COIs require the author/presented/stakeholder to be at risk of skewing results due to receiving financial benefit or being under pressure from their association with an organisation. Challenging the misinformation disseminated by those with antivaccination views is hardly a COI for a scientist or health professional. Indeed, I’d say they have a responsibility to communicate the accurate science on vaccination to protect the public. Full disclosure that I am both an author of a paper cited in this article and I am associated with Stop the AVN. I have no financial interests to declare.

  9. Peter Tierney says:

    Elizabeth Hart says:  “I also resent her use of ‘anti-vaccination’ rhetoric”

    Definiton of anti: opposed to; against. 

    You can try and  create your own interpretations of the scientific literature all you like; but, you don’t get to create your own definitons for a commonly understood prefix.

    Live with it. Own it. You’ll be surprised at the relief which comes from lifting such a burden from your guilt-laden shoulders.

  10. Macquarie University Publishers Packages says:

    Hi Anonymous, 

    This is because the vax only covers 70-80% of the viruses linked to cervical cancer. So testing should still be conducted for other strains  the vax doesn’t cover. 

    See the fact sheet at the Cancer Council “HPV are a group of over 100 different viruses. Some HPV types are more likely to lead to the development of cancer than others. At least 14 types of HPV have been found to cause cancer however the vaccine only protects against two out of the 14. Therefore, Pap tests are still critically important.

    Read more at http://www.cancercouncil.com.au/1060/cancer-information/cancer-risk-and-

  11. Patrick Stokes says:

    Leaving aside the strange and meaningless redundancy of quoting both a percentage and a ‘per 100,000 figure’, I wonder why Stephen Tunley failed to notice that the document he cites also notes that of the 2.3% administered Gardasil 9 who reported a serious adverse event only 4 (0.1%) were related to the vaccination (“pyrexia, allergy to vaccine, asthmatic crisis, and headache”); that 3.3% developing systemic auto immune disorders is “similar to rates reported following GARDASIL, AAHS control, or saline placebo in historical clinical trials” (my emphasis), and that 12.7-14.6% spontaneous abortion is “consistent with pregnancy outcomes observed in the general population.” Why did you leave out those details Mr Tunley?

    And just to mollify Ms Hart I’m also an SAVN admin, and proudly so.

  12. Dr Deirdre Little says:

    I am the author of one of the case series1 of idiopathic POI in schoolgirls following quadrivalent human papillomavirus vaccination. My first case was published in BMJ case reports2.  The peer-reviewed publication of my patient series analysed research presented as adolescent safety trials at licensing. Unfortunately, ovarian safety post vaccine was impeded by participant hormone contraceptive usage at 66% to 83% in older teens3. The young teen studies had very small numbers fully vaccinated and followed up at 12 and 18 months4, 5 The ‘saline’ placebo control for this vaccine target group was not saline. Contrary to Product Information at the time it contained polysorbate 80, which has exhibited delayed ovarian toxicity to rat ovaries at all injected doses tested over a tenfold range6. In 2016 I have notified 4 further cases of POI to the TGA (7 in total) and last week presented my review of published safety literature concerning the adolescent ovary post QHPV vaccine to the 19th International Congress on Autoimmunity in Leipzig at their invitation. There is no research attesting to ovarian safety after this vaccine. Discouraging adverse event reporting by un-evidenced statements to the contrary serves neither public vaccine confidence nor public health. This matter needs further research.

     

     Dr. Deirdre Little mbbs dranzcog facrrm

    VMO Bellingen District Hospital

     

     

  13. Dr Deirdre Little says:

    References relating to Dr Deirdre Little comment above

    1.           Little DT and Ward HRG. Adolescent Premature Ovarian Insufficiency Following Human Papillomavirus Vaccination: A Case Series Seen in General Practice. Journal of Investigative Medicine High Impact Case Reports. 2014; 2.

