Gardasil Researcher Drops A Bombshell (vaccines will do little to reduce cervical cancer rates)

Dr. Diane Harper, lead researcher in the development of two human papilloma virus vaccines, Gardasil and Cervarix, said the controversial drugs will do little to reduce cervical cancer rates and, even though they’re being recommended for girls as young as nine, there have been no efficacy trials in children under the age of 15.

Dr. Harper, director of the Gynecologic Cancer Prevention Research Group at the University of Missouri, made these remarks during an address at the 4th International Public Conference on Vaccination which took place in Reston, Virginia on Oct. 2-4. Although her talk was intended to promote the vaccine, participants said they came away convinced the vaccine should not be received.

“I came away from the talk with the perception that the risk of adverse side effects is so much greater than the risk of cervical cancer, I couldn’t help but question why we need the vaccine at all,” said Joan Robinson, Assistant Editor at the Population Research Institute.

Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.


http://thebulletin.us/articles/2009/10/25/top_stories/doc4ae4b76d07e16766677720.txt

Especially for those who demean anyone who questions vaccines.

THANK THE WALL STREET MENTALITY

some apologies from the people who kept attacking them. :shrug:

Anyone who questions ANY universal vaccine strategy is immediately labeled anti-vax, as if all vaccines are equally important.

in all ways, without any risks or flaws that should be discussed, without any possibility of improvements given more research and testing, and every vaccine is absolutely necessary immediately for everyone if society is to survive and thrive. Anyone who dares to disagree apparently hates science and isn't too bright. :P

It is amazing how everything is so simple, so black and white, and so absolute for some people, and this justifies them mocking people constantly because they dare to have concerns. :(

I'm very pro-vaccine. I am probably only alive right now because of the Pneumonia vaccine. I believe that most vaccines are vital and at least 99% safe. But I don't have the delusion that any vaccine is 100% safe, especially the newest ones that have been rushed to market. I don't have the delusion that vaccines have been tested so thoroughly that we know fully how they influence and affect our bodies. No reliable scientist would claim that.

We do know too much about how corporate money systematically short-circuits every review process at the FDA, and at the CDC, and certainly in universities that depend on corporate grants. We need more research, and it needs to be independent research, free from corporate influence.

But I am amazed that pure faith in anything called science so easily blinds so many people to the profit motives, the politics, the corporate games and often the bigotry in medicine makes this more than just pure science. So many flaws will be overlooked, so many risks will be ignored, and so much politicking will smoothed over just because it's a vaccine, and vaccines are always good!

A voice of reason, once again. :hi:

"...I plan to be fully armed, with both Vitamin D and the best modern conventional medicine has to offer." — John Cannell, MD Vitamin D Council, Executive Director


Letter from Dr J Cannell: "Vitamin D is incredibly protective against H1N1" -- New Evidence, 9/17/09

depite the fact that there are a number of excellent scientific studies that cast doubt on the efficacy of vaccines for things like flu and cancer.

http://www.democraticunderground.com/discuss/duboard.php?az=show_mesg&forum=389&topic_id=6738770&mesg_id=6738770

This needs more exposure. Thanks for posting again!

:rofl:

it does, it doesn't, it does, it doesn't . . .

she's been misrepresented, she's suing, she's speaking out, she thinks it's great. And safe. and btw - no - she was not - under any definition a "lead researcher". She was, by her own admission "involved in clinical trials".

vaccine, involved in clinical trials for Cervarix.

that's just the hype - she was "involved in clinical trials" - that's it. Not a "lead" anything - except lead confusing the hell out of people.

http://dms.dartmouth.edu/faculty/facultydb/view.php?uid=2880

Disagreement with a scientist, does not mean we can change someones resume.

all the press, etc (not just Dartmouths) - it vacillates between her being a "lead researcher" and "involved in" and "designed" and "participant" - depending, of course, on the slant of the article and/or the person writing it. Interesting, n'est pas?

