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Should girls be forced to receive HPV vaccine?

Re: Should girls be forced to receive HPV vaccine?

Gay men seek 'female cancer' jab
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Homosexual men are requesting a controversial "sex disease" vaccine designed to prevent a female cancer.


Gardasil protects against the most common of sexually transmitted infections, human papillomavirus (HPV), which can cause cervical cancer.

But HPV also causes genital warts and anal and penile cancer, and men argue the jab would guard against these.

Many private clinics are offering it to men. One in London says it has immunised dozens in the last six weeks.

Controversy

Gardasil has been causing controversy since it was launched in the UK late last year, mainly because it is designed to be given to children before they become sexually active and can catch HPV.

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The government is considering whether all girls, and possibly boys, aged 11 or 12 should get it routinely in schools, ultimately to cut cervical cancer rates.

Gardasil is licensed for boys and girls aged nine to 15 and women aged 16 to 26. But doctors can opt to give it to other people "off licence" if they wish.

Strong demand

Dr Sean Cummings at the Freedom Health clinic in Harley Street, where dozens of men have had the jab, said he was happy to recommend Gardasil to his adult men, at ?450 for a three-dose course.

"We've had a strong demand for it. I had a man come in for the vaccine this morning. He was 24. Then I have one this afternoon who is 67 years old.

"The motivation is to protect themselves and to prevent spreading HPV to their partners."

Opponents say there is no point in immunising people who are already sexually active.

More proof

But Dr Paul Fox, a genito-urinary medicine expert at the Chelsea and Westminster and Ealing hospitals, believes it can be worthwhile.

He argues that it is unlikely a person will have encountered all of the four strains of HPV found in Gardasil, including the two linked to cancers, even if they are leading a very promiscuous sex life.

"We should not just be looking at vaccinating people in their pre-teen years. Other people would benefit as well."



Dr Jo Longstaff, of the Independent General Practice private clinic in Cardiff, which also offers the Gardasil vaccine, agrees.

"Our first enquiry about Gardasil was from a male patient. I think they should be considering it."

Dr Anne Szarewski, clinical consultant for Cancer Research UK who has been involved in evaluating both Merck's Gardasil and GSK's rival jab Cervarix, says there may be a case for immunising men.

"Men who have sex with men are at a much higher risk than average of anal cancer and genital warts, particularly if they are HIV-positive.

"Clearly it would be very important if the vaccine could protect. The problem is we do need proof."

Trials in men

Merck is currently testing the vaccine's efficacy in 4,000 men, including 500 men who have sex with men. And the US National Institute of Health is also carrying out trials to see what benefits it could have for people with HIV.

Merck said its priority was to tackle cervical cancer, but has not ruled out giving the vaccine to other groups - including men who have sex with men.

Roger Peabody of the Terrence Higgins Trust said if the trials were successful, there would be a good case for vaccinating young boys, not only to stop the spread of HPV to women, but to protect men against HPV-related disease.

Dr Szarewski agreed, saying: "It is bad enough suggesting to people that their 12-year-old daughter might need a vaccine against a sexually transmitted infection.

"I would be interested to see the response of suggesting to parents that they should vaccinate their boys at 12 in case they become gay."

She said heterosexual men and women also risked anal cancer.

About 400 people are diagnosed with anal cancer each year in the UK. The disease is slightly more common in women than men.


Story from BBC NEWS:
http://news.bbc.co.uk/go/pr/fr/-/2/hi/health/6342105.stm
 
Re: Should girls be forced to receive HPV vaccine?

I read today the posts. Thank you JJackson and AD.
___
#19:
"... NICE uses a unit called Quality Adjusted Life Year (QALY). Basically a questionnaire asking about your health gives a Quality of Life score between 0 (dead) and 1 (perfect health). If a treatment increases your score by .2 for 5 years (or .1 for 10 years) then it scores 1 QALY. If this can be achieved for under a given amount (currently £20,000 to £30,000) then NICE is likely to approve it, more than this and you will not get it on the NHS. ..."<?xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /><o:p></o:p>

Maybe to set up a law by which it must ask the taxpayers how much of the collected tax money they want to be diverted to health purposes ...
If that's heretic, insert new tickets ...

