third cervical cancer vaccine on the horizon

[xchrom]

VGX Pharmaceuticals Receives FDA Approval Of IND For Novel DNA Vaccine For Cervical Cancer Therapy

http://www.medicalnewstoday.com/articles/113837.php

VGX Pharmaceuticals, Inc. (VGX) announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Investigational New Drug (IND) application for its DNA vaccine for cervical cancer therapy, VGX-3100. The Company expects to initiate the Phase I clinical study for VGX-3100 in patients in a multi-center study in the third quarter of 2008. More information on this study is available here.


"We are pleased with the FDA's acceptance of our VGX-3100 IND application for treating cervical cancer," stated Dr. J. Joseph Kim, President and Chief Executive Officer. "This accomplishment further demonstrates the potential and efficiency of our DNA-based product development platform."
VGX-3100 is a DNA-based therapeutic vaccine that has the potential to treat cervical cancer caused by the human papilloma virus (HPV). VGX-3100 utilizes synthetic consensus sequences based on HPV antigens that offer coverage across different viral sub-types (types 16 and 18), which could potentially treat 71% of all cervical cancers. Prophylactic vaccines for HPV, including Merck's Gardasil® and GSK's Cervarix™ have been recently approved and are helping to prevent HPV infection. There is still an unmet need for treating individuals who have previously been exposed to HPV.

More information about VGX can be found at http://www.vgxp.com.

[WillYourVoteBCounted]

1. now this looks promising - a treatment

Look forward to finding out more about this.

I hope this gets better studying and doesn't use the same nasty adjutants as Gardasil.

Many vaccs don't use aluminum.

[xchrom]

4. gardasl is more effective tha first thought -- and prevents lesions

that are related to other hpv varients.

[TZ]

6. Its getting the SAME AMOUNT OF STUDYING

That Gardasil got. All vaccines have to go through a standard procedure..10 years of clinical trials. What the propagandists also ignore is the HPV vaccine was invented in another country and has been through MULTIPLE safety studies in multiple countries (Australia, Europe and US).
As for ADJUVENTS...aluminum hydroxide is HARMLESS and is actually in more vaccines then you think..In fact its been in vaccines for 30 years now..And its been proven over and over to be safe. Did you know that before a vaccine goes to clinical studies there are AT LEAST 3 years of pre-clinical toxicity studies on animals? I think the "nasty adjuvents" would show up dangerous there if they were.

[WillYourVoteBCounted]

9. we need to know why Gardasil is killing some girls and making some very sick

Some healthy girls are getting sick and some have died following the administration
of this vaccine.

We need to know what is causing this.

[Liberal Veteran]

11. Everyone who drinks water dies sometime afterwards.

When are you going to start railing against the dangers of water since it is a killer.

[varkam]

21. I'm going to ask you a straight-forward question, and I would like a honest answer from you:

How many people are you reasonably certain that Gardasil has killed?

[mhatrw]

54. I'm going to ask you a straight-forward question, and I would like a honest answer from you:

How many people are you reasonably certain that Gardasil has saved?

[varkam]

59. Yawn.

:boring:

[Hannah Bell]

27. Link to this "ten year" rule, please?

you're the second person who'd mentioned it; i asked for a link the first time but never got a response.

[mhatrw]

53. Please share with us the results of the these toxicity studies!

Please provide the links!

[WillYourVoteBCounted]

2. one quibble - Gardasil and Ceravix are not Cervical Cancer Vaccines

they are vaccines against the HPV virus.

HPV itself does not CAUSE cervical cancer.

Long term existance of HPV combined with other factors can increase the chances
of displasia, which can lead to cancer.

Many people have HPV yet do not suffer nor do they develop cancer.
Their own bodies fight the virus off.

But if you smoke and also there are other factors, you can weaken your system
and eventually it can lead to worse problems.

[xchrom]

3. you need to educate yourself further -- if you believe that. nt.

[TZ]

5. HPV *IS* linked to cervical cancer

And thats been accepted by the scientific community for at least 20 years. I learned about that in 1988!
If you think otherwise, you don't understand the biology.
And people DON'T fight the virus off..Viral infections NEVER go away..some people simply are asymptomatic..but that doesn't mean they can't transmit. Thats why HPV is so prevalent (I think its about 80% of the adult population with HPV).