Gardasil vs. the Cervarix? She was a lead researcher on Gardasil (worked for twenty years to develop the vax) and participated in studies on Cervarix. That said, her issues are not with either vaccine per se, but with promoting its use in young girls. She has scientific reasons for opposing how the vaccine was rolled out, but that's another thread. ;)

:hi:

instincts, believe.....

sheeit

this pisses me off

:rofl: Good stuff. I love the faux outrage.

CUE THE PAID PHARMA SHILLS.

Anything to promote their paranoid agenda- irrespective of the facts.

you got your check yet?

I'm taking a trip to Belize with mine!



:rofl: :rofl: :rofl: :rofl:

Yep, a load of inaccurate hype from big Pharma trying to get millions, nay billions, of dollars. Even to the point of almost having it mandatory in schools, for girls only of course, not the boys.

Either way, I'm not at all surprised. I wouldn't have given it to my daughter if she had still been younger, and strongly recommended against it for those I knew with younger daughters. The stats and data surrounding this one in particular just didn't hold up as being pertinent for the USA.

OMG - what to do what to do?

dither dither dither dither

We all know how easy it is for women to get regular pap smears in sub saharan Africa. :eyes:

Oh, yeah, that was Merck, by making the price of its cash cow, wonder-of-modern-marketing vaccine $400.

Fortunately, she hasn't exhibited any problems (it has been over a year since she completed the series), but still...

WTF?

this is just the anti's making hay out of a few selective sentences. . . .

who have been skeptical.

what's to misrepresent?

To summarize this http://content.nejm.org/cgi/content/full/356/19/1991">published medical journal article:

1. In the FUTURE I trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 2 and grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the only recognized precursors to cervical cancer.

2. In the larger FUTURE II trial, GARDASIL demonstrated no clinical efficacy among the general subject population for overall reduction in the rates of grade 3 cervical intraepithelial neoplasia and adenocarcinoma -- the strongest (and many would argue only valid) precursors to cervical cancer.

3. Extrapolating from GARDASIL's very limited clinical "success" (in the FUTURE II study only) against grade 2 cervical dysplasias (40% of which regress spontaneously), 129 women would be have to be vaccinated (at a cost of about $60,000) to prevent a single grade 2 cervical dysplasia.

4. GARDASIL's protection against cancer associated HPV strains 16 and 18 appears to cause a disproportionate increase in of pre-cancerous dysplasias associated with other HPV strains associated with cervical cancer "raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18."

5. Even if look only at the FUTURE II results (in which for some reason GARDASIL performed better among the general female population), we are talking about just a 17% decrease in all high grade dysplasias -- many of which would spontaneously regress without treatment. So we would have vaccinate 129 women (at about $500 for the three shot regimen) to avoid a single, eminently treatable dysplasia. That's about $60,000 per dysplasia prevented.

This is all directly from the article linked above.

See also: http://jama.ama-assn.org/cgi/content/full/297/17/1921">JAMA

It appears that the vaccinated cohort sees a 20%+ increase in high grade cervical dysplasias caused by cancer-associated HPV strains other than HPV 16 and 18.

One possible explanation is that the very common, non-cancerous HPV 6 or HPV 11 infections that Gardasil confers protection against are antagonistic to more dangerous HPV infections.

Sounds like room for a vaccine to me.

Looks like Dr. Diane Harper, frequently abused by the anti-vaccer nuts, agrees.

http://jdc325.wordpress.com/2009/10/04/dangerous-nonsense-in-the-sunday-express/

:sarcasm:

Another big scam brought to you by Big Pharma.

“I did not say that Cervarix was as deadly as cervical cancer. I did not say that Cervarix could be riskier or more deadly than cervical cancer. I did not say that Cervarix was controversial, I stated that Cervarix is not a ‘controversial drug’. I did not ‘hit out’ – I was contacted by the press for facts. And this was not an exclusive interview.”
Professor Harper did not “develop Cervarix”, as the Sunday Express said, but she did work on some important trials of Gardasil, and also Cervarix. “Gardasil is not a ‘sister vaccine’ as the Express said, it is a different compound. I do not know of the side effects of Cervarix as it is not available in the US.” Furthermore she did not say that Cervarix was being over marketed. “I did say that Merck was egregiously overmarketing Gardasil in the US- but Gardasil and Cervarix are not the same vaccines.”

