Science, vaccines, and fear mongering (regarding Gardasil)

[TZ]

Okay guys (warning longish rant coming) in the last week there have been some really heavy duty nasty threads regarding Gardasil, Big Pharma, and vaccines in general with some real sludge being posted with very little support. These threads really really bother me. As someone in the vaccine development field (I want you all to see my agenda) I really get tired of being treated like me and many other good scientists and techs in this field are little better than money grubbing Nazis. We are not!!
I make a decent living doing what I do and I don't think I should feel bad about that. But I am in this field because I, like many other people in this field care passionately about helping people. I would be wrong if I didn't say there is not corruption and highly unethical behavior in this field. There is and i have seen it. But I object to the fear mongering and just out and out irrational numbers and ignorance I am seeing. I have no objection to having a good sound rational scientific debate on the merits and safety of vaccines in general and Gardasil in particular. I do object to people just pulling crap off the internet. Or just making numbers up. Straight statistics are easily manipulated. If you want to prove something to me about safety issues please find actual factual sources like reputable science journals (Nature, Science, Procedings of the National Academy of Sciences and such). Also although many regulatory places have been compromised by *, places like NIH, NIAID, FDA still have a lot of very informative and helpful websites about research. Vaccines are a proven life saver. Are they 100% safe for everyone? No. But what is. The science I have seen is pretty amazing. I wish I could share some of it with you. But that would take to long.
My former boss and mentor never ever took anything for granted. If he said something could be done in a way that contradicted what I had previously believed he would set out to prove it. He never imposed his beliefs on me. Can't say that seems to be true at DU in some respects. Which really bothers me. I always felt that the tactics of irrationality and fear were the weapons of the right.
I have no problem with a differing view if you can back it up with RATIONAL EVIDENCE. We all have a right to our own opinions. But I do object to baseless and irrational slander and attack on good science which in turn may be due to sheer ignorance and fear in some. I would love to be able to educate everyone. Obviously thats not possible. But I felt after as angry as I have been (and others) that it was important for me to air this opinion, because as I expressed earlier, this is something I care alot about and its hurt me and upset me to see how people just slander this field. It feels very personal to me, even if it was never meant that way. So I want to have my 2 cents worth here. Sorry on length. Please forgive a very hurt person a very personally needed way to vent.:rant:

[antigop]

1. McCown: Governor's HPV order is unconstitutional

http://www.statesman.com/search/content/region/legislature/stories/02/07/7mccown_edit_rs.html

>>
Under the state constitution, the governor administers the law; the governor doesn't make the law. This principle is textbook civics. Making law is for the Legislature.

With this principle so clear, how can the governor possibly claim the authority to require vaccinations? Well, when the Legislature passes a law, it cannot think of every detail, particularly in our increasingly complex world. To deal with the details, the Legislature often authorizes a state agency to adopt rules. So, in his executive order, the governor hasn't actually required vaccinations; rather, he has ordered a state agency to write a rule requiring vaccinations.

Rules, however, must be consistent with state law and must implement, not expand, the law. To ensure that rules comply with the law, the Legislature requires a state agency to go through a careful process of evaluating its legal authority before adopting a rule. In addition, to ensure that a rule is wise, the Legislature requires a state agency to give the public notice of any proposed rule, give the public a chance to comment, consider the public's comments and provide a written justification for the final rule.
>>

Now are we going to stand up for democratic principles or not?

This is DU -- the DEMOCRATIC Underground. DEMOCRATIC.
Valentine

[Warpy]

7. Right, he can't do it by fiat

The lege has to cooperate and pass the legislation. That's the reason for the fundy opt out clause, I suspect, to make it more palatable to legislators who are only there with wingnut church approval.

[antigop]

9. This is DEMOCRATIC Underground -- emphasis on DEMOCRATIC

And it's amazing that people don't want to admit the problem that what Perry did is anti-democratic.

Isn't it amazing that people bitch and moan about Bush's executive orders, but they give Perry a pass?

Can you spell h-y-p-o-c-r-i-s-y?

[Horse with no Name]

23. It is only anti-Democratic

if what he did wasn't provided for in the Texas Constitution.
And if that was the case...with all of the uproar, he would certainly be impeached.
You live within the laws. That's not giving someone a pass.
That's just the way it is.

[antigop]

34. and it is anti-democratic

and if you don't see the danger of having a governor unilaterally decide health policy, then I'm sorry you don't understand.

[Horse with no Name]

54. If it is provided for in the Texas Constitution--and it is

Then it is not un-Democratic. And to tell the truth...Texas needs more than a small nudge regarding health policy.
You are aware that sometimes public health supersedes politics? I'm sorry if YOU don't understand that.
Texas doesn't fare so well in certain areas that heavily impact health, education and women. What has the legislature done to change that?

50th in percentage of population over 25 with high school diploma;

1st in percentage of uninsured children;

1st in percentage of population without health insurance;

49th in percentage of women who vote;

1st in air pollution emissions;

1st in toxic chemicals released into water;

1st in cancer-causing carcinogens released into air;

The truth is...they have done nothing except deregulate industries so that they can make more money and tracking down wayward Democrats to shove THEIR agenda down our throat. How is that helpful to the average Texan?
It isn't.
What I cannot understand is why people aren't as up in arms over the TTC as they are over this? Now THAT is unconstitutional.
The hidden truth in ALL of this is that there are probably a good many legislators that secretly applaud Perry's decision to do this.
Sure they are going to make noise because it plays well in their local hicktown newspapers and their constituents feel like they are fighting the sin and sex. But when the day is done...regardless of HOW it happened...something actually GOOD for the people came of it.

[antigop]

70. No-- subverting democracy is NEVER good

I'm sorry you don't understand that. And I'm sorry you don't under what precedent this sets.

[Horse with no Name]

79. You are a broken record

Quit cutting and pasting the same old tripe and provide something to back up your ignorant rant.
Like...the fact that if it is provided for in the Constitution, it is considered "Democratic".
You don't like it? Fine. Amend the Constitution.
But quit calling it "subverting Democracy" when it is totally within the legislative bounds.
That is just hyperbole.

[antigop]

81. I posted several articles -- I suggest you read them

Instead of pushing this, you should be screaming about what Perry did -- he did an end-run around the legislature.

[Horse with no Name]

83. Is what he did UNCONSTITUTIONAL?

I don't care how the legislation got here...I am happy it is here.
With the sloped foreheaded, anti-vaccine crowd...this never would have made it.
And the state with the WORST RECORD of allowing carcinogens into the environment and the HIGHEST RECORD of uninsured people would not get this needed vaccine.
You don't want it? No problem.
But get the fuck out of the way so that the people who want it can get it.

[PLF]

91. Nobody is stopping anybody from getting it, so cut the horseshit.

You insist on pushing that phoney baloney horseshit when every body here knows goddamn well that Perry's executive order is not the only way to go about this.

The arguments you are pushing are just like when Condi Rice brought up mushroom clouds while trying to convince people to support invading Iraq.

[antigop]

126. Thank you. It's a power grab by Perry. n/t

[antigop]

128. OMG! You don't care how the legislation got here -- you don't care about democracy???? n/t

[antigop]

155. Did you read the articles?? I suppose not. n/t

[antigop]

82. This isn't politics -- it's democracy -- there is a difference

Public health NEVER supercedes democracy.

NEVER.

[Horse with no Name]

90. There certainly is a difference. THIS however, is politics.

Sorry you are confused about that.

[antigop]

135. Sorry if you don't like democracy n/t

[TZ]

101. I don't have a horse in this battle but..

I can see merit in both arguments and since I have never been to Texas I have no idea about the legal issues. But really is their is a bird flu pandemic or small pox outbreak, trust me public health will supercede democracy.

[antigop]

131. It can only supercede in an emergency -- this is not an emergency n/t

[antigop]

42. With all the uproar he would certainly be impeached === HA!!!

Yeah. Just like Bush.

We're still waiting for his impeachment.

[Horse with no Name]

59. You are aware that there is a DIFFERENCE in state and federal

aren't you?:freak:

[antigop]

74. And you are aware that what Perry did is anti-democratic?

And you are aware of the precedent this sets -- having a GOVERNOR unilaterally dictate health policy?

[Name removed]

95. Deleted message

Message removed by moderator. Click here to review the message board rules.

[Cessna Invesco Palin]

144. Right.

We should vote on whether or not you should be allowed to pass a cancer-causing virus to other people. I mean, it's your choice, after all. :eyes:

[Richard Steele]

40. That's the 3rd time I've seen you cut-n-paste that. Thank you for kicking this thread.

:hi:

[antigop]

44. Thank you for trying to uphold democratic principles! n/t

[Richard Steele]

52. Thank you for keeping this kicked.

:patriot: :patriot: :patriot: :patriot: :patriot:

[antigop]

68. Thank you for sticking up for democracy! n/t

[Richard Steele]

77. Thank you for keeping this kicked.

:patriot: :patriot: :patriot: :patriot: :patriot:

[TZ]

102. we got a love fest going here!

Now this is one battle I can enjoy. I was hoping we could have a nice fun rational debate here. Seems to be working (mostly):) :loveya:

[Richard Steele]

110. Thank you for keeping thi...oh, hi there, turtlensue!

I am looking foreward to a RATIONAL debate as well,
free from the constant hysterical disruptions of off-topic
broken record cut-n-paste artists, grumpy old mysogynists,
and posters who ADMIT to being mouthpieces for tombstoned trolls.

Oh, what a day THAT will be, eh? :hug:

[TZ]

115. so frar I am pretty pleased

although we got some intense debate going on this thread it seems pretty healthy. A couple of people who insist that I don't have my facts straight have snuck in but I am trying to answer even them to the best of my ability:)

[antigop]

136. Thank you for letting everyone know that Perry is a dictator and does not support democracy n/t

[Richard Steele]

143. Have you noticed that no one else seemed to think this was a "Dictator Perry" thread?

If so, what conclusions have you drawn from that?

[antigop]

146. Have you noticed that Perry is a dictator! Thank you for keeping this thread going! n/t

[Richard Steele]

150. That would be a "no" then, would it? Bless your heart!

[antigop]

151. Bless yours for noticing that Perry is a dictator. I'm glad you see it that way n/t

[Richard Steele]

209. Have you tried taping a penny to your head? Doesn't always work, but it's worth a shot.

[antigop]

213. Thank you so very much for the opportunity again to educate people that Perry is a dictator n/t

[redqueen]

2. Nice rant.

:hi:

[Horse with no Name]

3. Good rant.

:thumbsup: Thank you.
First of all...can you explain the role of Big Pharma in the development stages of a vaccine?

[TZ]

107. do you have a couple hours for that?

It is soooo complex. The short answer is that vaccine development is almost always a government and private industry joint venture. Vaccine development actually is usually not a big money maker but these collaberations seem to really efficiently get the development going. Usually govt like NIAID does developmental research and runs clinical trials. Private industry (yes Merck does this) contributes in large scale manufacturing of the vaccine and lends other resources.

[AikidoSoul]

231. You say it's "soooo complex" ... Do you really know what is involved?

If so, you would know that:

Vaccine development has suffered from quality and research control issues for a very long time, so please don't tell us that we should "trust" vaccine developers. In all due respect, you only have your finger on your part of the picture, which is tiny... the one where you do your job. You have no idea what the big picture looks like, and neither are you involved at every level of the science.

Nobody is. It's done with teams -- and there are several components to vaccine development.

The important point is that vaccine development methods and especially scientific oversight and testing -- do NOT have a good reputation. The industry works hard to suppress the bad PR.

I hope you all remember Nicholas Regush -- he was the former medical/ science writer for ABC News with Peter Jennings for ten years, and has written many books on health. Regush quit ABC after ten years in disgust because of the continual interference by ABC's advertisers in his reporting on illness -- especially chemical and drug induced illnesses. If you pay attention, please notice that the advertisers on ABC News are primarily the chemical/ pharmaceutical industry. After Nick left he started his own health magazine in Montreal called Red Flags Daily. He was articulate about the extremely poor record of vaccine development oversight.

Here I offer one of his comments about the vaccine industry:

"The fact is, the vaccine industry is truly in a mess, but not for the reasons
the White House would have us believe. The industry does not do relevant
research on vaccines and continues, with help from its CDC, FDA and doctor
friends, to heap one vaccine after another on children without doing anything
close to what might be considered appropriate safety and efficacy research.
And this has been going on for decades."

http://www.redflagsweekly.com/extra/2002_nov16.html:

[TZ]

251. just like everything there is good and bad

and yes, I am involved with these collaborations and I do believe that they are actually are good and bad. As I said this is really not a big money making industry. A lot of biotech companies that jump in are the not for profit groups. There are a surprising amount of companies in this category. I am sorry that you think that all these vaccines are bad. There is a lot of very innovative and quality work going on. Do you not know that I am familiar with people in other parts of the industry? For a group that has such a bad rep they sure save a lot of lives.
HIV is getting closer to having a vaccine. West Nile Virus will soon have a vaccine. There is a new technology that I was reading about which will just accelerate the research. I read journals and papers and scientific articles and go to symposiums so I do know the happenings. In the past there have been some issues that are justified. And a lot of work is international. I do happen to trust the CDC over many gov't agencies btw. I know people there and for a large government corp its pretty science oriented and not so money oriented. Also the WHO and many other organizations oversee vaccine research since many programs have a strong international flavor as well. If you want to tell me how evil the WHO is I am going to be very skeptical. That is a highly reputable organization. I do know the industry, "reputation" or not it does very good work and if you choose to be suspicious I think thats is very sad.
Not all big corp and money is bad either. The Gates foundation is funding a lot of very good research and despite what you might hear he just doesn't toss money randomly.

[AikidoSoul]

253. You said vaccine makers are "...not a big money making industry" . Pulleeeezzze! This industry

is BigPharma--it's all about profits. This is the same industry that produces drugs and all types of synthetic chemicals. If you keep up with what's in the business section of any newspaper you'll remember that it's often cited as as THE most profitable business of the year. That happened until the recent war. Now the defense and oil industries are making more... with chem/pharm not far behind.

Biotech firms "non-profit"???? I have yet to see a biotech company that's not controlled by a for-profit mother, for-profit group.

Look at those listing as non-profits and see whether they are subsidiary to a mother corporation registered as a profit-making corp. And look at the trend of not-for-profits created in partnership with, or under the auspices of, university departments -- with the main players being university personnel. Then look at the major funding coming from the chem/pharm industry -- which then profits tremendously from the research. The funders (large chem/ pharm firms) have direct linkages to these departments and exert a great deal of influence. Not only that but they often hire grad students that work on these projects that are housed at universities.

Either you are naive about this kind of involvement, or you are too willing to believe that these projects are completely independent. If there are any -- I'd like to know the name of the project, the name of the "non-profit", and the name of the university where it's housed. I'll bet anything that I'll find chem/pharm money flowing to that department and a technology license arrangement with the mother corp.

Not all vaccines are terrible -- historically there were some single virus vaccines that did a good job, partly because the vaccine was introduced with a major public information/education program that also focused on sanitation and nutrition.

Recently several DUers who work and/or teach in biotech made excellent cases about why and how the vaccines today are much more suspect... as is the industry itself which has increasingly been caught in criminal activities. Also different today is FDA oversight which has degenerated tremendously. Corruption of industry, FDA and the medical industrial complex -- is at an all time high. The corruption of science, clinical data, medical / scientific journals -- and other federal agencies -- all at an time high.

You say you trust the CDC. Well that only goes so far -- when data threatens industry the CDC will not provide the public with information that threatens industry's bottom line. Surely you must know that the CDC was caught red handed suppressing data about thiermosol. It actively suppressed the negative data. There is a videotape of one of the top level meetings at CDC where it was clearly stated that the data about Thiermosol "must not get out."

You say you go to symposiums and read journals. You ought to read the critiques by former editors of medical journals who talk about the huge corruption of information that is taking place at this time -- and perhaps you would be just a little more critical of what you are hearing.

These are the reasons that many people no longer are willing to allow their precious children to be exposed to vaccines.

This is a complicated topic.... but the depth and breadth of the corruption is something that you need to study much more carefully before you tell us to trust vaccines and/or this tainted industry.

