A fact sheet should have facts

There are only two organs in the human body where we know the cause of cancers that effect them.

One is the liver, which has shown a definite link between the hepatitis B [HBV] virus and liver cancer. The other is the cervix with an irrefutable link between human papillomavirus [HPV] and cervical cancer. As we have vaccines to prevent infection with these viruses, HBV derived liver cancer and cervical cancer may thus be considered “preventable cancers”.

In the case of the HPV vaccine, anti-vaccine lobbyist and University of Wollongong student Judy Wilyman continues to deny its success. A cervical cancer “fact sheet” on her web site contains irrelevant or misleading snippets of misinformation. Designed to create a fiction, the item is anything but a “fact sheet”.

It begins with the confusing claim that the HPV vaccine Gardasil was not trialled against cervical cancer. Rather it was trialled in 16-26 year old women against pre-cancerous lesions. Wilyman criticises the age group because women therein rarely present with cervical cancer. She criticises the focus on pre-cancerous lesions because most do not lead to cervical cancer.

Later Wilyman observes that cervical cancer takes 8-25 years to develop answering her own concern about lower rates of cervical cancer in the sample group. With respect to pre-cancerous lesions her thinking is disturbing. Cervical cancer develops from these lesions and the trial demonstrated a reduction in development by almost half.  Unsurprisingly Wilyman then notes the death rate is 1.9/100,000 – “a very low risk to Australian women”.

We’re informed, “there are more than 15 high risk strains associated with cancer not covered by the vaccine”. Strange. Now Judy has a sudden concern for cancers caused by HPV? No. She’s omitted that 70% of cancers are caused by HPV strains 16 and 18 and that Gardasil also targets HPV 6 and 11, responsible for 90% of genital warts. The vaccine is almost 100% effective against these strains.

We read that, “the duration of this vaccine is unknown as it has only been tested in adults for 3-4 years”. I’m sure Judy means the duration of immunity. Perhaps she overlooked the role of antibody response and concentration in predicting immunity. The reality is that whilst research is ongoing, close to 100% protection remained after five years. Protection shows no signs of weakening. Whilst the need for a booster has not yet been established it appears to be unlikely that it will.

  • “We don’t know how long vaccine protection will last”, is regarded as a Myth by the Australian Cancer Council.

Further criticism of trials include the observation that, “in young women pre-cancerous lesions have a high clearance rate and do not always lead to cancer”. This completely ignores the necessity to vaccinate before the onset of sexual activity and exposure to wild HPV. Vaccines are preventative, not curative. It is a most strange complaint from a “PhD candidate”, failing to understand the very aim of the trial.

Five separate references to trials being conducted and funded by drug companies are listed. This assumed conspiracy is frequently cited by Wilyman in regard to all vaccines without making any links to, or cogent arguments about, inefficacy or unsound trials. Conflict of interest and the influence of drug companies should be, and is, taken very seriously by relevant sections of the scientific community. But accusatory assumption without evidence is unacceptable.

Wilyman seems to deliberately mislead by documenting as a “concern” that 94 deaths and 21,635 adverse reactions are associated with Gardasil. Citing anti-vaccine lobby group S.A.N.E. she then notes that only 10% of reactions are picked up by the passive surveillance systems that produced those figures. What does this mean?

When authorities talk of under-reporting in passive surveillance they refer to minor events – soreness, redness, swelling, a bit queasy post influenza jab etc. These are so minor as to be inconsequential to the recipient, thus never reach the vaccine provider for reporting to the system. Her intent is to insinuate close to 950 deaths and well over 200,000 adverse reactions are possibly/probably associated with or causally linked to Gardasil.

Of reactions that are reported there is no evidence of any link. Great efforts are made to convey causality has not been demonstrated. All that’s known is that the event occurred sometime after vaccination. Also, reports remain on the database no matter how unlikely or ridiculous. Despite easy access on how to avoid the trap Judy Wilyman has set, she has chosen to obfuscate the reality.

These reporting systems exist to highlight trends from which likely adverse reactions are chosen for follow up study. It’s the findings of these studies that provide any evidence backed conclusions on adverse reactions. When links are shown to not exist the reports still remain on the database.

We may confidently dismiss her figures of 94 deaths and 21,635 adverse reactions. Conclusions cannot be drawn from unverified reports.

The “fact sheet” also includes claims that the aluminium adjuvant is, “known to cause allergies/anaphylaxis and auto-immune reactions in humans”. This claim has been criticised with regard to many vaccines. With 65 million doses of HPV vaccine given safely in over 100 countries, rates of serious allergic reactions are being recorded at about three per one million doses.