[WillYourVoteBCounted]

7. Gardasil: "FDA Approval Not Based On Actual Cancer Prevention"

Gardasil "may" prevent infection with certain types of HPV viruses that are
"associated with" cervical cancer.


Cancer Not Measured

How effective is Gardasil in decreasing the incidence of cervical cancer? 100%? 50%? No one really knows because this question has not yet been answered. As of today, the Gardasil vaccine has never been proven to decrease the actual incidence of cervical cancer. In the studies that led to the vaccine’s approval, the incidence of cervical cancer was not measured. Instead CIN (cervical intraepithelial neoplasia) 2/3 and AIS (adenocarcinoma in situ) were used as the surrogate markers for prevention of cervical cancer because according to the vaccine’s insert “CIN 2/3 and AIS are the immediate and necessary precursors of squamous cell carcinoma and adenocarcinoma of the cervix, respectively.” While this is true it is also true that CIN 2/3 and AIS usually do not lead to cancer. For example, according to published data, CIN2 only leads to invasive carcinoma 5% of the time and CIN3 only leads to invasive carcinoma 12% of the time.(1)

HPV Alone Insufficient to Cause Cancer

In addition, Gardasil is targeted against Human Papilloma Virus (HPV) (types 6, 11, 16, and 18).

However, during discussions at the FDA it was admitted that HPV alone is insufficient to cause cancer.

Dr. Elizabeth Unger of the Centers for Disease Control stated, “So it is believed that infection alone is insufficient to cause cancer, and additional factors are required for neoplasia. There are certainly lots of questions about HPV infection…”(2) This point is echoed in the medical textbook Cancer: Principles & Practice of Oncology whose editors include Dr. Vincent DeVita, Jr. who was President of the National Cancer Institute and Dr. Steven Rosenberg, Chief of Surgery at the National Cancer Institute. According to this text, “HPV infection is not sufficient for cervical carcinogenesis…”(3)

More at Cancer Monthly here:
http://www.cancermonthly.com/blog/2007/12/gardasil-cervical-cancer-vaccine.html

[WillYourVoteBCounted]

8. "...HPV alone is insufficient to cause cancer."

However, during discussions at the FDA it was admitted that HPV alone is insufficient to cause cancer. Dr. Elizabeth Unger of the Centers for Disease Control stated, “So it is believed that infection alone is insufficient to cause cancer, and additional factors are required for neoplasia. There are certainly lots of questions about HPV infection…”
http://www.cancermonthly.com/blog/2007/12/gardasil-cervical-cancer-vaccine.html

[Hannah Bell]

28. no, a virus isn't cancer. & yes, people can clear various types of viruses

so they're undetectible by assay.

& no, it's not 80%. last study 3.4% for 16 & 18, the types the vaccine targets.

24% for all types.

[Liberal Veteran]

10. That's sorta like saying preventing HIV infection doesn't prevent AIDS

[trotsky]

12. And the same people who deny that...

tend to be anti-vaxers. Go figure, huh?

[WillYourVoteBCounted]

14. straw man much?

what a load of dog shit.

[Liberal Veteran]

15. Straw men and dog shit are still worth more than your "expert opinion"....

...on this vaccine, Doctor.

All this hand wringing and fake concern over 0.0002625% (21 divided 8 Million x 100) chance of having fatal reaction to a vaccine (and that's extremely generous to your viewpoint considering that you are using anecdotal reports to base your "expert opinion" on).

So don't presume to lecture me on the risk to benefit ratio of a vaccine until you learn how to do basic math.

[dropkickpa]

16. don't forget to consider

493,000 women worldwide diagnosed yearly with cervical cancer
274,000 women worldwide die yearly from cervical cancer

[Liberal Veteran]

17. And isn't that REALLY what's at issue here? If we can prevent 25% of these cancer cases...

It's more than worthwhile at even the worst case scenario risk put out by the alarmists.

[Hannah Bell]

31. in the us, that would be 1000 lives saved, at a cost of several million

dollars per life (in terms of number needed to treat).