    2.           Little DT and Ward HR. Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination. BMJ Case Reports 2012;doi:101136/bcr-2012-006879. 2012.

    3.           Miller NB. Clinical Review of Biologics License Application for Human Papillomavirus 6, 16, 18 L1 VirusLike Particle Vaccine. (S. cerevisiae) (STN 125126  Gardasil) Center for Biologics Evaluation and Research Food and Drug Administration. 2006.

    4.           Gajdova M, Jakubovsky J and Valky J. Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats. Fd Chem Toxic. 1993; 31: 183-90.

     

  14. Chris Morgan says:

    Rachael,

    So why subject yourself to the risk of an adverse reaction if the protection is minimal?

  15. Ebony McKenna says:

    It continues to boggle me that people look for some kind of conspiracy in doctors caring so much about the health of their patients that they will go to extraordinary lengths to explain basic health concepts like vaccines to the public.

    It’s not a conspiracy, they’re doing their job.

    Vaccines don’t make gazillions of dollars, because once a person is vaccinated – either a few doses over a few months or at most a booster once every 5 years, the vaccine’s job is done and people don’t need them any more.

    Stop complaining about things that don’t exist and get worked up about actual conspiracies, like the Panama Papers and billionaires not paying taxes.

  16. Elizabeth Hart says:

    Yes Rachael Dunlop, I emailed you in May 2013, after I saw you interviewed on Channel Ten’s The Project program in relation to vaccination.

    Charlie Pickering introduced you saying “Dr Rachael Dunlop is a researcher from UTS. She’s also a podcaster, blogger and science communicator.”  I do not recall any disclosure of your position as an administrator of SAVN.

    You were also included in a discussion titled “Should immunisation be compulsory?” on ABC’s Life Matters in February 2015 where you were introduced as “… a cell biologist, an activist promoting the uptake of vaccination in Australia as Vice President of Australian Sceptics Inc”, but there was no disclosure of your position as an administrator of SAVN.

    I tried to leave some comments on the ABC’s “Should immunisation be compulsory” webpage, but my comments were not published, i.e. they were censored. 

    That’s not the first time comments of mine on an article associated with you have been censored.  Two of my comments were also censored on your article “A view on: vaccination myths”, published on The Conversation on 28 May 2013.  (I understand that people associated with SAVN are ‘moderators’ on The Conversation, can you confirm this?)

    In my email to you dated 24 May 2013 I enquired as to your expertise in the area of vaccination practice, asking if you were qualified to answer questions re MMR, HPV, pertussis and flu vaccines.

    You did not respond.

  17. Tracey McDermott says:

    Great article. 

    Some of the comments here from anti-vaccine activists helpfully demonstrate how prolific, but wrong they are.

    This is the issue that we have to deal with. They are everywhere, and it is difficult for the average person to understand what is real and what isn’t. As such, it is important for health care professionals to keep up to date with claims made by professional anti-vaccine advocates so that they can refute them confidentley. 

    For the benefit of Ms Hart, (who happens to run an anti-vaccine website), I am involved with SAVN, and a co-author on one of the papers mentioned in the article. 

     

     

     

  18. cswannell@mja.com.au says:

    To Miss Hart.

    As you can see, I am publishing most of your comments. However, that will not continue if you persist in — to coin a sporting phrase — play the man, rather than the ball. Pointing out the pro-vaccination stance of the scientists involved in this article and subsequent discussion is a bit like telling a teacher they’re pro-education. Scientists are pro-vaccination because they understand the science. It’s that simple. Try rebutting the science if you want a meaningful debate.

  19. Macquarie University Publishers Packages says:

    “Rachael,

    So why subject yourself to the risk of an adverse reaction if the protection is minimal?”

    Ah the nirvana fallacy, one of the favourite canards of the anti-vax movement. Last time I checked, 70% was not minimal. It’s a lot better than 0%, wouldn’t you say Anonymous? 