-snip-

“I fully support the HPV vaccines,” she says. “I believe that in general they are safe in most women.”

http://www.badscience.net/2009/10/jabs-as-bad-as-the-cancer/

She's an honest scientist who believes in her work, she's just not willing to lie for "big pharma."

should be marketed and given to women over 21 because that's when our bodies can use the vaccine.

Too bad they don't have a way that you can get your money back.
$270.00 per shot X3. Our insurance did not cover it.

:puke:

Smallpox eradicated thanks to vaccines You can puke to this picture.

smallpox vaccine. anyone. come on, show me where one poster has made one remark about not getting the smallpox vacc. no? why? cause no one has. ever

stupid argument

for "big pharma". So some vaccines are GOOD while others are BAD? Is that the case? Is that really your argument?

no where. no where was that fuckin said.

shouldn't be given to people and that they are worse than what they are preventing. That is what is wrong.

it seems to me like each person that has voiced anything.... that is not 100% all for vac now, and all, and make it law without question, research, information or thought... have various reasons for why they may have issue with vac in general, or specific vacs.

there is not any one reason. nor is it black and white. all or nothing

How about here: http://www.democraticunderground.com/discuss/duboard.php?az=view_all&address=389x6872085

People constantly rail against the polio and smallpox vaccines. Admitting any vaccine did any good seems to cause some of them physical pain.

Only you, as far as I can see.

www.archetypeltd.co.nz/Smallpox.htm

lost on you?

smallpox to hpv (which doesn't kill millions) is.

who'll latch on to any story, even when it's shown to be false, to prop up their mistaken beliefs.

:rofl:

Sid

Memo to all the scientifically illiterate CONSPIRACY THEORIST FUCKFITS:

How about checking your facts.

You people are a menace- every bit as bad as Republicans, Fox and fundies.

of a particular story. She obviously believes in the vaccine, but she's not willing to be dishonest about what it can accomplish and what the cost for doing so may be.

Dr. Harper began her remarks by explaining that 70 percent of all HPV infections resolve themselves without treatment within a year. Within two years, the number climbs to 90 percent. Of the remaining 10 percent of HPV infections, only half will develop into cervical cancer, which leaves little need for the vaccine.

She went on to surprise the audience by stating that the incidence of cervical cancer in the U.S. is already so low that “even if we get the vaccine and continue PAP screening, we will not lower the rate of cervical cancer in the US.”

There will be no decrease in cervical cancer until at least 70 percent of the population is vaccinated, and even then, the decrease will be minimal.

Apparently, conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment. Even if 70 percent of women get the shot and required boosters over the same time period, which is highly unlikely, Harper says Gardasil still could not claim to do as much as traditional care is already doing.

Dr. Harper, who also serves as a consultant to the World Health Organization, further undercut the case for mass vaccination by saying that “four out of five women with cervical cancer are in developing countries.”

Ms. Robinson said she could not help but wonder, “If this is the case, then why vaccinate at all? But from the murmurs of the doctors in the audience, it was apparent that the same thought was occurring to them.”

However, at this point, Dr. Harper dropped an even bigger bombshell on the audience when she announced that, “There have been no efficacy trials in girls under 15 years.”

The Guardian's bad science columnist Ben Goldacre has discovered that it was false in every respect because it rested on statements from a single expert, Diane Harper, who trenchantly denies all the quotes attributed to her.

http://www.guardian.co.uk/media/greenslade/2009/oct/10/sundayexpress-express-newspapers

And after how many posts throwing darts at people who want to discuss vaccines based on the science of vaccines? "Pharma shill," my arse.

Every single fact she related in the OP article is true.

Instead of lame appeals to authority, how about dealing with the presented FACTS:

*70 percent of all HPV infections resolve themselves without treatment within a year.

*Within two years, the number climbs to 90 percent.

