Gardasil vaccine

robinson said:
600 billion a year. Oh the benefits of modern medicine.
Click to expand...
That's million, as Ivor said.

I must say I'm becoming somewhat inured to the huge numbers that emerge from UK Government.
Seems that to get an NHS computer system up and running taxpayers have to find £20 billion.
Because one of the building societies here was irresponsibly overlending money and got caught in the wake of the credit crunch, UK Gov has guaranteed £50 billion of taxpayers money to underwrite it all.

When I think that I am having to pay thousands of pounds to cover this profligacy, perhaps a couple of hundred £ to protect my daughter isn't such a concern, be it paid by me directly or by the taxpayer (me again)
 
The price will go down before too long. Mandating it for boys in the US would probably help with that a lot.
Universal use of expensive new vaccines in the developed world bring manufacturing costs down for the developing world, where most of the deaths are.
http://www.who.int/immunization_supply/int...eproduction.pdf

Pricing considerations
The pricing of vaccines has been characterized by heavy tiering across markets, which
is possible because of highly scale sensitive manufacturing economics and product
life cycles. The product life cycle has three distinct phases, as seen in Table 2: new
product launch, market penetration, and product maturity. Most price tiering has been
seen with mature products. The challenge for bringing new products to market is to
ensure effective management of the life cycle29 so that both manufacturers and the
market will benefit.
Click to expand...

Page 11 has a chart that shows the cycle:


On launch, there is typically only one producer, who owns product and process
intellectual property. This phase will have limited capacity, low demand, high
production costs and high prices. During market penetration, new manufacturers will enter the market, either through their own development efforts or through licensing of the original manufacturer’s patent, and capacity will increase. Limited price tiering will be possible. Once the product reaches maturity and the intellectual property
protection expires, there may be many manufacturers, both in the developing as well
as the industrialized world. Production costs are low and often there will be
overcapacity so that availability is high and demand is global. Prices will be heavily
tiered.
Click to expand...

GSK's Cervarix is about to enter the market in the US and Europe, so that'll effect everything, also.
 
Deetee said:
Merck think tank:

"Damn shame that cervical cancer only affects girls, huh?"
"Yeah, maybe we could contrive a way to persuade people there is a case to vaccinate the boys too. We'd double our massive profits overnight."
"Hmm... how about a study showing that if both sexes are vaccinated there would be a reduction in the time lag taken to achieve full protection?"
"Yes, that could work..."
Click to expand...

HPV causes genital warts in both boys and girls but cervical cancer only occurs in girls (obviously). Don't forget, girls are getting the virus from boys in the first place, which is why boys will be receiving the vaccine in a couple of years or so.
 
Deetee said:
I think studies show it prevents most types of HPV infection, which is a pre-requisite for invasive cancer. It can prevent CIN (precancer) but I don't think studies have been done long enough to say conclusively it prevents invasive cancer.
Logic, and Humean philosophy, suggest it will, since cancer rates in those without HPV are trivial.
Click to expand...

It depends on the population you're looking at. There are some weird things going on with the vaccine so far.

This is about the large FUTURE II study…


http://content.nejm.org/cgi/content/full/356/19/1991

In these trials, called Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I and II, what is the efficacy of vaccination among all subjects, regardless of causal HPV types? In the FUTURE I trial,5 rates of grades 1 to 3 cervical intraepithelial neoplasia or adenocarcinoma in situ per 100 person-years were 4.7 in vaccinated women and 5.9 in unvaccinated women, an efficacy of 20%. Analyses by lesion type indicate that this reduction was largely attributable to a lower rate of grade 1 cervical intraepithelial neoplasia in vaccinated women; no efficacy was demonstrable for higher-grade disease, but the trial may have lacked adequate power to detect a difference. Vaccinated women also had lower rates of external anogenital and vaginal lesions (1.3 vs. 2.1). In the larger FUTURE II trial,6 rates of grade 2 or 3 cervical intraepithelial neoplasia or adenocarcinoma in situ were 1.3 in vaccinated women and 1.5 in unvaccinated women, an efficacy of 17%. In analyses by lesion type, the efficacy appears to be significant only for grade 2 cervical intraepithelial neoplasia; no efficacy was demonstrable for grade 3 cervical intraepithelial neoplasia or adenocarcinoma in situ.
Click to expand...


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.
Click to expand...

Some other stuff...

http://www.fda.gov/cber/review/hpvmer060806r.pdf

Scroll down to page 362

(table 279)

-11.7 efficacy compared to placebo in those infected with 16 and 18 before vaccination. So that's quite possible a disease enhancement effect that can happen in some populations.


Also check out pages 147-149.


Look at the “by lesion type” at the bottom of table 92...the effectiveness drops as the CIN grades get worse. There wasn’t any actual cancer in the Gardasil group or the placebo group, but there were 35 cases in both groups for CIN3/AIS…rendering an effectiveness of basically zero.

Now go down to table 93. They didn’t calculate the observed efficacy, but you can calculate it yourself.

