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Article By: Heidi Stevenson
One girl’s ovaries were destroyed, with Gardasil the only potential cause. Worse, though, is that Merck either didn’t bother to examine potential effects on ovaries or hid them—but did examine effects on testes.
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The BMJ has published the case report of a healthy 16-year-old Australian girl whose womanhood appears to have been stolen by Gardasil vaccinations. She has been thrust into full-fledged menopause, her ovaries irrevocably shut down, before becoming a woman. The authors, Deirdre Therese Little and Harvey Rodrick Grenville Ward1, draw direct attention to the fact that, though the girl has been thoroughly examined and tested, there is no known explanation other than the series of three Gardasil vaccinations she had.
Making matters worse is that there may be many other such cases, but most are likely masked by the routine treatment of irregular or scanty menstruation with oral contraceptives. Indeed, it’s only because this girl refused them that the truth of her situation was unmasked. Just how many other girls have lost their chance at motherhood, but don’t know because their condition is masked?
The authors noted that, although the Therapeutic Goods Administration (TGA) of Australia provides data on the histology of rat testes and epididymides in the Australian Public Assessment Report for Human Papillomavirus Quadrivalent Vaccine*, no information is provided for rat ovaries. They sent a Freedom of Information request for “documented rat ovarian histology post-quadrivalent* HPV vaccination that may have been performed by the sponsor and forwarded to the TGA”.
*Note: There is only one “quadrivalent HPV Vaccine”. It’s Gardasil.
Here is their report of this highly significant missing data:
It is not known whether this event of premature ovarian failure is linked to the quadrivalent HPV vaccine. More detailed information concerning rat ovarian hist-ology and ongoing fecundity post-HPV vaccination was sought from the Therapeutic Goods Administration (TGA). Although the TGA’s Australian Public Assessment Report for Human Papillomavirus Quadrivalent Vaccine, February 2011, does report on the histology of vaccinated rat testes and epididymides, no histological report has been available for vaccinated rat ovaries.
The TGA subsequently agreed to a freedom of information application in the public interest (FOI 001-1112) requesting documented rat ovarian histology post-quadrivalent HPV vaccination that may have been performed by the sponsor and forwarded to the TGA. However, a histological report of the ovaries of vaccinated rats remained unavailable beyond a numbering of the corpora lutea present at postweaning euthanasia following the first litter.
Why did the manufacturer provide information regarding male rat testes, but not for female rat ovaries? This is more than a little shocking. It’s absolutely damning! We must question the sincerity of both the manufacturer, Merck, and the TGA—not to mention questioning other regulatory agencies, such as the US’s FDA and the UK’s MHRA.
Potential Gardasil Risk to Ovaries
Is it conceivable that Merck didn’t consider the possibility of harm to the ovaries? In point of fact, it’s unreasonable to suggest that they were unaware of potential harm to ovaries. At least one Gardasil ingredient, polysorbate 80 (also called by brand names Tween 80, Alkest, and Canarcel), is a known cause of ovarian deformities, degenerative follicles, hormonal changes, and womb and vaginal changes in rats2,3. Worse, that ovarian damage is known to be caused by injection of polysorbate 80—just as it’s injected with Gardasil.
Another Gardasil ingredient, L-histidine, a naturally-occurring amino acid, carries signficant risks, too, in the same manner that squalene does. It’s a naturally-occurring substance in the human body, so injecting it could have the effect of causing an autoimmune response to that substance wherever it’s found in the body. There is more on this issue in Gardasil Destroys Girl’s Ovaries: It Should Have Been Predicted.
A large part of one girls’ life has been destroyed, and the only plausible explanation is that the cause is the Gardasil vaccination. This vaccine is sold as a cervical cancer preventative, though it has never been shown to prevent any cancer of any kind. Cancer prevention has never been more than a presumption, based on a possible connection between human papilloma virus and cervical cancer. No cause-and-effect has ever been documented.
The reports of deaths and debility from Gardasil keep pouring in. As this girl’s plight demonstrates, Gardasil cannot be assumed to be safe. There is highly significant—not to mention suspicious—missing data.
We don’t know, of course, whether Merck calculatedly avoided doing the studies on ovaries or is refusing to release data on such studies because of its damning nature. We do, though, know that the very fact that it’s missing—especially in light of equivalent data on the male reproductive tract being available—must be treated as suspicious.
Certainly, the combination of one girl’s loss of her ovaries, the probability of there being many others, and the utterly callous disregard for its potentially devastating effects, is more than enough reason to remove Gardasil from the market. Surely, it should be removed from governmental lists of mandated vaccines.
Sources:
- Premature ovarian failure 3 years after menarche in a 16-year-old girl following human papillomavirus vaccination, BMJ Reports 2012, Deirdre Therese Little, Harvey Rodrick Grenville Ward, doi:10.1136/bcr-2012-006879
- Polysorbate 80 Causes Infertility, An Emulsifier That Can Damage Your Reproductive Health
- Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats. Gajdová M, Jakubovsky J, Války J., Food and Chemical Toxicology, 1993 Mar;31(3):183-90.
Visit Gaia Health.com for more great/pertinent articles.
See original here: http://gaia-health.com/gaia-blog/2012-10-17/gardasil-destroys-girls-ovaries-research-on-ovaries-never-considered/
I have suffered from Human papillomavirus HPV) for 2years, I was given some tablets at the hospital but I refused to take it, They said I have to be on it for life so I don’t want take a drugs everyday for life. No point in taking medicine everyday when u won’t get cure from it and I was advice to seek for natural herbal cure, after some time I found dr Osas on the internet and he is the most trustful herbalist that have herbs to cure stubborn symptom’s. I emailed dr Osas, for 2weeks been his patient he cured my (HPV) with his herbal. I only used his natural herbs for two weeks it was 100% cure. I’m not (HPV) patient anymore. I’m happy about it i finally got cured out of this mess that has been in my body for 2years. I will also recommend you if you’re living with (HPV) or herpes symptoms i also want you to be free contact dr Osas with the email attach to my post. [email protected] or contact his number via +2348112252378 or you can as well add him on whatsapp with same number
Doctor osas also have cure for the following sickness, virus and diseases:-
H.P.V/TYPE 1 TYPE 2 TYPE 3 AND TYPE 4. TYPE 5, human papiloma virus, genital warts, herpes, syphilis, cancer, hepatitis a b and c. high blood pressures, body disease, diabetics, epilepsy, HIV aids, pregnancy, ALS
INEFFICACY OF THE HPV VACCINE SEEN BY DOCTOR OF DEEP PERÚ
From its inception until the appearance of uterine cervical carcinoma (UCC) takes a average of 20-30 years; the research of this vaccine have begun in 2000. It is evident that the scientific efficacy of this new vaccine will be determined the years 2025 – 2030.
HPV not causes definitely the (CCU); at the onset of this disease involves multiple risk factors, including the suspected HPV, but scientifically is proven by epidemiology and statistics that the sex is what generates this disease. Nix in 100.000 nuns found not any UCC.
http://www.portalesmedicos.com/publicaciones/articles/1832/1/Epidemiolog…
To accept that a virus or a bacteria causes a infection disease must unfailingly fulfill the five Koch’s postulate
http://www.xatakaciencia.com/salud/los-postulados-de-koch
1 – The agent must be present in every case of the disease and absent from healthy.
2 – The agent must not appear in other diseases.
3 – The agent to be isolated in pure culture from disease lesions.
4 – The agent of causing disease in a susceptible animal being inoculated.
5 – The agent must again be isolated lesions in experimental animals.
http://es.scribd.com/doc/44558220/MICROBIOLOGIA-1
Consequently, HPV not fulfill not any principle of Koch’s postulate. by not meeting this postulate, that is accepted as dogma in medicine, scientifically we must be ensure that the HPV is not the causative agent to the UCC..
Until May 2013 Vaccine Adverse Event Reporting Syntem (VAERS) published that the vaccines against the HPV caused only in Unites States 138 muertes and 30020 adverse events; 947 disabled: 12 males, 924 females and 11sex unknown; 4050 advers graves: 106 males, 3883 females and 57 unknown sex; 527 abnormal PAP smears, 214 dysplasia cervical and cervical cancer 214. Vaccine Adverse Event Reporting System secure that only the !% to 10% are denounced https://dub104.mail.live.com/default.aspx#n=1521802 http://holyhormones.com/vaccinations/hpv-vaccine/hpv-vaccine-adverse-eve…
http://therefusers.com/?s=cervarix
The Vaccine efects advers reactions (VAERS) ensures that only complaint between 1% to 10% of the adverse effects produced by this evil vaccine;this figures shown are calculated according to the statements of the VAERS: to 10%.
http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccio…
http://www.pop.org/content/merck-researcher-admits-gardasil-guards-again…
Dr. Harper, who contributed to the development of the vaccine by Merck, reports that the vaccine was not investigated in children under 15 years and the vaccine given to children under 11 years is a big public experiment.
http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gard…
The vaccine was approved to give girls uncontaminated with HPV, Dr. Howenstinc ensures that the women are vaccinated with HPV contaminated, have the possibility to acquire a 44.6% CCU
http://www.newswithviews.com / Howenstine/james170.htm.
Merck did not disclose that the vaccine was transgenic, the Sane Vax has discovered, which is transgenic because it has been found that the vaccine is contaminated with DNA recombinant vaccine Gardasil (DNArPVH) and has raised its concerns to the president of the FDA Margaret Hamburg. The FDA replied that the vaccine will not cause any damage transgenic
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-re…
http://bolsonweb.com.ar/diariobolson/detalle.php?id_noticia=26075
A vaccinated child was ill with rheumatoid arthritis, which is an autoimmune disease. 24 hours after vaccination and found that the aluminum adhered to DNArPVH, two years after vaccination and in autopsy 6 months after death in a New Zeland girl Jazmine Renata which had recibed this deadly vaccines
http://www.mecfsforums.com/index.php?topic=9331.0
Management time to get market approval of a drug the FDA is at least three years, it is a drug for cancer 15 years, but the authorization Merck had only six months and the European Medicines Agency (EMA in English) only 9 months: To introduce the vaccine are using the marketing of fear
http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-… http://mujeresenaccion.over-blog.es/article-vph-la-vacuna -of-marketing-of-fear-67210961.ht
HPV is ubiquitous; lives in wild and domestic animals, pollute us from birth, is on the doorknobs, on towels, on nails, on fomites, in gloves and specula of gynecologists,. sexual intercourse is not the only means of contamination.
http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/invest…
HPV also lives in the 400 nm outermost of our skin and mucous membranes. ,
If you live in our skin, our immune system produces cellular and humoral immunity is acquired or that our body is self vaccinatinge by PVHs living on our skin and mucous ..
http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
The PVHs is not distributed uniformly worldwide. It has been found that in Canada HPV 18 only reaches 3%; is more often HPV 31, in my country Peru no studies have determined that HPV types predominate; Gardasil contains 225 mcg. aluminum and Cervarix 500 mcg, that produce the Alzheimer, Parkinson and autism, produce too neurotoxic and immune system disorders (Blaylock 2012) and Polisorbato 80, a powerful contraceptive, that in experimental animals produces sterility, atrophy of the testicles and disturbance organic and funtional of the organs of the reproduction; is carcinogenic and mutagenic; also contains sodium borate considered poison unused in medicinal preparations (NLM)
http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
Have been discovered to date 200 types of HPV; HPV is not infectious, contagious; the intercourse is not only that the persons is contaminated
http://quimicaclinicauv.blogspot.com/2006/08/virus-del-papiloma-humano.html http://www-lab.biomedicas.unam.mx/smpv/queeshpv.htm
On 22-11-2010 FDA approved Gardasil for males aged 9 to 26 to prevent warts and cancer to the anus, is overkill
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-re…
http://salud.aollatino.com/2011/02/02/aprueba-fda-nueva-indicacion-vacun…
For the reasons from deep Peru Huancayo, I believe that this vaccine is a fraud?, a robbery?, a swindle?, a rough joke?, a crime?, a shame?, a scam?
The HPV is not scientifically proved for the moment that produce the UCC its effectiveness shall be verified just the years of 2025-2030.
Dr. Godofredo Arauzo
E mail: [email protected]
Don’t assume doctors are all biased/incompetent.
Doctors should file the report whether or not they think the event is related, since VAERS is for finding new relationships. Good doctors know this, and will do a good job filing the report. Heck, at least in some states, a report is required by law!
Have you asked your doctor whether she has already filed a report?
That is the correct website but YOU need to file the report. Doctors will not as they don’t believe gardasil is responsible. My daughters have been diagnosed with premature ovarian failure from gardasil. Please contact my attorney, Krueger & Hernandez 608-356-3961. He has several cases like ours.
http://vaers.hhs.gov is the place to file an adverse reaction report if you’re in the United States.
It’s probably best if you have your doctor do it, but if that doesn’t work, you can do it yourself.
(This is only to help researchers. If you want to claim injury damages, that’s a different matter.)
Where do you report if you had an issue with the injections? My daughter is now unable to get pregnant due to this shot. nobody ever mentioned this could be a possibility when they were pushing this.
I am glad, Anna. May you and your daughter thrive and prosper!
I took my daughter to get a tetanus shot today. I let her go back with the nurse by herself, because she is in her late teens. It wasn’t long, and the nurse told me she needed to talk with me. She was trying to get my daughter to get more than just a Tetanus shot. One was the Gardasil vaccine. Thankfully I had just read about the horrible risks of this shot. I told the nurse there was no way! my daughter was going to get this shot. Before we went to the Doctors office, I told my daughter what happened to her Grandpa, my Dad. My younger sister took him to his Doctor for an exam. The Doctor told my Dad that he needed to get a Flu shot. My Dad kept telling him that he didn’t want it. My sister left the exam room for a moment. When she came back she saw that he had a bandage on his arm. She said, what happened. The Doctor said your Dad agreed to get the Flu shot. Never let your child go get a shot by themselves or leave an elderly person you bring in, alone with the Doctor
INEFFICACY OF THE HPV VACCINE SEEN BY DOCTOR OF DEEP PERÚ
From its inception until the appearance of uterine cervical carcinoma (UCC) takes a average of 20-30; the research of this vaccine have begun in 2000. It is evident that the scientific efficacy of this new vaccine will be determined the years 2025 – 2030.
HPV not causes definitely the (CCU); at the onset of this disease involves multiple risk factors, including the suspected HPV, but scientifically is proven by epidemiology and statistics that the sex is what generates this disease. Nix in 100.000 nuns found not any UCC.
http://www.portalesmedicos.com/publicaciones/articles/1832/1/Epidemiolog…
To accept that a virus or a bacteria causes a infection disease must unfailingly fulfill the five Koch’s postulate
http://www.xatakaciencia.com/salud/los-postulados-de-koch
1 – The agent must be present in every case of the disease and absent from healthy.
2 – The agent must not appear in other diseases.
3 – The agent to be isolated in pure culture from disease lesions.
4 – The agent of causing disease in a susceptible animal being inoculated.
5 – The agent must again be isolated lesions in experimental animals.
http://es.scribd.com/doc/44558220/MICROBIOLOGIA-1
Consequently, HPV not fulfill not any principle of Koch’s postulate. by not meeting this postulate, that is accepted as dogma in medicine, scientifically we must be ensure that the HPV is not the causative agent to the UCC..
Until May 2013 Vaccine Adverse Event Reporting Syntem (VAERS) published that the vaccines against the HPV caused only in Unites States 138 muertes and 30020 adverse events; 947 disabled: 12 males, 924 females and 11sex unknown; 4050 advers graves: 106 males, 3883 females and 57 unknown sex; 527 abnormal PAP smears, 214 dysplasia cervical and cervical cancer 214. Vaccine Adverse Event Reporting System secure that only the !% to 10% are denounced https://dub104.mail.live.com/default.aspx#n=1521802 http://holyhormones.com/vaccinations/hpv-vaccine/hpv-vaccine-adverse-eve…
http://therefusers.com/?s=cervarix
The Vaccine efects advers reactions (VAERS) ensures that only complaint between 1% to 10% of the adverse effects produced by this evil vaccine;this figures shown are calculated according to the statements of the VAERS: to 10%.
http://www.noticiero.enkoria.com/2011/diez-menores-que-sufrieron-reaccio…
http://www.pop.org/content/merck-researcher-admits-gardasil-guards-again…
Dr. Harper, who contributed to the development of the vaccine by Merck, reports that the vaccine was not investigated in children under 15 years and the vaccine given to children under 11 years is a big public experiment.
http://offtheradar.co.nz/vaccines/53-researcher-diane-harper-blasts-gard…
The vaccine was approved to give girls uncontaminated with HPV, Dr. Howenstinc ensures that the women are vaccinated with HPV contaminated, have the possibility to acquire a 44.6% CCU
http://www.newswithviews.com / Howenstine/james170.htm.