Good returns for merck, though.

You could save more lives with jobs programs. What a waste.

[Hannah Bell]

43. There are < 4000 deaths/yr. Supposedly V16 & 18 cause 70%

of them. So make it 2800 lives that could potentially be saved, best-case, if there's a 70% vaccination coverage, & the majority of them women over 40.

The trade-off is some number of deaths & disabilities in children under 18.

Personally, I wouldn't make that trade, & I certainly wouldn't mandate it for others.

[dropkickpa]

48. Totally ignoring the 11,000 women who don't die

Why am I not surprised that they don't matter to you?

And the 70% is the worldwide number, in the US it's more like 77%.

Have any hard numbers on confirmed "deaths & disabilities"? Or is this just fear-mongering?

This isn't a debate about mandation (though mandation WOULD get this vaccine to those most at risk and least likely to get it otherwise, the poor). And, personally, for my 7 1/2 year old daughter, I am going to have her vaccinated as soon as she is old enough.

[varkam]

52. No hard numbers.

So what was the other option?

[Hannah Bell]

55. no hard numbers because (the biggest) clinical covered only 12,000 women,

none of them under 15.

&, as you keep telling us, the relevant agencies "haven't yet determined" whether reported deaths, disabilities & reactions are linked to the vaccine.

But there are some, because there are some for every vaccine. I don't see the point of questioning that, especially snarkily. The question is whether the risk outweighs the benefit - & - if public health dollars are at stake - whether this is their highest use.

For individuals, their decision to make. But if it's mandated, or if public money is thrown into the mix, people certainly have the right to question without being bullied or shut down.

[Hannah Bell]

56. For example: a fairly recent case:

"In 1998...the world's first rotavirus vaccine, Rotashield™, was licensed for use in the United States. Clinical trials in the United States, Finland, and Venezuela had found it to be 80 to 100% effective at preventing severe rotavirus diarrhea, and researchers had detected no statistically significant serious adverse effects.4

The manufacturer of Rotashield™, however, withdrew it from the market in 1999, after it was discovered that the vaccine may have contributed to an increased risk for intussusception, or bowel obstruction, in one of every 12,000 vaccinated infants.4

The experience provoked intense debate among public health officials, scientists, vaccine manufacturers, and others about the relative risks and benefits of a rotavirus vaccine. As the debate continued, so did deaths, disease, and hospitalizations caused by rotavirus."


One in 12,000 & bowel obstruction, in infants. Pretty high risk. I suspect it's higher than the childhood death rate for the virus in the US.

It went through clinicals & got approval. But something went wrong. It happens.

There's nothing wrong with scrutinizing the work of "health professionals." It needs to be done.

http://www.rotavirusvaccine.org/vaccine-facts.htm.


I find it very interesting that rather than help poor countries provide clean water to their people, we sell them vaccines to counter the effects of dirty water & dirty food.

Kind of like pumping factory-farmed cattle with anti-biotics. It's the health "care" of the bottom line.

[Hannah Bell]

58. "77%": not according to the manufacturers.

[Hannah Bell]

29. link please.

in the us: 4000 deaths/yr, most in women over 40, & 12,000 new diagnoses, 75% of which go on to be cured. deaths = .003% of adult females, 2.4% of total deaths, & the incidence of the disease, & the death rate, are both declining.


CC kills more % of women in underdeveloped countries, for the same reason every disease does. More poor people lacking simple resources: basic nutrition & sanitation.


We could prevent more deaths by guaranteeing nutrition in the third world & cutting down on our driving in the first.

[dropkickpa]

40. several

http://www.path.org/files/RH_prp-accp_cervical_cancer_worldw.pdf
http://www.nccc-online.org/
http://info.cancerresearchuk.org/cancerstats/types/cervix/incidence/

[Hannah Bell]

44. OK, read the Gates report. I note:

Highest incidence mentioned = 69/100,000 in Tanzania = .07% incidence.

However:

Infant mortality: 70.5/1000 live births (7% incidence)

Biggest killer disease: infectious diarrhea/Intestinal (water & food-borne): 31% of deaths

Others: Hep A (contaminated food & water), typhoid (contaminated food & water), malaria (treatable, preventable), & plague.

