Disagreement over Gardasil – take it now or wait and see
read time: 377 words, about two minutes
It would be interesting to see a study that compares the level of fear people experience when shown the word cancer and when shown the word terrorist.
Both words are pretty charged to the point that people REact – perhaps irrationally so – to them.
An interesting point - at least with cancer is - it’s at least partially a lifestyle disease. Yet people won’t change their lifestyle choices.
Enough rambling…
There’s an article in SF Gate today with regards to an editorial published in The New England Journal of Medicine about Gardasil.
A couple of UCSF doctors are warning against widespread use. Reason: there’s simply not enough data. Data to prove it’s safe. Data to prove it works.
Dr Karen McCune, Associate Professor of Obstetrics and Gynecology at UCSF:
“At this stage, the vaccination can still be considered experimental. To be discussing mandatory vaccination when the main clinical trials are still ongoing seems extremely premature. We’re feeling like the enthusiasm is driving policy rather than data.”
Also at issue is the fact that Gardasil acts on 2 strains of HPV that are associated with cervical cancer. There are 13 additional strains.
Dr McCune is concerned about the possibility that some or all of the additional 13 strains “may fill a ‘niche’ left if the two more common strains are wiped out entirely”
I know cancer is a scary word.
If you’re standing on a train track with a train hurling at you, it’s wise to REact.
If you’re considering a pharmaceutical product, it’s wise to consider the RISKS as well as the credibility of the promise… and ACT accordingly.
The article concludes with:
“But while many doctors agree that there are still questions about the vaccine, they note that there is no question that Gardasil is effective at stopping the most common cancer-causing HPV strains. And because the vaccine is most effective before a woman has had sex, it’s important that girls get vaccinated as soon as possible, even if some doubts remain, some doctors say.”
(emphasis added)
I don’t understand. Shouldn’t the DOUBT be resolved first? After all, the results will be yours to keep whether you like them or not. Merck won’t take them back. Ask the families of people who died from the “results” of Vioxx.
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2 Responses to “Disagreement over Gardasil – take it now or wait and see”
To summarize this published medical journal article:
1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the only recognized precursors to cervical cancer.
2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma — the strongest (and many would argue only valid) precursors to cervical cancer.
3. Extrapolating from GARDASIL’s very limited clinical “success” (in the FUTURE II study only) against grade 2 cervical dysplasias (40% of which regress spontaneously), 129 women would be have to be vaccinated (at a cost of about $60,000) to prevent a single grade 2 cervical dysplasia.
4. GARDASIL’s protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer “raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18.”
5. Even if you segregate out the women who hadn’t been previously exposed to either HPV 16 or 18, we are talking about just a 17% decrease in all high grade dysplasias (266 out of 6080 vs. 219 out of 6087) — many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That’s about $60,000 per dysplasia prevented.
This is all directly from the article linked above.
I myself would add that we currently have only 3 years of follow up to go on in terms of both GARDASIL’s safety and efficacy among the 16 to 26 year female population, no data concerning its efficacy among 9 to 12 year old girls and only 18 months of follow up on less than 600 total preteen girls in terms of safety data about GARDASIL within its targeted population.
Latest report July 28, 2008: HPV Vaccine Adverse Events Worrisome Says Key Investigator
“According to the US Food and Drug Administration (FDA), as of June 30, 2008, more than 9700 adverse events have been reported since the vaccine was approved 2 years ago. Of these, 94% were classified as nonserious events and 6% as severe.”
http://www.medscape.com/viewarticle/578110?sssdmh=dm1.371364&src=nldne
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