___
#21:
"... But HPV also causes genital warts and anal and penile cancer, and men argue the jab would guard against these.
...
Gardasil is licensed for boys and girls aged nine to 15 and women aged 16 to 26. But doctors can opt to give it to other people "off licence" if they wish.
...
"The motivation is to protect themselves and to prevent spreading HPV to their partners."
...
Opponents say there is no point in immunising people who are already sexually active.
...
But Dr Paul Fox, a genito-urinary medicine expert at the Chelsea and Westminster and Ealing hospitals, believes it can be worthwhile.
He argues that it is unlikely a person will have encountered all of the four strains of HPV found in Gardasil, including the two linked to cancers, even if they are leading a very promiscuous sex life.
"We should not just be looking at vaccinating people in their pre-teen years. Other people would benefit as well.
...
Roger Peabody of the Terrence Higgins Trust said if the trials were successful, there would be a good case for vaccinating young boys, not only to stop the spread of HPV to women, but to protect men against HPV-related disease."


From the above, it can be read that there are enaugh reasons to include the male also, and not gay only, because the hetero male population if illnessed can got warts also (that's enaugh debilitating) plus they spread it further, maybe got the other strains, or related illnesses, dependable of the microbe spreading clusters.

If the spread reach 80% until 50, that is an state of epidemic, so if it can, it must be prevented by an wide scale vaccination, like for the childhood illnesses.
 
Re: Should girls be forced to receive HPV vaccine?

A warning letter dated April 28, 2008 sent to Merck from the FDA can be found here http://www.fda.gov/foi/warning_letters/s6756c.htm.
No reply from Merck has been posted.
This company is not new and the list of violations is long.
Anyone who takes a Merck medication should read the whole letter.

Here are just a few of the findings and comments; on parts such as a, d & c, some of the information has been redacted so the general public only has a partial clue as to what the FDA found:

...between November 26, 2007, and January 17, 2008. During the inspection, the FDA investigators documented significant deviations from current good manufacturing practice ... products include Liquid PedvaxHIB?, RECOMBIVAX HB?, ProQuad?, Gardasil?, VAQTA?, and COMVAX?.

At the close of the inspection, the FDA investigators issued a Form FDA 483, Inspectional Observations, which described a number of significant objectionable conditions relating to your firm?s compliance with CGMP.

1. You failed to thoroughly investigate any unexplained discrepancy of a batch...
2. You failed to establish adequate written procedures describing the handling of all written and oral complaints regarding a drug product...
3. Your firm failed to assure that there are written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess...
4. You failed to assure that equipment used in the manufacture, processing, packing and holding of a drug product is calibrated, inspected, or checked according to a written program designed to assure proper performance
5. You failed to exercise appropriate controls over computer or related systems to assure that changes in master production are instituted and input and output from the computer or related system of formulas are checked for accuracy and maintained [21 CFR 211.68(b)], in that there is no documentation to support software manufacturing change performed to the [redacted] used in the manufacture of Gardasil?, lots [redacted] and [redacted].
6. You failed to establish test procedures or other laboratory control mechanisms designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity and to assure that any deviation from the written test procedures or laboratory control mechanisms shall be recorded and justified [21 CFR 211.160...

a. You submitted a Biological Product Deviation Report to FDA in October 2006, due to the [redacted] of Varivax III being out-of-specification at the two month stability time point. This product had been shipped to [redacted] and then returned to the United States before being placed on stability. The product was not licensed in the United States at the time of the deviation. Your investigation concluded that the failure was due to the ingress of [redacted] into the vial headspace during shipment [redacted]. Your investigation did not include testing of other potentially affected products shipped [redacted], for example, ProQuad?, to determine if there were any detrimental effects on these products.

d.Product lots that failed the initial [redacted] visual inspection for critical defects such as [redacted] and [redacted] were not thoroughly investigated. For example, MMR II? lots [redacted] and [redacted] failed the critical defect category for [redacted] and no investigations were performed. These lots were subsequently distributed.

c. Not all lots of product that may have been affected by fibers being shed from [redacted] lot [redacted] were assessed. Only [redacted] lots of product, where the fibers were observed during filling, were quarantined and assessed. Approximately [redacted] lots of lyophilized product and [redacted] lots of liquid products were filled during the time of receipt and use of [redacted] lot [redacted].
 