[TZ]

264. research TIGR (The Institute for Genomic Research)

Thats a highly successful not for profit biotech. And if its so profitable why have so many people I know in the vaccine field been laid off from jobs (and sometimes multiple jobs). One of my former employers spent a great deal of money on a brand new state of the art facility to help manufacture vaccines. It never panned out and they ended up closing it up and transferring the production overseas to a facility in Scotland less than 5 years after opening.
This industry is no more or less corrupt than any other profession. And I am very very tired of hearing people badmouth a lot of very hardworking dedicated passionate decent intelligent people who want to help others! And who want to make a good living! When the hell did that become evil btw?!
Did you know until last year Merck didn't even have a division devoted to vaccine research? Because they didn't feel it was worth the investment. They lent researchers and other resources to collaborations but that was it. Dont tell me I don't know what goes on around me! That is highly insulting! How the hell does anyone who has not been in my shoes know what the hell I see or know!
And I am very sorry there are a growing number of people who want to expose their precious children to potentially deadly and painful diseases. And I hope the hell they keep them away from the rest of us who have enough common sense to understand the risks and benefits of vaccines so they don't get the rest of us sick. Please don't bother to reply to this comment. Its obvious that you won't ever understand the truth and rationality of the science. :rant:

[mzteris]

4. well - if you expect everyone to be all

RATIONAL. . . :rofl:

Rational Evidence, Critical Thinking. Reputable, verifiable sources. What ARE you thinking?!?

Don't you know a good scare-mongering and just making chit up works far better?


:rofl:


Seriously though, thanks for your post.

[Recursion]

76. Fine, I can do rational re: Gardasil

I'm not one of those "aluminum or mercury or whatever will kill your children" people (though don't we all wish they had never put thimerosol in vaccines?), but I will give some rational thoughts about Gardasil:

1. There have been no safety studies for prepubescant recipients, but it's being proposed to be given to all girls at ages as young as 9.

2. It is being billed as a "cancer vaccine" when in fact it guards against a family of viruses that have been shown to have an association with a 1.5% increase in the risk of cervical cancer. The vast majority of women who get HPV never develop cervical cancer, and a large number of women who never carry HPV do develop cervical cancer. It is not known if the 1.5% increase in cancer risk represents cancer being caused by the virus or elevated common risk factors for both cancer and the virus. Furthermore, in no sense will this vaccination mean you should not continue to be on the watch for cancer.

3. In just the past few years we have seen the pharmaceutical community rush out several "neccessary" drugs for this or that dangerous condition, which turned out to be more dangerous than the condition itself (post-hysterectomy HRT, ant-statins, VIOXX, etc). In each case, legal proceedings have shown that the safety study infrastructure for pharmaceuticals is, to put it bluntly, broken industry-wide. These tragic stories should teach us all that if you simply trust corporate-funded science you take your life in your hands in the process.

4. This is a re-statement of number 2 because I think it really deserves emphasis: no-one has ever said HPV "causes" cervical cancer. Carrying some strains of HPV is associated with a 1.5%-higher risk of cervical cancer than the negative population. The majority of sexually active adults carry HPV, the vast majority of these will never develop cervical cancer. We do not know if HPV causes cervical cancer, or if it shares common risk factors with cervical cancer; in fact, we know of one common risk factor they both share (early sexual activity). So we know at least some portion of that 1.5% increase is not from HPV but from that one shared risk factor, and there may be (and probably are) others. To the extent that HPV and cervical cancer share risk factors, this vaccine will do nothing but prevent warts.

If you have rational contradictions to these statements, I am all ears. If you read these statements, weigh them, and judge that Gardasil is still right for you or your children, by all means receive the vaccination with my blessing (I'll even vote to make it free for you if possible).

But don't tar me and people like me who point these facts out as crystal-watching, herb-contemplating, snake-oil-selling luddites when these objections are entirely empirical and scientific.

[TZ]

109. I would have to do some research

but I do believe that younger women were included in clinical studies. Safety studies are always built in to clinical research. In fact I believe that basically stage 1 of clinical trials is all about establishing if it is safe or not.
HPV (at least certain strains) does cause cervical cancer. That link has been known for a long time. I could do some research if you wish but I think you could ask any OB/GYN because I was taught this link as far back as 1990. It is not 100% cause, (again nothing is) but I think that there are several scientific papers that show a 70% link of HPV with patients that have cervical cancer.

[Recursion]

125. As you say, no one thing causes cancer

HPV (at least certain strains) does cause cervical cancer.

Well, no. Like I said, 16 and 18 are associated with a 2.5% lifetime incidence of cervical cancer, as opposed to a roughly 1% general population risk. Never anywhere in all of pubmed have I seen an actual model of carcinogenesis that points the finger at HPV. And we've been trying for decades to definitively link various cancers to viruses and we keep not being able to do it, only to find tantalizing associations like this. The hypothesis of this as the link is the best current science, but it's still unconvincing science even if it's the best.

We simply don't know how cancers work. There is some very compelling new research on aneuploidy and polyploidy, but that too is unconvincing.

All I'm saying is, this is your body and your health. A white lab coat does not make someone right, and recent history is full of fatal recommendations made by medical researchers with the best current information and intentions. If you want the vaccine go get it, but despite your assertion, there is no widely-accepted model of carcinogenesis from HPV, merely a wide recognition of a 2.5% risk vs. a 1% risk over the patient's lifetime -- if you know of one please tell me because I can't find one. Many researchers suggest a common causality model like I have.

[TZ]

134. nor does working for a pharmaceutical make you a ignorant

whore as some have suggested. Everything should be taken with a grain of salt. I tend to believe the college professor who taughtme that there was a link between HPV and cervical cancer. She had a very compelling argument. My point is that anything that can LIKELY HELP prevent cancer should not be so easily dismissed. Many diseases have incredibly complex problems (genetic and environmental) so often many different approacches are needed. I often thought that the idea that a vaccine could possibly (again nothing is ever garrenteed) worth the risk

[AikidoSoul]

254. You deserve not only valentines, but kisses dmesg

Thank you for taking the time to state this so clearly.

Sending you three valentines.

[kysrsoze]

5. I spoke with my doctor about my daughter and Gardisil - he strongly recommended holding off

I asked him about clinical trials and he said he was unaware of any large trials. He said it's very expensive and he wouldn't consider recommending this shot for at least another 6 to 12 months to get more of an idea how safe the vaccine actually is. He did mention that it may very well turn out to be a good vaccine, but at this point not enough is known.

In the past, my doctor has never even come close to bringing up politics, but he mentioned the extremely quick FDA approval without much study had a lot of political overtones to it. He also mentioned Merck has a big presence in Texas and connections to Rick Perry.

That's friggin' scary. Here's some info from Political Friendster on Perry's connection to Merck:

"Perry has several ties to Merck and Women in Government. One of the drug company's three lobbyists in Texas is Mike Toomey, Perry's former chief of staff. His current chief of staff's mother-in-law, Texas Republican state Rep. Dianne White Delisi, is a state director for Women in Government.

Perry also received $6,000 from Merck's political action committee during his re-election campaign. "

[Horse with no Name]

8. He was "unaware" of the clinical trials...yet was still willing to

tell you to wait?

http://www.womentowomen.com/sexualityandfertility/garda ...
>>>snip
The data submitted to the FDA represented tests conducted on 27,000 girls and women ages 9 through 26 and boys ages 9 through 15. The makers are now lobbying to mandate vaccination for little girls, while the FDA reports that the data are insufficient to support approval for boys and that separate trials for men and boys are currently under way.

Initial reports of the vaccine’s efficacy first came in 2002 when the New England Journal of Medicine described a trial (funded by Merck) in which nearly 1200 young women (ages 16–23) were vaccinated and an equivalent number given placebo injections. After following the subjects for a median of 17 months, the researchers found the vaccine to be 100% effective: none of the vaccinated women developed either infection or precancerous changes, while 41 of the nonvaccinated women did become infected, and nine of the latter developed precancerous cervical growths.

Since then, Merck has tested the vaccine on approximately 25,000 additional males and females in 33 countries, ages 9–26 and declared the drug to be safe and 100% effective. Richard Haupt, executive director of medical affairs with Merck’s Vaccine Division, says the vaccine is most effective when given to girls as young as nine years of age, before they become sexually active. That’s because trial subjects who had already had exposure to the four strains showed higher rates of cervical neoplasia (abnormal cancer cell precursors), raising questions as to whether the vaccine impairs immune response under such circumstances, or whether there were demographic factors at play, or both.
>>>snip Meanwhile, on a global scale, cervical cancer continues to rank as the number-two cancer-related cause of death in women — 80% of all cases occur in developing nations (morbidity is highest in sub-Saharan Africa, South Asia, and Latin America). And while most insurance carriers in the US are expected to cover the cost of vaccination in young female subscribers, and Merck plans to provide free vaccines to uninsured adults meeting low-income guidelines, there remain billions of women worldwide for whom access to the vaccine is doubtful.

According to a 2005 article in New Scientist, the International Agency for Research on Cancer in Lyon, France, estimates that by 2050 deaths from cervical cancer could “reach a million a year in poor countries if rates of infection, and of cancer detection and treatment, do not improve.” According to their own press release, Merck is partnering with India’s Council of Medical Research to study Gardasil, and also has plans to collaborate with PATH and the Gates Foundation to facilitate introduction of Gardasil to impoverished nations. Adequate cervical screening programs can control HPV-caused cervical neoplasia, but if vaccines are more cost-effective in preventing cervical cancer than regular gyn exams and routine Pap screening — another healthcare “luxury” few women worldwide have access to — to what lengths are we prepared to go to ensure affordable global distribution of this vaccine?

[kysrsoze]

15. You're talking about 17 month clinical trials. Is that enough time to develop infection or

precancerous changes? Don't you think it a bit strange how strongly Merck is pushing state governments for mandatory vaccines? I'd rather wait a bit for more information.

[Horse with no Name]

20. I have no problem with you waiting on the vaccine

You have attempted to educate yourself with the correct information. You have discussed it with your doctor.
You have done the right things.
However...since you asked for the clinical trial stuff...he should have found the info so that you could know the truth for yourself.
But that's just me.
The girls that are at the most risk, won't have parents doing what you have done.
That is the problem.

[kysrsoze]

45. I fully agree with you there on people educating themselves and doctors providing info

I think my doc should have known. I'm REALLY leery when it comes to vaccines and short timespans. I don't trust pharma companies, but I do realize there are a lot of good vaccines which should be administered. Thanks very much for the info.

[KittyWampus]

57. There HAS NOT BEEN extensive testing on general population as every other vaccine

has had in the past.

The poster is lying.

The numbers that person posted do not indicate extensive testing nor do they reflect that it hasn't been extensively tested on pre-teens.

There are no facts known on how effective this will be in a few years or if it will require revaccinations.

[TZ]

112. the clinical trial size is typical of many vaccine studies

and some are actually smaller. Its possible that revaccination could be required in the future but that is not particularly bothersome if you ask me. Efficacy studies are always included in clinical trials btw

[moc]

6. You're more eloquent in your rants than I am.

:hi:

As a scientist as well, I appreciate the emphasis on reliable science from strong journals to back up one's claims - not just citing baseless critical opinions that don't even address methodological issues.

With that said, I'm one individual who has posted in opposition to Perry's mandate. I don't believe there's been enough safety data on the target age group (9-12yo) to support a mandate at this time. (N of existing clinical trials is no more than 500 for this age group.) As the mother of a 10yo in Texas, I'll be opting out.

[TZ]

25. I don't have a problem with that at all

so far my rant seems to be getting some people doing critical thinking. And that really was something I wanted to accomplish here. A positive debate is good!!!:)

[kestrel91316]

10. As a veterinarian who has seen rabies firsthand up close and personal,

and who has seen Feline Leukemia Virus go from a common cause of death to a rarity because of testing and vaccinations, I have to give you guys in the vaccine development field a BIG HAND. THANK YOU FOR BEING THERE AND DOING WHAT YOU DO!!

Rabies vaccination literally saved my life.

[Horse with no Name]

19. I had a cat in the mid-eighties who got feline leukemia

we did some kind of chemo on him and it was miserable.
He did get better for awhile.
Was very glad to see a vaccine for this.

[kestrel91316]

238. The newest FeLV vaccine by Merial (those damned French!)

is light years better than older ones. It is 99% effective, as opposed to the typical FeLV vaccine's 90% effectiveness. It's a genetically-engineered live canarypox-vectored vaccine, given by needle-free injection. Much safer (smaller vaccine volume, less risk of fibrosarcoma) and more effective. I've been using it for two years and am happy with it.

Sorry about your kitty. I lost more than a few patients to it, even though the vaccine came out when I had only been in practice a few years.

[TZ]

29. Thank you!!

Made my day!!:loveya:

[antigop]

11. Sen. Robert Duncan (R-Lubbock) questions governor's authority to issue exec order that changes law

http://www.gosanangelo.com/news/2007/feb/11/perry-move-draws-outrage


>>
“There’s some question about the governor’s authority to issue an executive order that changes law and appropriates funds,” Duncan said last week. “That is constitutionally a legislative function.”
>>

WoW! We have to depend upon Republicans to stick up for our democratic p

[Turbineguy]

12. Good points.

In 1996 I was a stockholder in ICOS (the Cialis people). Someone described the place as "more PH D's per square foot than anywhere in the planet". I got a nice tour of the facility and some really good explanations of some research being conducted there, in particular in the area of anti-inflammatory drugs. Dr. George Rathman was running things then. Nobody there struck me as "money grubbing nazi's". Even among the stockholders (if there were ever "money grubbing nazi's") there seemed to be a purposeful mission.

The strange thing it seems to me with Gardasil, is the anti- crowd's bizarre illogical moralistic approach is provoking a less than desirable response of lobbying to make the drug mandatory.

We tend to think of ourselves as striving for a higher cause. But this is self delusional. Victorian morals were based on the practical reality that incurable venereal disease was rampant and the number of illegitimate children was overburdening the social safety nets of the time.

When the subject came up about condoms in schools (it was not that I wanted my 13 year old daughter to jump in the sack with every male that struck her fancy) I told the Chairman of the School board: "You have to save the children" and that meant handing out condoms. (End of my rant)

[TZ]

117. here is what is odd to me

we seem to have the fringe on both ends of the spectrum (left and right) trying to accomplish the same thing if for different reasons. It really is very funny (and somewhat sad)

[antigop]

208. here is what is odd to me

People post on DEMOCRATIC Underground (that's DEMOCRATIC) and don't seem to care that Perry subverted democracy with his executive order.

[Kagemusha]

13. Here's to rational evidence.

That's what I really believe in here, and I wish you very well.

[antigop]

14. Here's to democratic principles! Let's uphold them! N/t

[Bridget Burke]

16. I could understand a Texas parent wanting to hold off a bit.....

Before getting their pre-teen vaccinated. And non-Texans ought to see what's happening in their state, concerning either of the competing vaccines. www.news-medical.net/?id=21876

But those enormous threads turned up a depressing number of links to anti-vaccination sites--that usually sell "natural" products to cure what ails you. And too many people professing total hatred & fear of modern medicine. Not that I "trust" all doctors; I leave faith to the religious folks & work on being an educated consumer when it comes to my health.

Big Pharm does make too much money--& more of it goes to idiotic TV ads than research. Personally, I'd be glad if more of my taxes went to research: medical & purely scientific. (I'm sure there would be work for you & the other good folks--in whatever research setting that evolved.)

And...how many of the angry ones missed the entire fact that the "mandatory" vaccines can be refused? No wonder that "science" stuff is too hard for their little brains.

[Warren DeMontague]

17. If this wasn't about an illness related to -GASP!- sex, most of the objections would evaporate.

Scratch the surface, and this is really all about religious right nutjob puritanism.

[The Straight Story]

28. I think that is just a tad off

Some things you can get from simple contact from others, so there is a greater risk for the entire community, some things you get from more intimate contact - hence a controllable risk.

Kind of like smoking :) The left is the fundie on that subject...

[Warren DeMontague]

33. So we shouldn't vaccinate people, because they should "choose" to avoid the risk?

That's ridiculous, but it's a fair condensation of most of the arguments against this vaccine I keep seeing.

[The Straight Story]

50. It should be up to them in some cases (nt)

[Warren DeMontague]

55. It is. People can opt out. nt

[The Straight Story]

60. Couldn't they before? Makes me wonder why the gov got involved

for funding of it?

[seabeyond]

31. that isnt true. i have been having an issue with the continual additions

in mandated vaccinations for a lot of years. this is simply another and put out onto the market and forced faster than most, by a gov connected to the drug company. has nothing to do with a drug that has to do with sex

[Warren DeMontague]

35. Seems to me a certain percent of the objections are around that.

Most of them, though, seem to be coming from the crowd that is worried about ir "encouraging" certain kinds of behavior.

