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The Forum > Article Comments > Gardasil: we must not ignore the risks > Comments

Gardasil: we must not ignore the risks : Comments

By Renate Klein and Melinda Tankard Reist, published 1/6/2007

Rushing Gardasil on the market in Australia for mass immunisation might be good for CSL shareholders, but what about our pre-teen girls?

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Very compelling rhetoric, Pam, but nonetheless somewhat problematic.

First, Merck didn’t authorise the use of Gardasil. Its use is authorised by drug regulatory bodies in many countries.

The FDA states emphatically that Gardasil is authorised for use with 9 to 26-year-old females http://www.fda.gov/cber/products/hpvmer060806qa.htm Australia’s Therapeutic Goods Administration has approved Gardasil for 9 to 26-year-old females, with the additional note: “Immunogenicity studies have been conducted to link efficacy in females aged 16 to 26 years to the younger populations.“ http://www.tga.gov.au/docs/html/adec/adec0246.htm Interestingly, the TGA also states that Gardasil is indicated for 9 to 15-year-old males.

Nice that you’ve read thousands of pages about Merck’s business practices, but you’ve failed to reveal how this relates to the approval of Gardasil. Your objections about testing with a particular age group appear to have been dealt with, at least as far as the TGA is concerned.

Working on Wall Street, may have given you the tools to take on the business practices of Smith Barney http://multinationalmonitor.org/mm2002/02april/april02interviewmartens.html and now Merck, but I need to be convinced how that prepared you to judge drug trial sampling, over the heads of the FDA and the TGA, among others. I think you need to separate your campaign against Merck http://snipurl.com/1n63r from the debate about the use of Gardasil.

Finally, the babysitter analogy is powerful, but it doesn’t work. If your child’s life depended on using this particular babysitter, then your attitude to the risks involved would be very different. If a powerful authority told you that despite the previous record it was safe to use that babysitter, you would probably accept the risk, given the catastrophic alternative.

Parents have access to many potential babysitters, but only one approved drug for protecting their children twenty, thirty, forty years hence from avoidable disease. The informed choice, with today’s best available information, is to get the vaccination.
Posted by jpw2040, Monday, 4 June 2007 6:43:28 PM
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Dear jpw2040 (previous post)

You state: "The informed choice ... is to get the vaccination."
But that is a distortion, a failure to understand the concept of "informed choice" or "Informed consent".
Informed choice is not about you, or another authority deciding for others what choice to make. It is about individuals, about patients and their families, weighing up the information and making choices that relate to their personal situation, values, medical concerns etc etc.
How can you claim the omniscience to know what "informed choice" is for all readers, all women, all Australians.
I am sure you didn't mean what you wrote - you couldn't have. I am sure you meant to say that YOUR choice for yourself or child would be to try the vaccine.
Posted by Ironer, Monday, 4 June 2007 8:18:57 PM
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Pam, pharmaceutical companies such as Merck love to present themselves as philanthropic organizations of impeccable altruistic credentials. Many of us, however, recall Adam Smith’s words in “The Wealth of Nations (1776)”:

“It is not from the benevolence of the butcher, the brewer, or the baker that we expect our dinner, but from their regard to their self-love, and never talk to them of our own necessities but of their advantages”

Jpw 2040 is right that it is up to authorities other than the brewers themselves to evaluate their claims. Whether Merck lied about what they knew about Vioxx is yet to be decided by the courts. I’ll be watching closely when alternative brewer Glaxo brings out their HPV product soon.

Also, I note that Gardasil has been approved for 9-15 year old boys in Australia, but not funded. Now the main benefit is probably the reduction of HPV related cancers in the female partners of those males, although reduction in penile cancers (very rare) and anal cancers (mostly in gay men) may be significant. But try selling that to parents in the US Bible Belt. I reckon that would defeat even Merck’s finest marketers.

Lastly, it’s fine for Tankard-Rice and Klein to quote the views of Barbara Loe Fisher and her so-called “United States National Vaccine Information Centre”. However, if they do so while implying this is an authoritative source and ignore any more balanced or opposing views they betray their own biases.
Posted by Snout, Monday, 4 June 2007 10:26:07 PM
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To fully appreciate the depth of the fake hype around Gardasil, try this: put the following phrase into the Google search engine:

hpv AND “70 percent”

It brings up 110,000 hits all referring to the “fact” that Gardasil targets HPV 16 and 18 which cause 70 percent of cervical cancer cases.

Not one link, however, will tell you where that “fact” came from. Strip away the hype and the legions of public relations firms working for Merck and you have: (1) Merck's own clinical trial findings that conclude that Gardasil has only a 17% effective rate in decreasing high grade cervival dysplasias, the precursors to cervical cancer, among a general female population. (2) The same published finding in the New England Journal of Medicine, a peer reviewed medical journal.

Prior to this Gardasil marketing blitz, the U.S. Centers for Disease Control and Prevention (CDC) and major medical journal studies explained that HPV, alone, could not be the sole factor in cervical cancer. Research showed that cigarette smoking was, at the very least, a co-factor with tobacco substances found in the cervical mucous of women who had pre-cancerous lesions.

In a July 9, 2006 Florida Supreme Court decision (revised on December 21, 2006) the court overturned a $145 Billion punitive damage award against Big Tobacco but affirmed findings that smoking of cigarettes causes a host of cancers, specifically stating that it caused cervical cancer. (Engel et al v. Liggett Group et al)

I would say that ruling could be an issue for Big Tobacco with cervical cancer causing close to 4000 deaths in the US each year and being a leading cause of cancer deaths in other parts of the world.

In looking at the “educational” legislation passed by numerous U.S. states, I find it interesting that HPV is inserted in the legislation as the sole cause of cervical cancer. Equally interesting is that among a broad group of Big Pharma donors to Women in Government, Altria (parent of Philip Morris and defandant in Engel et al v. Liggett Group et al) pops up.

Pam Martens
Posted by Pam Martens, Tuesday, 5 June 2007 1:34:19 AM
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However if you search for hpv and cancer on Google Scholar, you get a range of scientific literature that quotes where that source is. In fact you can find the paper that is most likely to be referenced:

http://jnci.oxfordjournals.org/cgi/content/abstract/87/11/796?ijkey=0d708d92354b467f4a38d726171edee53b0e09eb&keytype2=tf_ipsecsha

It even breaks down the prevalence of each HPV by region, how about that!

I'm sure you will find it very interesting reading and yes, the link between cervical cancer and HPV is strong and independent of other factors.

Read the peer-reviewed science, stop reading nutbag websites and then make your decison. Use Google Scholar,or Pubmed, they have properly reviewed literature and should always be the first resource for making informed decisions.
Posted by Bugsy, Tuesday, 5 June 2007 2:03:03 AM
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I didn't have to read the entire article. As soon as I saw that the authors were citing the National Vaccine Information Center as some sort of authority I knew that I would be wasting my time. You don't cite Holocaust deniers when discussing history, you don't cite AIDS deniers when seriously discussing public health, and you don't cite anti-vaccination liars when discussing vaccines. NVIC exists to oppose all vaccines for all people of all ages against all diseases. All Barbara Loe Fisher needs to know is that it is a vaccine, and that is enough for her to oppose it.

Once upon a time the anti-vaccination liars only hated children. Now they hate women as well.

Peter Bowditch
www.ratbags.com
Posted by Peter B, Wednesday, 8 August 2007 3:31:48 PM
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