Leslie Carol Botha: Elizabeth Hart posted a comment on the article I wrote on India Women Activist’s Historic Writ of Petition over Unethical Trialing of HPV Vaccines, Gardasil® and Cervarix® Accepted by Supreme Court and included a link to this well documented and researched letter she wrote to the Editor-in-Chief of The Australian. Her letter is reprinted with her permission.
8 October 2012
Open letter for the attention of:
Mr Chris Mitchell,
Editor-in-Chief, The Australian
Is universal HPV vaccination necessary?
A recent ‘exclusive’ report in The Australian noted that University of Wollongong PhD student Judy Wilyman had “questioned the value of the vaccine Gardasil in the fight against cervical cancer” (University stands by anti-vaccine student, Rick Morton, 26 September 2012.)
While Ms Wilyman’s views on vaccination are highly controversial, she is not alone in questioning the value of the HPV vaccine against cervical cancer. Citizens are entitled to ask well-founded questions about vaccination when it appears powerful vested interests are pressing lucrative medical interventions on healthy people. In my opinion the HPV vaccine being urged upon 12-13 year old’s is highly questionable, as even the co-inventor of the technology enabling the HPV vaccines, Ian Frazer, has admitted the risk of cancer is very low.
In an article titled “Catch cancer? No thanks, I’d rather have a shot!,” published on the CSIRO and university funded website The Conversation (10 July 2012), Ian Frazer stated: “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.”
The National Cervical Screening Program (NCSP) website notes: “HPV infection is very common and in most people it clears up naturally in about 8-14 months…Genital HPV is so common that it could be considered a normal part of being a sexually active person. Most people will have HPV at some time in their lives and never know it…A few of the many types of HPV have been linked with causing abnormalities of the cervix and in some cases the development of cancer of the cervix.” The NCSP website highlights that: “It is important to remember that most women who have HPV clear the virus naturally and do not go on to develop cervical cancer.”1
I suspect many Australians are unaware of this apparently benign information on the risks of HPV, because a few days after publication of his article on The Conversation, Ian Frazer and Federal Health Minister Tanya Plibersek beat up the dangers of HPV in the mainstream media 2 3 (including a report in The Australian 4) while promoting ‘Australia’s world first’ HPV vaccination for boys, and overlooked mentioning the fact that Professor Frazer receives royalties from sales of the HPV vaccines in developed countries. (This pertinent information about royalties was not included in Minister Tanya Plibersek’s media release 5, nor Ian Frazer’s ‘Message of Support’ 6.)
Considering the concerted push for global HPV vaccination 7 , for example the recent announcement that a million 11 and 12 year old girls are to be vaccinated in Mexico 8 , I suggest the thoughts of Professor Emeritus David Sackett, (a pioneer of evidence based medicine), on “the arrogance of preventive medicine” be borne in mind, i.e.:
“But surely the fundamental promise we make when we actively solicit individuals and exhort them to accept preventive interventions must be that, on average, they will be the better for it. Accordingly, the presumption that justifies the aggressive assertiveness with which we go after the unsuspecting healthy must be based on the highest level of randomized evidence that our preventive manoeuvre will, in fact, do more good than harm. Without evidence from positive randomized trials (and, better still, systematic reviews of randomized trials) we cannot justify soliciting the well to accept any personal health intervention. There are simply too many examples of the disastrous inadequacy of lesser evidence as a basis for individual interventions among the well: supplemental oxygen for healthy premies (causing retrolental fibroplasia), healthy babies sleeping face down (causing SIDS), thymic irradiation in healthy children, and the list goes on.”9
I agree the ‘unsuspecting healthy’ need to be cautious of so-called ‘preventive manoeuvres’ being pushed by a pharmaceutical industry looking for new markets. An article in New Scientist in late 2011 reported: “While the rest of the pharmaceutical sector struggles to keep afloat as expiring patents send profits plummeting, the vaccine industry has become remarkably buoyant.”10 A recent report on the global vaccines market notes: “Thanks in part to the adult influenza market and vaccines such as Gardasil and Prevnar, the global vaccines market has enjoyed a decidedly solid boost in revenue. Ten years ago, the vaccine market sat at $5.7 billion dollars…now, that market has soared to $27 billion.”
For the first half of the financial year, Merck’s Gardasil HPV vaccine is the third best-selling vaccine with sales of $608 million, and GlaxoSmithKline’s Cervarix ranks at No. 8 with sales of $285 million.11
With vaccine manufacturers sizing up the potential for lucrative global vaccine markets, and scientists lining up for vaccine royalties, there are strong vested interests to consider. Couple this with queries re the long-term efficacy of the vaccine, inadequately researched possible adverse reactions to vaccination, plus the, in effect, limited liability of international vaccine manufacturers, and the ‘unsuspecting healthy’ need to be very wary indeed.