[seabeyond]

i have heard that thru the rw christian coalition factor. i have not heard

that argument coming from other conservatives and those on this board that oppose. when the vaccination first came out the first to yell were the religious using that argument. i dont give a shit about a person sexual practice. not my issue at all. and not the issue of many i am hearing opposing this mandatory decree

[Warren DeMontague]

53. First off, everyone knows that NO vaccine is "mandatory"

People can opt out. That's all they have to do under this "decree" if it bugs them that much. I opened my paper today and there's a quote from some guy in Texas, saying "I'm raising my daughter to know right from wrong. So we don't need or want this"

Uh, yeah, dude. So if your daughter actually stays a virgin until she's married -against something like 10 to 1 odds, I might add- she's going to need to marry ANOTHER virgin, and then under those limited circumstances there will be no chance she'll come into contact with HPV. But the important thing isn't protecting your kid's health, it's sending the right and godly "message". Sorry, that sort of thing just pisses me off. I haven't seen any reason not to trust this vaccine- of course, I don't reflexively distrust science or even pharmaceutical companies.

[moc]

78. Personally, I wish opt out requirements for other vaccines were much more stringent,

that is, only if medically contra-indicated (with documentation from an MD). Also religious objections but it has to be related to tenets of some organized faith. (Jehovah's Witnesses would fall into that group, I think?)

I was not very happy when the last Texas legislative session passed laws that allowed parents to opt out for general "objections". If enough opted out of routine vaccines such as MMR and DPT, they would put others at risk when they enter school

There's a vast difference, however, between the vaccination required for things like pertussis, measles and mumps and something like HPV. The former are transmitted via casual contact or via air, therefore creating problems of contagion in schools. The importance of ensuring high enough vaccination levels to result in "herd immunity" cannot be understated. There will always be individuals who cannot be vaccinated because of medical contra-indication or who are vulnerable due to being immune compromised. There are also a small proportion of children who will fail to seroconvert despite having the full course of the vaccine. Having unvaccinated individuals in public schools puts these persons at risk. For example, there was a teacher at my dd's school who was undergoing chemotherapy. She would be vulnerable to catching serious infections if enough unvaccinated children were in the school population.

The same does not apply to HPV and it's relevance to population health and school contagion. Because it is not transmitted by casual contact, the school environment does not provide the public health risk that failure to vaccinate for, say, pertussis would.

edited because I had a brain fart

[mzmolly]

87. MOC, please let me know what you think of my posts below. Also the trouble with

getting a medical exemption from an MD is that most MD's are not open to the possibility that vaccines can actually harm people. Further a two month old infant has little medical history to go by in order to make an educated decision on the matter. Thankfully, the PEDS I've found locally are very open to vaccination choice. And, they even think "critically" about the issue. ;)

Anyhow, interested on your thoughts to my responses below, but I can't check in for a while.

:hi:

Have a great day.

[moc]

98. Hi Mzmolly. You already know how I feel, but the reason that

many MDs aren't open to the possibility is because there's little if any empirical data supporting they are. From a personal perspective, if I were an MD I'd be very averse to not vaccinating a 2 month old. In 1940, my mother's 2 month old brother died after being exposed to pertussis. I know my grandmother would have given her left arm to have vaccinated him. I think that many folks today truly do not remember the tragedies of so many infants who died because of infectious diseases.

I read your post below but I admit that I didn't see the relevance to the current thread.

[mzmolly]

111. How would empirical data exist if no one is gathering impartial data on this matter?

Also, according to my conversation with the CDC some time ago:

Vaccinating against pertussis is said to protect "others" not the babies being injected. Why? Because generally, one is not considered at risk of death from pertussis unless one is < 6 months old. And one is not considered "protected" until they receive the last shot of the series at 15-18 months.

Interesting to note, the vaccine was available since 1930 and was in wide spread use since the 1940's.

Lastly, there are babies who die from vaccinations as well, and until we can determine which children are at risk we need to allow for "choice."

[moc]

113. Why do you think impartial data/analyses don't exist?

I've read the studies. They're pretty rigorous from what I can tell.

[mzmolly]

116. The government doesn't track the number of deaths from vaccination.

And the vaccine adverse event reporting system is passive, that's why.

[moc]

121. Do you understand the difference between an active tracking system and a passive one?

It's referred to as "passive" because it relies on the provider or parent to initiate the report, as opposed to the agency sending out data collection staff. However, providers are mandated by law to report all "clinically significant" reactions to vaccination, and I'm sure death would fall in that category. Are you suggesting that a provider who had a child die as a result of a vaccine fails to report it? Or are you suggesting that providers report it but the CDC suppresses the report? And finally, if you are suggesting either, do you have objective, verifiable information to back up such a claim?

[mzmolly]

129. VAERS reporting is voluntary. Unless that's changed in the recent past?

Frankly, what I'm suggesting is that when a child dies as a result of vaccination it's most often called a sad "coincidence."

http://www.immunizationinfo.org/immunization_issues_detail.cfv?id=35

VAERS accepts voluntary reports from health care providers, parents, patients or anyone else. They are encouraged to report any untoward event that occurs after a vaccination (from a mild fever to hospitalization to death) whether they believe that the vaccination was the cause or not. Vaccine manufacturers are required to report all potential adverse events of which they become aware.

...

The number of reported adverse events is also highly influenced by publicity. In Canada reports of a mild allergic type reaction after influenza vaccine resulted in a 3- to 5-fold increase in reports of all types of adverse events of influenza vaccine compared with the previous year. Thus reports to VAERS of a particular adverse event may be the result of parents or physicians having heard about it in the media, independent of any possible causal relationship between the vaccine and the event in question.

Health care providers, parents ect. are "encouraged" to report, vaccine manufacturers are required, if they become aware.

Also, the limitations this method of "gathering data" are an issue.

http://www.vaccinesafety.edu/VAERS.htm

Underreporting is an inherent problem of passive surveillance systems, including VAERS. The degree of underreporting varies according to the adverse event. For example, one study estimated that 68% of cases of vaccine-associated polio are reported to VAERS, but only 4% of MMR-associated thrombocytopenia are reported9. This variability in undereporting can make it hazardous to assume that the relative frequencies of adverse events in VAERS reflects their relative rates of occurrence. In addition, for new products on the market, increased reporting of adverse events may occur; this has been termed the "Weber effect"10.

[TZ]

140. the other problem if you wish to argue the point

is it is indeed possible to not know that a vaccine has caused a severe illness or death. OR if there was something else wrong with the individual that was not previously known its possible a death could be blamed on a vaccine when its due to something else. This kind of subjectivity is kind of inevitable in vaccine use. I don't ever think this should be used necessiraly to slam any particular vaccine

[mzmolly]

152. I agree. Nor do I think we should "assume" the reverse.

death could be blamed on a vaccine when its due to something else.

And, death could be blamed on a "something else" when its due to vaccine reaction.

PS please check out my post #84. Since you're in the "biz" I really want to know your thoughts. Thanky :hi:

[AikidoSoul]

257. Your argument is the same as the vaccine manufacturers

What you don't acknowledge is that there has been suppression of information about adverse incidents.

It is difficult if not impossible to prove causation.

The law is on the side of the vaccine manufacturers --partly due to precedent based on a court case decided in favor of defendant Dow Chemical -- known as the Daubert Doctrine --and also due to legal immunities gifted by the Bush administration's efforts to protect vaccine makers.

[moc]

158. Health care providers are mandated by law to report certain adverse

events after vaccination.

see p. 18, last paragraph.

http://www.cdc.gov/nip/publications/surv-manual/chpt18_vaers.pdf

Are you suggesting that if a parent thought his/her child died as a result of vaccination that s/he wouldn't report it even if the provide deemed it a "sad coincidence"?

[mzmolly]

I'm suggesting most parents have never heard of VAERS.

Also, the reporting guidelines you point to are limited to specific events within a specific time frame.

I assume the info you were noting was this on page 16 and is as follows?

Effective date: July 01, 2005. The Reportable Events Table (RET) reflects what is reportable by law (42 USC 300aa-25) to the Vaccine Adverse Event Reporting System (VAERS) including conditions found in the manufacturers package insert. In addition, individuals are encouraged to report any clinically significant or unexpected events (even if you are not certain the vaccine caused the event) for any vaccine, whether or not it is listed on the RET. Manufacturers are also required by regulation (21CFR 600.80) to report to the VAERS program all adverse events made known to them for any vaccine.

Here is the regulation referenced (42 USC 300aa-25): http://www.fda.gov/opacom/laws/phsvcact/300aa-25.htm which appears to refer to the National Vaccine Injury Compensation Program? After reading this, it appears that in order to qualify for the NVIC one must submit info to VAERS in X amount of time? But, I still have some digging to do. I attempted to contact the FDC VAERS hotline, but they are gone for the day from what I can tell.

Regardless, the data is very limited and not a sufficient means to gather reputable/reliable info according to the FDC, CDC: http://www.vaccinesafety.edu/VAERS.htm

[HiFructosePronSyrup]

62. Agreed.

People are fine with polio shots and tetanus shots but seem to still think that the people who get STDs deserve it for being sinners.

There's a number of people here that think HPV "isn't communicable."

They often say things like "I'm not prude, but..."

Then there's always that "but."

[AikidoSoul]

256. That is not true, and it's sad that you're saying so. If you read the posts you'll perhaps

notice that many of us have nothing whatsoever against sex.

Please don't lump us with the rightwing nuts.

[Sapere aude]

18. Even if all you say is true and I suspect it is, there is nothing right about forcing

a vaccine on children like is proposed. There must be more long and I mean long term studies on the side effects before we give it to a whole generation of women!

[TZ]

123. mandatory or not let me ask you one thing here

and I am dead serious here. How long do you think studies should be done? Clinical trials are long term studies that takes years. They are not done overnight by mandate. It would not be practical to wait 30 years for real long term studies. As I said I am mixed on whether or not it should be mandatory but I think that MOSTLY (there are some exceptions where the FDA can "fast-track studies but thats a whole other issue)

[Sapere aude]

142. I would not have a problem with 30 yrs. I would not want something in my body

that I was not at least 99% sure it would not harm me let alone some government telling me I have to have it placed in me.

I don't understand the thinking that says we can pass a law making a vaccine mandatory. We have our mail opened, our phones tapped, our internet usage recorded, all our demographic information is on file and now we are willing to turn our bodies over to medical science? Fuck no!

[TZ]

161. so let me float a theory

If bird flu becomss pandemic and highly contagious and the only way to stop it would be to vaccinate everyone what would you think? This would be a situation where it could endanger large populations of people if even a handful of people refuse the vaccine. Just consider this. Thats why so many scientists are big on mandatory vaccines.
And who knows whats going in our bodies anyway with all the processed food we eat anyway. I really do understand your pov but I just want people to think critically on something that could become quite possible in the near future.

[Richard Steele]

21. Kicked and recommended.

[China_cat]

22. You aren't the only one who objects to the very

non-scientific 'evidence' spouted about this vaccine. Especially the implications that it will ONLY save about 1300 lives per year and then they will only be women who deserve to get the cancer anyway or that the women dying of it are old and have to die of something. The objections to the vaccine on rational grounds or objections to the legislation of administration have been buried under some really nasty anti-woman propaganda.

[JuniperLea]

24. Think of all the drugs and food additives that have been released and subsequently recalled

in the past 30-40 years.

No thank you.

There are good and bad people in every field. That doesn't mean that the Fed uses all that good work for the good of mankind. You have to realize that we as a society have been burned, and burned badly.

"Take this pill and we guarantee you will carry your baby to full term!"


"Hmmmm... odd we are having all these birth defects!"


Vicious circles of lies and deceits are hard to overcome.

[Horse with no Name]

27. The vaccine process is a little different

What was the last vaccine that was recalled?

[KittyWampus]

61. The vaccine process includes a limited run in the general population. That HAS NOT BEEN DONE

[Horse with no Name]

64. It has in other countries

Or don't they count?

[moc]

69. I don't believe so. Do you have a link?

I don't think it's been used anywhere for more than 12 months and, as I've said elsewhere, there's little if any safety data in 9-12yo.

One reason why I was not that concerned about the chickenpox vaccine (also new when dd was an infant) was because it had over a decade of experience in Japan.

[Horse with no Name]

75. New Zealand okay?

http://www.medsafe.govt.nz/Profs/Datasheet/g/Gardasilinj.htm

The efficacy of GARDASIL or the HPV component of GARDASIL was assessed in 4 placebo-controlled, double-blind, randomized Phase II and III clinical studies. One Phase II study evaluated all four components (i.e., HPV 6, 11, 16, and 18) of GARDASIL (Protocol 007, N = 551). An additional phase II study evaluated the HPV 16 component of GARDASIL (Protocol 005, N=2,391). The Phase III studies, termed FUTURE (Females United To Unilaterally Reduce Endo/Ectocervical Disease), evaluated GARDASIL in 5,746 (FUTURE I) and 12,157 (FUTURE II) subjects. Together, these studies evaluated 20,845 women 16 to 26 years of age at enrolment, the majority of whom had been sexually active. The median duration of follow-up was 4.0, 3.0, 2.4, and 2.0 years for Protocol 005, Protocol 007, FUTURE I, and FUTURE II, respectively. Subjects received vaccine or placebo on the day of enrolment and 2 and 6 months thereafter. Efficacy was analyzed for each study individually and for all studies combined.

[moc]

86. Thank you. This link is very helpful. However, it looks to be clinical trials data.

This looks very similar to the other clinical trials data I was looking at, but I'm not sure if that trial was in the U.S. or elsewhere. Also, it doesn't look like they provide their N for the youngest age group. My concern, expressed elsewhere, is that there are insufficient safety data in 9-12yo.

When I referred to other country data, I meant that it's been implemented in the general population for some time, not that it's undergone clinical trials in other countries. Sorry for the confusion. Do you know if it's been implemented in the general population in other countries, and if so, for how long? Many thanks. :hi:

[Horse with no Name]

89. Is your google broken?

I mean...just asking.

[moc]

94. Sorry, didn't mean to be a pest. You seemed to be knowledgeable

and didn't think you'd mind sharing information. Sorry to be a bother.

[Horse with no Name]

96. No problem

And thanks for the backhanded compliment.
I've grown to expect passive-aggressive behavior from some.
:hi:

[moc]

100. Apology accepted.

:-)

I'm truly just seeking information. No passive-aggressive motive here. I thought I read somewhere that it's pretty much new all around, but I can't remember where I read it.

Despite my concerns about Gardasil, I'm actually a very strong supporter of vaccination and even mandated vaccination in most situations. I'm in public health (maternal and child health specifically) so I know well how much illness has been eliminated due to vaccines.

:hi:

[Horse with no Name]

103. Then I apologize for the snark

There have been general population trials...but the only link that I can find is Merck and considering they are making money on this, really wanted a different link.
http://www.merck.com/newsroom/press_releases/product/2006_0608.html
>>>>snip
Studies examine impact of GARDASIL in the general population
A secondary analysis to assess the potential impact of GARDASIL on rates of cervical cancer and other HPV-related diseases on the general population was also conducted. This analysis included all women regardless of whether they were infected with HPV prior to vaccination, developed an infection after the start of vaccination and those who may not have completed the 3-dose vaccination. In this analysis, GARDASIL reduced the risk for development of cervical pre-cancerous lesions and cervical cancer caused by HPV types 16 and 18 by approximately 40 percent in just two to four years. Genital warts (related to type 6, 11, 16 and 18), which develop more quickly than cervical cancer and pre-cancerous lesions, were reduced by almost 70 percent. Virtually all of the cases of CIN and genital warts seen in subjects who received GARDASIL resulted from infections that were present when the women received their vaccination.

I will look for other corroboration.

[moc]

108. Thanks much. I'll do a quick medline search too.

Anything to avoid the book proposal I'm supposed to be working on. :-)

Update: Didn't find anything. Found 8 papers and also checked out their bibliographies. Only found reports of clinical trials or animal studies. Nothing population level.