Life expectancy: 52

Undernourishment: 44%

Female probability of dying before 5: 140/1000 (14%)

TB test positives: 44%

Literacy: 69%

"One of the poorest countries in the world"

1/2 million refugees there from the Congo Wars (which has killed about 5 million people since the 90s, & which the US helped/is helping to foment)

Illegal drug transhipment point, money laundering point


But the MOST IMPORTANT THING the US can do with its aid dollars in Tanzania is pay Merck to vaccinate children for cervical cancer.

What a crock 'o crap.

[beam me up scottie]

18. And just like the religious right, they claim if you abstain until you're married you're safe.

As long as your precious daughter remains pure she'll never have to worry about getting HPV.

Except, of course, if she marries a man who wasn't so pure.

Assholes. :mad:

[Liberal Veteran]

19. Western arrogance. The "they can get pap smears" brigrade is very western centric.

They don't understand that for many women, perhaps even most women, routine medical is a luxury.

[beam me up scottie]

20. And instead of hailing this as the success it is and for the lives it will save,

they go all conspiroid and try to convince us that the scientists and doctors are lying and maiming and killing scores of young girls in the name of profit.

[WillYourVoteBCounted]

22. why are some healthy girls getting sick after being vaccinated with Gardasil?

We need to know the answer to that question before we make more healthy girls sick.

We need to find out how many girls are being made sick by Gardasil.

I am hearing about cases in my own home state.

We don't know why this vaccine is making some girls sick, and that deserves an answer.

[varkam]

23. You're not asking that question, because you already know (or think you know) the answer.

Nevermind that for the scientists (you know, people who studied at some other institute of higher education than Google U) it remains an open question.

Bear in mind that all the data for now is raw from the VAERS database, which is extremely susceptible to variation from the possibility of litigation and publicity. I mean, that's been explained to you several times, but you're either completely ignoring it or it's going right over your head. I am honestly not sure which is the case.

[Hannah Bell]

32. no, it's not.

[varkam]

37. Oh, it isn't? Please enlighten us.

I'll be waiting.

[beam me up scottie]

24. When did you stop beating your wife?

I've seen you, imo, purposely misquote medical articles and attribute statements from anti-vaxers to them.

Afaic, you have no credibility, you're part of the disinformation campaign and I'm sick of the scare tactics, so don't expect me to indulge you by recognizing or answering your questions.

[Liberal Veteran]

25. Do you hear about the cases in your home state at your anti-vax/ufologist parties?

Seems like an odd (to say the least) topic of conversation in social settings.

[LeftishBrit]

26. Possibly for the same reasons as why some healthy girls are getting sick after NOT being vaccinated

with Gardasil.

Has any controlled study been done that shows that people are *more likely* to get sick if they're given Gardasil than if they're not? This is what seems to be lacking here.

[Hannah Bell]

30. The vaccine brigade is just as arrogant. Pap smear requires a swab &

microscope. You're saying there's not money for that, but plenty of $$$ to vaccinate every woman in the country?

It's crap. In one, the money mostly goes to local health pros & facillities, & would encourage development of same. In the other, the $ mostly goes to pharma corp, one-shot, encourages no local development.

[WillYourVoteBCounted]

34. "Vaccine Brigade"

you made my day. Thank you. Hilarious!

I have learned to enjoy the outragous irrational exhuberance that some in this
forum have for any and all vaccines.

It used to bother me, but I have found that instead it increases my desire to post
more news articles that debunk some vaccines.

To the Pro All Vaccine Zealots, no side effect is as bad as not getting your vaccination.
Not even death.

And there is not one whit of concern for those previously healthy young girls injured
for profit by Merck.

Some TRUST Merck. I say trust no one and make sure to verify.

[varkam]

41. Lame.

But thanks for playing!

[Liberal Veteran]

35. Yeah, because people in third world countries have access to routine gynecological exams.

:eyes:

Plus there's entire cultural difference to overcome. Poor people go to the doctor when they are sick....not for checkups.