*Of the remaining 10 percent of HPV infections, less than 10% will develop into cervical cancer.

http://www.reproline.jhu.edu/english/3cc/3refman/cxca_hpv1.htm

It is estimated that for every 1 million women infected, 10% (about 100,000) will develop precancerous changes in their cervical tissue (dysplasia). Of these, about 8% (8,000 women) will develop early cancer limited to the outer layers of the cervical cells (carcinoma in situ ) and roughly 1,600 (1.6% of those who develop precancerous changes) will develop invasive cancer unless the precancerous lesions and CIS are detected and treated.

*The incidence of cervical cancer in the U.S. is already very low.

*Conventional treatment and preventative measures are already cutting the cervical cancer rate by four percent a year. At this rate, in 60 years, there will be a 91.4 percent decline just with current treatment.

*Four out of five women with cervical cancer are in developing countries.

and she wanted screening tests, first.

for benefit of a pharm company. It has been proven that some vacs have been very beneficial it's true, but is this particular one needed for a child?

Have there been long term studies that show this vaccine significantly decreases cervical cancer rates? It is my understanding, and correct me if I am wrong, that the logic goes something like that-gardasil protects against 4 strains of HPV. Two of these strains are associated with 70 % of cervical cancer. Therefore, gardasil should protect against cervical cancer.
Has it actually been shown that in fact gardasil significantly reduces rates of cervical cancer?

I appreciate that your question is logical, but the time frame simply has not been long enough to tell whether Gardasil protects against cervical cancer. Most women will not develop cervical cancer until after 30, and the vaccine simply has not been in use long enough to be able to check that. What was confirmed was that the vaccine did confer a considerable degree of immunity against the strains included. Here is a CDC site which has information about HPV and cervical cancer:
http://www.cdc.gov/cancer/cervical/basic_info/index.htm#1

The efficacy of the vaccine seems to fade out after a few years. That's the reason for the boosters. In any case, testing has shown that the four strains of HPV covered by Gardasil are implicated in about 70% of US cervical cancers and about 90% of genital warts. So there are other causes of cervical cancer, and there are other strains of HPV out there. Viruses mutate. It's what they do. When you begin a vaccination program, you change the environment of the virus strains and change selection pressures.

The other issue about the universal vaccine strategy is that it is almost certain that if we vaccinated most of the population, new strains of HPV would be selected and would then become common. Natural selection is not debatable in the world of microbes. The story of Prevnar is a cautionary example:
http://www.msnbc.msn.com/id/20825107/

That is a bacterial vaccine, but viral vaccines are known to produce shifting of strains. One theory about H5N1 is that it was partially produced by vaccine selection, and that one of the characteristics produced was virulence due to partial immunities conferred by the H5N2 vaccine used in some poultry flocks in Asia.

That is one reason why universal vaccination may not be the best strategy. If you reserve it for young women most at risk, you may get the most benefit. Women who don't clear the virus are those who often get reinfected or have other health problems or a unique susceptibility. Basically, the best strategy would be like birth control, but women should be taught about this early and educated, so that if they are going to get active, they get the vaccine. It's hard, though, because there are clear and serious adverse effects associated with persons who were already infected when they got the vaccine (massive wart outbreaks, degradation of cervical tissue), plus the vaccine is less effective when given to older women, and that is why the suggestion to give it to girls very young was made. But the problem with vaccinating young girls or boys is that by the time they become sexually active, there may be little protective effect remaining.

It's too early to know what the best usage is. For some women undoubtedly it will be a great benefit. Giving it to boys might work the best, who knows, but even if it were mandated for every US person, HPV would not disappear, and probably within a decade there would be new strains causing problems. I'd hate for any woman to think that because she got the vaccine, using condoms wasn't as important or that she doesn't need to get PAP smears. That is not true. Gardasil should be considered another layer of protection, but it is not 100% and apparently some women have contracted HPV within a few years of getting the full course.