[Horse with no Name]

120. Here you go.

Not sure that this will cut and paste:

Table 1
Analysis of Efficacy of GARDASIL in the PPE* Population** Population GARDASIL Placebo % Efficacy (95% CI)
n Number of cases n Number of cases
HPV 16- or 18-related CIN 2/3 or AIS
Protocol 005*** 755 0 750 12 100.0 (65.1, 100.0)
Protocol 007 231 0 230 1 100.0 (-3734.9, 100.0)
FUTURE I 2200 0 2222 19 100.0 (78.5, 100.0)
FUTURE II 5301 0 5258 21 100.0 † (80.9, 100.0)
Combined Protocols ‡ 8487 0 8460 53 100.0 † (92.9, 100.0)
HPV 6-, 11-, 16-, 18-related CIN (CIN 1, CIN 2/3) or AIS
Protocol 007 235 0 233 3 100.0 (-137.8, 100.0)
FUTURE I 2240 0 2258 37 100.0 † (89.5, 100.0)
FUTURE II 5383 4 5370 43 90.7 (74.4, 97.6)
Combined Protocols 7858 4 7861 83 95.2 (87.2, 98.7)
HPV 6-, 11-, 16-, or 18-related Genital Warts
Protocol 007 235 0 233 3 100.0 (-139.5, 100.0)
FUTURE I 2261 0 2279 29 100.0 (86.4, 100.0)
FUTURE II 5401 1 5387 59 98.3 (90.2, 100.0)
Combined Protocols 7897 1 7899 91 98.9 (93.7, 100.0)
*The PPE population consisted of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naïve (PCR negative and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month Postdose 3 (Month 7).
**See Table 2 for analysis of vaccine impact in the general population.
***Evaluated only the HPV 16 L1 VLP vaccine component of GARDASIL.
† P-values were computed for pre-specified primary hypothesis tests. All p-values were <0.001, supporting the following conclusions: efficacy against HPV 16/18-related CIN 2/3 is >0% (FUTURE II); efficacy against HPV 16/18-related CIN 2/3 is >25% (Combined Protocols); and efficacy against HPV 6/11/16/18-related CIN is >20% (FUTURE I).
‡ Analyses of the combined trials were prospectively planned and included the use of similar study entry criteria.
n = Number of subjects with at least 1 follow-up visit after Month 7.
Note 1: Point estimates and confidence intervals are adjusted for person-time of follow-up.
Note 2: The first analysis in the table (i.e., HPV 16- or 18-related CIN 2/3, AIS or worse) was the primary endpoint of the vaccine development plan.
Note 3: FUTURE I refers to Protocol 013; FUTURE II refers to Protocol 015.

GARDASIL was efficacious against HPV disease caused by each of the 4 vaccine HPV types.

In a pre-defined analysis, the efficacy of GARDASIL against HPV 16/18-related disease was 100% (95% CI: 87.9%, 100.0%) for CIN 3 or AIS and 100% (95% CI: 55.5%, 100.0%) for VIN 2/3 or VaIN 2/3. The efficacy of GARDASIL against HPV 6-, 11-, 16-, and 18-related VIN 1 or VaIN 1 was 100% (95% CI: 75.8%, 100.0%). These analyses were conducted in the PPE population that consisted of individuals who received all 3 vaccinations within 1 year of enrollment, did not have major deviations from the study protocol, and were naïve (PCR negative and seronegative) to the relevant HPV type(s) (Types 6, 11, 16, and 18) prior to dose 1 and through 1 month Postdose 3 (Month 7).

Efficacy in Subjects with Current or Prior Infection

GARDASIL is a prophylactic vaccine.

There was no clear evidence of protection from disease caused by HPV types for which subjects were PCR positive and/or seropositive at baseline.

Individuals who were already infected with 1 or more vaccine-related HPV types prior to vaccination were protected from clinical disease caused by the remaining vaccine HPV types.

General Population Impact

The general population of young American women includes women who are HPV-naïve (PCR negative and seronegative) and women who are HPV-non-naïve (PCR positive and/or seropositive), some of whom have HPV-related disease. The clinical trials population approximated the general population of American women with respect to prevalence of HPV infection and disease at enrollment. Analyses were conducted to evaluate the overall impact of GARDASIL with respect to HPV 6-, 11-, 16-, and 18-related cervical and genital disease in the general population. Here, analyses included events arising from HPV infections that were present at the start of vaccination as well as events that arose from infections that were acquired after the start of vaccination.

The impact of GARDASIL in the general population is shown in Table 2. Impact was measured starting 1 month Postdose 1. Prophylactic efficacy denotes the vaccine’s efficacy in women who are naïve (PCR negative and seronegative) to the relevant HPV types at vaccination onset. General population impact denotes vaccine impact among women regardless of baseline PCR status and serostatus. The majority of CIN and genital warts, VIN, and VaIN detected in the group that received GARDASIL occurred as a consequence of HPV infection with the relevant HPV type that was already present at Day 1.



Table 2
General Population Impact for Vaccine HPV Types Endpoints Analysis GARDASIL or HPV 16 L1 VLP Vaccine Placebo % Reduction
(95% CI)
N Cases N Cases
HPV 16- or 18-related CIN 2/3 or AIS Prophylactic Efficacy* 9342 1 9400 81 98.8 (92.9, 100.0)
HPV 16 and/or HPV 18 Positive at Day 1 -- 121 -- 120 --
General Population Impact** 9831 122 9896 201 39.0 (23.3, 51.7)
HPV 16- or 18-related VIN 2/3 and VaIN 2/3 Prophylactic Efficacy* 8641 0 8667 24 100.0 (83.3, 100.0)
HPV 16 and/or HPV 18 Positive at Day 1 -- 8 -- 2
General Population Impact** 8954 8 8962 26 69.1 (29.8, 87.9)
HPV 6-, 11-, 16-, 18-related CIN (CIN 1, CIN 2/3) or AIS Prophylactic Efficacy* 8625 9 8673 143 93.7 (87.7, 97.2)
HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1 -- 161*** -- 174*** --
General Population Impact** 8814 170 8846 317 46.4 (35.2, 55.7)
HPV 6-, 11-, 16-, or 18-related Genital Warts Prophylactic Efficacy* 8760 9 8786 136 93.4 (87.0, 97.0)
HPV 6, HPV 11, HPV 16, and/or HPV 18 Positive at Day 1 -- 49 -- 48 † --
General Population Impact** 8954 58 8962 184 68.5 (57.5, 77.0)

* Includes all subjects who received at least 1 vaccination and who were naïve (PCR negative and seronegative) to HPV 6, 11, 16, and/or 18 at Day 1. Case counting started at 1 Month Postdose 1.
** Includes all subjects who received at least 1 vaccination (regardless of baseline HPV status at Day 1). Case counting started at 1 Month Postdose 1.
*** Includes 2 subjects (1 in each vaccination group) who underwent colposcopy for reasons other than an abnormal Pap and 1 placebo subject with missing serology/PCR data at day 1.
† Includes 1 subject with missing serology/PCR data at day 1.
Note 1: The 16- and 18-related CIN 2/3 or AIS composite endpoint included data from studies 005, 007, 013, and 015. All other endpoints only included data from studies 007, 013, and 015.
Note 2: Positive status at Day 1 denotes PCR positive and/or seropositive for the respective type at Day 1.
Note 3: Percent reduction includes the prophylactic efficacy of GARDASIL as well as the impact of GARDASIL on the course of infections present at the start of the vaccination.
Note 4: Table 2 does not include disease due to non-vaccine HPV types.

http://www.fda.gov/cber/label/hpvmer060806LB.htm

[moc]

148. Thanks. As best I can tell, they are taking the clinical trials data

and projecting it to the general population based on the results of the trial. I don't think they have data on a general population sample. However, clinical trials epi is not my "first language" scientifically speaking, and I could be misreading this.

I am having flashbacks to epi 2, though. :scared: ;-) That class always made me feel like my brain had been put through a meat grinder.

[Horse with no Name]

245. I have contacted one of the Australian researchers via email

and asked if she would send me the general population trials.
I will keep you posted.
:hi:

[ebayfool]

157. The problem w/Google is that those 'some' have spread their cut & paste ...

around some much that it's become a virus in need of a vaccine for itself. Stickdog, stick_doggie_dog, et al have done the cut & paste push-spam thing so much that it's like wading through mud on Google, anymore!

Almost looks like an organized effort to pollute the discussion & keep it off kilter, to my eye.

It's almost making me long for Skinners' now defunct block function, almost!
:evilgrin:

[JuniperLea]

85. I would agree that prolonged use is a good indicator, however

Chicken pox is one of those "childhood" diseases that can cause serious problems in adults. There was some concern that the vaccine did not last into adulthood, and I believe there is now a booster vaccine. I think there needs to be a much longer study. But then I'm a naturalist, animist tree hugger who would eschew them all if it were practical.

[moc]

106. When I looked into this back when dd was an infant, I'm pretty

sure there was close to two decades of experience with the varicella vaccine in Japan, and that immunity appeared to be maintained.

Unfortunately, I tried to pull up the information on the CDC website just now but their server is having issues. I'll add later if I can.

[JuniperLea]

65. 2000... 2006... many, many...

Google "vaccine recall" and you will find a lot.

[TZ]

124. happens from time to time

and usually thats a good thing. It means they are catching the problem. I will say I do know that some vaccines are definitely rushed into use with less than great safety testing (see Anthrax vaccine in the year 2000). From what I can tell its not the case here since other countries have had success with this vaccine

[moc]

67. Rotovirus. 2001 if I recall correctly.

[mzmolly]

122. Fluvirin?

http://aapnews.aappublications.org/cgi/content/full/e2006233v1

Rota-shield is another that comes to mind. And apparently the new "improved" Rota-tek has just been recalled for the same problem? http://www.reuters.com/article/healthNews/idUSWAT00695820070213

Menomune: http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2002/menomune_hpc-cps_e.html

Google vaccine hot lots or vaccine recall for a bit more info.

[antigop]

130. the vaccine process is different all right -- they are trying to shove it through undemocratically

n/t

[TZ]

36. some food for thought if you will?

Thalidomide caused horrible birth defects because of lack of study and other problems. But now, believe it not it turns out that Thalidomide is a very effective anti-cancer (and some other chronic blood diseases) medication. I agree that not everything the gov't does is good or right. But its wrong just to throw things away wholesale based on fear and ignorance. I really want to get people to get perspective on things here. Thats my point.

[JuniperLea]

56. I understand, but you have to realize

That there are those of us who have been not merely let down by big pharma, but have suffered irreparable damage. The lay person has no clue about how proper study is conducted, and further, we have good reason to believe we have been lied to in the past. I tend not to believe any entity that has lied. That goes for anything upon which the Food and Drug Administration puts its seal of approval. You can't blame the public at large for being leery. And to infer they are ignorant doesn't help your cause. I'm sure you meant no harm, but it is really horribly offensive.

[TZ]

127. I am not trying to offend people

but several times I have gotten factually wrong responses to my arguments. Including calling vaccines "chemicals" or "drugs". If you don't understand what a vaccine is how can you justify your arguments? Don't you think you ought to know the facts before you tell someone they are wrong? I always try to make sure I know what I am saying before I make a point but sometimes I am in error, and then I will apologize. But when I get the same argument over and over with the same inaccuracies from the same person what is that but willful ignorance?

[JuniperLea]

165. Perhaps try explaining the difference?

Then perhaps you can find a good reason why anyone would want to put a foreign substance in their body. This from someone who worked in the health care industry and refuses to wear contact lenses because of all the horrors I've seen.

:)

[TZ]

170. umm

vaccines are not really foreign substances. They are slightly altered versions of natural pathogens desgined to make your body's immune system work. And the idea is that they create a "memory" in your immune system so that even after a long time from initial vaccination you have designer antibodies to keep you from getting sick next time you are exposed. The "vaccine" itself doesn't usually linger for years and years like a drug or chemical would. I kind of think of it as a natural helper actually

[JuniperLea]

221. If it doesn't already come in my body

Its a foreign substance. You've done a good job explaining how they work, but not what they are. I understand how immunities work. When you have had chicken pox, for example, there are naturally occurring antibodies created in your immune system. If exposed again, the antibodies block it.

So what we have in a vaccine is "altered". Its the "altered" that bothers me. Much like genetically altered foods bother me.

But what bothers me most of all is big pharma or government telling me I must be injected with something. That sends up a red flag that no amount of science training is going to change.

[AirmensMom]

224. I'm with you, Juniperx.

:thumbsup:

[TZ]

227. okay not very easy to explain but I will try

some vaccines are weakend or what they called "attenuated" virus of that particular disease and injected into your body to make your immune system react and create antibodies to protect you at a low enough level that you won't get sick but since you have now been exposed the immune system remembers and now you are protected. There are other vaccines that are not virus per se but a certain gene that researches have discovered is key in causing infections in people (for instance I have knowledge of malaria vaccine research and one they are currently testing takes an antigen- the gene that the parasite has and is most likely the one that triggers an immune response and puts it into a vaccine). It's called a recombinant vaccine and while that sounds very outlandish the technique is very sound. Basically those vaccines are tiny little bits of parasitic/bacterial/viral particles being injected into you to get antibodies to form. I actually think its really neat stuff. Does that help any?

[lizerdbits]

58. If I remember correctly from organic chemistry...

The problem with thalidomide was that one enantiomer was the one that alleviated morning sickness and the other caused birth defects but both were present in the drug. They found they could isolate the enantiomer they wanted but what woman would take that based on history if it was approved? Probably none.
:hi:

[TZ]

147. actually I may be faced with a choice

because of my chronic blood disease caused by bad bone marrow where it is either take thalidimide or get a bone marrow transplant. I would choose the thalidimide in that situation but thats probably unlikely. I just wanted to get people thinking here. I think I succeeded don't you lizerdbits? I am really having fun patrolling my own thread. Hope you are enjoying it. Meant to tell you but I was focused on getting home safely in the ice as I see you did. :popcorn: :hi:

[seabeyond]

26. this is what happens when you abuse and lose trust. and the pharma

co. in the arms of govt certainly as done here part on losing trust. your indstury is responsible and needs to own this.

[TZ]

41. tell me how?

I work for a very small company. They are trying to do biodefense work amoung other things. It really is in the best interest of these companies to put out a quality product. Most companies understand that. Some don't. I have always tried to fix things or at least not participate in things that are bad science. Its not always possible to stop it. A lot of people like me try. But there has to be a willingness of people to listen rationally and think critically about issues.

[seabeyond]

49. hence the dilemma n/t

[ceile]

30. Good rant.

[HiFructosePronSyrup]

32. This goes without saying.

Of course, it also goes with out saying that there are plenty of irrational anti-vaccine nuts out there.

So don't take anything personally.

[antigop]

38. It goes without saying that we should uphold democratic principles n/t

[HiFructosePronSyrup]

51. It goes without saying that chocolate is tasty.

:shrug:

I'm not seeing your point.

[TZ]

153. you just made me laugh

not sure why but you did:)

[TZ]

46. thats always been my problem

its too hard not to care passionately about things. Thats just who I am (and the naivity and hope that I can make the world a better place):)

[mzmolly]

80. And, there are plenty of irrational "pro big pharma" nuts out there as well.

And, please don't take that statement personally either. ;)

[HiFructosePronSyrup]

88. Are there?

[mzmolly]

104. Yes.

[HiFructosePronSyrup]

118. It's a big conspiracy, eh?

They're lurking behind every bush?

[mzmolly]

119. A consipiracy to make money

yes.

I'm not sure who's behind your bushes though?

[antigop]

137. and a conspiracy to subvert democracy n/t

[HiFructosePronSyrup]

139. Oh, my odds and bodkins!

First the chemtrails, now this!

[mzmolly]

156. In the case of Texas, indeed.

The CEO of Merck has contributed mega thousands to Republicans (the gov included) but I'm sure "they" all have our best interests at heart. ;)

[antigop]

159. It's also Perry's plan to grab power and set a precedent to keep that power n/t

[Lisa0825]

37. THANK YOU!!!

I'm a former scientist, and this debate has made my head spin. I wish we'd had to fight with Governor Goodhair to get the vaccine, so maybe people wouldn't be so instinctively opposed to it.

Thank y ou for the work you do!

[antigop]

39. uh, the Texas lege IS fighting goodhair because he doesn't have the authority to do this n/t

[ceile]

43. Totally agree!

If Perry had said "No way is my state vaccinating preteen girls" then we would be all up in arms calling him a misogynist, a christofacist, etc. and wishing Bell had been elected (of course we still do) because he promised the vaccine.

[antigop]

47. Instead you're giving Perry a pass for overstepping his authority n/t

[ceile]

63. I don't give Perry a pass for anything.

And how dare you assume so. I just happen to agree that young girls need this vaccine and honestly, I don't think they're going to get it. The lege will step up and stop him.

[antigop]

72. You had better hope that the lege will step up and stop him. This is a power grab. n/t

[Lisa0825]

48. Bell and Planned Paarenthood have both come out in support

of his decision, but the conspiracy mongers still won't let up.