Merck did not disclose that the vaccine was transgenic, the Sane Vax has discovered, which is transgenic because it has been found that the vaccine is contaminated with DNA recombinant vaccine Gardasil (DNArPVH) and has raised its concerns to the president of the FDA Margaret Hamburg. The FDA replied that the vaccine will not cause any damage transgenic
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-re…
http://bolsonweb.com.ar/diariobolson/detalle.php?id_noticia=26075
A vaccinated child was ill with rheumatoid arthritis, which is an autoimmune disease. 24 hours after vaccination and found that the aluminum adhered to DNArPVH, two years after vaccination and in autopsy 6 months after death in a New Zeland girl Jazmine Renata which had recibed this deadly vaccines
http://www.mecfsforums.com/index.php?topic=9331.0
Management time to get market approval of a drug the FDA is at least three years, it is a drug for cancer 15 years, but the authorization Merck had only six months and the European Medicines Agency (EMA in English) only 9 months: To introduce the vaccine are using the marketing of fear
http://mujeresenaccion.over-blog.es/article-vph-la-vacuna-del-marketing-… http://mujeresenaccion.over-blog.es/article-vph-la-vacuna -of-marketing-of-fear-67210961.ht
HPV is ubiquitous; lives in wild and domestic animals, pollute us from birth, is on the doorknobs, on towels, on nails, on fomites, in gloves and specula of gynecologists,. sexual intercourse is not the only means of contamination.
http://spa.myhealthygood.com/cancer-cervical-vacuna-contra-el-vph/invest…
HPV also lives in the 400 nm outermost of our skin and mucous membranes. ,
If you live in our skin, our immune system produces cellular and humoral immunity is acquired or that our body is self vaccinatinge by PVHs living on our skin and mucous ..
http://www.conganat.org/seap/bibliografia/HPVToday/HPVToday007SEAP.pdf
The PVHs is not distributed uniformly worldwide. It has been found that in Canada HPV 18 only reaches 3%; is more often HPV 31, in my country Peru no studies have determined that HPV types predominate; Gardasil contains 225 mcg. aluminum and Cervarix 500 mcg, that produce the Alzheimer, Parkinson and autism, produce too neurotoxic and immune system disorders (Blaylock 2012) and Polisorbato 80, a powerful contraceptive, that in experimental animals produces sterility, atrophy of the testicles and disturbance organic and funtional of the organs of the reproduction; is carcinogenic and mutagenic; also contains sodium borate considered poison unused in medicinal preparations (NLM)
http://www.telefonica.net/web2/paramahamsa/vacunaninosalerta.html http://detenganlavacuna.wordpress.com/2010/11/09/gardasil-cervarix/
Have been discovered to date 200 types of HPV; HPV is not infectious, contagious; the intercourse is not only that the persons is contaminated
http://quimicaclinicauv.blogspot.com/2006/08/virus-del-papiloma-humano.html http://www-lab.biomedicas.unam.mx/smpv/queeshpv.htm
On 22-11-2010 FDA approved Gardasil for males aged 9 to 26 to prevent warts and cancer to the anus, is overkill
http://real-agenda.com/2011/09/16/vacuna-gardasil-contaminada-con-adn-re…
http://salud.aollatino.com/2011/02/02/aprueba-fda-nueva-indicacion-vacun…
For the reasons from deep Peru Huancayo, I believe that this vaccine is a fraud?, a robbery?, a swindle?, a rough joke?, a crime?, a shame?
The HPV is not scientifically proved for the moment that produce the UCC its effectiveness shall be verified just the years of 2025-2030.
Dr. Godofredo Arauzo
E mail: godo.ara@ gmail.com
Jan: The point of having a vaccine isn’t to save you from having to get a Pap smear. it’s to save lives, even if you can’t save everyone. Even if you assume that the increases in MS & Lupus were caused by the vaccine, compared to the decrease in cancer rates, it’s a pretty sweet deal.
Note that no vaccine has ever conferred 100% protection, yet we seem to have derived significant value from, for example, the smallpox vaccine.
The $450 is for a complete round of Gardasil vaccinations (though they sell with as much a 99% discount in the developing world), and it is big business. However, most of the vaccinations that you and I have had cost a tiny fraction of that cost.
In Australia, this vaccine has been linked to an increase in M.S., Lupus, and a glandular fever type illness in young teenage girls. As the vaccine does not protect you entirely from all HPV strains women are still urged to have a Pap smear every two years. What is the point of having this vaccine if it doesn’t give you 100% protection?
The Australian Federal Government pays the Pharmaceutical company $450 for every person vaccinated. Vaccines are big business here.
Christina: Certainly one could make a case that there is a profit motive for the HPV vaccine. That would not be true of most vaccines (the economics or horrid). Do you believe there is no profit motive for the anti-vaccine argument?
@Christina: Japan as more than a bit of dysfunction when it comes to vaccines, so I’d not consider their decision of evidence of anything. They don’t have data on outcomes to base their decisions on and consequently their vaccine schedule doesn’t include a bunch of uncontroversial vaccines like mumps. They also have an epidemic of rubella (I wonder if anyone thinks that is a coincidence ;-).
Lots of other countries that do have data on outcomes seem to be continuing to push ahead. Is there some reason to believe Japan’s decision is more informed than others?
Dan Kegel, on Sept. 19 you invite me to continue our discussion and debate of Gardasil safety studies with you. As I recall, in our previous discussion, you spliced information from two studies into one sentence without attributing the information to two different studies. In another, you cited an FDA webpage for proof that Gardasil had been approved for older women when in fact FDA denied approval for older women because Merck failed to show effectiveness. In my book, that disqualifies you from further debate in this forum.
In the law, intentional misrepresentation of fact to lull others into a false sense of security and safety about a product to induce them to buy it is called fraud. Vaccine manufacturers, PR reps for pharma and CDC need to keep that in mind.
You may be a very likeable, well-meaning person, and yes, you said you were sorry, but I don’t have time to go through shenanigans like that again. This isn’t some silly game; girls are dying and being maimed for life by this unnecessary and dangerous vaccine.
Japan has already stopped recommending the HPV vaccine because of too many serious adverse vaccine reactions. Gardasil’s benefit-to-risk profile is not worth the risk in my book. Dr. Christiane Northrup, Dr. Diane Harper, and others agree with me.
The problem is how do you define pseudoscience? Science is about inquiry. Labeling something you disagree with as false indicates a closed mind. Remember Galileo and Semmelweis. Doctors used to say it was okay to smoke, even if you were pregnant (Your baby would just be born smaller.) And then there’s that profit motive. When corporations stand to profit by “science,” and have the budget to push their ideas on others, and even to interfere in health care decisions that should be individuals’ alone to make–such as whether or not to allow harmful substances to be injected into their bodies for a promised benefit, after being fully informed of all potential risks–we have to look closely at who is calling what “pseudoscience.”
Hi Heidi!
Right, particular alleles or maybe combinations may increase the likelihood to varying degrees of premature ovarian failure, but in general there’s still a lot we don’t know. Genetic counselling would be needed to interpret the results of any genetic tests. The article I linked to lists five or so genes, and diagnostic tests appear to be available for four of them already (it’s like we’re living in the future!); see
http://ghr.nlm.nih.gov/gene/BMP15
http://ghr.nlm.nih.gov/gene/GDF9
http://ghr.nlm.nih.gov/gene/NR5A1
http://ghr.nlm.nih.gov/gene/FIGLA
I’ve never used any of these genetic tests myself, so I can’t vouch for their usefulness. But if I were trying to answer the question of why both my daughters had experienced premature ovarian failure, and I could afford the tests, I’d sure go for it.
Hi Christina!
I agree that it’d be good to follow up on the one study I’ve found of gardasil ingredients in female rats ( http://www.ncbi.nlm.nih.gov/pubmed/8473002 ); I think that study gave rats an injection of polysorbate 80 each day at days 4 through 7 after birth (roughly equivalent to months 12, 15, 18, and 21 in humans, relative to sexual maturity?), with a total dose equivalent to the polysorbate 80 in about 60 doses of Gardasil. I’d like to see that study repeated as done originally, plus with lower doses to see where the threshold is, and in rats about four times older, closer to the equivalent age in humans when vaccinated, as well as with Gardasil rather than just polysorbate 80. But I don’t expect it to turn up any trouble, since the effect seen was with fairly large doses of very young mice whose ovaries are not yet developed, whereas in humans, Gardasil is given to girls rather closer to sexual maturity.
But as we’ve discussed before, there’s no evidence that the vaccine can increase the risk of cervical cancer. (I’d be happy to finish that discussion sometime – I think we were about 80% of the way through.)
I think there are now five studies of over 100,000 vaccinated women each that have looked for but not found any significant health risk; I’m still looking for a copy of the most recent one (mentioned in a Danish newspaper, http://cphpost.dk/national/study-finds-no-hpv-vaccine-risks ).
Given the general safety record of the vaccine, in any case where sisters both experience premature ovarian failure, one should probably consider genetic factors before blaming the vaccine.
My eyes and ears are wide open to any solid evidence of harm from the vaccine. If you’ve got any that’s statistically significant, bring it on! (In the meantime, I’m off on my next quest: figuring out how to get the meat industry to stop overusing antibiotics. Wish me luck!)
More to the point, they need to test that HPV vaccine in animal reproductive studies on both sexes. They know results on rat testes but have never disclosed results on female ovaries. These poor girls have been used as human lab rats. Girls and boys who have had Gardasil should be monitored for their entire lifetimes, to see how their cancer and fertility rates compare with those not vaccinated. And their children should be studied as well, for all health problems, including allergies and auto-immune disorders like arthritis.
Little 3-year-old girls are getting rheumatoid arthritis these days. By 2030, an estimated 67 million Americans will have the auto-immune disease of arthritis. it used to be a disease of those over 65. Not anymore. Maybe all the aluminum in all the vaccinations has something to do with it. There’s aluminum in IV’s, too, that many babies are exposed to at birth. Then there’s aluminum from chemtrails. All that stuff builds up in our bodies. It doesn’t seem wise to inject it into young girls necessarily. With this vaccine, the harm relatively equals any possible benefit the vaccine might conceivably convey.
Furthermore, metals have synergistic effects within the human body. The EPA and National Academy of Sciences agree that 8-10% of women already have enough mercury in their bodies to give birth to children with neurological problems. In an experiment conducted by Dr. Boyd Haley, chair of the Chemistry Dept. at the University of Kentucky, mercury and aluminum together raise the death of neurons synergistically by 60%. Dr. Boyd Haley, Chair, Dept. of Chemistry, University of Kentucky. http://homeoint.ru/pdfs/haley.pdf Mercury toxicity: Genetic susceptibility and synergistic effects. Medical Veritas 2 (2005) 535-542.
We need to exercise caution and restraint in what we inject into our children. Children don’t get cervical cancer, and by the time they are old enough to get it, the HPV vaccine they get now will not be doing them any good. Of course, who knows? Maybe because of this vaccine, children will start getting cervical cancer, and then we can vaccinate them more and more to prevent it–because, of course, vaccination is the answer to everything. And we just don’t know why little 3 year old girls are getting rheumatoid arthritis. Hey, maybe it’s genetic (Although, whoever heard of a genetic epidemic?).
Whoa, let’s calm down here.
All he said was that it “increases the likelihood” (hey, if certain genes “increase the likelihood”, do you think that makes environmental effects a likely factor as well?), and that they might want to check it out. As you point out, we all have certain hereditary (and for that matter environmental) advantages and disadvantages. I’m sure you’d advocate being aware of one’s strengths and weaknesses, no?
Hereditary links doesn’t mean you can “blame” anyone for a disease, and frankly that you went there suggests that you aren’t in a position to critique anyone’s empathy.
The scenario where Gardasil “causes” premature ovarian failure is if the immune system response somehow leads to the production of antibodies against one’s own ovarian tissue. _No one_ knows what triggers the immune response. Obviously Gardasil or anything else that triggers an immune response are likely candidates as factors, but it is just as clear that there are multiple factors (hence why not everyone vaccinated with Gardasil doesn’t suffer from it).
Given your concerns about Gardasil, I should think you’d be an advocate for testing for this gene defect. Wouldn’t it be great if we could screen out people at risk to having premature ovarian failure as a side effect, so that they aren’t given the vaccine? That’s the kind of win-win scenario that seems hard to quibble with: still get the benefits of herd immunity, but reducing all the horrors you are understandably concerned about.
Has your zeal for promoting Gardasil left you utterly bereft of empathy?
The article you suggest does NOT claim that it’s a simple gene defect, as you suggest, but combinations that may be involved and are not the immediate cause. It’s like blaming genes for a bacterial infection. The fact is that genes are a factor in every health problem, including bacterial infections, because genetics form the basis of our strengths and weaknesses. But genes are not the trigger, as is obvious in bacterial infections and in Gardasil damage.
Further, the article states, “Moreover, epigenetics may help to elucidate genetic factors underlying common diseases, focusing not on DNA variations but on the regulation of gene expression by DNA methylation”. That is, they’re making clear that environmental effects on genes may be a factor. The article you referenced does not, in any sense, offer any sort of way to test for a genetic cause for the two young women whose lives have been devastated. You’d know that if you’d actually read the thing. In point of fact, its conclusion discusses whether there might someday be a means of testing for susceptibility to ovarian failure.
The hunt for genes to blame is nothing but redirection from the cause. You went in search of something that appeared to support a genetic cause so that you could redirect attention away from Gardasil.
Your attempt to cover for what this woman has clearly stated was caused by Gardasil makes obvious that your purpose here is that of a troll. You owe her an apology.
Hi Joen,
first off, I’m sorry that your daughters have this problem.
It might not be a coincidence, though, that both of your daughters had it; perhaps they share a gene that increases the likelihood of premature ovarian failure. http://www.ncbi.nlm.nih.gov/pubmed/20668067 lists a few such genes, and says they may account for 20 to 25% of cases.
Has your doctor checked for those genes yet?
Hello Joen,
I am so very sorry to hear this. It simply stretches credulity too far to believe that it’s merely a coincidence. How many girls are going to lose their chance not only to become mothers, but also to fully mature? This is criminal. There is no other way to describe it.
I would very much like to be in touch with you. This article is a reprint from my original on Gaia Health. (http://gaia-health.com) You can contact me by going to the site. You’ll find a link to a form to send a message under the Home menu in Privacy Policy/Contact. Please do contact me.
My two daughters have been diagnosed with premature ovarian failure due to the Gardasil HPV vaccine! This vaccine has devastated our family! Please feel free to contact me.
Fun fact:
the British Homeopathic Association says in
http://www.britishhomeopathic.org/media_centre/news/vaccinations-statement-april-2013.html
“In line with the Department of Health’s advice, the BHA recommends that immunisation should be carried out in the normal way using the conventional tested and approved vaccines.”
This may have been prompted by the exchange described at
http://www.theguardian.com/society/2013/apr/15/homeopathy-measles-mp
in which a spokesman for the BHA was quoted as saying
“There is no evidence to suggest homeopathic vaccinations can protect against contagious diseases. We recommend people seek out the conventional treatments.”
Whether that includes the HPV vaccine, I don’t know, but their statement did seem rather all-inclusive. I’m rather impressed they said it.
Thank you for saying so, Dan. It seems to me that there comes a time when all good things must come to an end. Perhaps we shall meet again.
Hey Chris,
Christina’s tempted to write me off not just because of my two screwups, but also because she perceives me as being too willing to believe mainstream medicine’s lies. In spite of this, she’s actually been very polite and helpful about looking more closely at the origins of the claim that the vaccine harms women who are already hpv-positive, so give her some credit.
Christina,
thanks again for pointing out my mistakes in this discussion. Since they were both bad quotes or paraphrases, I’m mulling how best to continue discussing the evidence in a way that minimizes the chance of that kind of error. I’ll post here again when I have a good idea.
FDA’s approval document for Gardasil: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
Page two states that it was given Fast Track status in 2002.
Wikipedia is a perfectly legitimate _secondary_ source. It’s far from unimpeachable and I’d absolutely consider a primary source to be more authoritative; it’s just far more convenient to track down a find a link to Wikipedia. If you have a specific fact you feel Wikipedia got wrong, I’d seriously consider you’d got it right (and encourage you to contribute a correction), but I didn’t think any of the facts I linked to as being seriously in dispute so it didn’t seem worth the trouble tracking down primary sources.
I do not deny that safety studies of Gardasil have been ongoing since its approval. I’m not sure why you’d suggest otherwise, as I _specifically cited that point_.
My point was not really about Gardasil, but rather trying to help reset the tone of the discussion. As I demonstrated, it isn’t hard to find fault in people’s statements based on your own personal judgements which may not be fully informed or may be based on a misunderstanding _of them_ or _by them_. There’s not good cause to impeach the source on that basis.
I’m disappointed that this was your response.
If I read that right Dan, “Fast Track” doesn’t necessarily (though it could) mean what people tend to think it means: that Clinical Trials were not thorough. Given at least how long the trial period was and how many of those trials took place, I don’t see reason to believe the vaccine safety evaluation process was lighter than normal.
Even if it was, the “Accelerated Approval” process gets the drug/vaccine out to the larger population quicker, and given post-approval studies actually gets us to point where we can be confident about the effects of Gardasil faster than if it hadn’t had Accelerated Approval.
While “Fast Tracking” of a drug/vaccine might be a very valid concern to raise when a newly approved medicine is launched on the market, it really isn’t relevant concern for judging the safety of it *years* after it has been approved for market.
Please don’t cite Wikipedia as a source. It’s not reliable. Surely you do not deny that safety studies for Gardasil have been ongoing since its approval. If you want to believe Gardasil is safe, I am sure I will not convince you otherwise.
Hi Chris,
the fast track program in question is described here:
http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/speedingaccesstoimportantnewtherapies/ucm128291.htm
You can see evidence that Gardasil received fast track treatment on page 2 of
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
which says
“2002 CBER granted fast track designation to Merck’s development program for the HPV quadrivalent vaccine for prevention of cervical cancer….
2005 May: Pre-BLA meeting. CBER agreed that the efficacy data limited to the first 24 weeks of the phase 3 studies could be submitted to the BLA in order to support efficacy. CBER encouraged early (rolling) submission of CMC, pre-clinical and phase 1 and 2 clinical data. CBER agreed to grant a priority review of the BLA.”
(That document is linked to from
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm094042.htm ; there are a few other interesting documents there.)