[Hannah Bell]

36. right, the "third world" only goes to clinic when they're sick. that's why they'd be going

in for mass vaccinations with 3-year boosters.


the third world has clinics, pap smears & microscopes are cheaper than vaccines, & there are more pressing health needs than CC, i.e. basic nutrition & stop fomenting wars.

But it's a good way to siphon health "aid" dollars to pharmacorp.

[dropkickpa]

39. You have NO idea what you are talking about

with regard to cervical cancer in 3rd world AND developing countries. Worldwide, it kills 52% of women diagnosed YEARLY. It is the 5th leading cause of cancer death in women worldwide, and in the majority of developing countries it is still the #1 cause of cancer death in women. But fuck those poor whores. A vaccine that may be their only contact with a medical professional *ever* that would protect them isn't important.

11% of US women do not have any sort of regular screening. What the hell do you think women in countries where they may only see 1-2 medical professionals in their entire lifetime, if that, are going to do?

There's a whole lot of ignorance of the situation of the state of women's health care in the world (not just our doctor rich corner of it) in your post.

[Hannah Bell]

42. The biggest killer in the "third world" is poverty & violence, much of which

can be laid at the door of the "first world".

Overseas vaccination campaigns are financed by taxpayers, & the pharmacorps & their associated hangers-on get the biggest cut. Not out of "concern for women." It's graft.

Mortality rates for cervical cancer in various countries: (Cancer Incidence, Mortality, and Prevalence Worldwide, GLOBOCAN, 2000 American Cancer Society)

US: 3.3 women per 100,000 (.003% of women)


Some "developing" countries & CC mortality:


Azerbaijan: 1.9 women/100,000 (.0019%)

Chile: 10.6 women/100,000 (.016%)

China: 3.1 women/100,000 (.003%)

Colombia: 13.7 women/100,000 (.013%) (MURDER RATE: 63/100,000)

Kyrgyzstan: 11.3 women/100,000 (.011%) (INFANT MORTALITY: 37/1000 live births)

Mexico: 17.1 women/100,000 (.017%) (MURDER: 13/100,000)

Trinidad and Tobago: 15.0/100,000 (.015%)

Venezuela: 15.2 women/100,000 (.015%) (MURDER: 32/100,000)


Countries in Africa supposedly have the highest death rates from CC, & though I haven't found many good stats, the highest I've seen is 35/100,000 women. That's .035% each year.


Here's the rate of death from intestinal disease:

http://www.nationmaster.com/graph/hea_int_dis_dea_rat-health-intestinal-diseases-death-rate


Here are the chances of female children dying before age 5:

http://www.nationmaster.com/graph/hea_pro_of_dyi_bef_5_fem-probability-dying-before-5-females


Prevalence of undernourishment:

http://www.nationmaster.com/graph/hea_pre_of_und_of_pop-health-prevalence-of-undernourishment-population


But what's REALLY, REALLY IMPORTANT & a great use of aid is to vaccinate children in the developing world against hpv. Right.

[Hannah Bell]

46. PS: I also note that 1/4 of the CC cases in the developing world

are in India, a country with a developed health infrastructure & a lot of educated people who need jobs, so i doubt pap smears would be a big problem, or follow-up treatment, were it subsidized.

If there's money to pay Merck for vaccine, there's money for alternatives.

[dropkickpa]

38. dingdingding

Did I get your attention? Good. PAP is NOT a preventative! PAP is a diagnostic tool that is by no means perfect! And you know what, me getting 7 PAP smears in the 24 months preceeding my cancer diagnosis didn't prevent the cancer. I went from a normal PAP (I took part in a research study which is why so many PAPs), 6 months later my regular yearly PAP came back ASCUS, 3 months later a PAP AND biopsy that was CIN2 and a month after that a LEEP (taking a huge chunk out of my cervix due to the advancement of it in just a month, I saw the coploscopy pics, that shit spread like a motherfucker) that showed it had progressed to invasive cancer! Less than a year to go from normal to invasive cancer, and I *far* exceeded all PAP compliance recommendations. Even had the study researchers send my slides over to my doc's pathologist to see if anything had inadvertantly been missed. Nope!

