July 29th 2017

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COVER STORY The rise and rise of Old King Coal

EDITORIAL Behind Donald Trump's endorsement of Poland

CANBERRA OBSERVED Cory Bernardi claims strong flow to his ranks

INTERNATIONAL AFFAIRS Liu Xiaobo's extraordinary courage remembered

INTERNATIONAL AFFAIRS Why we must fight for freedom: Trump in Poland

HEALTH Gardasil(R) and the man upon the stair, Part II

INTERNATIONAL AFFAIRS Death of caliph will hasten end of Islamic State

MUSIC What's in a tune: minor change makes a major difference

CINEMA Spider-Man: Homecoming: Reboot on a domestic scale

BOOK REVIEW Moves that may push our constitution over

BOOK REVIEW Exposing the transgender agenda


GENDER POLITICS Edmund Rice Education Australia proposes transgender sex-ed

GENDER POLITICS Melbourne mum goes viral on 'Safe Schools'

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Gardasil(R) and the man upon the stair, Part II

by D Little

News Weekly, July 29, 2017

Yesterday upon the stair I met a man who wasn’t there. He wasn’t there again today ...

Dr Deirdre Little is a general practitioner in Bellingen, NSW. She has worked in primary care and GP obstetrics for over 30 years. In the first part of this two-part series, Dr Little outlined the investigations she had made and the research she had published in which she raised questions about the trialling and safety of the Gardasil® vaccine. In this part, she reviews some of the resistance she has come up against within the drug research community to her findings, although, as she says, her findings have not been refuted.

This author has now notified the therapeutic Goods Administration of seven cases of premature ovarian failure in very young women following Gardasil® vaccination. No, notifications don’t mean causation, but can raise safety signals.

The Vaccine Adverse Event Reporting System (VAERS) in the United States also presents some worrying facts. In the 10 years between the release of Gardasil® in 2006 to February 2016, there were 123 reports of missed periods after this vaccination. Only one of these girls was tested for menopause. The result was positive. Only one was tested for ovarian reserve. The result showed “sudden ovarian insufficiency” in the words of the notifying endocrinologist. Another had hormone testing, reported as “irregular”.

The diagnosis of the other 120 girls is unknown. Another 18 girls’ reports are classified as “ovarian disorder”, “ovarian failure” or “premature menopause” following Gardasil® vaccination. Although the term “premature ovarian insufficiency” has properly replaced “menopause” and “ovarian failure”, it is still not a VAERS diagnostic category, so cases are haphazardly assigned to a spray of other categories.

The same is true for the TGA. We do not know the background rate of young teens randomly entering menopause for no reason, coping with hot flushes in high school, because the condition is so rare it has never been measured in this age group. We can’t compare the notification rate of premature ovarian insufficiency after Gardasil® with its prevalence in young schoolgirls. Claims that the notification rate suggests no concern are not evidence based.

Julia Brotherton has been the medical director of Australia’s National HPV Vaccination Program. Her scientific response to the above cases in Insight, the Medical Journal of Australia’s magazine, with co-authors David Hawkes and Marion Saville, draws on the 200,000,000 distributed doses as assuring [1] enduring safety for ovaries.

Manufactured dose numbers, however, cannot be relied upon. Epidemiology needs to consider how many adolescents are on the contraceptive pill; how many have a contraceptive implant; how much teenage acne is treated with the pill? Critically, how many girls’ cycle disruption is treated with the pill? Each published Australian case had been “treated” with the pill, masking symptoms and delaying diagnoses for up to five years.

The Insight article overlooks the fact that only a tiny proportion of possible drug-adverse reactions are ever notified to the Therapeutic Goods Administration. It does not mention that even this number is falling. Indeed, the TGA’s latest performance report warns of a “serious decline in general medical practitioners reporting adverse drug reactions”.[2]

Reliance on the 200,000,000 factory doses as evidence of ongoing ovarian safety assumes doctors are notifying all cases of premature ovarian insufficiency after Gardasil® vaccination. However, the median under-reporting rate of serious and severe adverse drug reactions is 94 per cent.[3]

Research shows it normally takes five years to diagnose just 75 per cent of premature ovarian failure[4] in the community, and 25 per cent will then still remain undiagnosed. Furthermore, only 39 per cent of women who miss periods actually consult a doctor.[5]

Of some concern, the Medical Journal of Australia’s magazine, Insight, is published by the Australian Medical Association. It refers GPs and patients alike to the “excellent” blogsite Skeptical Raptor, “providing evidence about vaccine safety”. The site wrongly insists a saline placebo was used. A saline placebo was not used. Endorsement and reliance on such a blogsite could undermine public vaccine confidence and discourage pharmacovigilance by advocating and directing readers to an unreliable blogsite that disdains these notifications.

David Hawkes elsewhere disappointingly states there is no reason to be concerned that the original safety trials did not report new medical conditions, such as ovarian disorders, after month seven. Month seven happened also to be the time when safety trial participants were allowed to stop using contraception. Only then could ovarian disorders have become visible.