[ceile]

66. Yep.

It's all about big pharma-the lives of young women be damned!

[antigop]

71. Why do you all hate democracy? Why? This is DU? n/t

[mzmolly]

73. I don't think it's respectful to call an alternate view "fear mongering."

I have no problem with a differing view if you can back it up with RATIONAL EVIDENCE. We all have a right to our own opinions. But I do object to baseless and irrational slander and attack on good science which in turn may be due to sheer ignorance and fear in some.

In all honesty, "rational evidence" is subjective. And, irrationality has been a huge factor in both sides of this debate.

I'll be glad to post some information based on "science" later that may be of interest to you?

One of the primary DU objectors to mandating this vaccine is also in "vaccine development." Also, I would never suggest that those who are in the field are "Nazi's." I would suggest however that there are very important things people should take into consideration when considering the "science" surrounding vaccination.

[TZ]

167. thats fine

and a chose my words for this rant carefully. I really did not want to insult groups at large but I have very good reasons for saying what I did and I don't want to go into detail. And while nobody has called me a Nazi per se, there has been certain implications of that elsewhere again not going into detail. I am sorry if you found my post offensive or disrespectful. It was not meant that way. And trust me there were much angrier and nastier things I wished to say. And if scientific articles journals, teachings facta and knowledge are subjective how can anything be that way. Vaccine development is based on sound biochemical principles that I am not nearly smart enough to explain.
I don't mind posting evidence whether pro or anti as long as you can back it up. I don't think anti-vaccine blogs or pro natural remedy blogs are evidence btw which is what I have had thrown at me.

[mzmolly]

191. I agree we have to consider the source. However, I don't think that Merck

can be considered impartial either, and unfortunately with limited impartial data on vaccines we often have to choose between the manufacturer (and it's cohorts who push vaccination) or anti-western medicine groups. I do attempt to post "science" when I question and post information from people with medical credentials. My frustration comes in when information is from reputable sources is continually dismissed, without good cause. It's as though no one will entertain the possibility that vaccines can and do cause harm?

I have had all sorts of "stuff" thrown at me as well, and I also wish we could debate this issue like adults - period.

Thanks for opening discussion. :hi:

[TZ]

204. thats really what I was looking for to tell you the truth

adult debate. I really am kind of on the fence with the Gardasi myself but there is just so much nonsense associated with it that I wanted to take that on. And can I say that while Merck's corportate body might not be impartial and ceratinly there is a disturbing greedy element with this link between Perry of Texas (whom I would have thought would be screaming about the vaccine causing more casual sex at first blush) again, the scientists at Merck are probably pretty smart and motivated to help as well. Have I not admitted that I would work for Merck given the opportunity. Gotta take the good with the bad and they do actually do and fund a lot of good research (some of which I have been involved in including that paper I mentioned I contributed to)

[mzmolly]

207. The scientists at Merck are likely very good people. But any information

gathered in studies funded by Merck, is proprietary. As such, they can withhold data if they choose and cherry pick information that they release. Merck has proven it is not reliable when it comes to telling the truth IMO.

Thanks for the respectful discussion. ;)

[TZ]

214. You are very very welcome!!!

I have very much enjoyed this much to my cats regrets since I have been ignoring them to do this:) :loveya:

[mzmolly]

216. Don't worry my family feels the same. My husband had left overs and my daughter

a bologna sandwich with watermelon slices on the side. :evilgrin:

Peace to you and your kitties.

[mzmolly]

84. What about the "science" in this very recent study?

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17114826


Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice.

* Petrik MS,
* Wong MC,
* Tabata RC,
* Garry RF,
* Shaw CA.

Department of Ophthalmology and Program in Neuroscience, University of British Columbia, Vancouver, British Columbia, Canada.

Gulf War illness (GWI) affects a significant percentage of veterans of the 1991 conflict, but its origin remains unknown. Associated with some cases of GWI are increased incidences of amyotrophic lateral sclerosis and other neurological disorders. Whereas many environmental factors have been linked to GWI, the role of the anthrax vaccine has come under increasing scrutiny. Among the vaccine's potentially toxic components are the adjuvants aluminum hydroxide and squalene. To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed. Young, male colony CD-1 mice were injected with the adjuvants at doses equivalent to those given to US military service personnel. All mice were subjected to a battery of motor and cognitive-behavioral tests over a 6-mo period postinjections. Following sacrifice, central nervous system tissues were examined using immunohistochemistry for evidence of inflammation and cell death. Behavioral testing showed motor deficits in the aluminum treatment group that expressed as a progressive decrease in strength measured by the wire-mesh hang test (final deficit at 24 wk; about 50%). Significant cognitive deficits in water-maze learning were observed in the combined aluminum and squalene group (4.3 errors per trial) compared with the controls (0.2 errors per trial) after 20 wk. Apoptotic neurons were identified in aluminum-injected animals that showed significantly increased activated caspase-3 labeling in lumbar spinal cord (255%) and primary motor cortex (192%) compared with the controls. Aluminum-treated groups also showed significant motor neuron loss (35%) and increased numbers of astrocytes (350%) in the lumbar spinal cord. The findings suggest a possible role for the aluminum adjuvant in some neurological features associated with GWI and possibly an additional role for the combination of adjuvants.

I'll check back later tonight, but I wanted to get your thoughts on this.

I posted more info here: http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=167184&mesg_id=177001

Thanks :hi:

[mzmolly]

114. *whistles*

I am really curious about what people think about the info I posted above? :shrug:

[TZ]

173. okay here i go

This is an UNPUBLISHED STUDY on 10-20 mice using an a very potent ANTHRAX vaccine that most people will never get. If Alum was a problem why doesn't everyone who has had Hep A, B and other vaccines like chicken pox many of which are mandatory. This is JUNK SCIENCE at it's worst and I am tired of seeing it. I have said that not every scientist is credible and I am very tired of having this study from someone with an obvious poliitcal agenda pushed at me as the answer I have seen this at least 3 or 4 times now. I could go on hours and hours in all the holes in this piece of BAD BAD BAD science.
PS I worked with one of the world's premier biochemists/vaccine specialists who is very knowledgable and from what I learned I pretty much can tell you alum adjuvents causing this is physiologically impossible.
I would post one of his 250 plus publications (one of which if I may brag briefly i contributed data too) I contributed to but they are sooo technical that I have a hard time with them. Don't think it would help. Sorry hope I didn't offend but this is one of the things that set me off on my rant in the first place.

[mzmolly]

189. It appears it was published in - Neuromolecular Med. 2007;9(1):83-100.

This is an UNPUBLISHED STUDY on 10-20 mice using an a very potent ANTHRAX vaccine that most people will never get.

As I said, it's a new study published just this month (from what I can tell?) ;) And, the adjuvant is what was administered: To examine whether these compounds might contribute to neuronal deficits associated with GWI, an animal model for examining the potential neurological impact of aluminum hydroxide, squalene, or aluminum hydroxide combined with squalene was developed.

If Alum was a problem why doesn't everyone who has had Hep A, B and other vaccines like chicken pox many of which are mandatory.

It's hard for babies who've had the vaccines you mention, to tell us about side effects. And, when parents do, they are called "anti vaccine hysterics." Adults have been given "some" credibility via the GWI dx. but even their symptoms are dismissed by many as 'coincidental' events. Also, I don't think the chicken pox vaccine contains aluminum does it?

I have said that not every scientist is credible and I am very tired of having this study from someone with an obvious politcal agenda pushed at me as the answer I have seen this at least 3 or 4 times now.

Political agenda? Can you show me which of these scientists have a political agenda? I've looked at their research and found info no evidence of that. Those I could "locate" have excellent credentials and work for major universities. I don't know where you've seen this, as I stumbled upon this while digging. I did not get this info here, and as I said, the study appears to be quite new?

I could go on hours and hours in all the holes in this piece of BAD BAD BAD science.

I wish you would. Isolated studies can always be called "bad science," but given the reluctance to gather impartial data on vaccinations in the scientific community, consensus is going to be difficult to come by, no?

PS I worked with one of the world's premier biochemists/vaccine specialists who is very knowledgable and from what I learned I pretty much can tell you alum adjuvents causing this is physiologically impossible.

I remain open minded on the possibility.

I would post one of his 250 plus publications (one of which if I may brag briefly i contributed data too) I contributed to but they are sooo technical that I have a hard time with them. Don't think it would help. Sorry hope I didn't offend but this is one of the things that set me off on my rant in the first place.

No offense at all! I am not offended by differences in opinion on this matter. Perhaps you can send this info to your friend for analysis? I'm really interested in varied opinions. I did email one of the researchers with some questions, not sure if I'll hear back.

Peace :hi:

[TZ]

206. I can tell you we are really like minded

on many things so he would say what I did except he would go on at great detail and at length about the biochemistry (and I do mean length- one time he went on for about 30 minutes on how cricket was superior to american football even after his wife had told me earlier it hurt to talk so he was going to be silent). If I can contact him (he is difficult to get a hold of these days) maybe he will give me a helpful link or something. I tease him about being a bore even though he's not to me (if you can't tell this person is someone I admire above all others, truly an extraordinary person). In my rant I kind of am doing things he does to some extent. Giving back what I owe in some sense. Nothing I would love better than to have everyone sit and listen to him. That would change some skeptics I think!:) In fact I think I have to find a way to get him to read my post. I think he would love it and be proud of me

[AikidoSoul]

258. You're not making valid points here, merely judgments that appear to be

knee-jerky.

Your phrases like "This is JUNK SCIENCE" (an industry created term), and "I am tired of seeing it" and "I could go on for hours..." does not give me confidence that you have thought this through in an orderly way. Neither does your judgment that the aluminum study was based on "... BAD BAD BAD science".

These are not valid arguments.

There are many linkages to aluminum products and neurological disease as the medical literature adequately demonstrates.

For you to state your "knowledgeable" specialist tells you that "...alum adjuvents (sic) causing this (chronic neurological disease) is physiologically impossible" is grossly at odds with medical science literature.

You seem to wonder "why doesn't everyone" who has had vaccines come down with neurological problems and disease -- which is a false, absolutist construct. You know very well that not everyone responds similarly to neurotoxicants, or anything else that can be potentially harmful. Don't forget too that even if overt disease is not triggered --that does NOT mean that it is not affecting the person at the sub-clinical level.




edited to add the end parenthesis symbol

[TZ]

266. I can't explain the problems with this study here..

it would take too long. I see you did pick up that they were dealing with a problematic Anthrax vaccine. That indeed has been a problem vaccine and most in the professional community will tell you that themselves. I am working on getting some data from a personal friend of mine who is a internationally known vaccine researcher who can explain the faulty logic and science in the paper better than I. He can go on for hours about adjuvents. When I get the data I will post it.

[AikidoSoul]

270. If you qualify to "explain the problems with this study" then please do tell us what you think

I for one would like to see you analyze it.

Aluminum adjuvants are NOT the only issue of concern, but you responded to the study posted by MzMolly discussing the possible role of aluminum adjuvants in Gulf War Illness -- and you bascially say it's gotta be wrong.

I've posted the study name so you can go find it on PUbMed, read it, find the "faulty logic", and post it:

Below that one are other scientific publications listed examining the role aluminum adjuvants may play in a variety of chronic illnesses, including neurological ones.

1: Neuromolecular Med. 2007;9(1):83-100.

Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice.
Petrik MS, Wong MC, Tabata RC, Garry RF, Shaw CA.

Another of your earlier comments suggested that aluminum adjuvants couldn't really be hurting anyone when you suggested that "everyone" would be affected. What you're not considering is the variabilities exist in all populations. For example, Apolipoprotein E (apo E) allele variations have been associated with genetic susceptibility in neurodegenerative diseases. So have differces in detoxification efficiency based on liver and enzyme deficits. There are many, many other concerns having to do with variability.

There is also the HUGE problem that many doctors have no clue about how neurological symptoms can be triggered by neurotoxicants-- which can develop into full blown neurological disease. That fact should worry everyone because we are INCREASINGLY exposed to neurotoxicants --literally, all the time now. Because doctors only receive 2 hours of medical training in toxicology in medical school, they don't "see" it. So diagnoisis doesn't happen.

And neurological effects don't have simple tests that show markers.

To give an example of how difficult it is to diagnose aluminum induced chronic illness: Macrophagic myofasciitis (MMF) is an inflammatory muscle disorder characterized by infiltration of muscle tissue by PAS-positive macrophages caused by pathological persistence of vaccine-derived aluminum hydroxide. The diagnosis of this condition can only be established by an open muscle biopsy from the muscle that was used for intramuscular vaccination.

This is not done very often I can assure you, and so many people with this condition just suffer with it and take drugs.

Here are some other research papers you might read on the effects of aluminum adjuvants (this is not all of them):

Abstract Neurological adverse events associated with vaccination.
Curr Opin Neurol. 2002 Jun;15(3):333-8. Review.
PMID: 12045734
van Rensburg SJ, Potocnik FC, Kiss T, Hugo F, van Zijl P, Mansvelt E, Carstens ME, Theodorou P, Hurly PR, Emsley RA, Taljaard JJ. Related Articles, Links

Abstract Serum concentrations of some metals and steroids in patients with chronic fatigue syndrome with reference to neurological and cognitive abnormalities.
Brain Res Bull. 2001 May 15;55(2):319-25.
PMID: 11470334


Campbell A, Prasad KN, Bondy SC. Related Articles, Links
Abstract Aluminum-induced oxidative events in cell lines: glioma are more responsive than neuroblastoma.
Free Radic Biol Med. 1999 May;26(9-10):1166-71.
PMID: 10381187


Guo-Ross S, Yang E, Bondy SC. Related Articles, Links
Abstract Elevation of cerebral proteases after systemic administration of aluminum.
Neurochem Int. 1998 Sep;33(3):277-82.
PMID: 9759924


Flarend RE, Hem SL, White JL, Elmore D, Suckow MA, Rudy AC, Dandashli EA. Related Articles, Links
Abstract In vivo absorption of aluminium-containing vaccine adjuvants using 26Al.
Vaccine. 1997 Aug-Sep;15(12-13):1314-8.
PMID: 9302736

Redhead K, Quinlan GJ, Das RG, Gutteridge JM. Related Articles, Links
Abstract Aluminium-adjuvanted vaccines transiently increase aluminium levels in murine brain tissue.
Pharmacol Toxicol. 1992 Apr;70(4):278-80.
PMID: 1608913

Fischer D, Reimann J, Schroder R. Related Articles, Links
Abstract
Dtsch Med Wochenschr. 2003 Oct 31;128(44):2305-8. German.
PMID: 14593574

Just run a search on MEDLINE and you will find many others.

[mzmolly]

272. AikidoSoul may I just say:

:yourock:

Sorry about my previous convoluted/confusing reply to you, I am so FRIED on this topic I barely know my name. :spray:

Thanks again for your kind gesture. :loveya:

[AikidoSoul]

274. MzMolly, I didn't see anything by you that was "convoluted" or "confusing"

and even if that should happen, there's no reason for you to apologize. I trust your intentions. If I need you to clarify something I think I can trust you to make every effort to do so.

To me your posts are clear, fair, documented, gentle -- and with a tone of tolerance and kindness.

For these reasons there's a better chance you can teach something new to those who resist considering some of the problems with this Gardasil issue.

Thank you very much for being trustworthy.

edited to add "MzMolly" in the subject line

[mzmolly]

275. What a kind post.

And such a high compliment considering the source.

Thank you so very much. :pals:

[AikidoSoul]

271. If you qualify to "explain the problems with this study" then please do tell us what you think

I for one would like to see you analyze it.

Aluminum adjuvants are NOT the only issue of concern, but you responded to the study posted by MzMolly discussing the possible role of aluminum adjuvants in Gulf War Illness -- and you bascially say it's gotta be wrong.

I've posted the study name so you can go find it on PUbMed, read it, find the "faulty logic", and post it:

Below that one are other scientific publications listed examining the role aluminum adjuvants may play in a variety of chronic illnesses, including neurological ones.

1: Neuromolecular Med. 2007;9(1):83-100.

Aluminum adjuvant linked to gulf war illness induces motor neuron death in mice.
Petrik MS, Wong MC, Tabata RC, Garry RF, Shaw CA.

Another of your earlier comments suggested that aluminum adjuvants couldn't really be hurting anyone when you suggested that "everyone" would surely be affected. What you're not considering is that variabilities exist in all populations. For example, Apolipoprotein E (apo E) allele variations have been associated with genetic susceptibility in neurodegenerative diseases. So have differces in detoxification efficiency based on liver and enzyme deficits. There are many, many other concerns having to do with variabilities in reactions to drugs and toxicants.