But I won’t write you off just because you asked a question you didn’t know the answer to. After all, you’re not a lawyer 🙂
What is your basis for saying they were “fast-tracked”? The development dates back to 1993, which would make it 20 years old. The patent on it was filed in 1995, which means depending on the rules it would expire in either early or late 2015. With patent extension tricks, they can maybe stretch it through 2020. Initial FDA approval was in 2006. If that is “fast-tracked”, this would seem to suggest the “normal track” would make it impossible for a vaccine to be available to the general population while the company that developed it still could extract high margins from the market place due to a patent monopoly. That’d make conspiratorial notions of vaccines as a lucrative commercial venture for drug companies seem terribly ill founded.
According to Wikipedia http://en.wikipedia.org/wiki/Gardasil#Clinical_trials, Phase III trials started in June 2002. In 2006 (three years after the first Phase III trial finished) there was a clinical trial that was terminated early on ethical grounds so that the placebo group could receive the vaccine. That’s the closest thing to “fast tracked”, I can find evidence of, and that doesn’t actually accelerate its availability to the public. A three year period from Phase III trial FDA approval is on the long side of normal. From start to finish you usually have general availability of a successful drug in 7 years, not 11 (http://en.wikipedia.org/wiki/File:Drug_Evaluation_Process.jpg), or 13 if you count from when it was first developed.
Beyond that, we’ve had ongoing post-approval studies that you obviously are aware of as you’ve cited them like they are a cause for concern (despite that they are normal). Again as per the Wikipedia page, 40 million doses have been distributed worldwide as of early 2009. Four years later now… at what point does it not seem like there is adequate knowledge? There’s a chicken and egg problem here: you don’t like the vaccine being administered to children as you are opposed to kids as guinea pigs for safety studies, insisting that first there must be studies where kids are used as guinea pigs for safety studies (which in fact has already happened)…
Now, in your first sentence, you said two things that I found to not conform to my understanding of the topic, and when I researched it further, I found plenty of evidence to think they were misrepresentations of the facts. Would it be reasonable to write you off at this point? Or should I consider the possibility that this discussion is clearly controversial, there is a lot of being said, mostly by parties who are not fully informed as they have not been part of the vaccine development over the past two decades, so if there is any point to the process at all then there are going to be a number of parties (if not all) who are going to present information that either initially or subsequently is found to be misleading?
It seems to me I ought to *expect* honest participants to do and say things that I determine to be wrong and strike me as a misrepresentation of the facts (even if I later find out I’ve got it all wrong). If not, how could they possibly honestly disagree with me in the first place and why am I wasting my time talking to them?
The vaccine was fast-tracked before adequate knowledge was gained from safety studies, and our kids are being used as guinea pigs as safety studies continue. I had looked at these clinical trials 5 years ago, after my daughter had the shots and began to have chronic respiratory problems, and periorbital cellulitis (around her eye). Looking at them again in depth recently, thanks to Dan’s persistence, did nothing to give me confidence in their findings; in fact, quite the opposite. No, Dan, I do not find your responses satisfactory. Twice now you have misrepresented data in this discussion, that I’m aware of.
Christina,
you wrote
” It appears to me that Table 17 with 156 women (out of 5759 Study 13 women who got an extra shot) and Table 20 with 398 women (out of 10, 585 total Study 15 women) are comparable, as both 13 and 15 had “normal baseline pelvic exams” on Day One”
So we agree that Table 17 and Table 20 are comparable, good.
(Though I don’t know what you’re referring to with “women who got an extra shot”, and come to think of it, I’m not sure how both studies say in their introductions that all candidates had normal baseline pelvic exams on day one, and then say 3% or 6% of them had abnormal pap smears on day one in table 18. Maybe by ‘normal pelvic exam’ they meant manual exam, not pap smear?)
Since the claim that the vaccine increases cancer rates turns on the interpretation of Table 17, let’s focus on this a bit longer before turning to your other questions.
Given that Tables 17 and 20 were comparable, you’d expect similar results from both, right? But in Table 17, more vaccinated than nonvaccinated women got CIN2/3 or worse (that’s the harm people are talking about), but in table 20, more nonvaccinated than vaccinated women got CIN2/3 or worse.
Before we go into possible reasons for the different results for the two comparable experiments, let’s pause and contemplate a bit. In Table 20, we have a group of hpv-positive, vaccinated women who were evidently not harmed by the vaccine. Do you agree that this raises questions about the validity of the “vaccine increases risk of cancer in hpv-positive women” claim?
Good lord. As Christina points out, I mixed up the descriptions of Study 15 (from pages 4 and 5) with that of Study 13 (from pages 7 and 8). Sigh. Here’s a hopefully more accurate quote from page 7 and 8 about Study 13:
“Study 013… was designed to provide evidence of safety and efficacy for the prevention of cervical cancer… enrolled healthy female subjects 16-23 years of
age who had normal baseline pelvic examinations. Subjects were not prescreened for
HPV prior to randomization… Approximately 78% of subjects were included in the per
protocol efficacy population for HPV 6/11/16/18; 22% were excluded from per protocol
population. About 27% of subjects were either seropositive to a vaccine-relevant HPV
type or had positive PCR at baseline. This difference in proportions reflects the HPV
type-specific analyses of the data, where a subject could be excluded from one HPV typespecific per protocol efficacy population but be included in other HPV type-specific
efficacy populations as illustrated above by the subject in study 015.”
Anyway, the reason I was quoting the study description was to answer your question:
“Study 13 (5759 subjects), also no evidence of previous infection with HPV, yet 27% seropositive to a vaccine relevant HPV type or had positive PCR at baseline. (How seropositive if never infected?)”
Both studies 13 and 15 did not prescreen against HPV before randomizing women into vaccine or placebo groups. (Both study 13 and study 15 used the same wording in their summaries, “were not prescreened for HPV prior to randomization”.) They gave HPV tests before the study, and then used those test results later when analyzing. I hope that answers your original question without raising new ones, but I’m afraid I used so much text that it muddied things rather than clarified them 🙁
Christina,
thanks again for replying.
Glad you mentioned learning about PCR. I forget that not everybody knows
all these acronyms.
So many questions, so little time 🙂
I’ll try to answer a couple tomorrow. I feel like we’re on the verge of figuring out where our differing understandings of that data come from.
– Dan
… finishing the unfinished reply …
when I run into pseudoscience, I look at the details of what people are claiming, compare it with the evidence, and try to find out where disagreements come from.
Hi knowledgeme,
Dr. Harper wasn’t the lead developer of the vaccine; she ran one of the two big Phase 3
clinical trials. That’s not the same thing.
I’m *so* not on the payroll. As I said above, I make my living writing software for a startup in the human-computer interaction field. I’ve always been interested in science, though, and so when I run into pseudoscience, especially when it misleads people towards unproven treatments and away from ones supported by evidence.
– Dan
Dear Dan, you purported to quote p. 7 but about half-way through, after ellipses, you finished the paragraph with information from p. 5, as if all the information were found on page 7. That gives an indication of not being intellectually honest, or at best sloppy and inconsiderate of my poor eyes! Study 13 did not have 10,585 participants; that was Study 15. http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
No, your information was not helpful; sorry. My concern was how could women who had no evidence of HPV infection on Day One (p. 4 for Study 15, p. 7 for Study 13) also have a cohort which could be called PCR positive and/or seropositive on Day One? I did find an article that explained, among other things, that “not all women infected with HPV 16/18 have detectable levels of HPV 16/18 antibodies.” Only about half did, as per this study of women in Costa Rica.
(I learned that PCR is a polymerase chain reaction test for DNA profile, an HPV test.) In this study, if “seroconversion” happened and the person became seropositive (developed visible antibodies from HPV infection), it took a few months after infection for this to happen.(16 and 18 are the HPV strains associated with rare cervical cancers the vaccine purports to protect against. 6 and 11 are the genital wart strains, not being discussed here.) http://www.biomedcentral.com/1471-2334/10/238 Porras C. et al, “Determinants of seropositivity among HPV-16/18 DNA positive young women,” BMC Infectious Diseases 2010, 10:238. Abstract, Background.
Based on my reading, I cannot agree with your paragraph that begins “The study mainly measured…” either. All of study 13 and 15 participants began with “no evidence of HPV infection,” according to pp. 4 and 7. Table 17 is a smaller group than Table 19.
This is how I am assuming they got their numbers: Table 17 (156 got Gardasil) is of study 13 seropositive and PCR positive participants on Day One. Table 19 (685 got Gardasil) is Study 13 participants who were PCR positive AND/OR seropositive on day one.
I note also that the Study 13 participants each received an additional vaccination at the time of their HPV vaccination, either “concomitant” Hep B or a monovalent HPV 16 vaccine in “comparative” arm (other arm? We just have the two.). It appears to me that Table 17 with 156 women (out of 5759 Study 13 women who got an extra shot) and Table 20 with 398 women (out of 10, 585 total Study 15 women) are comparable, as both 13 and 15 had “normal baseline pelvic exams” on Day One. Table 21 combines women from Studies 7, 13, and 15 who were both PCR positive AND seropositive on Day One.
I do find the study to be confusingly written, with all the different subgroups, as if to obfuscate to facilitate FDA approval, perhaps. I am baffled still as to how a person could be both PCR positive and seropositive and also be said to have no evidence of prior HPV infection on Day One. Sorry, Dan, your explanation did not help.
What if it was that extra shot the women got in Study 13 that worsened their ability to fight off the HPV virus? I do not know if any scientist has raised this question. Heidi Stevenson recently posted on Gaia Health a recent article on auto-immunity, how mice who were given repeated vaccinations eventually developed auto-immune conditions. Too many shots at once can be a problem, as when Hannah Poling because autistic after having 9 catch-up vaccinations in one day.
I refer again to my last post (Post #35, 8/10/13 9:43 a.m.). This source does not give us a table comparable to Table 18 for Studies 7 or 15: why? It does not appear to me that many were added from Study 7 to Table 21. The totals in Table 21 were 568 and 580. For those who got Gardasil, adding 156 (Table 17, Study 13) and 398 (Table 20) means 14 from Study 7 were included to make 568. For those who got the placebo, adding 137 (Table 17) and 430 (Table 20) would mean 13 from Study 7 were included to make 568. I sort of wonder why they bothered adding just a few from Study 7. One thing: Study 7 (for which we very little data) was of a smaller geographic area, North America, Latin America, and Europe, whereas Studies 13 and 15 included South America, Asia, and Australia in addition. Also, Study 7 were called “baseline sero-negative,” whereas for Studies 13 and 15 it was said that on Day One they had no evidence of HPV infection.
I see from Google that many studies on HPV are ongoing, including studies involving HPV and HIV. Scientists are still learning about HPV, and I worry that our children are being used as guinea pigs–including my own daughter.
LMFAO! This comment board is a trip. Its quite obvious these guys are on the payroll-Dan/Trevor. How much do they pay you guys to stay with this thing? (I need a job) It’s gotta be good money. Jane killed the whole discussion on 8/1. Notice she never made another comment because she ended it. Like slamming the mic on stage after the show leaving it smokin’. lol
She directed you to the LEAD developer’s comments. Did I say LEAD? Dr. Harper? oh yea the Lead Developer. She said it dosen’t work, it’s dangerous and hasn’t been tested. What is there to talk about?
If I developed a pizza out of BS and told you it’s not real food, it’s dangerous, and I wanna try it out on you, would you step up an get a slice??? This is elementary, or your on somebodys payroll. I mean the LEAD developer told you it’s BS……..not “a” developer but the “LEAD” developer. Because she had what is known as a conscience.
Dan/Trevor knock it off & kick mud……….The People are Awake.
Hi I am the mother of a young woman that has had severe problems from the gardasil injection . For the last 3-4 years my daughter has suffered with dizzy spells that turned into fainting and then went on to develop into full blown seizures unfortunately as she was among the first round of the injections there was not much known about the side effects and it wasn’t until much later on that we became aware that the gardasil was a probable cause and as our doctor said that was very likely that the vaccine was the cause but there is really no way to verify it at this point but the fact is after reading a lot of information she has the exact symptoms that many other girls are suffering with I am not a hysterical mother my children have all been immunized but my daughters future has been totally changed by this vaccine. My Daughter was a happy healthy sporty young woman whose only childhood illness’s was ear infections now she suffers with daily nausea, dizzy spells, fainting, and tonic clonic seizures. thank to this wonderful drug
I updated the FAQ with a more complete answer for this question, see http://hpv.kegel.com/faq/#safetyIfHPVPos2
Hi Christina,
You wrote
“Study 13 (5759 subjects), also no evidence of previous infection with HPV, yet 27% seropositive to a vaccine relevant HPV type or had positive PCR at baseline. (How seropositive if never infected?)”
On Page 7, it says “Study 013: … The study’s primary objective was the determination of safety and efficacy in the prevention of cervical carcinoma due to HPV type 16 or 18 following administration of a three-dose regimen among women who had no evidence of previous infection with HPV… enrolled healthy female subjects 16-23 years of
age who had normal baseline pelvic examinations. Subjects were not prescreened for
HPV prior to randomization. … A total of 10,585 subjects, or 87% of all enrolled subjects, met the criteria for the per protocol population for the primary HPV 16/18 efficacy analysis. (See appendix C for definitions of the populations for the analyses).” Appendix C is the last page.
The study mainly measured efficacy in the “per-protocol” subpopulation, i.e. those women who were definitely not infected before vaccination was complete, but it also measured efficacy in other subpopulations (e.g. Table 17 measured it in all the women who were definitely infected before vaccination was started.)
Does that clear it up? (Took me 20 minutes to find that 🙂
You wrote
“Table 20 is just study 15. (gives “observed reduction”; previous tables (19) gave “observed efficacy.” Why the change in terms?)”
I think they’re used interchangably. Notice that the title for Table 20 says “efficacy”
just like the title for Table 17:
“Table 17. Study 013: Applicant’s analysis of efficacy against vaccine-relevant HPV
types CIN 2/3 or worse among subjects who were PCR positive and seropositive for
relevant HPV types at day 1. [From original BLA, study 013 CSR, Table 11-88, p. 636]”
vs.
“Table 20. Study 015: Analysis of efficacy against vaccine-relevant HPV types CIN
2/3 or worse among subjects who were PCR positive and seropositive for the
relevant HPV type at day 1.
[From additional efficacy analyses requested by CBER and submitted March 15, 2006,
Table 1a-1, p. 2.] ”
When you get back, I’m still interested in the question: do you agree that Table 20 essentially represents a re-running of the experiment from Table 17, with a different set of women (i.e. the Study 15 hpv-positive-on-day-1 women instead of the Study 13 hpv-positive-on-day-1 women)?
(And now to go get ready for my son’s birthday party… I have to set up four computers running Minecraft for the kids to play…)
Getting back to Dan, briefly. If we had Dr. Lee here, he could explain all of this better to both of us, I’m sure. One thing I note is that Study 7 (Phases I-2)(about 1000 subjects) included subjects who received low, medium, and high doses of the vaccine. There were more adverse reactions in the high dose group. The low dose group had a better safety profile with ‘comparable activity’ with the other groups. So, adding Study 7 to Studies 13 and 15 for numbers means you are no longer adding like things. You’re adding apples to oranges, it seems to me. So, looking at data for CIN (abnormal cervical cells), not genital warts (EGL)
I note that no separate data is given here for just Study 7, as is done for Studies 13 and 15. Study 15 had no previous infection with HPV, of 10,585 subjects (or so). Study 13 (5759 subjects), also no evidence of previous infection with HPV, yet 27% seropositive to a vaccine relevant HPV type or had positive PCR at baseline. (How seropositive if never infected?) There are technicalities the researchers could best explain to us.
Table 20 is just study 15. (gives “observed reduction”; previous tables (19) gave “observed efficacy.” Why the change in terms?)
Table 21 is combined, as are some of the other tables. (“observed reduction,” not “efficacy”
I also note that no “selected characteristics” table is given for Studies 7 and 15 as is given for Study 13 (table 18).
The way I read it, the best they could show was a “modest” efficacy” of about 20%, but in Study 13, you can’t deny, it’s still -44.6%, harming girls to that degree.
I’m sorry, I can’t devote more time to this for a few days. It’s been fun, and I’d like to learn more. But it seems they have not presented all the data the same across the board, and they have left out things without explanation. They presented it in a way most likely to win them FDA approval, no doubt.
Hi Dan, I will look at it and post a response in the morning. Thank you.
Hi Christina,
thanks for the reply! I appreciate you having looked into the issue I raised.
Yes, I do need to double-check what I write more thoroughly. (I used to be really good about getting things right the first time, but my typo and thinko rate started climbing about the time my son was born, and hasn’t stopped yet.)
You wrote
“I don’t know why the study didn’t make sure the control and Gardasil groups had the same level of pap smear abnormality in Study 13.”
I’m glad you mentioned that. I think this was a random controlled trial, but for a different question (whether the vaccine was effective overall, not just for hpv-positive women). So the total set of women in Study 13 (regardless of HPV status) in the trial was probably balanced with respect to pap smear status. Looking at the HPV-positive subgroup of women was just a side analysis.
You also wrote
“Averaging in the subgroup to make the numbers better did not negate the fact that the subgroup women were harmed by the vaccine, a disturbing finding. I understand that you disagree.”
I’m not worried so much by the fact that we disagree about the conclusion (although we do); I’m more interested in making sure we’re both clear on what was being averaged together. The group with the 44.6% increase in CIN2/3 was from Study 13 (Table 17). The group with the 5.4% reduction in CIN2/3 was from Study 15 (Table 20). Do you agree that Table 20 essentially represents a re-running of the experiment from Table 17, with a different set of women?
Dan, what I would say is please double check your facts. You did lose credibility with me after you told us there was FDA approval of the vaccine for older women and referenced the FDA denial. At least once you said abnormal (HSIL) pap smears were “twice as high” in the Gardasil group on day one, when the actual numbers were 6.5 in the Gardasil group and 3.7 in the placebo group, so I was looking for 2:1 numbers and didn’t see them. I’m sorry. These studies are hard to read and they don’t always define terms.