All vaccines are somewhat experimental when first introduced. Here is an article that covers some of the issues being discussed amongst the medicos:
http://www.medicalnewstoday.com/articles/70581.php

You might be most interested in this NEJM letter about the subject. It is heavy going but it does discuss several larger trials which extended over a few years which directly address the issue of whether the vaccine directly prevents cervical cancer:
http://content.nejm.org/cgi/content/full/356/19/1991

Notice that the writers comment on 15 known strains of HPV that can cause cancer:
"Another factor explaining the modest efficacy of the vaccine is the role of oncogenic HPV types not included in the vaccine. At least 15 oncogenic HPV types have been identified,4 so targeting only 2 types may not have had a great effect on overall rates of preinvasive lesions. Findings from the FUTURE II trial showed that the contribution of nonvaccine HPV types to overall grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ was sizable. In contrast to a plateau in the incidence of disease related to HPV types 16 and 18 among vaccinated women, the overall disease incidence regardless of HPV type continued to increase, raising the possibility that other oncogenic HPV types eventually filled the biologic niche left behind after the elimination of HPV types 16 and 18. An interim analysis of vaccine trial data submitted to the FDA11 showed a disproportionate, but not statistically significant, number of cases of grade 2 or 3 cervical intraepithelial neoplasia related to nonvaccine HPV types among vaccinated women. Updated analyses of data from these ongoing trials will be important to determine the effect of vaccination on rates of preinvasive lesions caused by nonvaccine HPV types."

So what this basically says is that the selection of other strains may already be an issue - that if you knock out just two, others may already be filling the biological niche. At the time (2007), these studies had only continued for about three years, so obviously everything is preliminary. You'll really only know after 8-10 years. The estimate of 20% efficacy was not too encouraging.

Since I'm an old fart, I haven't been following this much. This JAMA letter from 2009 shows that it is not just anti-vaccine freaks who are questioning the vaccine's risk/reward ratio:
http://jama.ama-assn.org/cgi/content/full/302/7/795

I was surprised to find that the original studies had not yet published follow-up reports.

This vaccine is being marketed as a cervical cancer vaccine. It's not fair to ask if there is data indicating it will actually decrease cervical cancer rates? Really?

GARDASIL is a vaccine from Merck that has now been clinically shown to strongly protect against two dangerous, cancer associated HPV strains -- HPV 16 and HPV 18 -- for at least four years among women previously unexposed to these strains. HPV 16 and HPV 18 are currently associated with 70% of all cervical cancer cases. Medical experts hope that this means that GARDASIL could potentially end up reducing cervical cancer contraction rates by as much as 70%. So far, the limited clinical evidence available tells a very different story.

Because so few women contract cervical cancer and because cervical cancer's average latency period after initial HPV infection is over 20 years, it would take hundreds of thousands of subjects and/or decades to conclusively demonstrate that GARDASIL actually reduces cervical cancer rates in any population. Therefore, the end points used to demonstrate GARDASIL's effectiveness against cervical cancer in GARDASIL's two biggest studies (FUTURE I & II) were chosen to be the number of high grade cervical lesions -- or alternatively, the number of patients with high grade cervical lesions -- prevented over a 3 year period. High grade cervical lesions consist of grade 2 and grade 3 cervical intraepithelial neoplasias and all adenocarcinomas in situ. Among women in the USA, the vast majority of high grade cervical lesions either regress spontaneously or are successfully treated. However, the FDA currently considers high grade lesions to be acceptable surrogate outcomes for cervical cancer.

Here are the most recent and by far most comprehensive clinical results for GARDASIL in terms of reduction of high grade cervical lesions over a three year period.

For the general 16 to 26 year old population

FUTURE I

For the unvaccinated group, there were 194 total high grade lesions diagnosed -- 101 associated with HPV 16 & 18 and 93 associated with other dangerous, cancer causing HPV strains. For the vaccinated group, there were 182 total high grade lesions diagnosed -- 76 associated with HPV 16 & 18 and 106 associated with other dangerous HPV strains. That's a 6% overall decrease high grade HPV lesions but a 14% increase in other dangerous unprotected HPV strains for the vaccinated group.