I am sick and tired of people holding up PAP smears as a reason to NOT vaccinate. It's pure bullshit and shows a serious lack of knowledge of what a PAP really is (diagnostic tool ONLY). You don't cure a broken leg simply by taking an x-ray, why the fuck do people seem to think a PAP is any different? And PAP does not even diagnose cancer, further, more involved tests are needed to do that.

[Hannah Bell]

45. Of course I know that; have you been following the conversation?

The original assertion was that medical care was a luxury, so paps were out of the question. But cost-wise they're cheaper than vaccine in a cheap labor country.

Here's how it works: we give aid dollars to poor countries, on the condition that they spend them on Merck's vaccine.

Or: we give aid dollars on the condition they're used to set up clinics & mobile units & train their own people, creating a source of income in-country.

Better yet: we give aid on the condition it be used to provide access to clean water & sanitary facilities, since water & food-borne disease is responsible for most deaths in most poor countries.


E.g Tanzania

Cervical cancer deaths among the highest in the world: 69/100,000 women (.06% incidence)

Intestinal infections: 31% of total deaths.

Undernourishment: 40%

Chance of a girl dying before age 5: 14%

[dropkickpa]

47. You still don't get it, do you?

A pap is cheaper, yes, but not a preventative and for most of the women in these countries, maybe a once in a lifetime event. It's not gonna help them. But being vaccinated, a quick and easy process that a medical assistant can do without a pathology lab or specialized equipment to back them up, gives women a better chance long term against at least one of thing stacked against them in their lives. Why would anyone deny some small improvement in their chances? When a woman dies, she leaves her family, children without mothers, husbands without wives, income either from work or from their labors in farming. And MANY of these areas have cultural objections to anyone messing in a womans vagina but her husband, so set up clinics, but compliance is not going to be what you seem to think it will be. These areas have SEEN the benefits of vaccination programs, and it is something that doesn't violate modesty and cultural taboos. Since there are still problems in the US with getting women to get regular screening (11% are non compliant), do you honestly believe that women and girls in these areas are going to flock to get a PAP? Seriously?

[Hannah Bell]

49. no, you still don't get it.

there's no "specialized equipment".

"these areas" won't get vaccines or boosters, either, unless someone spends the money & mobilizes the personnel to do vaccine & booster campaigns. compliance with those won't be good, either, unless its mobilized & subsidized. But is that a good use of aid money?

in "these areas," 14% of girls don't reach their 5th birthday, 1/3 of deaths are caused by diarrheal diseases, 40% of the population is undernourished, & the incidence of death from cc is < 1%.

If no one got a pap, but everyone got clean water, they'd be worlds ahead.

I note that 1/4 of CC cases in the stats you provide are in India. India has a developed public health system & plenty of educated personnel. as for your "modesty & cultural taboos," you're rather throwing everyone into the same basket, aren't you?

[Liberal Veteran]

50. Who ever posited that this was a binary equation?

Work on clean water to your heart's content and I will applaud that. But there is no assumption that this vaccine is being promoted as a panacea to all of society's ills except perhaps in the minds of the anti-vax crowd.

One might ask what good a pap would do if one doesn't have access to the diagnostic tools and medicines needed to treat a malignancy.

We are back to the "an ounce of prevention is worth a pound of cure" and that's what the real focus of this debate should be.

[Hannah Bell]

51. No, the debate should be: what's the best use of US aid dollars?

Graft for pharma or real development.

BTW, with 44% undernutrition, that means impaired immune response with reduced efficacy, + higher incidence of side effects.

The Gates paper says most CC shows up in 50-60 year old women.

Life expectancy in Tanzania = 52.


"Work on clean water" - right. The agenda is set by the interests of political & economic elites.

But sickening to hear the cheerleading from the rank & file.

[Hannah Bell]

57. It's funny, but I've seen no one make that claim, or any claim resembling it,

on any of these threads.

[WillYourVoteBCounted]

13. this may be the first "therapeutic" vaccine made to - treat - cervical cancer

From what I read at the website here:
http://www.vgxp.com/PR_070108.html

This vaccine actually treats cervical cancer.

It is not a prophylactic.

Sounds promising.

[DU GrovelBot]

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