I had to look up HSIL (high squamous cell intraepithelial lesion) to compare it to CIN2/3 (cervical intraepithelial neoplasia. C1 is low grade; 2 and 3 are high grade, by degree.) I think Dr. Lee was perfectly justified in presenting to FDA the study data on -44.6% in Study 13; FDA had the study and could read for themselves. Averaging in the subgroup to make the numbers better did not negate the fact that the subgroup women were harmed by the vaccine, a disturbing finding. I understand that you disagree.
I don’t know why the study didn’t make sure the control and Gardasil groups had the same level of pap smear abnormality in Study 13. Perhaps they planned it that way, then didn’t like the results.
Of course, the placebo was not harmless but was an aluminum adjuvant, causing its own side effects. If it had been a harmless substance, there would have been more contrast between Gardasil and control groups. There is no place for aluminum within the human body; it does not naturally occur. We need a control between aluminum adjuvant and harmless substance!
According to Dr. Frederick Jelovsek’s website, HSIL usually indicates moderate (CIN 2) or severe (CIN 3) dysplasia but it could be an invasive cervical cancer. Even so, only 1.5% of those with HGSIL pap smears “will progress to having invasive cancer of the cervix within the next 24 months.” http://www.wdxcyber.com/npapvg14.htm
It would be interesting to know if, among those with HSIL prior to vaccination, the rate of actual invasive cancer changes after HPV vaccination. But the study is over. I think the study should follow them for the rest of their lives, because cervical cancer is a disease of older women. And of course, if the women start taking better care of their health, they can improve their healing prospects before they get old.
I think OB-GYN Dr. Christiane Northrup’s book, “Women’s Bodies, Women’s Wisdom, ch. 9, is very good reading on this subject of taking good care of our sexual health which includes regular pap smears, vaccine or no.
I think my purpose here has been to clarify arguments, to urge caution in interpreting data (like the Lorax, I speak for the data), and to try to find common ground. (I haven’t been very successful at that last one.)
I’m still mystified how Christina, Heidi, and I can look at the same three pages of a paper – heck, the same three tables – and see completely different things.
I own up to my mistakes; if somebody points out how I’ve misread something, I thank them and correct myself. I’m still waiting to hear Christina or Heidi admit that I’ve gotten *anything* right (for instance, Christina claimed I had made up the results from Table 18, and has yet to say “Why, I’m sorry, you’re right, you didn’t make up that data, and it does seem relevant.”)
But regardless, I have really enjoyed being challenged, it’s refreshing to have a discussion where I have to dig up data from pubmed etc. I’ll try to collect the repetitive parts of the discussion at http://hpv.kegel.com/faq , I suspect they’ll come up again.
Dr. Lee puts it this way: people with persistent HPV infection, of the same HPV strain, are the ones most at risk of the pre-cervical cancer cell changes. That does not dilute the data’s implications, that this vaccine is negative 44.6% effective for this subgroup (i.e., harmful). You can average to make things sound better, but that doesn’t take away from the subgroup’s being more at risk.
There is also a need for a better pap smear, Dr. Lee argues. The current pap smear is good, but could be better. We might get all hung up on thinking the vaccine protects people and lose track of the continued need for pap smears, especially in light of this 44.6%. Early detection saves the most lives.
It’s easy to “lie” with statistics. There’s the old joke about asking the accountant what the figures said. “What do you want them to say?” he said. Your purpose here has obviously been to promote HPV vaccines, Dan. Mine is, I hope obviously, to urge caution. Thank you, Heidi, for the privilege of being allowed to post here.
Hi Heidi,
I think it’s reasonable to look at whether statements are supported by evidence.
Also, I think it’s productive to look at specific claims (like “Gardasil increases the risk of cancer in HPV-positive women”), since those hypotheses are eminently testable in repeatable experiments.
I do thank you for the responses you’ve given, and am sorry you feel the discussion has been unpleasant.
Dan, I’ve reached my limit with you. What’s obvious is that you have not read any of the science that points out the flaws and errors – and outright fraud – of the manufacturer-financed pseudo science. If you truly wanted to know the whole story, then you’d have read some of them. Instead, you come here and try to poke holes in the arguments against a particular vaccine. That clarifies what you are – a troll.
Heidi wrote:
” further studies have also documented that those who were already HPV-positive have significantly higher rates of cervical dysplasias and cancer after the vaccine.”
Do you have a reference? I don’t think I’ve seen those studies.
Hi Christina,
you wrote
“And please don’t make up facts that aren’t in the data unless you clearly label them as hypothetical (such as that the women in that subgroup had twice as many bad pap smears).”
That’s not made up; it’s directly from Table 18 of the document you reference, http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
which says
“Table 18; Study 013: Selected characteristics for subgroup of PCR positive and
seropositive for vaccine-relevant HPV types at day 1.
Study 013 subgroup Gardasil Placebo
Subgroup population 156 137
…
Pap test with HSIL 6.5% 3.7%”
Quoting Dr. Lee making the same mistake as you doesn’t make it any less of a mistake. And he’s got a business reason to make that mistake – he’s trying to sell women an HPV test based on this mistake. Given that he’s got a financial incentive to misconstrue the data, I wouldn’t trust what he says on the matter.
Your logic doesn’t work. The fact is that further studies have also documented that those who were already HPV-positive have significantly higher rates of cervical dysplasias and cancer after the vaccine.
If the FDA had meant what you are trying to suggest, that’s what they’d have reported, as it would have strengthened their support for the vaccine.
Pap smears are very relevant to discussions of cervical cancer in general, and especially here, where the two groups being compared differ greatly in their rate of positive pap smears.
The quote is from
http://gaia-health.com/gaia-blog/2012-10-25/gardasil-is-probable-cause-of-girls-deaths-brain-histology-study/#comment-728437304
where you wrote
“The reality is not as simple as you believe. The fact is that pap smears are effective, but the vaccines are not.”
But pap smears by themselves don’t prevent cancer; they only alert you to possible precancerous changes in the cervix, and you then have go get them looked at and possibly removed, if your doctor finds that they are worrisome. That implies that you agree that an abnormal pap smear is a sign of increased risk for cancer. Otherwise why would you say pap smears are effective?
That’s why Table 17 is unlikely to be useful as proof that the vaccine increases risk of cancer: the group being vaccinated was already at higher risk for cancer, as demonstrated by their higher rate of abnormal pap smears.
Looking at the question from another angle: if the vaccine really did somehow increase the risk of cancer, you would expect to see that not just in one study, but also in further studies with different women. But the same paper you reference shows in Table 20 that among a different (and larger) group HPV-positive women, the vaccinated women had a 5.4% reduction in cancer.
So: the claim that vaccination of HPV-positive women increases risk of cancer is based on a biased sample, and is not supported by a second similar experiment mentioned on the next page of that document. If you want to continue making that claim, you’ll need to find some other evidence to support it.
This is not the place to ask that question. If you think that the HPV vaccine is something you wish to get, then you should consult with those who recommend it.
Can you explain the plateau in vaccinations lately? And what about those who don’t complete all 3 rounds? It seems many teens are just getting the first dose and discontinuing. Are they only partly protected, or not at all? Then, do they have to start all over?
Your condescending tone is insulting and out of place.
The suggestion that pap smears make women more susceptible to cancer is just plain ludicrous. Nothing I’ve said suggests that.
I’ve demonstrated that what you wrote was wrong, and now you’re going to try to redirect attention by going down an irrelevant path … a standard troll maneuver. You seem to be under the mistaken notion that there’s an obligation to respond to you. There isn’t.
Heidi,
this is important, so let’s take it step by step.
1) You wrote “The fact is that pap smears are effective”, so you agree that women with pap smears are at higher risk of cancer. (Right?)
2) Let’s say there are two groups of women. 6.5% of the first group have abnormal pap smears. 3.7% of the second group have abnormal pap smears. You would expect that, without treatment, the cancer rate to be higher in the first group than in the second group. (Right?)
What nonsense! It doesn’t simply mean that it doesn’t protect you. It means that a girl is 44.6 times more likely to develop a cervical lesion of level 2 or 3 – which is far more than a simple infection. It’s pre-cancer.
And no, it doesn’t mean that girls who were sicker before vaccination are sicker after. It means that the vaccine has worsened their conditions. The fact is that – even according to the FDA – most infections, likely 99% of them, are cleared naturally within 2 years. A 44.6% greater chance of cervical lesions clearly is a direct result of the vaccine and completely contradicts your claim. It is not simply a worsening of their condition, as if their condition would naturally worsen. In most cases, it doesn’t – it heals. Obviously, it’s only on rare occasions that it does, so obviously, nearly all of these girls develop lesions as a direct result of the vaccine.
“Females who are sexually active may also benefit from vaccination, but they may get less benefit.”
What a masterful piece of evasiveness! You bet they get “less benefit”. They get -44.6% less benefit! According to the FDA’s own figures. This, by the way, has been borne out by follow-up studies.
Yet you toss that piece of garbage verbiage out as if it makes it okay not to test girls beforehand and not even to inform them of the risk!
Yes, Christina, that’s it. The FDA’s own report states that women given the vaccine when already infected have a 44.6% increased risk of precisely the condition that the vaccine is supposedly intended to prevent.
Yet, there is no testing for infection before giving the vaccine. That most assuredly does not speak of an agency that exists to support the health of people. It speaks of an agency that exists to promote the corporations it pretends to control. How much clearer does it need to be for the likes of those who keep citing the NIH, CDC, FDA, and such as experts witnesses in matters of health?
It isn’t just vaccines, of course, but a huge array of drugs, such as Vioxx, all the antipsychotics and antidepressants, dabigatran, beta blockers, statins, and so forth and so on.
Dan, you can try to argue away the data, just as FDA did. FDA doesn’t protect us like it should. But no, you haven’t convinced me, or Dr. Sin Hang Lee who argued to the FDA that women need better testing for HPV to save their lives. And please don’t make up facts that aren’t in the data unless you clearly label them as hypothetical (such as that the women in that subgroup had twice as many bad pap smears).
You are male, father to a son. You’ve already decided he will get the HPV vaccine. I presume he will make informed consent. But please, do not be so quick to tell women and young girls that you know what is best for us, because you don’t.
From Dr. Lee’s 2007 reclassification petition for his hpv dna testing device: “The recent introduction of type-specific HPV vaccines into the populace may require genotype monitoring of the HPV infection before and after immunization to develop prevention strategy for the individual patients when concurrent infection by a vaccine relevant HPV is suspected prior to vaccination . According to the VRBPAC Background ~ Document on GardasilT”‘, the HPV Quadrivalent Vaccine, presented to the FDA by Merck & Co., Inc. at the May 18, 2006 VRBPAC Meeting [14], the vaccine may cause more harm than placebo when it is administered to subjects who have already contracted the infection by HPV-6,-11,-16 or -18 . In a subset of clinical trial data, among the 156 subjects who were seropositive and PCR-positive for these so-called vaccine relevant HPV types, 31 subjects developed grade 2/3 or worse CIN lesions after
receiving the vaccine while only 19 of the 137 subjects in the same subgroup developed
~ such precancerous lesions after receiving placebo . In other words, the vaccine may
increase the risk of developing high-grade dysplasia by 44 .6% in a patient if she has
concurrent infection by one of the four HPV types contained in the vaccine . In addition,
diseases due to other HPV types also have the potential to counter the efficacy results
of GardasilTM for the HPV types contained in the vaccine, according to this document .
Therefore, a sensitive, specific and reproducible method for HPV detection and to
provide material suitable for genotyping to monitor HPV infection is needed to assist the
health care providers in dealing with these new developments in clinical management ….
http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf
(p. 30. Also see heading VI, pp. 7, 13, 18, 20, 26 for this discussion.)
found here http://www.cogforlife.org/2007/12/19/hpv-does-not-cause-cervical-cancer-fda-knew-it/
http://healthfreedoms.org/2010/08/07/hpv-vaccines-fraudulent-claims/
Here’s a shorter way of putting it, if it helps:
Before vaccination even started, that group had twice as many positive pap smears as the control group. Because the vaccine doesn’t protect you if you already have HPV, you would in fact expect the group that was sicker before vaccination to be sicker after vaccination. And that’s just what happened.
Christina,
Using the figure from Table 17 on page 13 without looking also at
Table 18 on page 14, and at the conclusion on page 15, is taking data out of context.
That table lists how effective the vaccine is at preventing progression to CIN2/CIN3 among a group of 156 women who currently have HPV.
That’s a small enough group that it might not be representative of HPV-positive women in general.
This idea is supported by Table 18 on page 14, which shows the vaccinated group had almost twice the positive pap smear rate *before* vaccination (6.5% vs. 3.7%) than the placebo group.
The vaccinated group was therefore already well on its way to cancer before being vaccinated.
This is one reason the FDA concluded on Page 15
“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. Finally, there is compelling evidence that the vaccine lacks therapeutic efficacy among women who have had prior exposure to HPV and have not cleared previous infection (PCR positive and seropositive), which represented approximately 6% of the overall study populations.”
and why “CDC HPV Vaccine Information for Young Women”,
http://www.cdc.gov/std/hpv/stdfact-hpv-vaccine-young-women.htm
says
“Ideally females should get the vaccine before they become sexually active and exposed to HPV. Females who are sexually active may also benefit from vaccination, but they may get less benefit. This is because they may have already been exposed to one or more of the HPV types targeted by the vaccines. However, few sexually active young women are infected with all HPV types prevented by the vaccines, so most young women could still get protection by getting vaccinated.”
After seeing that evidence, from the same reference as you cited,
do you still feel that vaccination increases the rate of cancer among HPV-positive women?
Sorry to keep posting, but Dr. Lee is in the very recent news: http://eon.businesswire.com/news/eon/20130730006091/en (July 30, 2013)
“Milford Hospital Announces Publication of Article By Dr. Sin Hang Lee in International Journal of Medical Sciences
Collaboration of Dr. Sin Hang Lee and a Chinese Academy of Sciences laboratory ”
“Novel Low Temperature PCR Reported in International Journal of Molecular Sciences” (release summary).
“….this technology “has been used to prepare templates for DNA sequencing-based molecular diagnosis of infection caused by Borrelia burgdorferi, human papilloma virus (HPV), Neisseria gonorrhoeae and Chlamydia trachomatis” and “may be useful in performing routine nested PCR to facilitate implementation of DNA sequencing-based diagnostic tests in community hospital laboratories.”
http://eon.businesswire.com/news/eon/20130805006124/en/Lyme-Disease-Test/Dr.-Sin-Hang-Lee/Milford-Medical-Laboratory (Aug 5, 2013)
“Milford Hospital Pathologist to Resume DNA Sequencing – Based Testing for Early Lyme Disease”
“Nested PCR followed by DNA Sequencing is the most definitive test available in the U.S.”
“Dr. Sin Hang, director of Milford Medical Laboratory, will be resuming clinical testing for Lyme disease, using Lo Temp nested PCR and DNA sequencing, the most accurate test available in the U.S.” (release summary)
I just found it, Heidi. P. 13, an efficacy rate of minus 44.6% for people already infected with one of the 4 HPV subtypes in the vaccine (2 subtypes associated with genital warts and two associated with RARE cervical cancers). Thank you.
According to Norma Erickson of Sanevax, most people are not tested before vaccination to see if they are infected with the types of HPV in the vaccine (6, 11, 16, 18). And, those who develop abnormal pap smears after being vaccinated with HPV vaccine are usually not tested to see what HPV strains are involved; i.e., whether the vaccine “worked.” Dr. Sin Hang Lee has offered to facilitate this testing with his lab equipment. It seems a good idea to collect as much data as possible about this vaccine’s effects on patients while it is still so new. This article is from Oct. 4, 2011.
http://sanevax.org/dr-sin-hang-lee-a-case-study-in-ethics-dont-pay/
Heidi, I have seen a number similar to that cited a lot, but am trying to find its original source. Are you getting that no. from p. 16, Table 23 of this document? http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
Thank you! I’ve been looking for this for awhile.
Regarding the lack of efficacy in those who have already contracted the virus, it’s worse than lack of efficacy. The FDA’s approval report for the vaccine documented that there is a 44.6% increase in precancerous lesions!
C Bax,
yes, as I wrote above (somewhere in the thicket),
“I’m not in the age group that is supposed to get the vaccine, but my son will be in a year or two, and we follow the standard vaccination advice, so he’ll get the HPV vaccine, too.”
I suppose that’s one reason I’m interested in the topic.
Dan,
Do you have kids?
On the risk of vaccinating someone who already has HPV present and the risk of birth defects when a pregnant girl is vaccinated:
http://www.newswithviews.com/Howenstine/james170.htm
Dr. James Howenstine, “Human Papilloma Virus Vaccine Fraud,” Nov. 3, 2008.
Dr. Howenstine discusses the forces behind HPV vaccine approval and how vaccinating someone who already has HPV present can be bad. This link to his reference should open: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf
VRBPAC Background Document
Gardasil™ HPV Quadrivalent Vaccine
May 18, 2006 VRBPAC Meeting
“One potential safety signal in the BLA was reports of congenital anomalies among women who became pregnant and gave birth during the study period. When limited to receipt of vaccine within 30 days of becoming pregnant, there were five reports of congenital anomalies among women who received Gardasil™ and no reports of congenital anomalies among women who received placebo. However, the five congenital anomalies were widely varied and did not fit a particular pattern. The following table outlined pregnancies and pregnancy outcomes that were observed in all clinical studies of Gardasil….(p. 23) Summary of the five cases of congenital anomalies in the Gardasil™ group: [Some babies had more than one anomaly.]