FUTURE II

For the unvaccinated group, there were 361 total high grade lesions diagnosed -- 207 associated with HPV 16 & 18 and 154 associated with other dangerous, cancer causing HPV strains. For the vaccinated group, there were 281 total high grade lesions diagnosed -- 103 associated with HPV 16 & 18 and 178 associated with other dangerous HPV strains. That's a 22% overall decrease high grade lesions but a 16% increase in high grade lesions associated with dangerous unprotected HPV strains for the vaccinated group.

In terms of individual subjects rather than lesions (some subjects had multiple high grade lesions), vaccinated patients were 17% less likely to develop high grade cervical lesions overall but 15% more likely to develop high grade cervical lesions associated with dangerous unprotected HPV strains.

Combined FUTURE I & II

For the unvaccinated groups, there were 555 total high grade lesions diagnosed -- 308 associated with HPV 16 & 18 and 247 associated with other dangerous, cancer causing HPV strains. For the vaccinated groups, there were 463 total high grade lesions diagnosed -- 179 associated with HPV 16 & 18 and 284 associated with other dangerous HPV strains. That's a 16.6% decrease in overall high grade lesions but a 15.0% increase in high grade lesions associated with dangerous unprotected HPV strains for the vaccinated group.

For the sub-population of subjects who tested negative for both HPV 16 and 18

FUTURE I: Merck chose not to publish these results.

FUTURE II: Vaccinated patients were 27% less likely to develop high grade cervical lesions overall and at most 8% more likely to develop high grade cervical lesions associated with dangerous HPV strains other than HPV 16 & 18.

For the sub-population of subjects who tested positive for either HPV 16 and 18 or both

FUTURE I: Merck chose not to publish these results.

FUTURE II: Vaccinated patients were 9% less likely to develop high grade cervical lesions overall and at least 105% more likely to develop high grade cervical lesions associated with dangerous HPV strains other than HPV 16 & 18.

This is not an opinion. These are Merck's very own published clinical results for http://content.nejm.org/cgi/content/full/356/19/1928">FUTURE I and http://content.nejm.org/cgi/content/full/356/19/1915">FUTURE II.

Over TWO YEARS AGO!

http://conspiracyfactory.blogspot.com/2007/05/cost-benefit-analysis-of-vaccine.html

Apparently you've taken a page from Karl Rove's playbook, that if you tell a lie often enough it becomes the truth?

Said "smackdown" consists solely of my "debate" opponent plugging his ears and yelling, "La La La. I can't hear you."

They clearly explained how you are misusing and misinterpreting the data. You are the one with fingers in your ears.

against HPV 16 & 18 dysplasias among the subpopulation of women who tested negative for both HPV 16 & 18 at the start of the trials.

He completely ignores the fact that HPV 16 & 18 are not the only HPV strains associated with cervical cancer and that is it possible that conferring resistance to some HPV strains (including the relatively innocuous and highly common HPV 6 & 11) could actually increase the infection rates of other more virulant HPV strains. This would explain why, even among the per-protocol population, GARDASIL demonstrated just a 27% efficacy against high grade cervical lesions caused by all HPV strains associated with cervical cancer. And that was only for the FUTURE II study. In FUTURE I, Merck decided not to release GARDASIL's efficacy against all HPV strains associated with cervical cancer for any population or sub-population.

His "smackdown" consisted solely of ignoring Merck's own published results and insisting that the only efficacy that matters is efficacy against HPV 16 & 18. But the idea is to reduce cervical cancer rates overall, not just those caused by HPV 16 & 18. Isn't it? What good is GARDASIL if other virulent HPV strains simply fill the ecological void created by conferring resistance to HPV 6, 11, 16 & 18?

"Half of the remaining 10 percent of HPV infections will develop into cervical cancer" (!)

That's a helluva lot of women who are going to get cancer because of HPV.

I think they just made the case of why the drug is necessary, didn't they?

than will eventually get the cancer.

