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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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My criticism of the authors of this article and the anti-vaccination warriors that joined OLO to respond to it, is that they all misrepresented the data in one way or another.

Cherry picking statements out of context is reprehensible. They stand condemned and their case is diminished because of it.
Posted by ruawake, Sunday, 3 June 2007 6:57:17 PM
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Pam, I think it’s a stretch to describe the vaccine as “experimental” notwithstanding the unanswered questions. The chain of causation from HPV infection through CIN 1,2,3 through carcinoma in situ to malignant disease is well understood. The vaccine is highly effective at stopping HPV 16 and 18 (which start the chain in 70 per cent of cases) provided women and girls haven’t already been exposed to the virus. You can’t ethically set up a trial vaccinating girls and then waiting to see how many get full blown cancer when we already understand the chain of causation. The question is not whether the vaccine will prevent cancer, but how often it will, given unknowns about the duration of protection and the possibility other cancer causing HPV types might be waiting in the wings. Merck are now claiming HPV4 might have some cross protection against other types:

http://www.pressreleases.info/EN/archive/2007/200704/20070418/20070418_146061.shtm

We’ll have to wait and see if the FDA agrees.

As for “unknown safety issues” the question is whether the safety data are good enough yet to make an informed decision about vaccinating girls. There can never be 100 per cent certainty about anything in medicine (or in life generally for that matter), but the medical consensus is that the available evidence is good enough to make that call now.

The dilemma facing parents of preadolescent and adolescent girls is do you wait for more certain data? If you do, then you risk missing the opportunity of vaccinating before your daughter is exposed to HPV 16 and 18. It’s too late, then. If you disagree with the current medical consensus, by what criteria do you decide when the data are good enough?
Posted by Snout, Sunday, 3 June 2007 10:03:05 PM
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Ironer, the question of “informed consent” is important, but complex. How much data does someone need to be “informed”, and whose responsibility is it to ensure the consenter has properly considered and understood this data? Tort law assigns the responsibility to the practitioner in principle, but is vague about how much information is enough. This keeps the plaintiff lawyers very busy.

What is “informed” in this case has been distorted by a whole range of voices with different agendas. The drug companies (following the dictates of self interest) have applied pressure to have their product inappropriately mandated on public health grounds in two US states. In claiming those mandating powers those states themselves have misunderstood public health principles. Anti vaccination activists are drumming up panic about common and minor reactions to shots, perhaps unaware that the anxiety they are ramping up is actually the cause of many of those reactions. Moral conservatives struggle with how a vaccine to prevent an STI highlights the emerging sexuality of girls. And radical feminists, fighting against the traditional patriarchy of the medical profession – sometimes with good cause - demand “full” disclosure from doctors while dismissing such information as hopelessly untrustworthy and inadequate.

The internet makes it easy to access more “information” on just about any subject than anyone can possibly digest. Whether you recognize it or not, everyone sifts according to who they have already decided is credible and authoritative. Among the competing voices do you pay most attention to the church? The state? Feminist academics? Drug corporations? Doctors? Alternative medicine proponents? Scientists?

And if you choose science, how do you navigate its complexities if this is unfamiliar territory? Is Duesberg a misunderstood genius or a stubborn crank?

The increasing tendency to question the authority of the medical profession is a good thing, but it places an increased responsibility on the consumer for his or her choices. For many, it means learning to navigate unfamiliar intellectual territory.

Choose your guides carefully.
Posted by Snout, Sunday, 3 June 2007 10:08:14 PM
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Pam - the National Vaccine Information Centre is hardly a reliable source. Take a look at what else they have opposed and the benefits they have brought to the community.

While I have some reservations about the process Merck has used to have Gardasil approved, I've no qualms about the product itself, and most of the anti-vaccine information that has been posted here is somewhat dubious.
Posted by TurnRightThenLeft, Monday, 4 June 2007 10:18:51 AM
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I am an independent writer/researcher and had never heard of the National Vaccine Information Center (NVIC) until I initiated research on Gardasil. I have thoroughly vetted the material published by the NVIC on Gardasil's safety red flags and I have found no misrepresentations.

I have personally read over 10,000 pages of Merck and/or Gardasil documents. An in-depth understanding of Merck reveals a corporation which refuses to accept the concept: "First, do no harm."

Merck currently is facing over 27,000 lawsuits for causing heart attacks, strokes and other serious health events while withholding information that its last blockbuster drug, Vioxx, was dangerous. Internal emails, published in The Wall Street Journal, confirm that Merck was aware that Vioxx carried cardiovascular risk while telling its sales force to "DODGE" the question. (That product was recalled after 160,000 deaths or serious injuries.) Merck is, according to its own SEC filing last month, under criminal investigation by the US Department of Justice.

Let's say you put an ad in the newspaper seeking a babysitter for your 11 year old daughter. A very nice sounding applicant calls you regarding the job. You ask for her references. She tells you she is facing 27,000 lawsuits for malfeasance and is under criminal investigation by the highest law enforcement agency in the U.S. Would you trust her with your child's life?

Pam Martens
Posted by Pam Martens, Monday, 4 June 2007 11:44:36 AM
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I know this is slightly off topic but I just thought I should point out this piece contained several distortions and half-truths.

Reist and Klein assert that Gardasil only protects against 2 of 13 cancer causing strains of HPV. Yet they fail to mention these two strains cause 70% of cervical cancers - a disease that affects half a million women per year. In fact Gardasil generally results in greater antibody immunity to HPV than when the infection is cleared naturally.

The authors also assert that eradication of HPV will also require vaccination of men. This is not entirely true; if all the women a heterosexual man sleeps with are vaccinated he will never get infected. Of course, we could vaccinate all men instead but the major diseases caused by HPV occur in women and as Gardasil can potentially provide protection to 20% of women who are already sexually active it’s just common sense to vaccinate women.

That said, I agree with the authors that we shouldn’t vaccinate if there is a lack of good data. However, the argument for not vaccinating should stand on its own and not rely on the unjustified smear of an effective vaccine.

References for this comment are:

Garland et al. (2007). Quadrivalent Vaccine against Human Papillomavirus to Prevent High-Grade Cervical Lesions. New England Journal of Medicine. Volume 356. Pages 1928-1943.

Garland et al. Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases (2007). New England Journal of Medicine. Volume 356. Pages 1915-1927.

Siddiqui et al. (2006) Human Papillomavirus Quadrivalent (types 6, 11, 16, 18) Recombinant Vaccine (Gardasil(R)). Drugs. Volume 66, Issue 9. Pages 1263-1271.
Posted by Sparky, Monday, 4 June 2007 4:14:48 PM
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