He writes that my co-author and I have provided “no rationale or biological mechanism for including a longer interval between HPV vaccination and the onset of premature ovarian insufficiency”![6] The biology is basic. If you stop recording new medical conditions exactly when you permit hormonal contraception to cease, you accidentally ensure you won’t pick up menopause or any other ovarian disturbance.

While events defined as life threatening – those needing hospitalisation and lethal outcomes – are still recorded after the seven months, deteriorating menstrual cycles will not signal among these “serious adverse events”. Rigorous scientific responses are owed to rigorous scientific questions.

There is a serious need for research into the mammalian ovary’s egg-bearing capacity after quadrivalent human papillomavirus vaccination. It is not known whether these ovarian events are or are not related to Gardasil®. This may all be a coincidence, just a temporal correlation, but we need to know. We need to complete the rat studies for the developing female ovary to the same degree as those for the male testis after Gardasil® vaccination. Meanwhile, its adjuvants and its excipients warrant closer review. A comparison of vaccinated and unvaccinated cohorts is also in order.

Yes, this vaccine has a role to play in preventing human papillomavirus cancers and deaths. Its total effect, however, is awaiting measurement at a population level. But premature ovarian failure, if related, also shortens life expectancy. A Swedish study of 22,000 women after menopause found those entering menopause even at age 40 to 45 had a 40 per cent greater risk of cardiac failure than those entering menopause after 50.[7] For each year’s delay in menopause onset the rate of cardiac failure fell 2 per cent. We don’t know the cardiac implications for teenagers entering early menopause.

For any medication, the benefits must substantially outweigh the risks. However, for vaccines given to well persons, the evidentiary levels of safety must meet the highest standards of all. Benefits and risks must be well researched, knowable as far as is possible and documented.

It is simplistic to accuse peer-reviewed questioning of being “anti-vaccination”. Vaccine confidence in the community is best upheld by sound research, scientific responses and pharmacovigilance. Family doctors like myself are committed to providing vaccination upheld by the pillars of science at one end, and to be there at the other end for those rarer adverse outcomes that may just possibly have slipped through the net. Pharmacovigilance.

What we don’t expect is for country town GPs to have to tell the TGA that Gardasil’s ® Product Information is wrong – that it misrepresents its trial placebo as “saline”. We don’t expect to be the ones who have to politely mention that the million-girl post-marketing study didn’t actually check for ovarian events, or to have to point out that girls with irregular periods don’t go to accident and emergency departments for a consult. Irregular periods won’t show up in accident and emergency studies. We don’t expect to have to do the literature review showing no published research has tested and evidenced the adolescent ovary’s ongoing post-vaccine safety. Neither do we expect to be denigrated for vaccine-adverse event reporting and for careful scientific peer-reviewed documentation. The efficiency and risk-benefit of all pharmaceutical products including vaccines relies on sound, transparent research and on pharmacovigilance.

Sixteen is an exhilarating, exciting age. The first breeze of life’s capacity wisps into schoolrooms, studies and friendships. It uplifts young eyes to see and sense the new season of adulthood, a richly hopeful and rightly protected space. Year 11. Even the number makes promises. Let’s not break them.

In the words of Edward Jenner: “I shall continue to prosecute my inquiry”.

NB: All young women and parents of girls who have a diagnosis of premature ovarian failure, premature menopause or premature ovarian insufficiency which began with abnormal periods after the Gardasil® course should notify the Therapeutic Goods Administration of their diagnosis.


[1] J. Brotherton, D. Hawkes and M. Saville, “Vaccination questions need patient response”, MJA InSight, April 11, 2016.

[2] M. Woodhead, “Concern over fall in GP adverse drug effect reports”, in Australian Doctor. October 7, 2016.

[3] L. Hazell and S.A. Shakir, “Under-reporting of adverse drug reactions: a systematic review”, Drug Safety, 2006, 29(5), pp385–396.

[4] N.H. Alzubaidi, H.L. Chapin and V.H. Vanderhoof, “Meeting the needs of young women with secondary amenorrhoea and spontaneous premature ovarian failure”, Obstetrics and Gynecology, May 2002, 99(No.5, Part 1).

[5] K. Munster, P. Helm, and L. Schmidt, “Secondary amenorrhoea: Prevalence and medical contact: A cross-sectional study from a Danish county”, Br J Obstet Gynecol, May 1992, 99, pp430–33.

[6] D. Hawkes and J. Buttery, “Human papillomavirus vaccination and primary ovarian insufficiency: an association based on ideology rather than evidence”, Current Opinion in Obstetrics and Gynecology, February 2016, 28(1), pp70–72.

[7] I. Rahman, A. Akesson, and A. Wolk, “Relationship between age at natural menopause and risk of heart failure”, Menopause, January 2015, 22(1), pp12–16.

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