I've seen the same argument against colonoscopy. A certain number of lives may be saved by the procedure - but just about the same number of people die from complications of the procedure. Its a wash.

The American Cancer Society's most recent estimates for cervical cancer in the United States are for 2009:

* about 11,270 new cases of invasive cervical cancer will be diagnosed.
* about 4,070 women will die from cervical cancer.

Some researchers estimate that non-invasive cervical cancer (carcinoma in situ) is about 4 times more common than invasive cervical cancer.


"Almost all (more than 99%) cervical cancers are related to HPV. Of these, about 70% are caused by HPV types 16 or 18. About 500,000 pre-cancerous cell changes of the cervix, vagina, and vulva are diagnosed each year in the United States, and over half are related to HPV 16 and 18. Low-grade changes in the cells of the cervix are caused by a variety of HPV types, including 16, 18, 6, or 11. Low-grade changes most often go away without treatment, although if they grow into warts doctors may remove them. But low-grade changes may be caused by some high-risk HPV types (as well as low-risk ones), and doctors who find low-grade changes often do more testing.

Nearly all cervical cancers are related to HPV, but most genital HPV infections do not cause cervical cancer. In research studies, most people who test positive for genital HPV DNA test negative later on, often within 6 to 12 months. Scientists are still not sure whether this means that a person's immune system has completely destroyed all of the HPV or has only suppressed the infection to an extremely low level (too low to be detected by the tests). If even a few cells of the cervix still contain HPV, it's possible that the virus may start to become active again if your immune system becomes very weak.

. . . Before it was approved, the HPV vaccine was tested in more than 21,000 girls and women in many countries around the world. There were no deaths due to the vaccine, and almost no serious side effects reported during those trials. The most common side effect was brief soreness at the injection site. The FDA has determined that the vaccine is safe and effective for females aged 9 to 26 years.

By late 2008, more than 20 million doses of the vaccine had been distributed in the United States. The Centers for Disease Control and Prevention (CDC) and the FDA monitor the safety of all vaccines used in the United States. As of December 31, 2008, the Vaccine Adverse Event Reporting System (VAERS) had received a total of 12,424 reports of potential side effects following HPV vaccination. (VAERS is a national reporting system that monitors reports of potential side effects following vaccination.) About 6% of those reports were serious side effects, about half of the average for vaccines overall.

There have also been 32 cases of death after vaccination reported to VAERS. Each death has been reviewed, and there was no common pattern to the deaths that would suggest they were caused by the vaccine. When there was an autopsy, death certificate, or medical record, the cause of death was explained by factors other than the vaccine. Some causes of these deaths include drug abuse, diabetes, viral illness, blood clots, and heart failure. An unusual neurologic illness caused 2 of the deaths and these deaths are being studied further.

There were also reports of Guillain-Barré Syndrome (GBS) after Gardasil vaccination in the United States. But only some of these have been confirmed as GBS. The CDC says the number of GBS cases reported are well within the range that would be expected to happen anyway (that is, the same number of cases would be expected in people who did not get the vaccine).

Serious blood clots have been reported in women receiving the vaccine. These did not occur in young girls, but instead in teens and young adults. This type of blood clot occurs in a deep vein in the leg, and is known as a deep venous thrombosis (DVT). DVTs are more serious when they travel to one of the blood vessels leading to the lungs. This is known as a pulmonary embolism (PE). Many of the women who had DVTs or PEs after receiving the vaccine had other reasons to get these blood clots. Still, blood clots occurred more often than would be expected. This is being studied further.

CDC and FDA doctors and scientists continue to review all reports of serious side effects reported to VAERS to watch for potential new vaccine safety concerns that may need further study. We will monitor those reviews and report any concerns about the safety of the vaccine.

What are the less serious side effects from the vaccine?

Most reports of problems after the HPV vaccine have been minor. Common events include pain at the injection site, headache, nausea, and fever. There have also been reports of people fainting.