There is also the HUGE problem that many doctors have little knowledge of how neurological symptoms can be triggered by neurotoxicants-- which can develop into full blown neurological disease. That fact should worry everyone because we are INCREASINGLY exposed to neurotoxicants --literally, all the time now. Because doctors only receive 2 hours of medical training in toxicology in medical school, they don't "see" it. So diagnoisis doesn't happen.

And neurological effects don't have simple tests that show markers.

To give an example of how difficult it is to diagnose aluminum induced chronic illness: Macrophagic myofasciitis (MMF) is an inflammatory muscle disorder characterized by infiltration of muscle tissue by PAS-positive macrophages caused by pathological persistence of vaccine-derived aluminum hydroxide. The diagnosis of this condition can only be established by an open muscle biopsy from the muscle that was used for intramuscular vaccination.

This is not done very often I can assure you, and so many people with this condition just suffer with it and take drugs.

Here are some other research papers you might read on the effects of aluminum adjuvants (this is not all of them):

Abstract Neurological adverse events associated with vaccination.
Curr Opin Neurol. 2002 Jun;15(3):333-8. Review.
PMID: 12045734
van Rensburg SJ, Potocnik FC, Kiss T, Hugo F, van Zijl P, Mansvelt E, Carstens ME, Theodorou P, Hurly PR, Emsley RA, Taljaard JJ. Related Articles, Links

Abstract Serum concentrations of some metals and steroids in patients with chronic fatigue syndrome with reference to neurological and cognitive abnormalities.
Brain Res Bull. 2001 May 15;55(2):319-25.
PMID: 11470334


Campbell A, Prasad KN, Bondy SC. Related Articles, Links
Abstract Aluminum-induced oxidative events in cell lines: glioma are more responsive than neuroblastoma.
Free Radic Biol Med. 1999 May;26(9-10):1166-71.
PMID: 10381187


Guo-Ross S, Yang E, Bondy SC. Related Articles, Links
Abstract Elevation of cerebral proteases after systemic administration of aluminum.
Neurochem Int. 1998 Sep;33(3):277-82.
PMID: 9759924


Flarend RE, Hem SL, White JL, Elmore D, Suckow MA, Rudy AC, Dandashli EA. Related Articles, Links
Abstract In vivo absorption of aluminium-containing vaccine adjuvants using 26Al.
Vaccine. 1997 Aug-Sep;15(12-13):1314-8.
PMID: 9302736

Redhead K, Quinlan GJ, Das RG, Gutteridge JM. Related Articles, Links
Abstract Aluminium-adjuvanted vaccines transiently increase aluminium levels in murine brain tissue.
Pharmacol Toxicol. 1992 Apr;70(4):278-80.
PMID: 1608913

Fischer D, Reimann J, Schroder R. Related Articles, Links
Abstract
Dtsch Med Wochenschr. 2003 Oct 31;128(44):2305-8. German.
PMID: 14593574

Just run a search on MEDLINE and you will find many others.

[AikidoSoul]

255. MzMolly -- I'm glad you posted this. Gulf War vets were exposed to a wide range of neurotoxicants

which can together, or alone, cause multi-symptom chronic illnesses.

One of the items considered was the anthrax vaccine that DoD pushed on vets even though it was considered experimental. Veterans had no recourse but to accept the vaccine, and could not sue the feds due to the Feres doctrine. Those who refused the shots were punished severely.

Over a period of several years I participated in Gulf War Illness forums made up of some veterans along with researchers and scientists who discussed and documented many of the vets' exposures -- which were multiple. This population had chronic, low level exposures to a wide range of central nervous system poisons.

Not only were they exposed to oil fire smoke, but also to contaminated water, to pyrethroid pesticided uniforms and underclothing, depleted uranium, low-level exposure to Sarin (organophosphate nerve gas poison) from the explosions at Kamisayah, and the almost nightly sprayings of the camps with organophosphate and carbamate pesticides. Add to that the fact they were given pyridostigmine bromide, also called "PB" -- which is a carbamate chemical made into a drug that was supposed to attach to the brain receptors to prevent organophosphates from attaching to those receptors. Organophosphates are more dangerous -- and so while carbamates are toxic, they were considered by the military to be a reasonable trade off to prevent permanent damage. Note that carbamates were used both as pesticides AND as a prophylactic drug! Note too that Sarin is an organophosphate nerve gas -- and that there are also organophosphate pesticides.

When vets took PB or the vaccines, many reported becoming sick. Many remained sick.

Gulf War vets had chronic, low level exposures to a wide array of drugs and neurotoxicants. The word "neurotoxin" means its a substance toxic to the brain and central nervous system. Depleted uranium dust is also toxic and once in the body and kidneys -- causes damage. It is especially dangerous to the kidneys. Depleted uranium in solid form is not considered to be harmful - but used in munitions to slice through metal -- explodes and pulverizes into tiny dust particles.

Our government never funded the right groups to study this population. Scientists with toxicant induced illness experience and knowledge were purposefully left out. The money was diverted to groups that created study designs never meant to get to the real issues involved in this multi-faceted illness.

But a few researchers have edged close to the truth because they were funded privately. Robert Haley, M.D. at the Univ. of Texas and Abou Donia at Duke University, were both (and still are) funded by Ross Perot. Later DoD contributed some funds to Haley, but if it wasn't for Perot's money and influence, these study designs would have been contaminated by industry.

Civilian groups who suffer from the same sequellae of toxicant induced chronic illnesses were hopeful that the studies of the vets would produce some understanding of so called "idiopathic" or unexplained illnesses being seen worldwide. Industry has fought all of these independent researchers and their results. It has done everything in its power to create controversy -- using the same "cigarette science" tactics borrowed from that other deceitful industry.

I have hope that the public will begin to take these issues seriously before it is too late and to see through the carefully orchestrated propaganda, hate mongering that attempts to blame the victim and attack those looking for the truth.

What happened to Gulf War veterans is also happening in the civilian population. It's time to realize that many drugs and toxic products, are causing a pandemic of chronic illness.

I'm sending you 3 valentines MzMolly!

[mzmolly]

260. AikidoSoul thank you so much!

:hug:

Indeed, we have to stop dismissing "PEOPLE" when they tell us something is wrong. We have to look at every option, and not DISMISS possibilities of vaccine additives etc. because they may have a benefit to society. We can improve upon how we do things, if we are honest with ourselves as a society. Vaccine reactions are so difficult to validate because a baby can't articulate how they feel after the fact, vs. before. Sadly, parents are given the "coincidence' meme, as are veterans who tell their story.

Thanks so much for the comprehensive info on GWI. :hi:

[lynne]

92. The only rational explanation I have is the lack of long term data on this vaccine -

- I would be interested in seeing any studies citing side effects or lack thereof with regard to this vaccine 5 and 10 years after being given. When that data becomes available then I consider giving it to my daughter.

[Horse with no Name]

99. And that is your perogative as an educated parent

:)

[antigop]

132. Why would anyone give this without know the long-term effects?

Oh, and also it was done on the sly -- Perry did an end-run around the legislature.

[antigop]

133. OMG! You mean they don't know the long-term effects? n/t

[The Cleaner]

93. TO THOSE WHO CONTINUE TO CLAIM OPPOSITION IS RW, ANTI-VACCINE, ANTI-WOMEN, LOOK AT THESE POSTS!

Personally I have not seen as many people come out against mandatory Gardasil here on DU as in this one thread. This tells me that 1) It CANNOT BE FRAMED AS RW anymore; 2) It is NOT FEARMONGERING PARANOIA due to the many posts here that cite sound empirical scientific data; and 3) It is most certainly not anti-woman or anti-vaccine.

All these accusations have always THEMSELVES been fearmongering paranoia! So let's get past all that and go on to discuss the anti-democratic nature of mandatory Gardasil, how difficult it is to obtain an opt-out affadavit, and the poor being used as guinea pigs.

And with that...I'm outta here. :)

[Horse with no Name]

97. Is that all?

pshaw.
Any more RW sites you want to direct us to?
I really enjoyed the one that told women not to do self-breast exams and not to trust mammograms.
Really gotta love the stealth women-haters around these parts.

[Name removed]

105. Deleted message

Message removed by moderator. Click here to review the message board rules.

[antigop]

141. You really gotta love the democracy-haters around these parts n/t

[AikidoSoul]

259. You really gotta love the stealth rational-thinking-haters around these parts

:sarcasm:

[donco6]

138. You mean you're not Satan's worker bee?

That's what you would think after reading some of these posts. Jeebus.

Keep doing what you do and ignore these idiots.

[antigop]

145. deleted n/t

[mzmolly]

163. Nope, Mercks worker bee.

I kid. ;) :hi:

[antigop]

149. Why are people willing to trade freedoms for perceived security?

They are willing to trade the FREEDOM of having ELECTED REPRESENTATIVES vote on health policy.

"If we restrict liberty to attain security we will lose them both."

[antigop]

160. tapping foot -- still waiting for a reply from anyone n/t

[antigop]

247. tapping foot -- still waiting for a reply from anyone n/t

[mainer]

154. Clapping for you!

As someone else who's worked in the medical field, I am beyond frustrated at the misinformation I see here about vaccines. Why is everyone so up in arms about Gardasil when they seem to accept vaccines against tetanus, Hep B and meningitis? Do they really want to return to the days when thousands died from polio and pertussis and diphtheria? Americans have no memory of the terrible days when so many children did not survive childhood because of common infectious diseases -- diseases that are almost unheard of now, thanks to the miracle of vaccines.

[Avalux]

162. It is not my burden to prove the vaccine isn't safe or effective -

it is however, Merck's burden to prove both. There is no argument Gardasil is effective against four strains of HPV that can cause cervical cancer. However I am not convinced the safety data is sufficient for this vaccine to be launched into the general population which would amount to mass inoculations - and every infectious diseases colleague I have talked to has reservations about it. We had a discussion about Ketek today; an example of a highly efficacious drug being rushed out too soon.

Sorry - I applaud your work in vaccine development, but with MY background in infectious diseases and clinical trials, I am not changing my mind about Gardasil.

[HiFructosePronSyrup]

164. Merck did prove it was safe.

They did all the necessary testing.

If they tested it for five more year or ten more years the anti-vaccine people would keep moving back the goal posts.

[Avalux]

166. Yep.

Merck did what the FDA told them to do and then the FDA approved the vaccine. I give up trying to discuss this issue in a scientific context; it's clear the "it cures cancer!" crowd doesn't want to consider safety issues.

[HiFructosePronSyrup]

169. No, it seems clear to me...

the "it's a big corporate conspiracy" crowd doesn't care about safety, nor peer reviewed science.

[WindRavenX]

174. you of all people know DU does not have a great grasp on peer-reviewed science

Scientific illiteracy is all over, right here, on DU.

[HiFructosePronSyrup]

175. Of course.

Particularly when it comes to vaccines.

Fear of needles, I suspect.

[WindRavenX]

176. The anti-vaccine crowd scares the shit out of me

There's something about it I can't really put my finger on, but it makes me uneasy.

[HiFructosePronSyrup]

178. They're usually self marginalizing.

Kind of like the people who say HIV doesn't cause AIDS.

They're sick, but they're not worth getting too worked up over.

[TZ]

180. here's what scares me with that

Isn't the current president of South Africa someone who doesn't think HIV causes AIDS. Not sure they are really as marginilized as we would all like to think.

[HiFructosePronSyrup]

182. Oh, right. Mbeki(?)

I don't know much about SA politics. I think the legistlature or his own cabinet overruled him on that.

[WindRavenX]

185. I think he's a witch-doctor and has made claims he can cure AIDS

IIRC.

[moc]

183. Can you grant that someone can have an objection to the vaccine based on sound scientific

reasoning?

I think you cast the net too widely when you assume that all of those of us who have posted in opposition to Gardasil do so because we believe it's a "big corporate conspiracy" and that we don't know how to read peer-reviewed science.

I'm very literate with regards to reading science; I'd venture to guess that I'm on the high end as compared with most DU posters as I have a doctorate in public health (maternal and child health specifically) and I'm a tenured associate professor at a school of public health. I have training in epidemiology, and I know how to read the epidemiological literature.

With all that said, I have serious reservations regarding Gardasil, specifically that safety in young girls, age 9-12, has not been demonstrated sufficiently in the available clinical trials conducted to date.

You should also note that sparonsare (whose post you are responded to) is an infectious disease researcher with many years of experience. I dare say she is literate in terms of reading the peer-reviewed literature and interpreting science.

Being scientifically literate and having significant concerns regarding Gardasil are not mutually exclusive.

[WindRavenX]

186. it's the degree of concern that seperates people

Many of the people who have objected to Gardasil also have had a history of very hostile attitudes towards vaccines in general--that's suspect.

The other people you mention obviously carry more weight in the debate and I do listen carefully to their objections.

[moc]

196. I agree that it all seems to get lost in the noise.

I've seen people react to my posting concerns as if I'm one of those people generally hostile to vaccines. It's like a knee-jerk reaction. Of course, the anti-vaccine loonies flood the thread, and it tends to really shut down reasonable debate.

I have very little patience with the vaccine-hostile group. Any discussion regarding actual science gets replied to with hogwash, and the funny (i.e., sad) thing is those posting it don't realize what hogwash it is. In the past I've tried explaining why what they're posting is hogwash, but it doesn't matter. So, I've given up. It's tried my patience way too many times.

[WindRavenX]

198. yeah, I generally only put people on ignore if it's something like that

It's really not possible to have a conversation if they reject the entire premise of science.

Same with the chemtrail loons.

[HiFructosePronSyrup]

188. And on what sound scientific grounds...

are these literate researches basing their objections on?

Because it seems to me they're basing their opinions on conspiracy theories.

[moc]

190. Did you read my post?

The main concern I have is that the sample size for the clinical trial for children in age 9-12yo was *at most* about 500. That's much too small a trial to detect side effects.

How is that based on a conspiracy theory?

[HiFructosePronSyrup]

193. And you think the reviewers at the FDA didn't notice?

[moc]

199. And your point is what exactly?

They claim the N is large enough? They claim more study is needed? Sorry, I'm not following. I haven't seen anything in the clinical trials data that reports specifically about the sample size for 9-12yo so I don't know how you'd know whether they'd noticed it or not.

[HiFructosePronSyrup]

202. My point is, if the sample wasn't big enough...

Then the FDA wouldn't have approved of its use. So whom I to believe? Actual scientists, or anonymous people on the intarnets?

[TZ]

194. I have never said that

I think that many people have concerns, many valid. But too many people are not so rational in their opposition to Gardasil. I also think that there are WAAAAAY more important things that are much more impotant and dangerous than this vaccine. In fact, I actually am not sure I know the ins and outs of this and could you please tell me on average how long the actual vaccine exists in the bloodstream? I always thought that vaccines actually just train the immune system and the actual vaccine does not last that long and therefore REALLLY long safety studies are kind of pointless. I need some clarification on that point and you seem like you might know. I think it might be helpful in this debate as well. I know that safety studies can and have been rushed on certain vaccines and so I think this would be helpful advice. I guess I am asking what the "half-life" is of this vaccine if you know so to speak.

[moc]

205. My post wasn't direct at you. I'm sorry if you thought it was.

I was directly responding to others who were stating that those who were anti-vaccine were scientifically illiterate.

I'm not a virologist, so I can't really answer your questions. I don't know that I'm interested in longer term studies with regards to safety (although it would be relevant for efficacy issues), I'm just concerned they didn't enroll enough pre-adolescents in the trial to base safety claims for that group. As the mother of a 10yo in Texas, this has very personal implications for me. Maybe there's no danger at all in a 10yo having the vaccine, but I don't know we can say that for sure based on the extant data. In terms of weighing risks and benefits, I have *zero* worry that my daughter will be exposed to HPV in the next couple of years so I'm planning on opting out on her behalf. I'm just going to wait and see for a couple of years. If no untoward side effects emerge once this is implemented at the population level, I can have greater peace of mind giving it to her.

[TZ]

210. okay thanks

maybe I will ask my former boss (if I can get a hold of him, a real issue) he loves to talk about science and he would know the answer. Sorry if I seemed snarky,:pals:

[Pithlet]

225. You're on to us.

We don't care about safety at all. If it kills people to cure cancer, so be it :sarcasm: Holy mis-characterization, bat man.