The Cochrane Collaboration has initiated a systematic review of HPV vaccination 12 and it will be interesting to analyse their review of industry sponsored HPV vaccine trials in due course. A paper published in June in the Journal of the Royal Society of Medicine raises questions about the conduct of HPV trials in India. 13 Recently, (September 2012) the authors of this paper stated: “Whether HPV vaccine will reduce cervical cancer incidence and mortality rates is completely unknown and yet HPV vaccine is being promoted, promulgated and sold world-wide in the absence of absolute proof of principle, relying on proxy endpoints. At the same time, information about the evidence underpinning the decision making process is unpublished and not in the public domain.”14
As things stand, I remain unconvinced of the need for universal HPV vaccination, and suspicious of the motives for its promotion. I also suggest public confidence in the (ever-growing) national vaccination program is at risk of being undermined by the addition of vaccines of questionable value. Given the low risks of HPV admitted by Ian Frazer and the Federal Government’s National Cervical Screening Program, I am astonished Merck’s Gardasil HPV vaccine, (distributed by CSL in Australia), was fast-tracked onto the Pharmaceutical Benefits Scheme 15 and the National Immunisation Program Schedule. 16 I suggest there should be an urgent independent investigation into this matter.
Mr Mitchell, HPV vaccination is not beyond question. Citizens rely on an objective media to provide impartial information, independent thinking, factual reporting and penetrating analysis. 17 I suggest Rick Morton’s article failed in this regard, by fueling the polarised pro/anti vaccination argument without acknowledging that there are legitimate concerns about the ever-increasing amount of ‘recommended’ vaccines, and the burgeoning international vaccine market. The media should provide fair and objective analysis on this topic rather than foster crude polemics.
*Note: For further discussion on this topic, also refer to comments on The Conversation’s article ‘Study should dispel HPV vaccine myths’18
References: (Links current as at 8 October 2012. Copy and paste link into browser if link doesn’t connect.)
1. HPV (human papillomavirus). National Cervical Screening Program. Australian Government Department of Health and Ageing:
2. Boys to get free Gardasil vaccine. ABC News. 12 July 2012
3. Schoolboys to get Gardasil vaccine. Brisbane Times, 12 July 2012: http://www.brisbanetimes.com.au/queensland/schoolboys-to-get-gardasil-vaccine-20120712-21xqg.html
4. Boys first in cancer vaccine rollout. The Australian, 13 July 2012: http://www.theaustralian.com.au/national-affairs/health/boys-first-in-cancer-vaccine-rollout/story-fn59nokw-1226424883455
5. HPV Vaccine Extended to Boys. Media release – Tanya Plibersek, Minister for Health. 12 July 2012: http://www.health.gov.au/internet/ministers/publishing.nsf/Content/mr-yr12-tp-tp059.htm
6. Message of support from Professor Ian Frazer AC (creator of the HPV vaccine): Funding of national HPV vaccine program for boys. 12 July 2012: http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/home/$file/Frazer-message-of-support.pdf
7. Preparing for the introduction of HPV vaccines. Policy and programme guidance for countries. World Health Organisation. WHO reference number WHO/RHR/06.11. 2006: http://www.who.int/reproductivehealth/publications/cancers/RHR_06.11/en/index.html
8. Mexico orders HPV vaccinations for all 5th-grade girls, saying it will end threat of cervical cancer. The Kansas City Star, 3 October 2012: http://www.kansascity.com/2012/10/03/3846457/mexico-orders-hpv-vaccinations.html
9. Sackett, D. The arrogance of preventive medicine. CMAJ. Aug. 20, 2002; 167 (4) 363-364:
10. Debora MacKenzie. Vaccines enjoy a healthy return. New Scientist. 28 September 2011. Magazine issue 2831:
11. 20 Top-selling Vaccines – H1 2012. FierceVaccines, 25 September 2012:
12. Arbyn, M et al. Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors. Cochrane Summaries:
13. Controversial vaccine trial should never have been run in India, researchers say. Royal Society of Medicine Media release, 21 June 2012: http://www.rsm.ac.uk/media/pr305.php Reference details for the paper: Mattheij, I, Pollock, AM, Brhlikova, P. Do cervical cancer data justify HPV vaccination in India? Epidemiological data sources and comprehensiveness. J R Soc Med June 2012 vol. 105: 250-262: http://www.ncbi.nlm.nih.gov/pubmed/22722970
14. Pollock, AM, Brhlikova, P, Mattheij, I. Letters, J R Soc Med 2012: 105: 366-367:
15. Australian Government Funding of Gardasil. Archived Fact Sheets:
16. National Immunisation Program Schedule. Immunise Australia Program. Australian Government Department of Health and Ageing:
17. The Australian – A word from our Editor-in-Chief: http://www.newsspace.com.au/the_australian
18. Study should dispel HPV vaccine myths. (Charis Palmer, News Editor). The Conversation, 2 October 2012: https://theconversation.edu.au/study-should-dispel-hpv-vaccine-myths-9914#comments