1. Hip dysplasia
2. Pyloric stenosis, ankyloglossia
3. Congenital hydronephrosis
4. Congenital megacolon
5. Left talipes equinovarus….
(p. 24)
Concerns Regarding Primary Endpoint Analyses among Subgroups
There were two important concerns that were identified during the course of the efficacy review of this BLA. One was the potential for Gardasil™ to enhance disease among a subgroup of subjects who had evidence of persistent infection with vaccine-relevant HPV types at baseline. The other concern was the observations of CIN 2/3 or worse cases due to HPV types not contained in the vaccine. These cases of disease due to other HPV types have the potential to counter the efficacy results of Gardasil™ for the HPV types contained in the vaccine.(p. 13)
Finally, there is compelling evidence that the vaccine lacks therapeutic efficacy among women who have had prior exposure to HPV and have not cleared previous infection (PCR positive and seropositive), which represented approximately 6% of the overall study populations….(p. 15)”
As for the studies. I think an obvious exception to the principles I mentioned would be fetuses and infants, who not only are *much* smaller, but whose metabolism is quite different and where a foreign body might interfere with the actual creation/formation of their organs.
That said, I don’t think those studies are really an exception anyway. Those babies don’t ingest their food, but if they did, I’d have to imagine ingesting hundreds of times (let alone thousands or millions) the dose that was injected would be harmful to them as well.
Sorry for the confusion. I wasn’t reference your sources, but Heidi’s (thought I was replying to her comments, but may have gotten that wrong). Specifically: http://www.whale.to/vaccine/polysorbate.html
Chris, I had some trouble parsing your reply (I cite a lot of sources, so I’m not sure which one you’re referring to), but it made me go back and check http://www.ncbi.nlm.nih.gov/pubmed/8473002 again, and I had misread the phrase “on days 4-7”. Somehow I thought that meant on one of those days, but now I think it means all of them. So, yes, daily doses, but only for four days.
So the total dose is four times greater than I figured before, or 3000 micrograms in a 11 year old girl . That’s 60 times the amount in a single dose of Gardasil, or 20 times the amount in the series of 3 gardasil doses. So the margin’s bigger than I thought, good news.
Yes, it is wierd that a substance so common could be harmful, but nature is full of strange things… somebody needs to confirm this measurement (and maybe not just in rats), and find the threshold dose, if it hasn’t been found yet.
One more data point: I just searched a bit longer, and found this:
http://www.cdc.gov/mmwr/preview/mmwrhtml/00000319.htm
http://www.ncbi.nlm.nih.gov/pubmed/3960626
Injection of 1ml daily of E-Ferol (a non-FDA-approved injectable vitamin supplement consisting of 9% polysorbate 80 / 1% polysorbate 20 / vitamin E), daily seems to have caused death in some premature babies.
“Drug Injury: Liability, Analysis, and Prevention” has one case where a baby died after one month of this treatment. That’s about 100 times the dose the rats got, and about 6000 times the dose in one shot of Gardasil, I think.
As I acknowledged, there are plenty of substances which are transformed by the digestive process and therefore have very different impacts when ingested vs. injected. However, the source you cite claims it should not be eaten, drunk, put on the skin or injected. How many substances can you think of that are dangerous in all those contexts, but for entirely unrelated mechanisms (which seems to be what you are now implying)? How many of them remain a mystery as to the nature of that mechanism?
The point about concentrations was not that really small concentrations don’t matter. It was about how unlikely it is that a substance that isn’t “digested” (and really, most of the time even things that *are* digested) wouldn’t make it into the bloodstream in some comparable proportion.
In this case, we have a substance that does make it in the bloodstream, but is metabolized very quickly thereafter. Small does that cause problems generally aren’t metabolized quickly (often aren’t metabolized at all) or have very immediately consequential impact that makes the mechanism obvious and unmistakable.
tl;dr: it is really weird to have a substance that is generally toxic, present in the entire population’s diet in not insignificant quantities, not digested, metabolizes quickly, but is apparently dangerous doses which are proportionately much, much smaller are injected directly into the bloodstream a handful of times over someone’s lifetime.
I believe the evidence on this is consistent with what I am saying, as all the rat studies that have found problems have involved daily injections of much larger quantities of the substance. Is that not true?
I’m afraid that trusting intuition and instinct often leads one to believe things that are demonstrably false. Consider the gambler whose intuition convinces him that he’ll win back his losses if he keeps playing. Or the potato chip eater whose intuition tells him that just one more potato chip can’t hurt (and, one bag later, has a stomach ache). Or the contestant on Monty Hall ( see http://en.wikipedia.org/wiki/Monty_Hall_problem ; this one is so counterintuitive it stumped even geniuses ).
Sadly, cold hard data is the best way to go when it comes to understanding the natural world.
Sounds like the boss approves.
I finally came out from under my rock and found the paper Heidi pointed to, http://www.ncbi.nlm.nih.gov/pubmed/8473002
Assuming the rats weighed 1 pound, they showed an effect at about 10 micrograms/1 pound of body weight. 11 year old girls weigh about 77 pounds, so the equivalent dose in girls would be 770 micrograms.
The vaccine has 50 micrograms, one fifteenth the dosage, and is administered much later in life than in the rat study, so there is less room for mischief, but it’d take a real biologist to make the comparison.
Incidentally, http://www.ncbi.nlm.nih.gov/pubmed/9096282 repeated the rat study using oral administration, and didn’t find any effect. So it might be specific to injection. (Or it might have been a bad study. Has anyone found a study that confirms the effect?)
Surely something is known about the pharmacology of polysorbate 80. Let’s see…
http://www.ncbi.nlm.nih.gov/pubmed/10537361 says
“Because of rapid degradation of polysorbate 80 by esterases in plasma, the concentration of this vehicle substance declined very rapidly. Consequently, this substance was not able to interfere in the disposition of docetaxel.”
http://www.ncbi.nlm.nih.gov/pubmed/21129189 says
“anaphylaxis … has been shown to occur in < 0.1% of patients treated with omalizumab. … There were no fatalities … 78% of the remaining episodes occurred within the first two hours after injection. … At the present time, there is no consensus regarding the mechanism(s) underlying omalizumab-associated anaphylaxis… Previous research has shown that it may be associated with hypersensitivity reactions when used in formulations of erythropoietin or darbopoietin [21]. Investigation into two anaphylactic reactions to omalizumab also concluded that it was the polysorbate component of the formulation that was responsible for these particular reactions [22]." They recommend monitoring for three hours after injection.
Given these two studies, a long term effect seems unlikely.
I just wanted to say I hope everyone that is concerned about these issues trusts their deepest instinct. The pro-rampant-vaccination crowd is trying to twist data to fulfill their own agendas.
Peer-reviewed means just this… Peers aka Tribes (of whom have their own biases) get together and say this or that is right or wrong.
I just hope that one day they will realise that whatever money and/or benefit they get from promoting this rampant over-vaccination epidemic at the cost of destroying lives… was never worth it.
“Perhaps we ought to be more suspect of the real agendas behind sources against the vaccine, and probably less so of those supporting it.”
It’s unbelievable that anyone could make such a statement with a straight face! Are you suggesting that the parents of vaccine-injured children have an agenda beyond what’s happened to devastate their lives?
Regarding your logic in the middle paragraph, trying to follow it makes my brain hurt. Suggesting that the vaccine makers have a lot to lose by the rapid distribution of their products?
And the sources I cite are tainted by pharmaceuticals? In point of fact, in this particular instance, I know one of the scientists involved. I know that this person left a high-paying research position because of conscience – a refusal to falsify data. This person chose to risk unemployment – and was unemployed for some time – rather than do dirty work to promote vaccines. And was thrilled to be offered a far lower paying position in an honest lab. Tainted by pharmaceutical money to produce honest science that documents the truth about vaccines? I am gobsmacked at the suggestion!!
Of course it’s meaningless to compare ingestion with injection. A substance that’s injected can induce an autoimmune disorder, when it’s perfectly safe – even edible – if eaten. Freund’s adjuvant is, basically, an oil. You could eat it, and while it would be considered good for you, it wouldn’t induce an autoimmune disorder. Yet, when injected, it does precisely that – and is routinely used for just that purpose in lab animals because it consistently causes immune disorders in them.
It is, therefore, untrue to suggest that there’s value in comparing the two methods of a substance entering the body.
The suggestion that concentrations measurable in millionths or billionths are meaningless is also mistaken. It ignores the fact that hormones work in just such concentrations. So even tiny amounts of injected toxic substances can have enormous effects.
There is a lack of objectivity in your statements. The sources you cite supporting your argument are just as indirectly “tainted” by pharmaceuticals.
I think though, there is a misplaced notion of the incentives here. There are multiple vaccines, so it would be entirely in the interest of one purveyor to actively fund and support the case against the other. Even if those two reached some kind of agreement around mutually assured destruction, the rest of the medical & pharmaceutical establishment has very strong incentive to undermine these vaccines, as they threaten all those revenues from the treatment of the disease. Multiple governments have calculated that within the first few years a mandatory HPV vaccination program would be cheaper than the costs of HPV treatment (and unlike with treatments, the vaccine costs are obviously higher the first few years and should decline over time), and that’s assuming not a penny is saved in costs for cancer treatment. This would suggest that the collective medical establishment (which ironically includes Merck) has far more to lose with distribution of the vaccine than with that distribution being prevented.
Actually, if one were to cynically try to maximize profits, you’d hope to get vaccine sold on the market where you know a good portion of the population won’t just want it, but demand it, while simultaneously sewing enough fear and doubt to ensure that a sizeable enough minority of the population don’t take the vaccine, thereby preventing any kind of herd immunity arising, and ensuring a continued flow of new patients.
Perhaps we ought to be more suspect of the real agendas behind sources against the vaccine, and probably less so of those supporting it.
While there are differences between injecting and ingesting something, comparing the two is NOT meaningless. The difference is ingestion involves the digestive process before a substance is absorbed into the bloodstream, which can be relevant as some substances get broken down during that process. Of course, if you have any lesions, cuts or sores, small portions of the substance (say 0.1% –which for the average person would be 1000 micrograms a day), that’d allow the substance to bypass that. But let’s assume people with any sources are careful to avoid touching any food or related products or eating any processed foods.
The source you cite (unfortunately the links that page cites are all dead) describes it as “toxic” and “should not be eaten, drunk, put on the skin, or injected”. Such claims would suggest it can at least in part of the ingested material survive the digestion process. These are not biased claims from “pharmaceutically-sponsored junk science”, but from an unbiased and unimpeachable authority of real medical science: an organizer for an anti-vaccine advocacy group. That authority is a bit muted by the fact that the article it cites being sourced having Merck as a gold sponsor, but the world is never perfect…
In this case though, both kinds of sources are in agreement about the metabolization of the chemical. If you were to test for polysorbate 80 in the average person’s blood stream, particularly after a meal, you’ll find a significant portion of their daily consumption is there, and eventually accumulates in fat deposits. This also lines up with all the allergists who feel that hypersensitivity reactions can occur just from ingestion.
So, while there is a difference, it doesn’t change the validity of the claims against
THE HPV vaccine has 50 *micrograms* of polysorbate 80. Assuming that went directly into the bloodstream of a ten year old, without any of it being absorbed by the skin or other body tissues. That would work out to a concentration at most 1 billionth of their blood, and about half of a millionth of what is in the food they consume daily. In short: it wouldn’t measurably change the levels of polysorbate 80 in their bloodstream, even at the moment of injection. Of course, if they have eye drops, or if they are taking any of a number of directly injected medications which use it as an excipient, the HPV vaccine’s polysorbate 80 payload will be so negligible as to be be completely irrelevant.
Of course, one might receive the HPV vaccine but a handful of times in one’s lifetime, whereas the other polysorbate 80 delivery mechanisms are happening on a regular recurring basis, so maybe that particular extra one billionth delivered so quickly and directly is a shock to the body…
Your press release link probably isn’t the best one; Lee published a paper on the case, see http://www.scirp.org/journal/PaperInformation.aspx?paperID=25840.
His data is a single case study, without a control; it’s quite likely this test would detect HPV DNA in even unvaccinated people. And as http://www.ncbi.nlm.nih.gov/pubmed/23507078 notes, ” this type of PCR is notorious for contamination problems.” So I wouldn’t put too much trust in Dr. Lee’s report, quite aside from the problem that it was sponsored by Sanevax, a noted opponent of vaccination.
See previous comment about aluminum: http://www.marketwatch.com/story/sanevax-announces-medical-surprise-gardasilr-hpv-dna-discovered-in-post-mortem-blood-and-spleen-tissue-2012-08-08
Six months after vaccination, coroner’s report found hpv dna fragments ” firmly bound to the amorphous aluminum hydroxyphosphate sulfate (AAHS) particles used as an adjuvant in the vaccine formulation. “
Your study was from 2004; not exactly recent. Aluminum is part of the problem in the HPV vaccine. This from 8/8/2012:
TROY, Montana, Aug 08, 2012 (BUSINESS WIRE) — According to Norma Erickson, President of SaneVax Inc., testimony provided for a coroner’s inquest into the death of Jasmine Renata in New Zealand by Dr. Sin Hang Lee, a pathologist on the medical staff at Connecticut’s Milford Hospital, revealed the discovery of HPV DNA fragments in post-mortem samples 6 months after Gardasil(R) vaccination.
Dr. Lee’s testimony stated:
“The finding of these foreign DNA fragments in the post-mortem samples six months after vaccination indicates that some of the residual DNA fragments from the viral gene or plasmid injected with Gardasil(R) have been protected from degradation in the form of DNA-aluminum complexes in the macrophages; or via integration into the human genome….Dr. Lee testified, “The naked DNA in the vaccine was probably stabilized through a chemical binding between the mineral aluminum and the phosphate backbone of the double-stranded DNA.”
http://www.marketwatch.com/story/sanevax-announces-medical-surprise-gardasilr-hpv-dna-discovered-in-post-mortem-blood-and-spleen-tissue-2012-08-08
Hi Christina – I saw the video. Yes, the vaccine is highly promoted, the drug company has spent a million or two on it’s development and their research and respected independent peer reviews show that the risk benefit ratios are extremely favourable. Like promoting seat belts or only crossing roads on pedestrian crossings, it’s great to make profits and help people at the same time. Professional people such as doctors, lawyers, accountants or pharmacists so this all the time.
Is there any doubt that cervical cancer can be caused by the HPV?
“Most HPV viruses are self-clearing and do not pose a health risk”. Most times you can cross a country road blindfold and not get hit but I wouldn’t recommend that it’s a great idea
.
Absolutely right! Manufactures of these vaccines certainly do not claim to stop all of the known HP viruses. Just the most common ones that are included in their vaccines. Better to include the few that are causing most of the problems than make a vaccine that is unaffordable and is hopeless because it never gets used.
You’re right again! How dumb would it be for anyone to guarantee that their vaccine prevents absolutely all cases of cervical cancer? That’s why they don’t.
“The HPV vaccine is offered in three shots and is offered to teenage girls”. That’s right again. No, they don’t offer it to 80 year old men!
Aluminium is not a toxin. Aluminium does however have a toxic level. If you removed everything that had a toxic level in our bodies from our world such as all of the oil soluble vitamins, or fluoride, we would all be very unhealthy. Yes, there are serious side effects from toxic levels of all sorts of natural and other chemicals in our bodies. (Try natural or chemical table salt).
It is absolute speculation from anecdotal cases without evidence that every serious disorder that a person might get after having had the vaccine is any more likely than had they not had the vaccine. Or do people who have not had the vaccine never suffer from any of these disorders?
I just saw this video. Compelling. http://www.how-to-diy.org/Is6UGFiXah5ACW/The-Dangers-of-the-HPV-vaccines-Gardasil-&-Cervarix-(HPV-Vaccination-Side-Effects-Cervical-Cancer).html
Hi Christina,
http://hpv.kegel.com/cancer/ is a cancer-specific timetable. (Cancerous genital warts figure into it, though, since that’s how zur Hausen got the idea that led to his Nobel Prize and the vaccine; http://hpv.kegel.com/cancer/#condylomata1976 ) And it’s been established that HPV all by itself can immortalize cells – perhaps the most important step in carcinogenesis (http://hpv.kegel.com/cancer/#immortal ). And positive pap smears are down 50% in women under 20 in Victoria after 5 years of national vaccination ( http://hpv.kegel.com/cancer/#campaign ).
That’s not hype; that’s a real benefit, since it means fewer followup tests and fewer conectomies.
You’re right, though, that there’s no debate about harm from HPV vaccine, because no solid evidence of harm has yet been presented; VAERS reports are not reliable for computing risk ( http://vaers.hhs.gov/data/index ), the computed reporting rate nevertheless appears to be low, and the ratio of serious reports has been declining since 2008 ( http://www.cdc.gov/vaccinesafety/Vaccines/HPV/Index.html ), and studies of hundreds of thousands of women have found no harm ( http://www.ncbi.nlm.nih.gov/pubmed/21907257 ).
And now, I suppose, we’re back to the question of whether mainstream medicine is thoroughly corrupt and not to be trusted.
I also find it interesting that Dan’s timetable doesn’t include a single study that documents the harm from HPV vaccines, nor does it include any of the research by scientists who have demonstrated that the studies he has posted are not valid or demonstrate that there is no proven efficacy in the HPV vaccines – and clearly never will be, even if the figures given by the sold-out pseudo science were accepted as valid.
Yet, he and his ilk continue to state that those who disagree with them are “conspiracy theorists” – which has absolutely nothing to do with this topic – are “hysterical”, don’t understand science (when all they can do is cite studies, not even understanding what’s in them – as you’ve just demonstrated, Christina – and that the science is on the pro-HPV vaccine (and other vaccines) side, as if the science they quote were anything but pseudo science.