I really wish you wouldn't give up, because I'd like to see more than just "I don't think it was tested enough" If people would actually come up with some data and evidence that this was rushed and that there isn't enough data to mainstream it, I'd be all over that. I'd change my position in a heartbeat. But no one on the Gardasil isn't safe/hasn't been tested enough camp has come up with any, at all. General mistrust isn't enough for me. It isn't that I or anyone else doesn't care about safety.

[Avalux]

237. The problem is that there is no data yet -

I can't prove to you it isn't safe - there's a black hole. 5-10 years down the road, there may be case studies of autoimmune disorders or other disorders linked to the vaccine.
I was lumped into the "anti-vaccine" group for my view and I am certainly not anti-vaccine. I wouldn't be involved in the research I do if I didn't think it was necessary and it benefited society as a whole. I am not promoting general mistrust; just applying my 20 years of infectious diseases research knowledge to this particular vaccine. No hard feelings Pithlet. :hug:

[TZ]

177. youve got that right for sure

I just really am trying (and hopefully) succeeding in educating people so they can make INFORMED decisions. I don't like people trying to scare others into their pov which IN MY OPINION is what has been happening to some extent

[WindRavenX]

168. rock on

:yourock:


There is an awful lot of scary, anti-science sentiment out there. Thank you for sharing your story.

[Ian David]

171. Taking Gardasil if you're a virgin is dangerous...

...because your hymen bursts into flames.

It's terrible!

If you've ever seen a vagina-fire, it's something you'll never forget.

Why, god? Why?

It happened to a friend of mine, at one of those parties where all the girls sit around shooting-up Gardasil.

I tried to warn them, but they wouldn't listen.

Please, think of the children and their delicate, inflammable vaginas.

[WindRavenX]

172. "vagina fire" ROFL

:rofl: :rofl:

Oh, if I had money, I'd give you a valentine's day heart :hi:

[Ian David]

181. Hey, see if you laugh when YOUR vagina burns all your friends to crispy cinders. n/t

So, I was at a Gardasil party with this girl...

[WindRavenX]

184. omg

staaaawwwwp :rofl: :rofl:

[TZ]

179. Maybe the funniest post I have ever seen

Thanks for the laugh:rofl: :rofl:

[Lurking Dem]

195. G-d I wish I could rec this post!

:rofl:

[Richard Steele]

234. ROFLMAO!

[TZ]

187. Thank you DU

I really really enjoyed having this debate (which will no doubt continue). Obviously many of us will never see eye to eye on things but I hope at least this gives people the opportunity to make some informed decisions. I really enjoy these back and forths (well, most anyway) and the majority have been very kind and informative. Can I say now I feel a little, no a lot better about myself and others as well. Really wonderful and cathartic!! And without being too hypocritical I hope, maybe an end to more endless threads on the topic?:grouphug: :loveya:

[antigop]

211. Thank you -- now everyone knows that this was nothing more than a power grab by Perry

I am so glad that people are now aware of it.

[xchrom]

192. texas administrative code

Texas Administrative Code Next Rule>>
TITLE 25 HEALTH SERVICES
PART 1 DEPARTMENT OF STATE HEALTH SERVICES
CHAPTER 97 COMMUNICABLE DISEASES
SUBCHAPTER B IMMUNIZATION REQUIREMENTS IN TEXAS ELEMENTARY AND SECONDARY SCHOOLS AND INSTITUTIONS OF HIGHER EDUCATION
RULE §97.63 Immunization Requirements in Texas Elementary and Secondary Schools and Institutions of Higher Education
------------------------------------------------------------------------
Every child in the state shall be immunized against vaccine preventable diseases caused by infectious agents in accordance with the following immunization schedule.
  (1) In accordance with the Department of State Health Services Immunization Schedule as informed by the Advisory Committee on Immunization Practices' (ACIP) recommendations and adopted by the Executive Commissioner of the Health and Human Services Commission and published in the Texas Register annually, for all vaccines herein, vaccine doses administered less than or equal to four days before the minimum interval or age shall be counted as valid.


  (2) A child or student shall show acceptable evidence of vaccination prior to entry, attendance, or transfer to a child-care facility or public or private elementary or secondary school, or institution of higher education.

http://info.sos.state.tx.us/pls/pub/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=25&pt=1&ch=97&rl=63

[xchrom]

197. what vaccines have done for humanity

http://blogs.cgdev.org/globalhealth/

January 22, 2007
Hundreds of Thousands Saved: A Measles Success Story

The numbers are in! The Measles Initiative, which set out to halve the global measles burden between 1999 and 2005, has surpassed its goal with a 60 percent reduction. A new Lancet study (subscription required) reports an estimated drop in measles deaths from 873,000 in 1999 to 345,000 in 2005 (based on a natural history model to evaluate mortality trends).

For related coverage, see The Economist, the Washington Post, the New York Times and elsewhere. But also be sure to check out CGD's Millions Saved for a detailed account of how measles was nearly eliminated in seven southern African countries in the late 1990s. The case study suggests some key ingredients for the intervention's success: the commitment of governments, the strengthening of surveillance systems, and the integration of measles vaccinations with other health services. Some of these reasons are echoed by WHO director Margaret Chan in an International Herald Tribune op-ed on the more recent Measles Initiative success. She said that "it took a new partnership - with commitment, caring and cash - to turn things around," and noted that the success in countries was aided by their ability to build on the strategies and infrastructure of existing health programs and services.

As usual in public health, this success implies more work to be done. In a good sign that past successes are being used to inform future aims, the Measles Initiative has already set a new goal of reducing measles mortality 90 percent by 2010. Margaret Chan is optimistic that the new measles target will be achieved; so am I.


http://www.cgdev.org/section/initiatives/_active/vaccinedevelopment/overview

Nowhere are the potential benefits greater than in the production and distribution of new vaccines to prevent the diseases that needlessly take lives and destroy livelihoods in developing countries.

In 2003 we established a Working Group, including economists, public health professionals, lawyers, experts in public policy and pharmaceutical and biotech experts, with the mandate to develop a practical approach to the vaccine challenge: to go from ideas to action. The result is this report.

My colleagues propose an elegant solution to enable the high income countries to work together to accelerate the development of vaccines for diseases of low-income countries to guarantee to pay for such vaccines if and when they are developed. The solution is simple and practical. It unleashes the same combination of market incentives and public investment that creates medicines for diseases that afflict us: arrangements that have been spectacularly effective in improving the health of the rich nations in the last century. It creates incentives for more private investment in these diseases. And it will ensure that, once a vaccine is developed, the funds will be there to get the vaccine to the people who need it.

Adequate investment in global public goods should be a cornerstone of foreign assistance. By definition, we all benefit from global public goods, and we share a responsibility to see that they are properly funded and available to everyone. These are investments with high returns and low risks of corruption and appropriation. Furthermore, this proposal ties funding directly to results: if the commitment does not succeed, there is no cost to the sponsors.

Every so often, an idea comes along that makes you ask: now why didn't I think of that? This is such an idea.
Nancy Birdsall
President


http://www.savekids.org/vaccines/v.html

the above site is comprehensive in recording both past achievements and current achievements for saving millions of lives through vaccinations.
truly a remarkable human achievement.

this describes an effort to save 5 MILLION CHILDREN through vaccination
http://www.dfid.gov.uk/news/files/pressreleases/iffi-bond.asp

The first step was taken today to raise funds for a mass immunisation programme for children in the developing world, at a ceremony in London attended by the Chancellor of the Exchequer Gordon Brown, Queen Rania Al-Abdullah of Jordan, and representatives of Britain’s faith groups.
The International Finance Facility for Immunisation (IFFIm) will deliver 4 billion dollars over the next ten years to be spent on the immunisation of up to 500 million children in the world’s 70 poorest countries against preventable diseases like polio, measles and diphtheria. It is estimated this will save 5 million lives in the years up to 2015, and a further 5 million afterwards, and lead to the eradication of polio.
Speaking in advance of the launch, the Chancellor said:
"Millions of people campaigned to Make Poverty History last year, and now we can say to them all: we are delivering the promises we made, your hopes are becoming a reality, and millions of young children's lives will be saved as a result."
IFFIm uses long-term, binding commitments from donors as collateral against which to borrow money up front from institutional and private investors, which can be spent immediately on mass vaccination programmes. Commitments have so far been made by the UK, France, Italy, Spain, Sweden, Brazil and South Africa, together with the Bill and Melinda Gates Foundation.

The first step was taken today to raise funds for a mass immunisation programme for children in the developing world, at a ceremony in London attended by the Chancellor of the Exchequer Gordon Brown, Queen Rania Al-Abdullah of Jordan, and representatives of Britain’s faith groups.
The International Finance Facility for Immunisation (IFFIm) will deliver 4 billion dollars over the next ten years to be spent on the immunisation of up to 500 million children in the world’s 70 poorest countries against preventable diseases like polio, measles and diphtheria. It is estimated this will save 5 million lives in the years up to 2015, and a further 5 million afterwards, and lead to the eradication of polio.
Speaking in advance of the launch, the Chancellor said:
"Millions of people campaigned to Make Poverty History last year, and now we can say to them all: we are delivering the promises we made, your hopes are becoming a reality, and millions of young children's lives will be saved as a result."
IFFIm uses long-term, binding commitments from donors as collateral against which to borrow money up front from institutional and private investors, which can be spent immediately on mass vaccination programmes. Commitments have so far been made by the UK, France, Italy, Spain, Sweden, Brazil and South Africa, together with the Bill and Melinda Gates Foundation.


''Vaccines have been one of the most important health gains in the past century. Infants and young children are particularly vulnerable to infectious diseases; that is why it is critical that they are protected through immunization. The benefits of vaccination far outweigh the risks. Children who are not immunized increase the chance that others will get the disease. Since this effort 50 years ago, we can now protect children from more than 12 vaccine-preventable diseases, and disease rates have been reduced by 99% in the United States. Immunizations are extremely safe thanks to advancements in medical research and ongoing review by doctors, researchers, and public health officials; yet without diligent efforts to maintain immunization programs here and strengthen them worldwide, the diseases seen 50 years ago remain a threat to our children.''
http://www.cdc.gov/nip/events/polio-vacc-50th/

the above quote is from the cdc re: the fiftieth anniversary of the polio vaccine and takes in the scope of what vaccines have brought humanity -- millions have been saved -- and many millions more will be through hard work and determination.

[WindRavenX]

200. but corporations make a profit so it's bad!!11

:sarcasm:

Thank you for posting that.

[xchrom]

203. if we could nominate nutty flame wars

i would give this the biggest nut.

thanks for the nod windraven.

[xchrom]

201. gardasil is going global, baby! or merck has subverted the whole world.

HPV vaccines
Vaccines are being developed to prevent HPV infection.  There are many different HPV strains.  Some are known to be high risk for cervical cancer.  If we had effective vaccines against all these strains, we might be able to prevent cervical cancer altogether.  Several research trials have been testing vaccines as a way of preventing infection with HPV.
A trial testing Gardasil called FUTURE II reported its results in October 2005.  This phase 3 trial involved over 12,000 women aged between 16 and 26.  These women did not have HPV before the start of the trial.  The women were divided into two groups.  Half the women were given Gardasil and the other half had a dummy vaccine (placebo).  Both groups of women had 3 injections of either the vaccine or placebo over six months.  Over the following two years the women had regular checks to see if they had developed HPV, or had any precancerous changes to the cells of the cervix, which could develop into a cancer.  The group who had the vaccine showed no precancerous changes.  Of the 5,258 women who had the placebo, 21 had precancerous changes, which is 0.4%.  The researchers found that Gardasil protected against HPV types 6 and 11, as well as 16 and 18.  Gardasil was licensed for use within the European Union in September 2006.  
Two other phase 3 trials have tested the vaccine Cervarix.  The first was for women under 26 and closed in July 2005.  It involved over 18,000 women from all over the world, including the UK.  This study was called ‘PATRICIA’ (PApilloma TRIal to prevent Cervical cancer In young Adults).   The second was for women of 26 and over, and closed in August 2006.  The aim of the trial is to find out the effect of the Cervarix vaccine on long term HPV infection. So it will be some time before we know the results.
It is possible that these vaccines will be used in a national vaccination programme in the UK in the future.  The research suggests that they would dramatically lower the number of cases of cervical cancer.  They would also reduce the need for colposcopy.  At the moment, they are only available on private prescription.  There is more information about HPV vaccines and cervical cancer in the cervical cancer questions and answers section of CancerHelp UK.
http://www.cancerhelp.org.uk/help/default_printer_friend.asp?page=9596

merck is not the only company who developed this vaccine -- a french drug company was also the developer

Comparable strategies needed to evaluate human papillomavirus vaccine efficiency across Europe

K Soldan1 ([e-mail]), J Dillner2

1Health Protection Agency Centre for Infections, London, United Kingdom
2Dept of Medical Microbiology, MAS University Hospital, Lund University, Malmö, Sweden
A quadrivalent vaccine against human papillomavirus (HPV) types 16, 18, 6 and 11, known as GardasilTM (or Silgard, see note) was granted a marketing license by the European Commission in September 2006 following the positive opinion of the European Medicines Agency’s (EMEA) Committee for Medicinal Products for Human Use in July 2006 <1>.

HPV infection is the most frequent sexually transmitted infection in Europe. Certain HPV types have been established as causative agents of cervical cancer (and its precursor stages that are the target of cervical screening), as well as of some other rare cancers of the ano-genital tract and oral cavity. A meta-analysis of published studies found just over 70% of invasive cervical cancer cases in Europe to be positive for HPV types 16 or 18 <2>. Pre-cancerous stages of cervical disease are common and often resolve with time. However, their follow-up, including treatment, repeated screening and examination of the cervix (colposcopy), is associated with considerable costs and anxiety. HPV 6 and 11 are not causally linked to cervical cancer, but are associated with some low-grade cervical lesions, the vast majority of genital warts and the rare condition of recurrent respiratory papillomatosis <3>.

The Gardasil vaccine is composed of virus-like particles (VLP) generated by the synthesis and self-assembly of the major HPV capsid protein (L1) in yeast cells (Saccharomyces cerevisiae). Gardasil has been licensed for the prevention of high-grade cervical intraepithelial neoplasia (CIN grades 2 and 3), cervical cancer, high-grade vulvar intraepithelial neoplasia (VIN grades 2 and 3), and external genital warts (condyloma acuminata) causally associated with HPV types 6, 11, 16, and 18 <1>. Trials have been undertaken to demonstrate the efficacy of the vaccine in women aged 16 to 26 years and immunogenicity in girls and boys aged 9 to 15 years. Protective efficacy in males has not been reported in the literature yet, but the results of more trials involving males are expected over the next few years.

Another vaccine composed of virus-like particles (VLP), a bivalent vaccine for HPV 16 and 18, manufactured by GlaxoSmithKline, is currently under evaluation by the EMEA. Both these prophylactic vaccines have been shown to have very high efficacy in uninfected women against infection, cervical intraepithelial neoplasia and, by implication, against cervical cancer caused by the HPV types targeted by the vaccine <4>.

The availability of efficacious vaccines now means that vaccination strategies should be designed and evaluated to inform decisions on efficient control of HPV-related diseases. Several questions about HPV vaccination efficacy and effectiveness are still under consideration <5> For example, data on its efficacy against disease in males and in women aged over 26 years (of whom many could have been previously infected) are still awaited. A longer follow-up of vaccine programmes is needed to determine the duration of protection. The impact of vaccination on the epidemiology and disease burden of HPV types not covered by the vaccine is also uncertain. There are some data from trials which suggest cross-protection against HPV-types closely related to the vaccine types. The possibility of type-replacement with non-vaccine types emerging as the cause of more disease is also a concern to be evaluated further. It is likely that most European countries will first consider vaccination of girls who have not yet become sexually active
http://www.eurosurveillance.org/ew/2006/061123.asp

regarding the stigma around hpv --
Social Stigma
 
"There is unfortunately a social stigma associated with cervical cancer because HPV is a direct cause in approximately 70% of cases," Dr. Makhija told Medscape. "People are under the impression that this means the patient slept around or was in some way more sexually active, but this is often not the case, and she may well have been with 1 person who had the infection."
 
HPV is the most common sexually transmitted infection in the US. The Centers for Disease Control and Prevention estimates that about 6.2 million Americans become infected with HPV every year and that over half of all sexually active men and women become infected at some time in their lives.
 
"Our expectation is that the far-right machine will gear up its disinformation and fearmongering tactics, all aimed at reducing availability of the vaccine by threatening funding and clouding the facts regarding the safety and the need for this vaccine," Ms. Julie Kay, an attorney for Legal Momentum, a New York City–based women's-rights organization, said in a statement to the press.
 