So Gardasil has some problems. It apparently causes disease enhancement if you’re already infected with a vaccine strain, and it apparently causes an increase in incidence of non-vaccine types in everyone else. And if you look at table 93 really closely, it almost looks like the replacing serotypes, while less proliferative, might be more oncogenic.

It also looks like co-infection with multiple HPV types might be very, very common:

http://www.fda.gov/cber/minutes/0910evolv.txt

(go down to page 84)

As we look at these women over a period of
time through these six month or so samples, what we
also find, and other labs have exactly the same
results, is every time we sample, you may or may not
see the type you saw before. It may switch. For

85

instance, we have this patient who had 6 plus 16, and
then 11 plus one that was minor and we couldn't tell,
then jyn 2, and then type 40, and then we had a type
53, but the others disappeared.
Everyone's experience in the field has
been that the viruses rise above a detectibility
threshold, stay there for a while, days or weeks or
months, and then fall below detectibility,only to be
replaced by a different HPV type. These are not new
infections. They are basically cryptic or latent
persistent infections that fluctuate in their levels
of replication and detectibility. Pretty much anybody
is showing that flexibility.
Click to expand...

We have found
a brand new HPV type for every 10 people that we have
looked at. Philodelius and Ethel Michelle Diveres and
zur Hausen and Shamen in European study of tutanius
papilloma viruses have found a new papilloma virus for
just about every other person they have looked at when
they use the combination of nested PCR and DNA
sequencing.
Robbie Burke's group, Jill Polefski's
group, have very comparable experiences looking at

86

anal papillomas or female genital tract.
It is my contention right now that instead
of 80 HPV genotypes or 150 that have been officially
named, that there probably are millions of variants,
virtually a continuum. We feel that basically
everybody has their own personal micro flora, that
these are passively acquired or vertically acquired,
not necessarily sexually, but certainly possibly
sexually, and that they simply are part of the human
condition as are microflora, just as we have
microflora composed of bacteria and many other
viruses, and that they basically are utterly
ubiquitous.
Click to expand...

So to summarize this part of the talk, I
feel that they are virtually ubiquitous. they are
typically sub-clinical, persist in or latent


88

infections. There are staggeringly large number of
genotypes if we take the care to look. I might say
that the reason these are typically not found is that
people use generic cross-hybridizing probes or have
cut off their probe sets. If you're not probing for
something, you are not going to see it.
Click to expand...

And this:
(I haven't read it but I think the title probably says it all)

J. Clin. Pathol. 2004;57;68-72

Multiple high risk HPV infections are common in cervical neoplasia and young women in a cervical screening population
 
So $700 per child for a worthless vaccine? A vaccine that is required by some states?


Reminds me of Zetia, the cholesterol drug. Seems it didn't prevnt heart disease, though it did lower serum cholesterol. But the makers charged a LOT for it. Made millions, before getting caught sitting on the study results. I'll bet they get to keep the profits.


And, don't we have laws against making laws that mention people by name? (is there a latin phrase?) And isn't requiring the use of a patent monopoly the same thIng?
 
http://info.cancerresearchuk.org/cancerstats/types/cervix/incidence/

In 2004, 2,726 new cases of cervical cancer were diagnosed in the UK, making it the twelfth most common cancer in women and accounting for around 2% of all female cancers.
Click to expand...

http://info.cancerresearchuk.org/cancerstats/types/cervix/mortality/?a=5441

In 2005, there were 1,061 deaths from cervical cancer in the UK1-4 giving a European age-standardised death rate of 2.6 per 100,000 females and a crude rate of 3.5 per 100,000
Click to expand...

I can't help but think for rare illnesses, mass vaccination seems a rather inelegant solution, especially when it is not targeted and costs so much.

I'll shut up now, because I know the vast majority of you disagree.:)
 
casebro said:
So $700 per child for a worthless vaccine? A vaccine that is required by some states? ...
Click to expand...

FAR, far, far, far, FAR from useless.

But we are being gouged on the price.

And it should be required for all children, male or female, once the price has been forced down.

And I'm one of those evil bastards that thinks you ought to be forced to be vaccinated EVEN if your religion says otherwise. Maybe ESPECIALLY if your religion says otherwise because we sure as hell aren't going to see you as a patient any time before you're in hospice, and vaccines are a great way to delay that day.

My mother died of this kind of cancer, so I am just bit opinionated on this one.
 
robinson said:
Isn't this the first vaccine ever, for a sexually transmitted disease? Well, several of them at once.

I wonder why they don't force boys to get it as well.
Click to expand...


when i talked to planned parenthood they said they were 'coming out with' one for boys. I think they might have only done the testing on girls because its really hard to detect in men unless they have the kind of hpv that results in warts. I dont think its a different vaccine it just has to go through testing i would imagine.
 