So, they put on a condescending manner and continue their posturing, as if it makes them smart. It doesn’t.
Well I don’t have time to double-check all of Dan Kegel’s information, after he posted a denial of approval for HPV vaccine for older women by FDA and told us it was an approval. Now he is calling his “timetable” re “genital warts,” a “cancer timetable.” There is a difference. HPV does not “cause” cervical cancer by itself. It may be a cofactor. The Gardasil vaccine contains 4 of over 150 HPV strains. Two cause genital warts. Two are associated with RARE strains of cancer. So in my opinion, the vaccine is more hype than science as an “anti-cancer” vaccine.
There is no “debate” about the fact that the HPV vaccine is damaging girls and that its risks exceed any real, proven benefit. It has never prevented a single case of cancer. Dr. Maurice Hilleman, inventor of vaccines, called vaccines the “bargain basement of health care.” Yes, but they are very lucrative for big pharma these days, especially if you can convince the world that every single infant needs a vaccine for a virus that 40% of children and 50% of adults naturally have present, that usually causes no harm, that the body usually clears on its own with no problem, by using cancer scare tactics.
Heidi,
you’ve said in the past that you want to advocate for homepathy, and the article we’re discussing was posted on your homeopathy advocacy site, so it seems quite reasonable to bring your views on homeopathy vs. mainstream medicine into the discussion.
But I’m perfectly happy to focus on the article itself again. It quotes a case study where a 16 year old girl’s ovaries shut down, and says “there is no known explanation other than the series of three Gardasil vaccinations she had”.
Let’s see what’s known about causes of premature ovarian failure.
http://www.ncbi.nlm.nih.gov/pubmed/21188402 says the incidence is 1:10,000 women by age 20 years, and 1% by age 40, and then goes on to discuss genes which have been implicated in the development of the disease, namely BMP15, FMR1, FMR2, LHR, FSHR, INHA, FOXL2, FOXO3, ERα, SF1, ERβ and CYP19A1.
http://www.ncbi.nlm.nih.gov/pubmed/20668067 says
“On the basis of the references quoted in Table 1, the prevalence of known genetic alterations in POI patients can nowadays be estimated as ranging 20–25% of the cases originally classified as idiopathic. Therefore, the pathogenic mechanism still remains unknown in most cases. However, when a genetic alteration is found in a woman, it can be useful for family counseling because it can predict the female relatives that are at higher risk for POI and fertility loss in young age.”
Table I lists variant genes and their incidence in ovarian failure, e.g.
BMP15 variants 1.5–12%
PGRMC1 variants 1.5%
GDF9 variants 1.4%
NR5A1 variants 8% in 25 Europeans
FIGLA mutations 2% (in 100 Chinese)
So there are some suspected genetic causes of the disease – potential smoking guns. Was the 16 year old in your report tested for any of them? I don’t have a copy of the paper, can you check?
Dan Kegel – What a great debate you have had with Heidi, Christina and others.. Congratulations on the rational, sensible, well considered, non hysterical, pragmatic approach to your arguments.
In the conspiracy theorists world, you either agree with them or you must be a participant in the conspiracy. No one can exist who is otherwise informed and intelligent.
When they cannot play the ball anymore, the conspiracists always attack the person as a plan B strategy. I am pleased to see that this has not affected you as they intended.
Good on you. Keep up the good work and keep having fun doing so!
You lost the opportunity to engage in a conversation with your irrelevant and inappropriate comments, Dan. Your intent became clear. You’re a troll trying to redirect attention away from the real issue to give a false impression.
Heidi,
I didn’t look for anything nasty about you; I just looked briefly for your name, and found a page where you said you are a graduate of the British Institute of Homeopathy, a registered homeopath, an advocate for homeopathy, and a producer of Gaia Health, http://gaia-health.com; and pages at that stie which suggest you don’t believe that HPV causes cervical cancer and that you think evidence-based medicine is a lie. (Heck, it’s even in the title and URL of one of your articles, http://gaia-health.com/gaia-blog/2012-04-28/mens-cancer-treatment-is-ineffective-evidence-based-medicine-is-a-lie/ ).
That’s all quite relevant to the discussion here, which seems to have come down to conventional medical evidence and its trustworthiness. Your position on evidence-based medicine seems quite clear; you have rejected every piece of published evidence I have shown you, on the grounds, essentially, that mainstream medicine is fully corrupt and not to be trusted.
Is there any sort of evidence we could agree upon? For instance, do you agree in principle that double-blind clinical trials are a valid way to demonstrate that placebos can be effective at releiving pain?
Christina,
I believe I have disclosed my interests; my resume shows how I earn my living, and I already described my interest in science as a hobby. I also tend to write web pages about whatever I’m interested in at the moment. The cancer timetable took me about six hours (I should have been doing chores, but I had a stomach-ache, and played hooky). I really enjoyed putting it together, partly because I learned a few things while doing it, and partly because I’ve been meaning to do it for a while now.
I’m not in the age group that is supposed to get the vaccine, but my son will be in a year or two, and we follow the standard vaccination advice, so he’ll get the HPV vaccine, too.
Why do I care? Because I like theories that make accurate predictions, and dislike theories that make inaccurate predictions, and for better or worse, the scientific method seems to be the best tool in our toolbox for coming up with increasingly accurate theories.
How interesting. You couldn’t respond adequately to my comments, so you went out on the internet in search of something that you would consider nasty about me. That says all that needs to be said about you – no need to go on a search about you.
Regarding homeopathy, to suggest that it has anything whatsoever to do with this article or topic is absurd – utterly. You know that, but you think that you can use it as a means of attack, even though it’s totally irrelevant.
Your claim that I have a financial interest in disproving mainstream medicine is absolutely not untrue and just plain stupid. You presume that I make a living out of homeopathy. The fact is that I do not.
I don’t ask anyone to believe what I say based on who I am – but only on what I write and document, the same way I judge any other writing. Trying to suggest that there is any other legitimate way to know whether what I write is valid is … well, at best, it’s an attempt to redirect attention away from the fact that you were not successful in your points – that you were losing the debate.
You have demonstrated that you will attempt any sort of low-life scum attack, as long as it gets you what you want.
You are unable to win a legitimate debate, so you sink to an ad hominem attack, even to the point of inventing nonexistent claims – which is nothing but an attempt to redirect attention away from the topic, which, obviously, you were losing. And you’ve clearly demonstrated that you are a very bad loser.
Instead of parading around as a grown-up, why not try just growing up?
After you cited as a reference something that said just the opposite of what you said it said, I am reluctant to trust any reference you give. You said there was approval from the FDA for giving Gardasil to women over age 24, and you gave a reference that said just the opposite. The reference said approval was denied because there was insufficient evidence the vaccine did any good for women over age 24. That is the age at when you might expect cervical cancer to start actually showing up. And yet the vaccine was denied FDA approval for women over age 24. Credibility is important. I am actually surprised to see you continue to post here after misleading us as you did.
Dan have you disclosed all of your interests–financial and otherwise–in promoting HPV vaccines? Who helped you put together that time-table? If you did it yourself, it must have taken you a full day. Why do you care? What is your interest in promoting this relatively new vaccine that the government of Japan has dis-recommended for safety concerns as “very safe?” Have you had all 3 doses yourself? Did the doctor test you first to see if you were already infected with HPV?
Heidi,
I see from http://www.homeopathyworldcommunity.com/profile/HeidiStevenson
that you’re a homeopath advoate; and in
http://gaia-health.com/gaia-blog/2012-06-24/brit-scientists-show-hpv-vaccine-is-not-justified-anywhere/
you wrote
“the cause of cervical cancer is likely mostly associated with something that’s controllable in the environment”.
It seems you don’t believe that HPV causes cervical cancer.
So it seems you have a financial interest in disproving mainstream medicine;
if everybody followed science-based medicine, you’d be out of a job.
Why, then, should anybody trust you when you attack those who point out that your method of making a living is based on sugar pills and placebos?
You have to look a lot deeper than that to see the drug company ties. Look at the authors’ conflicts of interest. Look at who they work for. Remember that most universities are now beholden to pharmaceuticals. And then consider that the governmental agencies are also bought out, so any association with them is also highly suspect. Therefore, I am far from impressed simply because there’s no obvious pharmaceutical funding. And yes, the NCI is deep in pharma pockets, as well as the Nat’l Inst of Allergy and Infectious Diseases, and the NIH. They are anything but impassive observers. So, no – you have not cited anything close to solid science.
There’s a good deal more to VAERS than you acknowledge – like the fact that the rate of adverse effects for HPV vaccines is far higher – several times, in fact – than for any other current vaccines. Or that, at best, only 10% of adverse effects are reported, possibly no more than 1%.
I dont’ have time to fool around with you. Everything you’ve used to come back at my responses have been clearly shown to be invalid. I’ve far better things to do than continue with this – such as actually reading the studies and then reporting on them. Not just blindly quoting conclusions that, as often as not, are not supported by the evidence in them.
Heidi,
You’re quite right about bias in corporate-funded research. I hear drug companies often fail to publish negative results, or compare a new drug to a crappy old one instead of the best competitor. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1182327/ (“Why Most Published Research Findings Are False”) describes another bunch of problems related to the study’s power, bias, and how much of a fishing expedition it is.
So it’s worth being skeptical of studies by the vaccine manufacturer, and looking at independent studies.
And you’re right that a timeline centered on cervical cancer would be better, so I’ve put one together at http://hpv.kegel.com/cancer/ (including affiliations and sponsorship info when I could find it; thanks for the nudge).
Looking at the timeline, it seems Merck and Glaxo didn’t fund the studies that showed HPV is the cause of cervical cancer or that a VLP-based HPV vaccine could prevent HPV infection; most of that was done by universities, hospitals, and government institutes, and was independently verified. And http://www.ncbi.nlm.nih.gov/pubmed/23785124 by the CDC recently verified that incidence of HPV is falling in the US in vaccinated age groups.
So it seems the science on efficacy is sound.
Presumably you’re objecting mainly to the safety studies done by Merck, right?
I know of a couple that were done without funding from drug companies:
http://www.ncbi.nlm.nih.gov/pubmed/11181775 was a Phase I trial on a predecessor to Gardasil/Cervarix done by the National Cancer Institute, the Karolinska Institute, and the National Institute of Allergy and Infectious Diseases, and was funded by the NIH and National Cancer Institute. (Novavax was involved, too; they fabricated the experimental VLP vaccine).
http://www.ncbi.nlm.nih.gov/pubmed/21907257 was a big post-licensure study done by Kaiser and the CDC, funded by the CDC, that found no signfiicant safety problems,
So it seems we have some solid science on safety.
Against the backdrop of this solid science, you, Christine, and VAERS present a few reports of premature ovarian failure. As I wrote above, the background rate of ovarian failure by age 20 is about 1 in ten thousand, so those three reports out of ten million vaccinated girls don’t seem like a red flag, but infertility should be added to the next postlicensure study just in case.
P.S. I do not have time to waste on someone whose first response is so off-base and clearly intended to take the topic away from what’s at issue.
Trying to turn the topic back on me is not the point. The point is that YOU seem to believe that corporate-bought pseudo research is of any value. The fact is that the reality of it is now well documented, and if you’re unaware of that fact, then you need to inform yourself. My views on when or how it happened are irrelevant, and trying to draw me down that path is not legitimate debate, but merely an attempt to redirect away from the topic.
Your timeline is of no meaning. It’s out of context. As you admit yourself, it’s about warts, not cancer. It’s meaningless. Prevention of warts does not justify any risk in a vaccine, and has nothing to do with cancer.
Heidi wrote:
“Risk-benefit ratios defined by pharmaceutically-sponsored junk science hold little meaning …
It’s utterly shocking that anyone would promote as legitimate the garbage that passes as science supporting vaccines or the result of a less-than-greedy industry.”
Heidi, I’m interested in your belief that the science supporting the efficacy of vaccines is illegitimate. Presumably you agree that science itself is legitimate, but that at some point corporate greed corrupted things. When did that happen, in your opinion? Was it when Merck got involved?
I put together a timeline of the vaccine’s development at http://hpv.kegel.com/warts (the timeline is for genital warts, not cervical cancer, but the vaccine and much of the science is the same). If you could have a look and let me know what you think the last unsullied bit of science in the timeline was, I’d appreciate it.
Risk-benefit ratios defined by pharmaceutically-sponsored junk science hold little meaning to the thousands of people whose lives have been destroyed by this product or the parents who realize they’ve allowed their children to come to such harm – other than to call it what it is: statistical fraud.
Of course, it’s ever-so-easy to dismiss this comment as the ranting of a hysterical mind, rather than address the reality of fact that nearly all the studies that are published in so-called scientific journals are fraudulent, and that most of those that show negative results are buried.
It’s utterly shocking that anyone would promote as legitimate the garbage that passes as science supporting vaccines or the result of a less-than-greedy industry.
Hi Jennifer,
it doesn’t matter what you or I believe; what matters is what works, and what is safe. Don’t you agree?
Dan Kegel – Great reply. Rational, non hysterical, balanced, pragmatic and sensible. The risk benefit ratio demonstrated by all respected independent research and papers published by all the respected independent medical journals from many countries and independent peer reviews done by all of the medicines authorities from the different countries in the world show Gardisil has an extremely good risk benefit ratio. (sorry Jane, It’s true)
Hi Christina,
nope, I’m here more to fact-check. Deciding whether or not to vaccinate is important, and the decision should be based on high-quality evidence. http://en.wikipedia.org/wiki/Hierarchy_of_evidence gives guidance as to the relative quality (or usefulness for measuring risk) of various kinds of evidence.
VAERS reports are case reports, so they’re not suitable for measuring risks, but they are good for getting a handle on the potential range of problems; later studies of higher quality data are then needed to quantify the suspected risks.
http://www.ncbi.nlm.nih.gov/pubmed/19690307 looked at the VAERS reports for Gardasil, and tallied the reports of serious side effects; http://www.ncbi.nlm.nih.gov/pubmed/21907257 looked at records of large HMOs to measure how often various health risks occurred after Gardasil.
Neither of these studies involved Merck; they were done by the FDA, the CDC, and Harvard. They did not find significant risk from the vaccine.
You quoted four articles as giving evidence of risk. Let’s look at each of them briefly.
The first was a web page by Dr. Northrup which starts off with the false statement “The HPV vaccines Gardasil and Cervarix do not prevent cervical cancer or any other type of cancer.” It can therefore be discarded as untrustworthy. (Or do you contend that preventing HPV infections and abnormal pap smears does not lead to prevention of cancer?)
The second points to a study that says that, in normal mice, 1 part in ten million of injected aluminum makes it to the brain. Since a dose of Gardasil has about 200 micrograms of aluminum, that means a dose of Gardasil might lead to depositing 20 picograms of aluminum in the brain. This is an exceedingly small quantity. The study also does not demonstrate any harm.
The third page is a case study of a single girl who fell ill after being vaccinated.
The fourth is a case study of a single girl who became infertile after being vaccinated (we’ve come full circle, that’s the original subject of the web page we’re having this discussion on!). (As I wrote above, I checked VAERS, and found only two reports in the US of premature menopause after Gardasil, so that’s three reports of ovarian failure; the background rate of ovarian failure by age 20 is about 1 in ten thousand, so those three reports don’t seem like a particular danger signal.)
So that’s something like four reports of harm. How should we weigh this evidence against pubmed 21907257, which measured the rates of harm in about 200,000 vaccinees, and found no significant harm? The second study has about 200,000 times as much data as the case study, and is probably more trustworthy and useful for estimating risk. Even if you listed a hundred such stories, they wouldn’t begin to have anywhere the quality or quantity of data as pubmed 21907257, let alone the other two studies of about 200,000 HMO patients that had similar findings.
The evidence does not seem to be on the side of those who claim Gardasil is dangerous. Why do they persist in making those claims? In the case of parents whose children have fallen ill, and who blame vaccines for the harm, I think this is natural. We are built to make theories about the world based on what we see around us. Carefully looking at statistics is simply not in our genes! Heck, our gut feelings about even simple things like coin tosses tend to be wrong; see http://en.wikipedia.org/wiki/Coin_flipping#Counterintuitive_properties
So it’s no wonder that our intuition is a lousy guide to what’s true and not true about vaccines. Even doctors can be led astray by it (like Drs. Northrup and Weil; see e.g. http://www.sciencebasedmedicine.org/christiane-northrup-md-science-tainted-with-strange-beliefs/ ).
Cheers,
Dan
Hi Dave,
no, I don’t work for any health company, I’m a software engineer with a spare biology degree. (See my CV at http://kegel.com/resume.html .)
Jock’s point was that vaccine trials should compare vaccine with and without aluminum, right? That’s why I wrote
“meta-analysis of five trials of DTP vaccines with and without aluminum found no evidence of harm from aluminum ( see http://www.ncbi.nlm.nih.gov/pubmed/14871632 )”. I think that was on point. (If alum is bad in Gardasil, it’s probably bad in DTP and vice versa, right?)
Now that I look for it, I see that there was one early, small HPV vaccine study that compared the vaccine with and without aluminum: http://www.ncbi.nlm.nih.gov/pubmed/11181775
In this study, they gave 10 or 50 micrograms of VLP with 0 or 500 micrograms of alum. (For comparison, Gardasil contains 20 micrograms of VLP with 225 micrograms of alum.) The study said in part
“Most of the local and systemic reactions were classified as mild. Clinical responses of the subjects who received 10 μg of vaccine without adjuvant were almost identical to those of the placebo group. Subjects who received 50 μg of vaccine without adjuvant reported local side effects about twice as frequently as the placebo recipients.” At the low dose, the vaccine alone had fewer reactions than the one with alum, but at the high dose, the vaccine alone seemed to have more reactions than vaccine with alum (see Table 3 in the paper).
