FDA Rejects – Health Canada Accepts

Merck Dodges FDA Bullet and Wins Approval for Gardasil Expansion from Health Canada

by Leslie Carol Botha
Vice President Public Relations


PRLog (Press Release) May 02, 2011 – SANE Vax Inc. is highly disturbed Merck has not taken FDA advice to prove vaccine efficacy in 26 to 45 year old women prior to getting approval from other governments for use in this age group. According to a press release issued by Merck on April 6, announcing the FDA’s decision not to expand use for Gardasil for this age group: “An indication for adult women was not granted; instead, the Limitations of Use and Effectiveness for GARDASIL was updated to state that GARDASIL has not been demonstrated to prevent HPV-related CIN 2/3 or worse in women older than 26 years of age.”(1)

According to Ed Silverman at Pharmalot:

“Less than a month after the FDA refused to approve the Gardasil vaccine for preventing HPV in women ages 27 to 45, Health Canada has gone in the other direction and issued an endorsement. Although Canada is a smaller market than the US, the approval is a notable step for Merck, which has been counting on a larger demographic target to boost sorely needed vaccine revenue.”(2)

On April 26, 2011, Merck Canada (http://merck.ca)  issued a press release announcing the expansion stating:

“… Health Canada has extended the indication of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Recombinant Vaccine] in women up to the age of 45. Merck’s HPV vaccine is now approved for girls and women nine through 45 years of age for the prevention of cervical cancer, vulvar and vaginal cancers, precancerous lesions and genital warts caused by the Human Papillomavirus (HPV) types 6, 11, 16, 18. Previously, GARDASIL® was approved in girls and women nine through 26.” (3)

On April 26, 2011 Health Canada stated: Nothing – nor has the government agency released confirmation or a release regarding the expansion of Gardasil to this older demographic now subjected to a potentially dangerous vaccine.  According to Leslie Carol Botha, Vice President of Public Relations at SANE Vax, Inc.,:

“A press release from Merck without corroboration from the corresponding government agency is akin to Merck’s studies on Gardasil safety and efficacy without an independent assessment.”

Merck’s Press Release Slap in Face to FDA?

One has to wonder what type of marketing/political maneuvering Merck is doing in an attempt to regain market shares and to ‘boost sorely need vaccine revenue’ in the Canadian market.  The SANE Vax team is wondering if the Merck announcement is a slap in the face to the FDA decision. One thing is for certain – the issue of Gardasil safety and efficacy has been sidestepped/ignored in lieu of Merck’s political and financial posturing.

The question remains – at what cost to women?

Merck’s April 26 press release also quoted Dr. Vivien Brown:

“The decision to be vaccinated against HPV-related diseases as an adult should be taken by each individual woman in consultation with her healthcare professional,” said Dr. Vivien Brown, a family physician on staff at Mount Sinai Hospital, the University Health Network and North York General Hospital. “The HPV quadrivalent vaccine is not only for young people, both girls and boys, who have not yet been exposed to HPV, it’s also effective in older women.”

Just wait one minute…the vaccine is for boys and girls not exposed to HPV – No one knows who has been previously exposed and no HPV tests are recommended prior to vaccination. No one knows, or seems to care if the carcinogenic strains HPV 16 & 18 are even prevalent in this part of the population. Nor does anyone seem to know whether the HPV vaccine will stimulate other carcinogenic strains. Furthermore, an older woman is more likely to have been previously exposed to HPV.  How will this pre-exposure plus vaccination affect her health outcomes?

What is the difference between the FDA’s Decision and Health Canada’s?

We believe the FDA has listened to concerns expressed by SANE Vax, Inc. (http://sanevax.org),   Truth About Gardasil (http://truthaboutgardasil.org) and individual medical consumers regarding Gardasil vaccine safety and efficacy. Peer reviewed analysis, government studies, and constant press releases pointing out the flaws in the clinical trials and the approval process have been issued to the public as well as to FDA contacts. SANE Vax Inc. has written letters expressing our science –based concerns to FDA Commissioner Margaret Hamburg and to former VRBPAC chair Jack Stapleton.  The FDA decision might very well lie in the fact they know that we know the truth about Gardasil –the vaccine has not been demonstrated to prevent HPV-related CIN 2/3 or worse in any age group of women.

Where is the Research, Merck?

Canadian women should be demanding to see this research as well.  Obviously, Health Canada is not representing their welfare by bowing to pharmaceutical/political pressure. Where is the transparency in Health Canada’s agenda?  How can the vaccine not be proven effective in the U.S. and yet deemed effective in this age group of women across our northern border? And who chose this arbitrary age?  And why is the vaccine not effective in 26 to 45 year old women and effective for 9 to 25 year olds?  These are questions that need to be answered and answered now.

SANE Vax Inc. seriously doubts Gardasil is effective in any age group of women no matter the country they reside in.  We also believe Gardasil has not been demonstrated to prevent CIN 2/3 or worse in women younger than 26 years old. Until adequate research is presented to demonstrate its safety and efficacy, Gardasil is nothing more than another tool used to exploit women’s pelvic goldmines.


1. U.S. Prescribing Information for GARDASIL® Updated; Indication Not Granted for Use in Adult Women – view http://www.merck.com/newsroom/news-release-archive/vaccine-news/2011_0406.html

2. Canada Approves Gardasil For Use in Most Women – Pharmalot – view http://www.pharmalot.com/

3. HEALTH CANADA APPROVES GARDASIL® FOR WOMEN UP TO AGE 45 – view http://www.merck.ca/assets/en/pdf/press/product_info/gardasil/press_releases/Gardasil_Adult_Women_Release_EN.pdf

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SaneVax believes only Safe, Affordable, Necessary & Effective vaccines and vaccination practices should be offered to the public. Our primary goal is to provide scientific information/resources for those concerned about vaccine safety, efficacy and need.

Author: Leslie Carol Botha

Author, publisher, radio talk show host and internationally recognized expert on women's hormone cycles. Social/political activist on Gardasil the HPV vaccine for adolescent girls. Co-author of "Understanding Your Mood, Mind and Hormone Cycle." Honorary advisory board member for the Foundation for the Study of Cycles and member of the Society for Menstrual Cycle Research.