Ivor the Engineer said:
http://info.cancerresearchuk.org/cancerstats/types/cervix/incidence/



http://info.cancerresearchuk.org/cancerstats/types/cervix/mortality/?a=5441



I can't help but think for rare illnesses, mass vaccination seems a rather inelegant solution, especially when it is not targeted and costs so much.

I'll shut up now, because I know the vast majority of you disagree.:)
Click to expand...

I would imagine abnormal cell growth that isnt quite cancer yet (displaysia?? i cant remember the name) is a lot more common than cervical cancer. the treatment for that is very painful and has to be done over and over again. Ive known quite a few women who have had that and it has the potential to become cancer without the treatments.
 
Posted by KellyB
Look at the “by lesion type” at the bottom of table 92...the effectiveness drops as the CIN grades get worse. There wasn’t any actual cancer in the Gardasil group or the placebo group, but there were 35 cases in both groups for CIN3/AIS…rendering an effectiveness of basically zero.

Now go down to table 93. They didn’t calculate the observed efficacy, but you can calculate it yourself.

So Gardasil has some problems. It apparently causes disease enhancement if you’re already infected with a vaccine strain, and it apparently causes an increase in incidence of non-vaccine types in everyone else. And if you look at table 93 really closely, it almost looks like the replacing serotypes, while less proliferative, might be more oncogenic.
Click to expand...

Well, this is interesting. If you are already carrying HPV there could be problems. Even if you aren't, it could cause an increase in the non-vaccine types.

Do you all really think they've got this all perfectly figured out? That the vaccine is going to work exactly as planned? Like this:

All girls get vaccinated with Gardasil or another HPV vaccine. The vaccine prevents HPV infection with the cancer provoking strains, doesn't cause any increase in other strains, doesn't cause any other problems in millions of girls and women and results, 30 or 40 years from now, in a decrease in cancer of the cervix in millions of women. Thereby justifying the expenditure of billions of dollars and the injection of aluminum and other substances into millions of women. And if it doesn't work out as planned? Merck and competitors will get to keep the money. Their chances of getting sued for false advertising 30 years from now are zero.

I don't think I'll be recommending this vaccine. There are other ways of avoiding death by cervical cancer.
 
nails3jesus0 said:
I would imagine abnormal cell growth that isnt quite cancer yet (displaysia?? i cant remember the name) is a lot more common than cervical cancer. the treatment for that is very painful and has to be done over and over again. Ive known quite a few women who have had that and it has the potential to become cancer without the treatments.
Click to expand...

That's really where Gardasil shines.
Unless the replacement effect takes off on a community level in some bizarro way, Gardasil will do a great job of eliminating most of the false alarms, which are extremely bad in their own way. My best friend had a CIN grade II a while back, (and that's where Gardasil's "tipping point" appears to be) and it was very scary and painful for her to deal with.

Time will tell if Gardasil ends up actually saving lives. But it really does seem to work well against the lower grade neoplasias. And there's merit in that, alone.
 
BenBurch said:
Such as?
Click to expand...

Having paps?

Gardasil has, thus far, shown a low to nothing effectiveness against cervical cancer. At best, it's 17-20% effective for mildish neoplasisa. And it goes to hell after that point.
 
BenBurch said:
Such as?
Click to expand...

Keeping your slutty legs closed.

I can't get Gardasil. It's not approved for women my age.

I'm 28.

Not that I'm planning to pick up HPV anytime soon, but I've had to have a cervical biopsy. It's probably akin to get your nuts goosed. Anything to avoid more trouble.
 
robinson said:
I don't believe that for a second.
Click to expand...

Did you read my FDA link from above?
Where this came from?

It is my contention right now that instead
of 80 HPV genotypes or 150 that have been officially
named, that there probably are millions of variants,
virtually a continuum. We feel that basically
everybody has their own personal micro flora, that
these are passively acquired or vertically acquired,
not necessarily sexually, but certainly possibly
sexually, and that they simply are part of the human
condition as are microflora, just as we have
microflora composed of bacteria and many other
viruses, and that they basically are utterly
ubiquitous.
Click to expand...
 
kellyb said:
Did you read my FDA link from above?
Where this came from?
Click to expand...

No I didn't read it. I was responding to the link
http://www.cdc.gov/STD/HPV/STDFact-HPV.htm

which states, among other things:

Approximately 20 million people are currently infected with HPV. At least 50 percent of sexually active men and women acquire genital HPV infection at some point in their lives. By age 50, at least 80 percent of women will have acquired genital HPV infection. About 6.2 million Americans get a new genital HPV infection each year.

How do people get genital HPV infections?

The types of HPV that infect the genital area are spread primarily through genital contact. Most HPV infections have no signs or symptoms; therefore, most infected persons are unaware they are infected, yet they can transmit the virus to a sex partner.
Click to expand...

I don't believe the claim - By age 50, at least 80 percent of women will have acquired genital HPV infection.

By the information they state, in and of itself, it is obvious they are making unfounded claims.

No surprise they don't list any evidence to back up the claim.
 
Last edited:
You must log in or register to reply here.

Back
Top Bottom