Since Gardasil has less alum than they used, and an intermediate amount of VLP, this study would seem to hint that the reactions due to alum in Gardasil should be comparable to or smaller than those from the VLPs. But it was a small study, and only looked for reactions for a week, so we should take that with a grain of salt.
You and Jock contend that the reason Merck did trials comparing Gardasil to a placebo also containing alum was to make their vaccine look good… but there’s a less malevolent possibility: they may have felt that aluminum in vaccines has been well-studied (e.g. pubmed 14871632 and 22001122 ), and just wanted to see what new things happened due to the new antigen without confusing it with the known level of reactions due to aluminum.
Speaking of new articles, here is one http://www.ncbi.nlm.nih.gov/pubme d/23902317
Human Papilloma Virus Vaccine and Primary Ovarian Failure: Another Facet of the Autoimmune/Inflammatory Syndrome Induced by Adjuvants.
Colafrancesco S, Perricone C, Tomljenovic L, Shoenfeld Y.
Am J Reprod Immunol. 2013 Jul 31. doi: 10.1111/aji.12151. [Epub ahead of print]
PMID: 23902317 [PubMed – as supplied by publisher]
Here’s the Abstract:
“Abstract
PROBLEM:
Post-vaccination autoimmune phenomena are a major facet of the autoimmune/inflammatory syndrome induced by adjuvants (ASIA) and different vaccines, including HPV, have been identified as possible causes.
METHOD OF STUDY:
The medical history of three young women who presented with secondary amenorrhea following HPV vaccination was collected. Data regarding type of vaccine, number of vaccination, personal, clinical and serological features, as well as response to treatments were analyzed.
RESULTS:
All three patients developed secondary amenorrhea following HPV vaccinations, which did not resolve upon treatment with hormone replacement therapies. In all three cases sexual development was normal and genetic screen revealed no pertinent abnormalities (i.e., Turner’s syndrome, Fragile X test were all negative). Serological evaluations showed low levels of estradiol and increased FSH and LH and in two cases, specific auto-antibodies were detected (antiovarian and anti thyroid), suggesting that the HPV vaccine triggered an autoimmune response. Pelvic ultrasound did not reveal any abnormalities in any of the three cases. All three patients experienced a range of common non-specific post-vaccine symptoms including nausea, headache, sleep disturbances, arthralgia and a range of cognitive and psychiatric disturbances. According to these clinical features, a diagnosis of primary ovarian failure (POF) was determined which also fulfilled the required criteria for the ASIA syndrome.
CONCLUSION:
We documented here the evidence of the potential of the HPV vaccine to trigger a life-disabling autoimmune condition. The increasing number of similar reports of post HPV vaccine-linked autoimmunity and the uncertainty of long-term clinical benefits of HPV vaccination are a matter of public health that warrants further rigorous inquiry.
© 2013 John Wiley & Sons Ltd.”
Dan Kegel,
Nice job completely ignoring Jock’s point. You don’t put aluminum in the control if want accurate results about the safety of a vaccine. But Merck has never been interested in accurate safety data, of course — it is only interested in creating the illusion that Gardasil is safe by whatever means possible. By the way, do you work for Merck? You seem to have quite the vested interest in defending Gardasil on this forum.
Thank you Jane and Jennifer. I am not really at liberty to talk about my daughter without her consent, else I would go into it more. Twenty-five years ago, my kids only got a few vaccines as babies; now they give kids so many more, starting on their first day of life. Vaccines have become hugely profitable since 2009. The industry has virtually no liability and gets huge amounts of governmental subsidy. Yet there seems to be new research all the time into the damage vaccines cause us, the most-vaccinated nation. “US Health in International Perspective: Shorter Lives, Poorer Health,” http://sites.nationalacademies.org/DBASSE/CPOP/US_Health_in_International_Perspective/index.htm#.UfwjsKTD9jo
dear Christina..thank you for taking the time to present a clear and concise reply with supporting evidence…people like Dan are the kind that write and edit wikepedia pages in support of “mainstream” allopathic medicine..no other point of view or belief is allowed to be inserted..and if it is it is immediately edited out…they think they have “science” on their side and know how to twist and turn any and all evidence or lack of such to their advantage..people like Dan have a clear vested interest in maintaining the “status quo”…to keep that money train going..if they have to damage people, even babies, then so be it…
Dear Dan, it seems clear your purpose here is to beef up the reputation of the Gardasil vaccine and persuade us it is as safe as Grandma’s chicken and dumplings. But no vaccine is “really, really safe.” Legally, vaccines are “unavoidably unsafe,” according to the Restatement on Torts, a classic lawyer’s reference work. We don’t have independent safety studies here to cite to; rather, we have Merck running its own clinical trials, and obviously it has a financial interest in finding the vaccine to be safe.
Here is Dr. Christiane Northrup again on HPV, saying the HPV vaccine is an unnecessary vaccine, so why have it, when the risk of harm is higher than the conceivable benefit?
http://www.drnorthrup.com/blog/2013/08/the-hpv-vaccine-what-you-need-to-know-today
And here is an article on a study on aluminum adjuvant in vaccines, “Vaccine Alum Adjuvant Path to Brain Found: Study. (Admin, April 12, 2013) http://gaia-health.com/gaia-blog/2013-04-12/vaccines-alum-adjuvant-path-to-brain-found/
Here is the story of a girl who got scleroderma after having the Cervarix vaccinations:
http://sanevax.org/my-daughter-cervarix-and-scleroderma-what-do-they-have-in-common/ (Admin, July 31, 2013)
“Absence of evidence of harm is not evidence of absence of harm,” but actually, there is plenty of evidence this vaccine has unacceptable level of risk, for me.
You yourself have no sources verifying your own claims (sorry, it’s true).
And of course science isn’t going to reproduce the exact problem of a unique human being, all it can do is generalize problems that can happen to the general population. The question is -is it worth the risk?- It comes down to: reduce the minimal risk of possibly one day having cervical cancer or substantially increase other risks, like entering menopause at 16 and other such reactions(http://www.judicialwatch.org/press-room/press-releases/new-fda-records-obtained-judicial-watch-indicate-28-deaths-related-gardasil-2008/)
Also, did you know that the lead developer of the vaccine no longer supports it? Know why? It doesn’t work, it’s dangerous, and it wasn’t tested properly. If you can’t honestly consider why the lead developer actively against it, despite whatever scientific proof you’re basing your argument on, then I hardly think you have a well-rounded view.
http://southweb.org/lifewise/the-lead-vaccine-developer-comes-clean-so-she-can-sleep-at-night-gardasil-and-cervarix-dont-work-are-dangerous-and-werent-tested/
There’s a good question here: what is good evidence of harm from a vaccine? Or, rather, how good are various kinds of evidence?
It turns out people have thought a lot about this question, and the answers are summarized by what’s called “the hierarchy of evidence” ( http://en.wikipedia.org/wiki/Hierarchy_of_evidence ); kinds of evidence are ranked roughly by how well they let you measure the effect in question.
Case reports, where a doctor gives a detailed report about a single event, the reports in VAERS, or something you saw happen to a cousin, are on the bottom of the hierarchy because they don’t let you calculate how often the effect occurs.
Meta-analyses of multiple randomly controlled trials are at the top, because they not only have detailed measurements of how often the effect occurs, they also check the measurements for bias and mistakes.
The studies towards the bottom of the hierarchy (case reports) are kind of an early warning system; they motivate scientists to do more controlled studies. (For instance, http://archpedi.jamanetwork.com/article.aspx?articleid=1363509 measured how often vaccinated women went to the doctor.)
So, in a debate where one person has a case report that says X, and another person has a meta-analysis that says Y, Y is probably right.
Does that make sense?
Unbelievable! Someone made an obviously sarcastic comment suggesting that the only way you would accept a vaccine-adverse effect connection would be if the person keeled over with needle in arm. And your response was to talk about how some people have psychological reactions to needles???
I’m not sure if you’re trying to evade the point or you really don’t get it.
Joann – There are lots of people who suffer psychological trauma from even the sight of a needle and who will faint when they have a needle put in there arm, just like some people do when they see blood or a baby being born.
Christina,
I’m sorry to hear that your daughter is ill.
You shouldn’t trust my opinion at all; you should look at the data. When I post, I link to the most solid-looking data I can find, and summarize it. I have no authority; all I have is a batchelor’s degree in biology ( my CV is at http://kegel.com/resume.html ) and an interest in science, in educating people about science, and in understanding other people’s viewpoints. What side am I on? On the side of safe and effective medicine. I don’t care whether it’s Western, Chinese, Indian, or Martian; all I care about is whether it works and whether it’s safe. So in a sense, we’re on the same side… I’m just more uniformly skeptical of claims about safety, risks, and efficacy than most people.
I agree, people should do their own research… but when they do, they should demand real, statistically significant data, not rumors or isolated testimonials.
About the question of getting vaccinated if you already have HPV:
as I wrote earlier, the 2006 safety review
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111287.pdf goes over the concern, looks at the data, and concludes
“Based on these data, CBER concluded that there was no clear evidence of vaccine related disease enhancement.”
But since you didn’t find that convincing, let’s find something clearer. How about
http://www.cdc.gov/std/hpv/stdfact-hpv-vaccine-young-women.htm
which says
“Ideally females should get the vaccine before they become sexually active and exposed to HPV. Females who are sexually active may also benefit from vaccination, but they may get less benefit. This is because they may have already been exposed to one or more of the HPV types targeted by the vaccines. However, few sexually active young women are infected with all HPV types prevented by the vaccines, so most young women could still get protection by getting vaccinated.”
So there you have it – the CDC says that it’s ok to get vaccinated if you already have HPV.
You wrote
“[Gardasil targets] … two rare ones associated with cervical cancer”
Call me picky, but it sounds like you’re trying to downplay the usefulness of the vaccine here by calling the strains it targets ‘rare’. So let’s see if they are.
The two cancer-causing strains it targets are HPV16 and HPV18.
http://www.ncbi.nlm.nih.gov/pubmed/21067372 estimates their prevalence in *healthy* women as HPV-16 (3.2%) and HPV-18 (1.4%); http://www.ncbi.nlm.nih.gov/pubmed/17405118 estimated “Combined HPV16/18 prevalence among ICC (invasive cervical cancer) cases was slightly higher in Europe, North America and Australia (74-77%) than in Africa, Asia and South/Central America (65-70%).”
So, rare in healthy women, but very much not rare in cancerous women.
I’d like to understand why you find the measurements scientists have done and the current statements from the FDA and CDC so much less convincing than the unverified theories of Dr. Christiane Northrup. You wrote:
“I believe my daughter’s immune system was damaged by the HPV vaccine.”
so I suppose it was your daughter’s illness that convinced you HPV was harmful.
What did your doctors say she had?
Dan Kegel, in answer to your question, I read the first clinical trials, and that is where I read if you already have the HPV virus, you should not get vaccinated with the HPV vaccine. I found them at either the CDC or FDA website. It was a long time ago. What is your authority; why should anyone trust your opinion on whether or not they should get vaccinated? Are you a doctor? It would be better, I hope you would agree, to present information and let people make up their own minds–ever if you were a doctor. Try to present it fairly, not just “your side.” I believe my daughter’s immune system was damaged by the HPV vaccine. People think it safe. People trust. The HPV vaccine is raking in millions of dollars for big Pharma. And the girls who are injured or killed are ignored, as plans are made by Merck to make an HPV vaccine that targets 7 strains of the 40 that are spread by sexual contact, instead of the two strains that cause warts and two rare ones associated with cervical cancer in the current vaccine. Will that mean more aluminum adjuvant in the vaccine when there are more strains of virus present? People, please do your research. Some of us can’t live online to post constant rejoinders to comments touting the benefits of vaccines.
Absolute proof? Science doesn’t work that way, sorry. It looks for good evidence, i.e. effects that are repeatable and not due to chance or bias.
There’s really, really good evidence that the vaccine is safe and effective.
There are also swirling rumors about people who took vaccine and to whom Bad Things Happened. Whenever scientists try to reproduce the problems (e.g. by watching 200,000 women for health problems in the six weeks after they get vaccinated), they don’t find Bad Things Happening any more often than in women who weren’t vaccinated.
So, yes, absolutely, balance pros and cons… but make sure the pros and cons you’re weighing are solid facts from looking carefully at an ensemble of events, and not just one-off testimonials.
But where is the absolute scientific proof that the vaccine does what it says it’s supposed to do? Isn’t it a little vaccine-happy to just ‘go with the flow’ without need or balancing the pros verses cons?
Let’s look at the data:
Teen pregnancies are down significantly (by 20% to 34%) from 2007 to 2011:
http://www.cdc.gov/features/dsteenpregnancy/
Percent of girls who have never had sex increased slightly (by 6%, from 54% to 57%) from 2002 to 2006-2010:
http://www.cdc.gov/nchs/data/series/sr_23/sr23_031.pdf
Condom use among teens declined (by 5%, from 63% to 60%) from 2005 to 2011:
http://www.childtrends.org/?indicators=condom-use
According to http://www.guttmacher.org/pubs/win/contraceptive-needs-2010.pdf,
“Between 2002 and 2006–2010, the actual mix of methods used by women obtaining publicly funded contraceptive services improved, primarily due to the use of long-acting reversible methods, which increased from 4% to 11%, and the complementary decline in reliance on condoms or nonprescription methods, from 25% to 17%. As a result, the number of unintended pregnancies expected each year per 1,000 women using publicly funding contraceptive services fell from 67 to 62.”
So it seems likely that the decline in pregnancies is mostly explained by a shift from condoms to long-acting methods (like injectables or IUDs?).
Also, if it were due to vaccination, you’d expect to see genital wart rates decline only in, or faster in, women rather than men, and that’s just what has happened;
genital wart rates are going up among young males in Denmark and Sweden at the same time as rates are declining among young women, and in Australia, which has the highest vaccination rate, genital wart rates among young men are falling slower than among young women.
Still think the decline in genital warts isn’t due to the vaccine?
Not necessarily, at least in our country teen pregnancies have gone down due to more teens practicing abstinence and sexually active teens reporting higher condom usage. (according to CDC)
Unless the patient collapses w/ the needle in their arm, there’s no proof, right?
Thank you, Jock. You are absolutely right, and that is a highly significant point. That it is allowed is stunning – and tells us something highly important about whether to trust the trials of the company that wishes to profit from a product … and also about the FDA, which allows the practice.
There is a huge difference between ingesting something and injecting it. Comparing the two is meaningless.
I am so sorry to hear this. Please, do have your daughter checked.
I believe that it merely means having the virus. The wording of the FDA’s report leaves that as the only interpretation.
Most assuredly, they should be testing for existing HPV before injecting … but they don’t. It clarfies that health is clearly not the real reason behind the HPV vaccine.
Hi MaLinda,
I’ve seen no evidence that Gardasil can cause endometriosis, so from all I can tell, you made the right decision.
For what it’s worth, it looks like the chances of getting endometriosis are about 1 in 2000 per year ( http://aje.oxfordjournals.org/content/160/8/784.full ).
Brad,
to your question
“1) has Gardasil been shown to lower the incidence of cervican cancer”,
High-grade cervical lesions are the immediate precursor to cervical cancer, and there’s evidence both in clinical trials and from pap smear registries that Gardasil prevents those – and thus nips cervical cancer in the bud.
(http://cancerpreventionresearch.aacrjournals.org/content/2/10/868.short studied 9000 vaccinated women, and found “Vaccine efficacy against HPV 6/11/16/18–related high-grade cervical lesions in the per-protocol and intention-to-treat populations was … 93.3%-99.8% and 40%-60%, respectively.”
http://www.vccr.org/downloads/VCCR_stat_report_2011_FINAL.pdf shows that the rate of precancerous cervical lesions (i.e. positive pap smears) in women under 20 has gone down 50% in Victoria, Australia about five years into the national HPV vaccination campaign, matching the 40%-60% result from the clinical trial.)
To your question
“2, has it been shown that it lowers mortality?”
Given that cervical cancer takes ten years or more to develop and kill someone, it’ll be another five to ten years before enough deaths have been prevented to show up in solid statistics, but given the vaccine’s effectiveness preventing precancerous lesions, there is little doubt that it will prevent cancer and reduce mortality from cancer.
To your statement
“The only way they can get HPV is by having sex”,
You can get HPV from what used to be called heavy petting, and a lot of kids don’t consider that to be sex.
Hi Jock,
Aluminum has been widely used in many vaccines since the 1940’s ( see http://www.sciencedirect.com/science/article/pii/S0169409X98000088 , http://www.ncbi.nlm.nih.gov/pubmed/12184360, )
It’s included because it causes a much stronger immune response; the vaccine probably wouldn’t be very effective without it.
And a recent meta-analysis of five trials of DTP vaccines with and without aluminum found no evidence of harm from aluminum ( see http://www.ncbi.nlm.nih.gov/pubmed/14871632 ).
I, my family, and probably just about everybody I know have had vaccines containing aluminum, with the worst reaction having been a sore arm.
So I think the fears about harm from aluminum are unfounded.
This vaccine is still so new that you cannot say there are millions of girls who have not had those problems. The full impact of making guinea pigs out of our young men and women is yet to come, and it will not be good…
Most people don’t know that, in the original trial, the FDA allowed Merck to put reactive aluminum in the *placebo* – so that their poisonous Gardasil vaccine, which also contained reactive aluminum, would not compare unfavorably in their clinical “trial” (experiment) on young girls.