But Dr. Makhija said she has been pleasantly surprised by reaction so far. "I think people are realizing that this is not a political issue so much as a health issue." Based in Alabama, the investigator had worried about how difficult it might be to recruit women in the Deep South for the trial. "But we enjoyed an enormous response and had no trouble at all," she said. "People realized that this is something that could potentially protect their daughters, and the response has been excellent."
 
"Exciting Win Against Cancer"
 
Mr. Alan Kaye, from the National Cervical Cancer Coalition in Van Nuys, California, called the news "an exciting win against cancer." He is looking forward to what this could mean for public health.
 
But he is also glad from a personal perspective. Mr. Kaye founded the cancer coalition with his wife before she died of cancer. Today is the 5-year anniversary of her death. "It's wonderful to think that this amazing step forward has taken place on such an important day," he said. "My wife would be pleased."
 
http://www.brodstonehospital.org/your%20health.htm

other countries approve gardasil --
During an interview with Medscape, Jaime de la Garza, MD, from the Instituto Nacional de Cancerología in Tlapan, Mexico, agreed that the vaccines represent an important advance. He says they will be especially important for women in developing countries. "The incidence of cervical cancer is continuing to rise, and mortality rates are especially high in poor countries. If we can get vaccines such as these to patients, it will make a big difference."
 
Gardasil was approved last week for use in Mexico and is currently under review with regulatory agencies in the European Union, Argentina, Australia, Brazil, New Zealand, Singapore, and Taiwan.
http://www.brodstonehospital.org/your%20health.htm

this from an interview with dr tristram in the uk

Dr Tristram said, "This vaccine has to be given as a preventative, before there is any contact with the virus.


"If we are looking at the population and asking who should be vaccinated, we have to consider that one in four young people are sexually active before the age of 16, so we have to look at a younger age group.


"Another issue to consider is that, at around the time of puberty, if the cervix comes into contact with HPV, it is more likely to cause problems."

more --

Q Will the vaccine replace the need for regular smear tests?


A Dr Tristram said, "Cervical screening has been very successful in reducing the incidence of cervical cancer and this should not stop just because a vaccine has been introduced.


"There are lots of different types of HPV which can cause cervical cancer, not just 16 and 18, for which the current vaccine offers protection.


"The vaccine will reduce the incidence of cervical cancer further, but it will not get rid of it."

it also looks like some hpv related cancers are becoming MORE virulent and difficult to treat.

meps' in the uk supporting the use of gardasil

glynis wilmot is the labour mep for the west midlands

Cutting cancer deaths

I reported in the October edition that European Commission had licensed Gardasil, the first vaccine against HPV which can lead to cervical cancer. 

I am pressing the Commission on its plans to ensure that vaccination programmes are introduced in all member states, as well as a comprehensive programme of education to inform parents about the vaccine. Immunising every 12 year old girl could cut deaths from cervical cancer by more than 75%.

Latest information

http://www.gleniswillmott.labour.co.uk/ViewPage.cfm?Page=20338

planned parenthood's statement on gardasil

 Planned Parenthood Applauds FDA Approval of Gardasil
HPV Vaccine Is Crucial Step Forward for Women's Health  

New York, NY — Planned Parenthood Federation of America (PPFA) commended today's action by the U.S. Food and Drug Administration (FDA), which approved the first vaccine against two types of human papilloma virus (HPV) that cause about 70 percent of cervical cancer cases. 

"This is a huge step forward for women’s health.  Prevention is the key to good health, and this vaccine will give future generations the promise of health, safety and peace of mind," said PPFA President Cecile Richards.  “Now we must move forward to educate the public about the vaccine and ensure it is available to all Americans, regardless of their income level.” 

Planned Parenthood provides more than 1,000,000 women with cancer screenings each year.  This new vaccine will hopefully save lives. 

"The HPV vaccine is a public health breakthrough," said Richards.  "On behalf of the millions of women, men and teens Planned Parenthood serves every year, I thank the FDA for today's action." 

Worldwide, cervical cancer is the second leading cause of cancer deaths among women.  Each year approximately 10,000 cases of cervical cancer are diagnosed in the United States, and 4,000 American women die from the disease.    

###
http://ww1.ppgi.org/includes/media/prjune_06_c.asp

canada approves gardasil{ but of course merck has subverted the entire world to it's sinister plans}
HPV VACCINE APPROVED

In July 2006, a new vaccine to prevent against four strains of the Human Papilloma Virus was approved for use in Canada by Health Canada. Gardasil will be available by the end of August 2006 through Canadian physicians and pharmacists, and is designed to prevent cervical, vulvar, and vaginal cancer as well as genital warts.

For more information, please visit: http://www.cdc.gov/std/hpv/STDFact-HPV-vaccine.htm.
http://www.optionsforsexualhealth.org/

[antigop]

212. so what do you have against democracy? That's the issue.

Perry issued an executive order. The Texas legislature was not involved.

You post on DEMOCRATIC Underground. Why don't you care about democracy?

[xchrom]

217. you don't have the corner on what is or isn't a democracy.

for my money and vote -- i want a democracy that actively and aggressively promotes the health of it's citizens -- you would prefer a graveyard.

[antigop]

222. No -- I want health policy that has input/debate/vote from elected reps in Congress

I guess you want a dictator, huh?

[Justitia]

223. Well, that will never happen because these are states issues. -eom

[antigop]

229. Oh, that's rich-- I guess the people in Texas don't elect their representatives! n/t

[Justitia]

242. You said "Congress" - that is a federal institution. Immunization is a state issue. -eom

[antigop]

244. I want elected reps from Congress and state lege involved in health policies

I don't want a dictator like Bush.
I don't want a dictator like Perry.

For federal health policy, I want elected congressional reps involved. I don't want federal health policy dictated by Bush.

For state health policy, I want elected state reps involved. I don't want state health policy dictated by Perry (or any other governor).

[Justitia]

248. In case you haven't noticed, no one is buying your "dictator" schtick.

So why don't you give it a rest already?

This is just a moving shell game for you. You attack this vaccine from one talking point to another, constantly changing your rationale. As soon as one gets smacked down, up you pop with another. The "dictator" one is really over the top.

I'm confident you'll come up with something new soon.

"It's too new, not enough testing, not enough testing on specific population 'x', BigPharma is out to get us / make money off our suffering, vaccines are ineffective, vaccines are unnecessary, parents should be able to deny vaccines to their children, the disease consequence is not compelling enough to vaccinate, blah, blah, blah"

It's amazing how the anti-science subculture works so hard to spread their dangerous disinformation.
You people are ultimately responsible for the ignorance that leads to death.

[antigop]

249. I'm sorry if you don't understand that Perry dictated health policy

and it is unconstitutional.

And if he dictates policy, that makes him a dictator.

[antigop]

246. I don't want a federal dictator (bush) -- I don't want a state dictator (Perry)

n/t

[xchrom]

232. i want a good active health policy that keeps people

well and alive.

you like the other poster want to vote from the grave.

[antigop]

235. I see -- you want health care mandated by a dictator n/t

[xchrom]

239. you don't get to dictate what goes on in this democracy.

[antigop]

243. I'm not dictating anything --- Perry is n/t

[antigop]

230. I know what democracy is -- and Perry's executive order ain't it n/t

[xchrom]

233. and YOU don't define what goes on in this democracy.

kind of a dictator your own self, ain't ya?

[antigop]

236. I'm sorry you can't address Perry's unconstitutional act n/t

[xchrom]

240. who died and made you The Constitutional Authority of texas?

you don't get to dictate what goes on and what is good for everyone.

obviously others have adiffernt idea.

you aren't the last -- nor even the first say-so.

[antigop]

241. I'm sorry you are getting so upset -- I'm sorry I raised an issue you can't answer n/t

[xchrom]

250. indeed -- you are sorry.

[antigop]

252. You still haven't addressed the anti-democratic way Perry did this

Because you can't, can you?

[Ian David]

215. All Your Vaginas Are Belong To Us. n/t

[mzmolly]

218. Heh.

:rofl:

[xchrom]

219. lol -- dude you ae awesome! n/t

[AikidoSoul]

273. Thanks for that one

:rofl: :rofl: :rofl:

[xchrom]

220. some stats on cervical cancer rates among women in texas

Cervical Cancer

More than one half million women will die this decade from breast and cervical cancer. This is true despite the fact that essentially all deaths from cervical cancer and about 30% of deaths from breast cancer are preventable (HMA Associates, Inc., 1995).

Approximately 16,000 new cases of cervical cancer are diagnosed annually, and about 4,800 women die from cervical cancer each year (Woolf, 1997) -- that means about 1/3 of the women diagnosed with cervical cancer will die.

In Texas, cervical cancer is the tenth leading cause of cancer deaths among women. Cervical cancer accounts for 2.5% of all cancer-related deaths in Texas females. These deaths are largely preventable if the disease is detected early and appropriate treatment is sought (Texas Cancer Council).


Cervical Cancer in Texas

In 1992, there were 349 deaths from cervical cancer in Texas. Of those deaths, the ethnic breakdown was as follows:
Ethnicity Percent Number Age-adjusted Rate*
Anglo 50.4% 176 2.51
Black 22.9% 80 8.50
Hispanic 26.6% 93 5.25

*Rates per 100,000. Standard population is U.S. 1970 population.

(Texas Cancer Council)
http://fcs.tamu.edu/health/Health_Education_Rural_Outreach/Health_Hints/1998/March_April/Womens_Health_Focus_on_Cervical_Cancer.php#section1

[Pithlet]

226. K&R

I can understand your need to vent. Sometimes otherwise logical and sensible people get nuts when it comes to vaccines, along with the woo woos.

[TZ]

228. woo woos LOL

What a great term! I will remember that. I laugh everytime I see it!!:rofl:

[mhatrw]

261. Is this really fear mongering? Judge for yourself.

In medical cost vs. benefit modeling (which strongly informs national medical public policy making and far too strongly informs the medical policies of HMOs), the most critical component is a value called "cost per life year gained."

If the cost per life year gained is under $50,000, that is generally considered a decent investment by US medical policy makers. If "cost per life year" gained is over $100,000, that is generally considered a wasteful medical policy because that money could surely be put to much better use elsewhere. Yes, this is cruel and heartless to some degree, but wide scale medical cost allocations do need to be made and, more relevantly, are continually made using these cost plus risk vs. benefit analyses. Think HMOs. Now consider why pap smears, blood tests and urine tests aren't recommended every month for everyone. Testing monthly could definitely save more than a few lives, and there is no measurable associated medical risk. But the cost would be astronomical versus the benefit over the entire US population when comparing these monthly tests to other therapies, procedures and medicines.

Now on to GARDASIL. By the time you pay doctors a small fee to inventory and deliver GARDASIL in three doses, you are talking about paying about $500 for this vaccine. And because even in the best case scenario GARDASIL can confer protection against only 70% of cervical cancer cases, GARDASIL cannot ever obsolete the HPV screening test that today is a major component of most US women's annually recommended pap smears. These tests screen for 36 nasty strains of HPV, while GARDASIL confers protection against just four strains of HPV.

Now let's consider GARDASIL's best case scenario at the moment -- about $500 per vaccine, 100% lifetime protection against all four HPV strains (we currently have no evidence for any protection over five years), and no risk of any medical complications for any subset of the population (Merck's GARADSIL studies were too small and short to make this determination for adults, these studies used potentially dangerous alum injections as their "placebo control" and GARDASIL was hardly even tested on little kids). Now, using these best case scenario assumptions for GARDASIL, let's compare the projected situation of a woman who gets a yearly HPV screening test starting at age 18 to a woman who gets a yearly HPV screening test starting at age 18 plus the three GARDASIL injections at age 11 to 12. Even if you include all of the potential medical cost savings from the projected reduction in genital wart and HPV dysplasia removal procedures and expensive cervical cancer procedures, medicines and therapies plus all of the indirect medical costs associated with all these ailments and net all of these savings against GARDASIL's costs, the best case numbers for these analyses come out to well over $200,000 per life year gained -- no matter how far the hopeful pro-GARDASIL assumptions that underpin these projections are tweaked in GARDASIL's favor.

Several studies have been done, and they have been published in several prestigious medical journals:

http://dx.doi.org/10.1001/jama.290.6.781
http://tinyurl.com/2ovy95
http://tinyurl.com/2tbuma

None of these studies even so much as consider a strategy of GARDASIL plus a regimen of annual HPV screenings starting at age 18 to be worth mentioning (except to note how ridiculously expensive this would be compared to other currently recommended life extending procedures, medicines and therapies) because the cost per life year gained is simply far too high. What these studies instead show is that a regimen of GARDASIL plus delayed (to age 21, 22, 23, 25 or 27) biennial or triennial HPV screening tests may -- depending on what hopeful assumptions about GARDASIL's long term efficacy and risks are used -- hopefully result in a modest cost per life year savings compared to annual HPV screening tests starting at age 18.

If you don't believe me about this, just ask any responsible OB-GYN or medical model expert. Now, why do I think all of this is problematic?

1) Nobody is coming clean (except to the small segment of the US population that understands medical modeling) that the push for widespread mandatory HPV vaccination is based on assuming that we can use the partial protection against cervical cancer that these vaccines hopefully confer for hopefully a long, long time period to back off from recommending annual HPV screening tests starting at age 18 -- in order to save money, not lives.

2) Even in the best case scenario, the net effect is to give billions in tax dollars to Merck so HMOs and PPOs can save billions on HPV screening tests in the future.

3) These studies don't consider any potential costs associated with any potential GARDASIL risks. Even the slightest direct or indirect medical costs associated with any potential GARDASIL risks increase the cost per life year gained TREMENDOUSLY and can even easily change the entire analysis to cost per life year lost. Remember that unlike most medicines and therapies, vaccines are administered to a huge number of otherwise healthy people -- and, at least in this case, 99.99% of whom would never contract cervical cancer even without its protection.

4) These studies don't take in account the fact that better and more regular HPV screening tests have reduced the US cervical cancer rate by about 25% a decade over the last three decades and that there is no reason to believe that this trend would not continue in the future, especially if we used a small portion of the money we are planning on spending on GARDASIL to promote free annual HPV screening tests for all low income uninsured US women.

5) The studies assume that any constant cervical cancer death rate (rather than the downward trending cervical cancer death rate we have today) that results in a reduced cost per life year gained equates to sound medical public policy.

As I said before, if any of you don't believe me about this, please simply ask your OB-GYN how the $500 cost of GARDASIL can be justified on a cost per life year gained basis if we don't delay the onset of HPV screening tests and back off from annual HPV screening tests to biennial or triennial HPV screening tests.

The recommendations are already in: http://tinyurl.com/33p9q6

The USPSTF strongly recommends ... beginning screening within 3 years of onset of sexual activity or age 21 (whichever comes first) and screening at least every 3 years ...

[TZ]

262. I am sorry but I refuse to get into "economics"

I refuse to put a price on human life. That article in JAMA was a very cold cold piece and theoretical and not experimental.

[Horse with no Name]

269. I'm not sure what you are directing that at

lol...but aren't researchers required to do cost-effective studies on every new drug/therapy?
And I agree...it was cold. But if it was a mandated study...it does shine a different light on why it was done.

[tammywammy]

263. Gardasil won't delay pap smears

A pap smear tests for more than just HPV, so the introduction of a HPV vaccine wouldn't necessitate the elimination of the pap smear.

The recommendation for the 3 year pap for some women came out before Gardasil.

Here's an article from Webmd from 2003

http://www.webmd.com/content/article/75/89741.htm

Many Women May Not Need Yearly Pap Smear

Screening Every Three Years is OK for Many, Experts Say

Oct. 15, 2003 -- Most women over 30 who have had at least three consecutive negative Pap smears can safely forego annual cervical cancer screening, new government-supported research suggests.

The findings support revised Pap smear guidelines published last year by the American Cancer Society and two months ago by the American College of Obstetrics and Gynecology. Both groups now say the interval between Pap smears can be as long as three years for many women. "

[TZ]

265. yes that is so

I would never want to eliminate either. Pap smears are notorious for both false positives and negatives. Using both would be an excellent umbrella of coverage, in my apparantly limited opinion

[tammywammy]

267. I agree as well

But the poster I replied to, has tried to say that using Gardasil will make doctors not want to do the pap smear.

[TZ]

268. yeah well

there are a lot of woo woo posts here unfortunately. Logic does not enter into it.:eyes: