HPV vaccine can increase risk of cancer in some women

[Marnica]

This may be old news but wanted to post as some folks may not be aware of this. I know the HPV vax is not one we routinely discuss here.

http://www.opednews.com/articles/VAC...100816-12.html

According to FDA documents, HPV infections do not lead to cervical cancer. "Most infections by HPV are short-lived and not associated with cervical cancer," states an FDA news release dated March 31, 2003. According to another FDA document, the Gardasil vaccine has been found to increase the risk of developing precancerous lesions by more than 44 percent in young women already infected with the HP virus strains used in the vaccine.

Charlotte Haug, MD, PhD, stated her concerns about the Gardasil vaccine in an editorial in the Journal of American Medical Association: "Even if persistently infected with HPV, a woman most likely will not develop cancer if she is regularly screened."

[Baby~Braatens~Mama]

This I did not know. I just new I did not like the HPV campaign. Thank you for sharing!

[heathergirl67]

The FDA saying that "Most infections by HPV are short-lived and not associated with cervical cancer" in no way means that HPV infections do not lead to cervical cancer. According to the National Cancer Institute:

Cervical cancer is almost always caused by human papillomavirus (HPV) infection.... Most HPV infections occur without any symptoms and go away without any treatment over the course of a few years. However, HPV infection sometimes persists for many years, with or without causing cell abnormalities. This can increase a woman’s risk of developing cervical cancer.... In 2007, it was estimated that 11,000 women in the United States would be diagnosed with this type of cancer and nearly 4,000 would die from it. Cervical cancer strikes nearly half a million women each year worldwide, claiming a quarter of a million lives. Studies also suggest that HPVs may play a role in some cancers of the anus, vulva, vagina, and penile cancer (cancer of the penis) (2).

http://www.cancer.gov/cancertopics/factsheet/Risk/HPV

I would be very interested in reading about the FDA document the author referred to that claimed that the vaccine increased the risk of developing precancerous lesions by more than 44 percent in young women already infected with the HPV strains used in the vaccine. I have never heard that before.

[Marnica]

Originally Posted by heathergirl67

The FDA saying that "Most infections by HPV are short-lived and not associated with cervical cancer" in no way means that HPV infections do not lead to cervical cancer. According to the National Cancer Institute:


http://www.cancer.gov/cancertopics/factsheet/Risk/HPV

I would be very interested in reading about the FDA document the author referred to that claimed that the vaccine increased the risk of developing precancerous lesions by more than 44 percent in young women already infected with the HPV strains used in the vaccine. I have never heard that before.

Im pretty sure the article meant to say "Most cases" as it goes on to highlight that the vast majority of HPV infections DO NOT lead to cervical cancer. But I see your point in how it reads.

It is important to remebr that HPV is associated with cervical cancer but it being the ONLY factor in developing cervical cancer has never been proven. In fact according to a 2001 presentation by Elizabeth R. Unger Ph.D., M.D., then Acting Chief, Papillomavirus Section of the U.S. Centers for Disease Control and Prevention (CDCP): HPV infection alone is insuffcient to cause cancer and other factors need to be present.
Also they have not proven that getting this vaccine can prevent cancer. Cancer occurs 20-35 years AFTER HPV exposure yet the duration of the efficacy of the vaccine is unknown. The clinical trails on Gardasil only lasted 5 years. It is not possible for them to actually say that this vaccine prevents cervical cancer. All they are doing is speculating. In the FDA`s approval announcement, they state: "While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers."
So the FDA is bascially saying we THINK, but are not sure that this vaccine MAY provide some benefit possibly 20-30 years from now.

[Pirogi]

I agree with Heathergirl. It would be accurate to say "HPV infections do not ALWAYS lead to cervical cancer." There are certain strains that are definitely associated with cervical cancer. However, most women who have these strains don't develop cervical cancer, and if they do begin to develop pre-cancerous cellular changes, it is usually slow enough that regular screening will detect the changes, and procedures like LEEP can be performed to remove the sick cells.

I also remember hearing when the vaccine first came out that it was NOT indicated for those who already had the more dangerous HPV strains, bc their risk was higher if they get the vaccine. Maybe this issue is being downplayed now bc the target age group is unlikely to have already gotten HPV these days?

With HPV, I was in the very last age group that experienced it before the vaccine was readily available. It's going to go the way of chicken pox and measles ... HPV is going to be this very scary thing that no one really remembers how mild it usually was. The details, like the fact that it is usually a very slow progression to cancer, or that most women clear it on their own, or that a good diet/strong immune system is key in trying to prevent cellular changes, is going to be forgotten.

[heathergirl67]

While it may be true that cancer doesn't present until 20-30 years after one has been infected with HPV, many women start developing precancerous cells almost immediately. Those cells are what lead later to cancer. A friend of mine got HPV and 6 months later had to get some precancerous cells frozen off of her cervix. So maybe the vax manufacturers were confident that it would prevent HPV-related cervical cancer because five years after administering the vax, none of the participants showed precancerous cells.

[heathergirl67]

Originally Posted by Pirogi

I also remember hearing when the vaccine first came out that it was NOT indicated for those who already had the more dangerous HPV strains, bc their risk was higher if they get the vaccine. Maybe this issue is being downplayed now bc the target age group is unlikely to have already gotten HPV these days?

That's what I was thinking, too. Maybe that's why they're giving them to nine year olds? Because much older than that and, unfortunately, they may have already contracted it. Which is heartbreaking on a whole other level.

[Marnica]

Originally Posted by heathergirl67

I would be very interested in reading about the FDA document the author referred to that claimed that the vaccine increased the risk of developing precancerous lesions by more than 44 percent in young women already infected with the HPV strains used in the vaccine. I have never heard that before.

It's funny...the actual FDA document that says this has been removed from the FDA site. hmmmm BUT it is referenced in this document.
http://www.fda.gov/ohrms/dockets/doc...01-01-vol1.pdf

look at page 8 #2 of this reclasification petition from 2007

[Marnica]

Originally Posted by heathergirl67

While it may be true that cancer doesn't present until 20-30 years after one has been infected with HPV, many women start developing precancerous cells almost immediately. Those cells are what lead later to cancer. A friend of mine got HPV and 6 months later had to get some precancerous cells frozen off of her cervix. So maybe the vax manufacturers were confident that it would prevent HPV-related cervical cancer because five years after administering the vax, none of the participants showed precancerous cells.

Or maybe their body effectively eliminated the infection or maybe they were never infected in the first place? Who knows. There is no way to tell really.

[Marnica]

[QUOTE=Pirogi;15756751]
I also remember hearing when the vaccine first came out that it was NOT indicated for those who already had the more dangerous HPV strains, bc their risk was higher if they get the vaccine. Maybe this issue is being downplayed now bc the target age group is unlikely to have already gotten HPV these days?
QUOTE]

I think it's quite the opposite. They are downplaying it because the target age group has been expanded to include women into their late 20's who have likely been infected with HPV at some point in their lives.

[heathergirl67]

Originally Posted by Marnica

It's funny...the actual FDA document that says this has been removed from the FDA site. hmmmm BUT it is referenced in this document.
http://www.fda.gov/ohrms/dockets/doc...01-01-vol1.pdf

look at page 8 #2 of this reclasification petition from 2007

Found it:
http://www.fda.gov/ohrms/dockets/ac/...006-4222B3.pdf

I haven't looked it over yet...

[Marnica]

Originally Posted by heathergirl67

Found it:
http://www.fda.gov/ohrms/dockets/ac/...006-4222B3.pdf

I haven't looked it over yet...

nevermind! thanks for posting

[heathergirl67]

Originally Posted by Marnica

Or maybe their body effectively eliminated the infection or maybe they were never infected in the first place? Who knows. There is no way to tell really.

But, I mean, think of it this way: In the general population there are a lot of women who get HPV infection. A smaller amount get the cancer-causing strains. Some of those people are able to effectively fight those off, never getting cancer. But X% of those infected with HPV will get precancerous cells within five years.

So, say they give the vax to 10,000 women who don't yet have HPV. If after five years significantly less than X% of them have precancerous cells, it would be appropriate to assume that the vaccine protected them. If it did nothing then their numbers would reflect that of the general population, you know?

