In a Handbasket - It's not a black and white issue.

Do you trust the FDA? I think the questions I raised using the FDA's own info are important. Do you have any thoughts on my questions?

The question should not be do I trust the FDA. An analogous question would be do I trust the federal government, and if I answer yes then I believe everything that they say whereas if I answer no then I am assuming the opposite position. I will say that I do not think that the FDA is infallible. They have been wrong (sometimes awesomely so) before, and I assume that they will be wrong again; if not at this point, then certainly at some point in the future. I don't think, either, that everything that they put out is bogus. I'd much rather have an FDA than not.

I did have thoughts on the FDAs concerns that I posted previously, but I'll reword them here.

The first is that the vaccine may lead to an increased number of cases of a cancer precursor among patients already infected by any of the four virus types at the time they receive the vaccine, and whose immune systems have not cleared the virus from their bodies.

It seems to me that what this is saying is that there is evidence that being vaccinated if you are already infected with HPV may lead to a "cancer precursor" - whatever that means. This doesn't seem like it applies to women who are not infected, and are simply seeking to be protected from HPV (which, I would assume, is the vast majority of people who would be vaccinated). Further, it also seems that this is a concern that is easy to deal with: don't vaccinate anyone who already has HPV.

The second concern is that any advantage the vaccine provides in protecting against the four virus types could be offset by infection by any of the multiple other types of HPV that the vaccine does not cover, according to the FDA documents.

I don't understand how the advantage of protecting against certain types of HPV is offset by the fact that Gardasil does not protect against other strains of HPV. It seems to me that protection against even one strain would be better than non, but perhaps I'm simply not understanding the concern correctly.

FDA staff also asked that the committee examine five cases where children with birth defects were born to women who had received the vaccine around the time of conception.

I think this is probably the most legitimate concern that the FDA has, and as I noted before, this should be followed up on. One question I have is how statistically significant it is for five women to bear children with birth defects in the experimental condition (i.e. is it outside of the proportion that one would expect in the normal population). If it is significant, then I think that's a very strong argument for keeping it off the market. As I mentioned, I think this is the most legitimate concern out of the ones you posted.

I shall continue to point out the flaws in the current system by quoting directly from the FDA the CDC and other sources when ever possible. My apologies if that bothers you.

I'm not bothered by you pointing out flaws in the current system. I just take objection to what those flaws are, precisely.

I have come across info that causes me concern - so has the FDA apparently. Further, I can't make claims that Gardasil is very safe unless I have the evidence to back that up, I don't have such evidence. In fact, VAERS data contrasted to the GWS aluminum study and basic info on aluminum neurotoxicity also leads me to believe that this vaccine is not entirely safe. However, the burden is upon Merck to prove this vaccines safety to consumers.

It seems to me that a study on 21,000+ participants, involving adverse reactions of less than one percent of the experimental population, means that it is a fairly safe drug. That's what I take that data to mean. I agree that the burden of proof is on the individual who asserts the positive claim. In this case, originally that was Merck. This data seems like good evidence to me.

That said, I've searched various places for information, so it's likely I've got a bit more info to go on than those who rely soley on Merck, the CDC and FDA press releases.

It's always good to check multiple sources, but one must also be cautious. I've run across a few sites in my limited research experience that have a vested interest in casting doubt on the veracity of pharmaceutical company's claims. That's not to say that the info is not legitimate, just that one should be cautious. Further, I don't rely solely on Merck, CDC, or FDA press releases as I took that you implied.

There is evidence that it is not well tolerated as well. I just came across this Varkam: http://www.atsdr.cdc.gov/toxprofiles/tp22-... It's a 117 page report from the ATSDR branch of the CDC. I searched the document for "aluminum hydroxide" to narrow down information. After browsing this file, I am more concerned than I was previously. I am going to attempt to print and read the entire document this week, time permitting. However, after browsing the document, I don't feel one can claim an intramuscular injection of aluminum hydroxide in humans (especially children) is "safe." Why is such a controversial substance being used in vaccines for our children? That's my view. One can find info that contrasts my opinion quite possibly.
Aluminum is all around us, but the method of intake is key. Aluminum taken orally is poorly absorbed for example.

I think the following might be relevant:

Adverse events after immunisation with aluminium-containing DTP vaccines: systematic review of the evidence.
The Lancet Infectious Diseases
February, 2004
Jefferson T, Rudin M & Di Pietrantonj C.

Abstract: We have reviewed evidence of adverse events after exposure to aluminium-containing vaccines against diphtheria, tetanus, and pertussis (DTP), alone or in combination, compared with identical vaccines, either without aluminium or containing aluminium in different concentrations. The study is a systematic review with meta-analysis. We searched the Cochrane Vaccines Field Register, the Cochrane Library, Medline, Embase, Biological Abstracts, Science Citation Index, and the Vaccine Adverse Event Reporting System website for relevant studies. Reference lists of retrieved articles were scanned for further studies. We included randomised and semi-randomised trials and comparative cohort studies if the report gave sufficient information for us to extract aluminium concentration, vaccine composition, and safety outcomes. Two reviewers extracted data in a standard way from all included studies and assessed the methodological quality of the studies. We identified 35 reports of studies and included three randomised trials, four semi-randomised trials, and one cohort study. We did a meta-analysis of data from five studies around two main comparisons (vaccines containing aluminium hydroxide vs no adjuvant in children aged up to 18 months and vaccines containing different types of aluminium vs no adjuvants in children aged 10-16 years). In young children, vaccines with aluminium hydroxide caused significantly more erythema and induration than plain vaccines (odds ratio 1.87 <95% CI 1.57-2.24>) and significantly fewer reactions of all types (0.21 <0.15-0.28>). The frequencies of local reactions of all types, collapse or convulsions, and persistent crying or screaming did not differ between the two cohorts of the trials. In older children, there was no association between exposure to aluminium-containing vaccines and onset of (local) induration, swelling, or a raised temperature, but there was an association with local pain lasting up to 14 days (2.05 <1.25-3.38>). We found no evidence that aluminium salts in vaccines cause any serious or long-lasting adverse events. Despite a lack of good-quality evidence we do not recommend that any further research on this topic is undertaken.

PMID: 14871632

PubMed Link

In addition, here is an article from WedMD discussing this study:

Aluminum in Vaccines Poses No Harm
January 29, 2004
Sid Kirchheimer
Link

Jan. 29, 2004 -- Despite the ouch and some minor skin irritation, there's no real danger facing children who receive vaccines that contain aluminum salts, according to an exhaustive new analysis of previous studies.

...

"Aluminum salts have been added to vaccines since the 1920s because they enhance the immune response," says Paul Offit, MD, chief of infectious diseases and director of the Vaccine Education Center at The Children's Hospital of Philadelphia.

...

In fact, this new report comes just eight weeks after Offit published his own study in Pediatrics looking at the safety of vaccines given to children that contain various by-products -- including aluminum salts, formaldehyde, gelatin, egg and yeast proteins, and thimerosal, a mercury-derived preservative.

With the exception of rare allergic reactions to the gelatin and egg products in some vaccines, he also found no danger from any of these additives, used to help prevent contamination and the spread of bacteria in multidose vaccine vials.

emphasis mine