Nonetheless a paper cited by Wilyman does speculate on a possible role of adjuvants in auto-immune disorders. It must be stressed that in this review vaccine adjuvants alone have not been identified, nor is there any robust research behind the proposition. Possibly, Wilyman has not read the material.

Certainly, Judy Wilyman selectively cites trial methodology. Ignoring use of saline placebo in safety trials [page 4], she zeros in on AAHS because it’s “not a true placebo used to test safety”:

The manufacturer funded clinical trials used the adjuvant, aluminium hydroxyphosphate sulphate as the placebo in the unvaccinated group: a chemical known to be linked to adverse events including autoimmune diseases

One cannot stress enough that aluminium hydroxyphosphate sulphate is not “known to be linked” to ADRs or autoimmune disease. Five months later the authors write in The Rheumatologist:

Taking it all together, it seems that enigmatic but nevertheless common and often disabling complaints can coincide in many individuals diagnosed with siliconosis, MMF, GWS, or postvaccination events […]

Moreover, genetic links observed in animal models, and in the human disease MMF, bring about the notion that the adjuvant effect promotes the appearance of an adjuvant disease in subjects who are genetically susceptible or in those who encounter an additional trigger…

At best this is speculation. At worst the authors are attempting to coin a new syndrome based on review and suggest it be used to label challenging diagnoses. Examining their contention nonetheless, it’s clear they refer to a rare and individualised pathology.

Wilyman also cites anti-vaccine lobby group Immunisation Awareness Society, N.Z. in claiming that juvenile, rheumatoid and osteoarthritis are caused by Gardasil. As recently as January this year another study found no evidence of this.

  • “The vaccine has serious side effects that aren’t being reported” is considered a Myth by the Australian Cancer Council.

No attempt is made to mention the Australian HPV Register and its role in ongoing assessment. A large portion of Wilyman’s so-called fact sheet seeks to demote the risk of HPV infection, relegating it to developing nations or to a small promiscuous section of our community.

The rest seeks to spook readers into feeling that 200 cervical cancer deaths annually and unnecessary genital warts is acceptable collateral damage.

It is a biased and misleading document.

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About @advodiaboli
I'm not really a cast iron flying pig.

7 Responses to A fact sheet should have facts

  1. Ken McLeod says:

    I think I understand now.

    “in young women pre-cancerous lesions have a high clearance rate and do not always lead to cancer”. So we don’t need to immunise because some don’t develop cancer. Most cars are not involved in accidents, so why do we have seat belts?

    “Five separate references to trials being conducted and funded by drug companies are listed.” Boeing funds and conducts all its own research and development and testing and downstream monitoring, so why should we trust them?

    And she’s a PhD student?

    • Andrea Leong says:

      You doesn’t need great research skills or intellectually honesty to be a PhD student for a time. To enrol, you have to convince you supervisor that you have the capacity and a willingness to learn these skills. How long you can get away with it depends on how much your supervisor cares, and your uni’s review procedures.

      (I’m a PhD student.)

      • Andrea Leong says:

        Grammar: also not vital for PhD candidature. What was a doing for the 10 seconds when I should’ve been proofreading?

  2. Deb says:

    A former science teacher who doesn’t understand controlling variables, something taught from year 4 onwards. The placebos in trials are not acting as therapeutic placebos but as controls, therefore they should only have one difference from the active arm.

    Using lobby groups of sources of anything other than feelings? I wouldn’t have got away with that in my bachelor’s degree.

  3. Cytologist says:

    The reason we have such a low cervical cancer death rate is because we have possibly the worlds best screening program. She’s forgetting the thousands of cone biopsies/ LLETZ excisions done every year on women with high grade abnormalities (lesions that are more likely to become invasive if not treated) – the vaccine will not only prevent deaths in unscreened women, but also reduce the number of these costly procedures. Due to the success of the vaccine, the screening interval is also likely to change from 2 years to every 5 years in the near future, saving more money.

    • Andrea Leong says:

      Apparently Australian doctors are quite good at preparing pap smears at well, so they’re very likely to pick up any abnormalities (just a comment from a doctor acquaintance of mine who has worked here and in the UK (oooh, anecdotal)).

      Gardasil was made available in Australia when I was 21. I didn’t rush out to get it. About six months later I went for my scheduled pap smear, and it returned a “CIN2/3” result. Subsequently, I had a colposcopy, biopsy, and laser ablation (and 1-, 6-, and 12-month check up pap smears). Boy was my face red.

  4. Pingback: On HPV and cancer | complexitydaemon

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