Of course, it might be a moot point, because maybe that's not even how they tested.

[Marnica]

Originally Posted by heathergirl67

But, I mean, think of it this way: In the general population there are a lot of women who get HPV infection. A smaller amount get the cancer-causing strains. Some of those people are able to effectively fight those off, never getting cancer. But X% of those infected with HPV will get precancerous cells within five years.

So, say they give the vax to 10,000 women who don't yet have HPV. If after five years significantly less than X% of them have precancerous cells, it would be appropriate to assume that the vaccine protected them. If it did nothing then their numbers would reflect that of the general population, you know?

Of course, it might be a moot point, because maybe that's not even how they tested.

I see what your saying but it's all speculation. Also screening women who have already had HPV before the vaccine is given is not done, making it even more impossible to extrapolate this information to the general public.

[heathergirl67]

Originally Posted by Marnica

I see what your saying but it's all speculation. Also screening women who have already had HPV before the vaccine is given is not done, making it even more impossible to extrapolate this information to the general public.

Yeah, you're right. Speculation usually isn't all that useful, is it? But I thought that the study I linked to showed that they did screen women who have already had HPV before the vaccine is given?

[Fyrestorm]

Originally Posted by Marnica

I see what your saying but it's all speculation. Also screening women who have already had HPV before the vaccine is given is not done, making it even more impossible to extrapolate this information to the general public.

I wonder how many parents would allow their 9 YO dd's to have a pap before vaccination? Mandating it would seriously reduce uptake of the vaccine. Therefore this testing will never happen

[Marnica]

Originally Posted by heathergirl67

Yeah, you're right. Speculation usually isn't all that useful, is it? But I thought that the study I linked to showed that they did screen women who have already had HPV before the vaccine is given?

Yes, but they DON"T screen the general public...that's the whole point!

[heathergirl67]

Originally Posted by Marnica

Yes, but they DON"T screen the general public...that's the whole point!

Oh, I see what you're saying. But, they don't screen the general public because they don't need to. Because their clinical trials showed that there was no increased cancer risk for women who already had HPV.

It makes me wonder about the author/website in the original post. Why did they chose to misrepresent the research so egregiously?

[Marnica]

Originally Posted by heathergirl67

Oh, I see what you're saying. But, they don't screen the general public because they don't need to. Because their clinical trials showed that there was no increased cancer risk for women who already had HPV.
It makes me wonder about the author/website in the original post. Why did they chose to misrepresent the research so egregiously?

No..... one of thier trials DID show an increased risk, another did not. Conflicting data does not mean the one that did is wrong (or the one that didn't either). Not screening the general public has nothing to do with needing to or not needing to. It would the smart prudent thing to do, BUT it would not be cost effective. Think about this. It becomes common knowledge that in at least one of their clinical trials, for women that have had previous HPV infections, there may be an increased risk for precancerous legions down the line. They are actually honest about the conflicting data and admit that they really do not have a good grasp on this risk. Women, especially ones that are older (teens and up) would want to get screened, Perhaps many of them would discover that they have an HPV infection. (Hopefully they are getting yearly screens anyway, but Im sure lots of people don't) and then they decide they don't want to take that risk and get the vaccine. That's a whole lotta people that might decide not to get that vaccine afterall KWIM?

[heathergirl67]

I do see what you're saying. I saw it differently- namely that they had concerns, but after further inspection realized that those concerns were probably baseless:

This demonstrated a limitation of the evaluation of small subgroups, where subgroups might have imbalances in baseline demographic characteristics. In this case, it appeared that subjects in this subgroup of study 013 who received Gardasil™ might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients. In study 015, the applicant conducted a subgroup primary efficacy analyses for HPV 16/18. Here, the evaluation of this subgroup did not raise a concern about enhancement of cervical disease due to HPV

Therefore, while the subgroup from study 013 remains a concern of the clinical review team, there is some evidence that this represented an unbalanced subgroup where Gardasil™ recipients at baseline had more risk factors for development of CIN 2/3 or worse. Furthermore, when the subgroups from three studies are combined, these groups appear to be more similar.

I'm sure they studied that possibility further in later research. I'm going to see if I can find that...