Fainting is common after injections, even more so in pre-teens and teens. Falls that happen when someone faints can cause serious injuries, such as head trauma. To help prevent injuries, CDC and FDA recommend that people getting any vaccine should sit or lie down for 15 minutes after they get it. Those who get the injection may notice ringing in their ears, sweating, nausea, dizziness, or changes in vision, which can be signals that they are about to faint. It is also important to know that some people can have muscle jerks or lose control of their bladders, almost like they are having a seizure, as they are fainting. This is not a seizure, and symptoms get better quickly after the person lies down.



. . . The vaccine will prevent the 2 types of HPV that cause most cervical cancers (about 70%) and the 2 types of HPV that cause most genital warts (about 90%), but only in women who have not already been exposed to these types of HPV. It also helps prevent vulvar and vaginal cancers related to these 2 types of HPV. The vaccine will not prevent HPV in women who have already had these HPV types.

It is possible that the vaccine also could prevent some other HPV-related cancers, including some cancers of the anus and penis, as well as some head and neck cancers. It will be some years before studies can prove whether it will prevent these cancers.


http://www.cancer.org/docroot/CRI/content/CRI_2_6x_FAQ_HPV_Vaccines.asp?sitearea=

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 …

http://www.reproline.jhu.edu/english/3cc/3refman/cxca_hpv1.htm

It is estimated that for every 1 million women infected, 10% (about 100,000) will develop precancerous changes in their cervical tissue (dysplasia). Of these, about 8% (8,000 women) will develop early cancer limited to the outer layers of the cervical cells (carcinoma in situ ) and roughly 1,600 (1.6% of those who develop precancerous changes) will develop invasive cancer unless the precancerous lesions and CIS are detected and treated.

0.8% of women who get infected with HPV develop early cancer limited to the outer layers of the cervical cells.

0.16% of women who get infected with HPV develop invasive cancer -- unless the precancerous lesions and CIS are detected and treated.

is what she SAID.

From Harper's moderator at the lecture . . .

". . .I was the moderator for Dr. Harper's presentation, which she gave with dozens of slides on a PowerPoint. I have a copy of those slides. And I can say unequivocably that Dr. Harper is being misquoted and quoted out of context.

. . . he told us, for those women living in DEVELOPED countries, this vaccine should be a choice, not a mandate.

Dr. Harper started out by explaining what cervical cancer is, who gets it and how. Of those women who do get it, 4 out of 5 are in developing, or third-world countries. Of those who get it in developed countries such as the U.S., 50 percent have NEVER had a Pap test — the clinical reason why so few women in the U.S. die from cervical cancer. Another 10 percent had not had a Pap for five years or more. Thirty percent had a false negative report on their Pap test, and 10 percent had inappropriate medical advice.

As far as the vaccine goes, we learned that it works VERY WELL in women with no current HPV infection. What that means is, if you're positive for the HPV against which the vaccine protects, neither vaccine works. We also learned that children, both boys and girls can be positive for HPV whether they've had sex or not. However, since it may be unlikely that a person is positive for all four HPVs at the same time, getting the vaccine could help protect against the ones you're not positive for. It also has some "cross-protection," meaning the vaccine has been shown to be effective against a couple other HPVs that were not tested in the study.

. . . the U.S. would have to fully vaccinate a minimum of 70 percent of the female population in the U.S. for SIXTY years, straight, without fail, in order to see a significant drop in cervical cancer. If that rate goes down, Dr. Harper warned, the rise in cancer witll go up.

"Vaccinating in the U.S., then, will not reduce cervical cancer," Harper said. "But it will prevent a number of colposcopic exams and precancerous lesions."

. . . What then, is the value of this vaccine? If you live in Africa, where cervical cancer is one of the leading causes of death in women, the risks far outweigh the benefits because the vaccines do work. . . . to vaccinate or not should be an added option to consider for a girl's health plan — a CHOICE, not a mandate. On the other hand, it could save hundreds of thousands of lives in third-world countries. . ."

http://www.kpcnews.com/index.php?option=com_content&view=article&id=7645:So-what-DID-the-HPV-researcher-say?&catid=191:cindy-bevington

overall, she just never approved of it being used in children.

Seriously?