  20. Macquarie University Publishers Packages says:

    One might think I have the time or the inclination to answer blithering nonsense in long emails from anti-vaxers, but the simple fact is I have neither Elizabeth. I have never made it a secret that I admin SAVN, it’s very clearly on my TC profile. 

    In places where I have less control over content, for example in 2 min television reports or radio broadcasts, and it gets left out, it’s more likely to be a time issue than a conspiracy. I understand you desperately want it to be the latter, but you’re right out of luck I’m afraid! 

    You might also see Jo Benhamu’s comment here that details what precisely constitutes a COI. She maintains being a non-remunerated page admin on Facebook does not constitute a COI. I prefer to be as transparent as possible, so I declare it anyway, but since it involves no financial incentives I probably don’t need to do so. 

    As for SAVN admins on TC, you’d need to ask them or TC. I’m neither.  

     

  21. Randal Pittelli says:

    “It continues to boggle me that people look for some kind of conspiracy…”

    I haven’t heard anyone here claim there’s been a conspiracy (is there truly one wrt Panama?). Just as we need to be careful when asserting conspiracies, we need to be careful not to paint dissenters as conspiracy theorists. Take Wilyman, for example, who was recently lambasted in the media for supposed ‘conspiracy theories’ claimed in her thesis. Experts dutifully lined up denouncing her thesis for its ‘conspiracy theories’. The thing is, she never once used the term in her thesis.

    Conspiracy or not, there were real issues with how HPV vaccines were approved and marketed. It was fast-tracked, which IMO itself was scandalous, and at the time lobbyists were pushing for approval, vaccine efficacy against cancer was unknown because its effectiveness at preventing infection was not known to be nearly complete (if it turned out to be significantly less than 100% effective, it would be impossible to quantify its effectiveness against cancer). But by ‘cancer’ I mean the proxies used for cancer — we are still assuming pre-cancerous lesions, most of which would never become cancer, tell us how much cancer will be prevented.

    What makes some clinicians hate the scientific process so much, that they would denounce any criticism of vaccination as part of some evil force (conspiracy?) that must be hunted down and snuffed out? The ends, even if it were so black and white, does not justify the means.

  22. Randal Pittelli says:

    Editor Cate, To be fair, I don’t think it’s as simple as saying scientists are ‘pro-vaccination’, just as it’s not accurate to label critics of vaccination policy as anti-vaccination. The false dichotomy itself is ideological, kinda like how activists like to use the term ‘climate change’ to mean ‘predominantly anthropogenic global warming’, while dissenters are often called ‘denialists’.

    Ms. Hart from my understanding is not anti- (against) vaccination per se — any implication that she is (like several posts above yours) I would think is ‘playing the man’. Meanwhile there are many scientists who have issues with, say, fast-tracking vaccines (not the intended purpose of fast-tracking) or mandatory vaccination (which even from an ethical point of view at least used to be controversial in healthcare), who are nonetheless supportive of vaccines and (at least voluntary) vaccination programs.

    Dr. Randal Pittelli

  23. Elizabeth Hart says:

    Gardasil HPV vaccination was originally rejected for addition to the Australian National Immunisation Program Schedule by the Pharmaceutical Benefits Advisory Committee (PBAC) in 2006[1], a decision that was overturned within 24 hours after interference by then Coalition Prime Minister John Howard in the run-up to the 2007 federal election, when Gardasil vaccination was implemented for girls.[2] [3]

    In July 2012 then Labor Federal Health Minister Tanya Plibersek oversaw implementation of Gardasil vaccination for boys with enthusiastic public support from Ian Frazer.[4]  In his official message of support for the funding of the national HPV vaccine program for boys[5], Ian Frazer failed to declare his conflict of interest, i.e. that he receives royalties from the sale of HPV vaccines in the developed world.[6]

    The basis for mass vaccination with the Gardasil HPV vaccine to prevent cancers such as cervical cancer is highly questionable.  I suggest Gardasil HPV vaccination should not be on the taxpayer funded schedule, and that the fast-tracked implementation of this still experimental vaccine product in 2006/2007 should be subject to an investigation.

  24. Elizabeth Hart says:

    References for my previous comment above:

    1. Australian Government Funding of Gardasil® Archived Fact Sheets.

    2. See for example Haas, Marion. Government response to PBAC recommendations. Health Policy Monitor, March 2007.

    3. Significant events in human papillomavirus (HPV) vaccination practice in Australia. NCIRS Fact Sheet.

    4. See for example: Schoolboys to get Gardasil vaccine. Brisbane Times, 12 July 2012.

    5. Message of Support from Professor Ian Frazer AC (creator of the HPV Vaccine) Funding of national HPV vaccine program for boys. 12 July 2012.  This letter does not acknowledge Ian Frazer’s conflict of interest, i.e. that he receives royalties from the sale of HPV vaccines in developed countries.  

     6. “Ian Frazer as co-inventor of the technology enabling the HPV vaccines receives royalties from their sale in the developed world.”  This information was included in a disclosure statement on Ian Frazer’s article Catch cancer? I’d rather have a shot!, published on The Conversation, 10 July 2012.  I suspect that this disclosure was not made in mainstream news articles at the time, see for example: Schoolboys to get Gardasil vaccine, Brisbane Times, 12 July 2012. This article notes “The Queensland scientist who created the cervical cancer vaccine has hailed the decision to fund immunization for boys”.  The article does not disclose Ian Frazer’s conflict of interest, i.e. that he receives royalties from the sale of HPV vaccines in developed countries.

     

  25. Jennifer Jones says:

    Is this the same Julia Brotherton who some years ago reported that Gardasil caused anaphylaxis? 

    http://www.cmaj.ca/content/179/6/525.full?sid=6b4edb4b-32a3-4787-81d5-32

  26. cswannell@mja.com.au says:

    Jenny … How you can claim that CMAJ article says Gardasil “causes” anaphylaxsis just beggars belief. Very mischievous. The What it actually says is “From the 269 680 HPV vaccine doses administered in schools, 7 cases of anaphylaxis were identified, which represents an incidence rate of 2.6 per 100 000 doses” 

     

  27. Carl Bazergy says:

    Editor Cate, I believe your quote of the CMAJ article justifies Jenny’s statement in that the trial showed that Gardasil caused anaphylaxis in 7 patients in the study.

  28. Randal Pittelli says:

    I don’t think Cate was challening the causative nature of the 7 cases of anaphylaxis, but the mischief with bringing up a (relatively modest) risk of anaphylaxis without putting it into perspective.

    By comparison, penicillin, probably the safest antibiotic, is believed to cause up to 2 *fatal* anaphylaxis events per 100,000 doses administered (compared to the reported 2.6/100,000 *all* anaphylaxis events for HPV vaccine).

  29. Elizabeth Hart says:

    HPV vaccine entrepreneur Ian Frazer admits the risk of cancer associated with HPV is very low, saying: “Through sexual activity, most of us will get infected with the genital papillomaviruses that can cause cancer.  Fortunately, most of us get rid of them between 12 months to five years later without even knowing we’ve had the infection.  Even if the infection persists, only a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells.”  (My emphasis.)  (Ian Frazer made this statement in his article promoting HPV vaccination, i.e. Catch cancer? No thanks, I’d rather have a shot!, published on the Australian government and university and CSIRO-funded The Conversation website in July 2012,[1] at the time Gardasil HPV vaccination was being introduced for boys in Australia[2].)

    Ian Frazer admits only “a few individuals accumulate enough genetic mistakes in the virus-infected cell for these to acquire the properties of cancer cells”.  

    Given the admitted low risk associated with HPV and cancer, I question whether it is justifiable to compel children to have HPV vaccination.

Leave a Reply

Your email address will not be published.