Two questions: 1. Has Gardisil been shown to lower the incidence of cervical cancer, and 2, more importantly, has it been shown that it lowers mortality? The answers- NO and NO. Think twice about giving this to your children. The only way they can get HPV is by having sex.
If you have any advice, please message me!
My daughter was just recently diagnosed with endometriosis at the age of 16 years and 11 months. I was very adamant about getting her vaccinated with the Gardasil, however, was pressured by my Pediatricians office, so after discussion with her father, we went forth and she was vaccinated starting at age 12. Here we are 5 years later, and worried that this new diagnosis could potentially be related to the Gardasil. Feeling like quite a failure as a parent. Should have went with my gut.
Toril,
What you mean is that people who have been vaccinated have had problems with reproductive processes. But so have people who have not been vaccinated. There is no respected substantial evidence to show that people who have the Gardasil vaccine have a disproportionate number of problems. Only anecdotal examples that are found to fit the conspiracy model. Do you get the difference?
Congratulations, you’ve about to become a grandmother! Seriously, this is nothing more than a hoax. No verified sources anywhere – look for yourself.
Hi Christina,
I’ve replied to Norma’s post about the recent study, answering a few of her questions (see my comment there). I think the recent genital wart trends in the four countries that have posted data (Denmark, Germany, Australia, and Sweden; see http://hpv.kegel.com/warts/#campaign ) demonstrate fairly conclusively that HPV rates are going down among young women, especially in countries with high vaccine coverate.
After reviewing the genital wart trend info, do you still feel that the HPV vaccine is ineffective at preventing HPV infections?
By the way, I apologize for the double reply to your earlier post — my first reply didn’t seem to show up when I checked, and I assumed I had forgotten to click ‘post’ before shutting off my computer. (The second version seems better, so maybe it’s just as well.)
Hi Christina,
yes, my bad. However, the document still says the things I said it did. The FDA did approve adding that safety data for women 27-45 years of age to the package insert. (See http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM094042 for the master page on this stuff.)
Let’s also look at the 2006 safety review,
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111287.pdf
It says
“HPV related disease in non-naïve subjects
An exploratory subgroup analysis for study 013 suggested a concern that subjects administered Gardasil who were seropositive and PCR positive for the vaccine relevant HPV types had a greater number of CIN 2/3 or worse cases as compared to such subjects administered placebo. Review of the potential imbalances in baseline characteristics of this subgroup revealed that a higher percentage of these subjects administered Gardasil had High Grade Intraepithelial Lesion (HSIL) on Pap test at baseline [6.5%] as compared to placebo recipients in this subgroup [3.7%]. …Based on these data, CBER concluded that there was no clear evidence of vaccine related disease enhancement.”
The rumor about the vaccine being harmful to HPV-positive women came from probably started when somebody looked at the first part of that without noticing that the data was imbalanced, and that the increased rate of disease had to do with pre-existing conditions.
Thanks for the correction, and for giving me an excuse to go look this stuff up. Having reviewed the above, are you aware of any data that supports claims that the vaccine is harmful to HPV-positive or preganant women?
Sorry, I live in Australia … apart from drawing parallels with vaccine damage and chemical damage (same thing really) this may interest some of you also as Agent Orange is alive and well in your country also 🙁
http://www.abc.net.au/4corners/stories/2013/07/22/3806111.htm
Did anyone watch Monday night’s 4 Corners report on the ABC, The Chemical TIme Bomb? … (Agent Orange is still well and truly with us) Two things stand out for me here … One, a statement by the foreman still alive 30 years later trying to fight for compensation .. “It was a mistake to trust the Government” … and two .. we should not be naive, especially when it comes down to dealing with bureaucrats whose orders knowingly or not are given to protect the chemical and pharmaceutical companies at the stake of their shareholders …. meanwhile many suffer at such great personal cost with chemical and pharmaceutical damage …. to believe otherwise is just plain ignorant. Time always tells 🙁
TWO WORDS POPULATION CONTROL
How many cases of this are there and how would you know if you are or oral contraceptives?
Hi Christina,
oy, these government documents. Thanks for pointing out my error.
The document came from the FDA’s approvals page for Gardasil,
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM094042
The second and third links there,
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM251739.pdf
http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm251025.htm
show what happened: the FDA allowed the manufacturer to include data on women aged 27 to 45 in the vaccine packaging insert. This was labelled “Approval Letter”, hence my confusion.
That said, the document I pointed to did have the safety information I said it did, so I think my post stands, except for the part were I said the vaccine was approved for older women.
But as long as I’m looking at that page, the document labelled “Clinical Review – Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant – Gardasil, June 8, 2006”,
http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111287.pdf
actually does say “The clinical data provided support approval of Gardasil in females 9-26 years of age”, and has similar safety data on pregnancy (though the sample size is smaller) and on HPV-positive test subjects (after Table 35, it says “Overall, 15.5% of subjects were HPV DNA positive for at least one of the four vaccine types”, and before Table 62, it says
“There was a higher proportion of Gardasil seronegative and PCR negative subjects with systemic AEs (adverse effects) as compared to Gardasil recipients who were seropositive or PCR positive at baseline, although there were similar differences between the two placebo groups (who received the same placebo), thus the clinical significance of these
differences is uncertain.” So there were no more adverse effects in those who were already exposed to the virus.
Did you have some evidence showing that there are *more* adverse effects in women who were HPV DNA positive before vaccination?
Cheers,
Dan
Just a few things from sanevax: On July 22, 2013, Norma Erickson wrote a piece critiquing the questionable methodology in the recent “study” purporting to show that cases of HPV infection in teens have gone down.
http://sanevax.org/hpv-vaccines-resounding-success-or-future-failure/
And here is sanevax on reports of adverse events from the HPV vaccine from March 2011 through March 2012. http://sanevax.org/hpv-vaccine-vaers-reports-march-2012/
There are two stories on Japan’s withdrawing its recommendation on the HPV vaccine at sanevax.org. Just search “hpv” at the site.
It seems quite clear to me that a live virus vaccine is potentially more dangerous, since it can cause infection. But then perhaps I’m more familiar with molecular biology than the average bear (I did study it in college).
I haven’t overlooked the VAERS reports of death. In fact, I looked at them quite carefully; see my tally at http://hpv.kegel.com/safety/vaers.html
I counted only 22 credible reports of deaths in the US, and half of those involved additional vaccines or drugs; there was no discernable pattern linking the remaining dozen or so deaths. Still, the medical community took the reports seriously, and looked for similar problems in two very large studies (about 200,000 vaccinated women each); no significant extra risk from the vaccine was found. (See http://hpv.kegel.com/safety/ for links.)
I just noticed that you wrote “this vaccine should never be given to anyone who might be pregnant, as it caused significant birth defects in the first clinical trials.” Do you have a reference for that? I haven’t seen any reports of birth defects for Gardasil.
Do you agree with Dr. Northrup that a healthy immune system is invulnerable to HPV?
Dan, what you sent me was not the approval review for older women; it was a rejection of approval for older women. Do you have something else? The conclusion was: “The clinical reviewer concluded that the data submitted do not support a recommendation for approval of the request to extend the current indications for Gardasil to the population of women 27-45 years of age.”
Higher up in the document, “Efficacy in the prevention of high grade cervical disease was not established. In addition, for a number of other outcomes, including prevention of genital warts, prevention of abnormal Paps, and prevention of definitive cervical or genital therapy, the data did not establish a substantial benefit in a population of women 27-45 years of age unscreened for past or current HPV infection.That was in 2010. http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM251763.pdf
Would you please be sure this document says the other things you said it says, or find a document that does, if you can.
Gardasil is still a relatively new vaccine for which data are still being accumulated as to its safety and effectiveness. Please don’t overlook the many cases of vaccine injury or death among young girls who have had the Gardasil or Cervarix vaccines. “Inherently safer” is a stretch.
Hi CWaldman,
The FDA recently approved the vaccine for use in older women. Here’s the approval review: http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM251763.pdf
As you can see from Table 4, about 8% of the studied group were positive for HPV DNA, but no safety problems were observed during the studies.
So yes, the vaccine is safe for people already infected with HPV.
That same document says that there were 499 pregnancies during the study period, and no safety problems were observed in those pregnancies.
It’s worth noting that Gardasil is not based on a live virus, but Rubella vaccine is; therefore rubella vaccine can cause viral infections in newborns or immunocompromised individuals, but Gardasil can’t.
The safety data and nature of the vaccines are why Gardasil is officially category B (“not recommended for pregnant women”), whereas rubella vaccine is category C ( “contraindicated for pregnant women”).
So it’s not that times have changed – it’s that Gardasil is inherantly safer than Rubella vaccine.
What is your source for saying that, Dan? I read the first clinical trials on Gardasil and I distinctly remember that if you already had the HPV virus present in your body, the vaccine was contraindicated. The point Heidi made is that they tested male testes but if they tested female ovaries, which would have been fair, they did not say so. Did they know in advance of marketing that the vaccine might injure female ovaries and withheld the information? People are entitled to make informed consent based on full disclosure of all risks and benefits. To withhold information and thus cause someone to be injured would, arguably, be criminal fraud.
I also remember reading in the first clinical trials that you should not have the vaccine if you might be pregnant, due to the risk of birth defects. My daughter was not asked if she was pregnant before getting any of her 3 Gardasil shots. When I was 13, my family doctor refused to give me a rubella vaccination because he would not take the risk I might be pregnant. How times have changed! Now they target women of child-bearing age for vaccination with a vaccine known to cause birth defects. Although, I have seen in the literature on this vaccine since then, that the risk of birth defects is: “not known.” Hmmmm.
I just checked, and found only two VAERS reports in the US of premature menopause after Gardasil. Over 26 million doses have been distributed in the US, or about ten million vaccinated girls. That’s about a one in three million chance (judging by VAERS, which one shouldn’t do). For comparison, http://www.ojrd.com/content/1/1/9 estimates that by age 20, about one out of ten thousand women suffers from premature ovarian failure.
So I’m not sure what the excitement is about. So far I don’t see evidence of excess risk.
Also, Christina, there is no reason to avoid giving the vaccine to someone who already has HPV; it just won’t help them against the strain they already have. (Some people misread a study’s results, and claim it will harm them, but that’s inaccurate.)
Polysorbates are in everything! Read your labels, everything from toothpaste, mouthwash, eye drops every kind of processed food, soaps, medications you name it. Its a preservative and it has lots of other names too like sorbitol. So think about that….I doubt that polysorbates are the cause unless you are allergic.
They are jumping to conclusions and using insinuation instead of rational proof and logic. Even if it was caused by Gardasil, there has been so many millions of girls who have not had these problems that the statistics are greater that they would have cancer due to the hpv virus….along with genital warts and other problems such as passing it to their children during vaginal birth and the subsequent problems. When something is written so one sided without balance, beware.
Trevor,
There is nothing in the vaccine that previously has been shown to make noses fall off. There are, however, a couple of ingredients in the Gardasil vaccine that has been proven to interfere with reproductive processes in otherwise healthy people. Do you get the difference?
If your daughter wishes to start a family and has any issues trying, you may be rethinking all the stuff she was injected with.
It is a pain in the butt to report to VAERS (Vaccine Adverse Event Reporting Service), but anyone who thinks his or her child has been injured by the vaccine should report it. There have been many reports made to VAERS about Gardasil. Japan no longer recommends the HPV vaccine because of the many adverse events reported.
(At Sanevax.org, search HPV for two articles on Japan.)
See generally on HPV
http://sanevax.org/news-blog/vaccines/vaccines-against-hpv/
On July 22, Norma Erickson wrote a piece criticizing the recent “study” purporting to show cases of HPV infection in teens have gone down, but using questionable methodology
http://sanevax.org/hpv-vaccines-resounding-success-or-future-failure/
http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm(FDA page “last updated 2009”; they’re really on top of this).http://voices.yahoo.com/gardasil-vaccine-injuries-1345645.html (2008; already so many injuries!)http://truthaboutgardasil.org/injuries/
http://vaers.hhs.gov/index
http://sanevax.org/hpv-vaccine-vaers-reports-march-2012/ (March 11 to March 2012)
http://www.cdc.gov/vaccinesafety/Vaccines/HPV/HPVArchived.html (Page last updated 2/7/2011 by our really concerned Center for Disease Control.)
As Barbara Loe Fisher, founder of the National Vaccine Information Center, said, “While it is illogical and unscientific to assume that all serious health problems following vaccination are causally related, it is more illogical and even less scientific to assume that all serious health problems following vaccination are not causally related. (Barbara Loe Fisher, “Silenced Witnesses: The Parents’ Story, Vol. II, Ch. One by Barbara Loe Fisher, “The Vaccine Safety and Informed Consent Movement in America,” and frontispiece, ed. Martin Walker, Slingshot Publications, London 2009.
We have had our daughter vaccinated and it is amazing, she is still alive ad her nose hasn’t fallen off. Merck did not test for this either!
There is absolutely no evidence that this one case of premature ovarian failure has anything at all to do with the vaccine. Girls who have been vaccinated will nearly all suffer from some disorder during their lives. Are you going to attribute ALL of these disorders to the vaccine.
I’m in the process of having my 17 year old tested after her vaccines she came down with chronic fatigue and now her periods have been absent for 9 months
So does this mean having an active infection, or does having the virus latent in your cells also endanger you with this vaccine? I have read HPV can insert itself into your DNA, like herpes virus does. I ask because so very many would have been exposed, according to the sources I cited in my previous comments today.
I don’t know, and I wonder if the vaccine manufacturers know, either. But maybe they should be testing for it before they vaccinate these young kids.
I may have to correct myself. I thought I had read HPV infection usually cleared within a few weeks, but the CDC says within 2 years, and this source and several others say within a few months (or longer). Quote: “HPV types 6 and 11 are frequently found in sexually active adults, and are associated with low-grade squamous epithelial lesions. HPV types 16, 18, 31 and 45 are found less frequently, and are associated with progression to invasive cancer.” Swygart C.,
Clinical Microbiology and Public Health Laboratory, Addenbrooke’s Hospital, Cambridge, England, UK. Abstract, “Human papillomavirus: disease and laboratory diagnosis,” Br J Biomed Sci. 1997 Dec;54(4):299-303.
http://www.ncbi.nlm.nih.gov/pubmed/9624741
So, which strains is Gardasil supposed to protect against? 6 and 11, 16 and 18, says the National Cancer Institute Fact Sheet on HPV, worth checking out. There are over 150 HPV viruses. More than 40 are sexually transmitted, but you can see in the paragraph above, only a few are associated with cancer.
http://www.cancer.gov/cancertopics/factsheet/prevention/HPV-vaccineSource
Abstract to Swygart article, cited above:
Human papillomaviruses (HPVs) can be classified biologically or phylogenetically into cutaneous or mucosal types. Cutaneous papillomaviruses produce benign skin tumours (warts) which occur commonly on the hands, face and feet. They spread readily among children and young adults during recreational activities. Laboratory diagnosis of skin warts is usually unnecessary as they can be distinguished morphologically. Large numbers of cutaneous warts may develop in patients with epidermodysplasia verruciformis, a rare familial disorder. Exposure to sunlight sometimes causes these lesions to progress to skin cancer. HPVs are the most common sexually transmitted viruses, infecting both men and women. They can be transmitted from the vagina at birth, and may cause recurrent respiratory papillomas in childhood or adult life. Genital infection usually clears within a few months, but may persist in some individuals. HPV has been firmly linked with cancer of the cervix, and is also associated with cancer at other mucosal sites. The distribution of genital HPV types varies and is related to the degree of cervical dysplasia present. HPV types 6 and 11 are frequently found in sexually active adults, and are associated with low-grade squamous epithelial lesions. HPV types 16, 18, 31 and 45 are found less frequently, and are associated with progression to invasive cancer. Commercial dot blot hybridisation and DNA-RNA hybridcapture assays are available for laboratory diagnosis of genital HPV infection. The polymerase chain reaction (PCR) is used for diagnosis and epidemiological surveys. Detection of particular HPV types could be useful in the diagnosis and management of cervical cancer in older women, and for resolving equivocal (borderline) cytology. HPV assays, which can distinguish between high-grade and low-grade disease, may also have a role in routine cervical screening.
PMID: 9624741 [PubMed – indexed for MEDLINE]
Research, weigh, discern. Go to National Vaccine Information Center, truthaboutgardasil.com
That is, in fact, completely true about not injecting an HPV vaccine into someone with a preexisting infection. That was noted by the FDA before they approved it! It actually increases the likelihood of developing the same cancer that the vaccine is supposedly intended to prevent.
This is a very sad story and a warning to all. Read what Dr. Christiane Northrup has to say about the HPV virus in her book, “Women’s Bodies, Women’s Wisdom. She says HPV is normally found in 50% of adult and 40% of children’s genitals and does no harm usually. The body’s immune system generally clears an HPV infection within a few weeks. She says she suspects HPV’s presence at the site of cervical dysplasia is most likely like that of a buzzard circling over a sick calf; the buzzard did not cause the calf to get sick. It is an opportunist.
One of many concerns I have about the Gardasil vaccine is that I have read, I believe, that it should not be given to anyone who has the HPV virus already present in their body. If you do give it to them, it can harm them.
All this business about the vaccine reducing the prevalence of no more than two strains of the virus (out of many existing strains of HPV) in teens according to a questionable study. So what? I agree with Heidi. This vaccine has never prevented a single case of oral, cervical, or anal cancer, yet it is being given to prepubescent kids. I worry so about this vaccine and the long-term harms it will surely cause. And yet Merck is now working on an new and improved vaccine which is supposed to work on 7 of the many HPV strains, not just two. Our children are guinea pigs for this vaccine. Incidentally, this vaccine should never be given to anyone who might be pregnant, as it caused significant birth defects in the first clinical trials.