Re: Should girls be forced to receive HPV vaccine?

Thanks mixin,

from your post text is visible what is the real main contrary reason for an wide use of the vaccine, not the mandatory question, or etc.:

#24:
"Here are just a few of the findings and comments; on parts such as a, d & c, some of the information has been redacted so the general public only has a partial clue as to what the FDA found:
...between November 26, 2007, and January 17, 2008. During the inspection, the FDA investigators documented significant deviations from current good manufacturing practice ... products include Liquid PedvaxHIB®, RECOMBIVAX HB®, ProQuad®, Gardasil®, VAQTA®, and COMVAX®.
At the close of the inspection, the FDA investigators issued a Form FDA 483, Inspectional Observations, which described a number of significant objectionable conditions relating to your firm’s compliance with CGMP.
___

The same problem is maybe worldwide present.

___
#24: "A warning letter dated April 28, 2008 sent to Merck from the FDA can be found here http://www.fda.gov/foi/warning_letters/s6756c.htm.
No reply from Merck has been posted.
This company is not new and the list of violations is long."
___

Of course, if instead of nothing and wait, after an: "no reply",
the gov./fin. started with an "without 100% clean and safe products - no more funds from now, and no market sells", probably the vaccine would be very carefuly handled in production, and cared for after, to get on the market "o.k.", and hopefuly would be found a way without a few milions guinea torched animals more in the process.

Probably that is also the main reason why many health workers avoid to be vaccinated, and why many tryings to assure enaugh prepandemic vaccines fallen into the "lobying and corp. advocating for selling unnecessary potentialy harming vaccines to the public" basket, where such deviations tolerating fueled more resistance to a wider vaccine inoculation:

#24: "...
6. You failed to establish test procedures or other laboratory control mechanisms designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity and to assure that any deviation from the written test procedures or laboratory control mechanisms shall be recorded and justified [21 CFR 211.160...
..."

We can sum to the above text some persistent web published speculations with non-proved stories of purposedly builded vax failures/impurities, and it became visible why those (pre)pandemic vaccine stuff didn't take off yet ...

For the world pandemic and various illness anti-epidemic preparedness efforts, and for good health, if not cleared yet or suspected, it would be important to recheck the production quality steps and security restrictions at all vaccine production sites with further mandatory actions.

As previously stated in #14:
___
"... Instead of ousted an wide preventive vaccine use, the efforts must be redirected to control unnecessary vaccine Market induced proliferations by 100% proof vaccine control measures, and institutions.

In the meantime, it must be assured that such HPV vaccine are realy without harming collateral effects or builded components.

If the above is accomplished, maybe, giving that vaccine ..."
 
Re: Should girls be forced to receive HPV vaccine?

From bfbn:
http://www.birdflubreakingnews.com/...SvwNYD&usg=AFQjCNEnJB6COmNAJYl1iOlPC0-R-O9hYQ

Bird Flu, Fire Hazards and a Vaccine for Boys

<!-- /HEADLINE --><!-- MAIN PHOTO --><!-- /MAIN PHOTO --><!-- BYLINE -->RONI CARYN RABIN <!-- /BYLINE --><!-- PUBDATE -->
Published: Tuesday, January 6, 2009 at 6:01 a.m.
Last Modified: Wednesday, January 7, 2009 at 4:11 a.m.

...

Company Requests Approval for HPV Vaccine in Boys


Merck has asked the Food and Drug Administration to approve the use of its human papillomavirus vaccine in boys and young men, CNBC reports. The HPV vaccine protects against genital warts and against some strains of the sexually-transmitted virus that may cause cervical cancer.
 
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