And thankyou Ana, for stimulating the discussion. I have appreciated it. Regards, Linda

Hi, Ana
Actually, my opinion of Ms. Janak probably on a par with Charm's. However, one has to remember that science is a series of hypotheses, tests, and refinements. Vaccines have their short comings, as you already know to your grief and worry. In the future, the human race (if we don't go extinct entirely) will look back and be as astounded that we survived cytotoxic chemo, radiation therapy, and vaccines developed with a one-size fits all approach as we are looking back at successful trepanation in the new stone age and battlefield surgery in the American Civil War.
In assessing the information available, however, I would implore you to carefully review the statistical and methodological basis of the claims that are being made. What Ms. Janak says may be shown to be right, or partially right at some point - but it just seems to me that her level of proof is somewhat lacking.
Maria

Hi Maria, I'm sure your opinion is very close to Charm's. We're all under a ton of pressure dealing with this horrible disease. I have the added burden of having a very small window of deciding whether or not to immunize my son before he becomes sexually active, something that's not always completely planned out. I know first hand the very real risks of a bad vaccine reaction, remembering what my son looked like, 2 years old, grand mal seizure, after grand mal seizure, turning blue. You'll have to forgive me for leaving no stone unturned in an effort to best protect my family. I don't judge others for seeing these as easy choices, I hope I am not judged because this is yet another tough decision we are being forced by circumstances to address.

Thank you for the kind words Linda. Hubby has a huge chemo day tomorrow, thank you for sending me into it feeling a little less beat up.

Hi All
Ana, this is not to beat you up but just to share what I know about this. Given your situation, it is no suprise that you would be wary of vaccines and take the information you found exactly as you have. It is an unfortunate fact of life that people (including researchers) screw with data to get the results that fit with their opinions or the axe they have to grind. Here comes my perspective on the data ...

The submission that Ms Janak quotes is a submission to the FDA from Dr Lee to register a test for HPV. In order to persuade the FDA, he argued that his test was needed because women (they were looking at cervical pre-cancerous lesions caused by HPV) who already had active (I think) HPV infection had the vaccine, then their chances of developing grade 2/3 CIN or worse were increased by 44% compared with women who didn't. This is figure that Ms Janak took and didn't research. If she had, she would have discovered that Dr Lee misrepresented the figure. I didn't know about the stoush between Dr Lee and the FDA though - thanks Charm.

This number was taken from a substudy of the original HPV vaccination submission and specifically from substudy 013 which had approximately 160 women in each group (received vaccine vs received placebo). They found that approximately 35 women went on to develop cancer whilst only approximately 19 in the placebo group developed cancer.

HOWEVER, in the same submission, it was explained that the two groups of women were not similar and the group who received the vaccine also had a higher incidence of known risk factors including more sexually transmitted infections, higher smoking history and one other risk factor which I can't remember right now. One of the other substudies (substudy of 015) which was over twice the size of 013 found no such result and this substudy also didnt have the discrepancies in the baseline data. When the data were pooled there was no evidence that the HPV vaccine caused a higher incidence of cancer in women who already had pre-cancerous dysplasias.

IN THE SAME DOCUMENT that Dr Lee and subsequently Ms Janak misquoted, the FDA went on to reject the 44% increase in cancer finding, suggesting it was more likely a function of small study size and disparate comparison groups rather than any real difference.

I will try and find the original FDA document and for people to read but it might take a while as the submission was back in 2006 and my computer at home won't let me into as many sites as my computer at work will.

Disclaimer: My figures are approximate only as I am going on my own recollection of the figures.

Maybe Brian or DavidCPA can access the document which I think was minutes of the FDA meeting where Gardasil was submitted for registration? It was definitely 2006

Off to see if I saved the document somewhere safe - back soon

[quote]This demonstrated a limitation of the evaluation of small subgroups, where subgroups might have imbalances in baseline demographic characteristics. In this case, it appeared that subjects in this subgroup of study 013 who received Gardasil� might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients. In study 015, the applicant conducted a subgroup primary efficacy analyses for HPV 16/18. Here, the evaluation of this subgroup did not raise a concern about enhancement of cervical disease due to HPV: [/quote]

I'm back!

I got some numbers wrong - it was 31 ladies who developed CIN 2/3 or worse not 35 in a group of 156 vs placebo group of 137. There are likely other numerical errors too but the sentiment is correct. They also developed pre-cancerous lesions - not cancer as I reported in the last post - sorry.

The quote above comes from the original document that Dr Lee and Ms Janak misquoted. The figures they misrepresent are in table 17 page 13.

http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

I am not sure if I did the link right but you can go to the FDA website and just enter 4222B3 which is the number of the document and it pops right up.

Ana
you have opened up a discussion that is both valuable and interesting to many of us. thanks. I hope all goes well with your husband in a few hours.

I got involved in the HPV debate as a means of feeling useful whilst Alex was going through the worst of his treatment and it really helped me to feel like I was contributing. I hope your research does the same for you.

Karen

It's not secret that I have and will continue to object to posting false information and false statistics on OCF in a hard line tone. Why? Because even after Brian asks as nicely as possible:
[quote]While this doesn't necessarily apply to you, you would be surprised at the number of posters that will post some bit of information from an unreliable internet source, or a source with an agenda, such as to sell people things, or promote a perspective that is contrary to what peer reviewed papers indicate. We wish to ensure that we are only giving out accurate information.[/quote]
What does he get in return: Almost the textbook definition of unreliable internet garbage: A 5 year old petition dismissed by the FDA and the courts and a nut job columnist who would be right at home in the Star or Globe along with UFO sightings.
What causes cancer is not a topic to be spreading false information about under the passive/aggressive cover of
[quote]What do you think?[/quote]
The majority of OCF readers do not have the time or inclination to research and expose fraudulent postings and trust their OCF member not to post total garbage. If even one OCF reader had decided not to give their child the vaccine based on the false information here, that is one too many.
No apologies just a promise of vigilance and protection..
Charm

Karen, thank you so much for the valuable information. You and Maria have been particularly helpful as we sort through this information, given me a lot to think about. Ana

Karen mentions

"One of the other substudies (substudy of 015) which was over twice the size of 013 found no such result and this substudy also didnt have the discrepancies in the baseline data."

This is an important concept to keep in mind both for internet posts by the statistically uneducated, as well as basic research published in peer-reviewed journals. Small sample sizes are kind of like political polls - your sample MAY represent the population as a whole, but then again, it may not. How you take your sample, as well as it's size, is critical to the validity of the study to the general population, and in fact its own applied mathematical discipline.

For example, the recent data on matted lymph nodes was pretty scary (or encouraging, if you knew your/your loved one's nodes weren't matted). I'm glad it was posted on this site (although I'd seen it before) - but it's a small sample size. The authors of this study then went on to propose an alternate staging system based on HPV status, and whether or not the lymph nodes are matted. IMO, that is theorizing in advance of the data, but I suppose you have to float these ideas.