[Hilary Butler Letter re Gardasil vaccine Dec 2007]
In response to this article here: Are we sure Gardasil is safe? I’d like to be more detailed.
25 harrisville Road,
If you want to look at how effective Gardasil is, do two things:
1) Read this medical article from New England Med J May 2004. = 17%
2) If you are a mathematician, have a look at Merck's deliberately
convoluted 464 pages of data to the FDA:
If you work the data using other variables at best you get a 13% effectiveness, and as the Sawaga NEMJ article says, in those vaccinated, the rates of non-Gardasil viruses were higher, so already in a small trial, they had serotype replacement.
Work out how many people get a positive pap smear. In NZ it's 1 per 146 HPV infected returning a positive pap of any sort. Many of those naturally regress. So at best this vaccine might help one per 200 people, but only for two types. But even then, most of those people will NOT go on to get cancer.
Using Sawaga’s New England Medical Journal HPV data and the USA population for example, you can work this out:
2 million girls born each year (U.S. census data) divided by 10,500 new cases of invasive cervical cancer diagnosed each year (CDC) means that there's a 1:190 lifetime risk
(1 woman out of every 190 will be diagnosed with a CIN 3 smear)
When Sawaya reported the 17% efficacy of the vaccine in the general population, the lead Merck researcher responded that at least that was better than the 13% efficacy they had found in their licensing trials. Let's be nice and take the 17% efficacy, multiply it against the lifetime risk to give 1:1118
That means that the vaccine will prevent one case of CIN3 lesions for every 1,118 women vaccinated.
But only 12% of CIN3 develop into cancer, so we have to multiply by 12% to give us the vaccine protective effect against cancer. The answer is 1:9,317
That means the vaccine prevents one case of cervical cancer for every 9,317 women vaccinated.
You need to find a mathematician to do that data for Australia, because on that data alone, Ian Frazer’s statement:
He stands by the safety and effectiveness of his vaccine: "If 17 girls a week have been reported as having adverse reactions amongst 2.2 million women immunised in Australia to date, that sounds like a pretty small rate to me."
That's one in every 4,400 women.”
Is also a nonsense. The balance of risk/benefit does not stack up. It does for him, because he assumes that in 40 years time, his vaccine will have a 100% efficacy. If it only has a 17% ACTUAL efficacy now, then he is living in cuckoo land.
Furthermore, look what the FDA says here about page 85-88: http://www.fda.gov/cber/minutes/0910evolv.txt pages 85 – 88 say it all…
You will see that far from a few HP viruses in existence, they discover a new one every time they blink, and that was in 1999.
Ian Frazer's statement on TV: http://au.todaytonight.yahoo.com/article/43654/health/gardasil-effects-controversy ""If we had to wait to see if the vaccine could be proved its safe lifelong, we would be having epidemics of polio each summer, because the polio vaccine was only introduced 50 years ago."
is a nonsense.
Polio incubates in 3 - 11 days so you would see if your predictions came true within two to three years.
Cervical cancer develops 30 - 40 years after exposure, therefore his predictions can’t be verified till then, and in the meantime, women suffer. They don’t need to wait 40 years to see if their requiring physio long term is proof that this is the vaccine was a dud for them.
It disgusts me that Ian Frazer is barking hollow, simply to protect his minimum of $1.3 million dollar yearly royalty payments (he gets 10% of all profits from all HPV vaccines for the rest of his life) rather than actually “caring” about the women who have reacted badly.
I think some really good investigative journalism needs to be done on this, because just running win/win journalism so as to say little but not upset anyone really isn’t good enough for the women you need you to do some really deep shovelling on this issue.