Chapter 6: Article 2
The HPV vaccine was tested differently from most vaccines. That testing measured how protective the vaccine is against HPV infection. Most effectiveness trials measure anti-bodies only, they don't measure protective effects.
The testing proved that in the 16-24 year old age group, having vaccine anti-bodies did reduce incidence of specific HPV infections and CIN lesions for a period of time. In your doctors office, and through vaccine marketing, young women hear that HPV vaccination prevents cervical cancer. The vaccine's affect on reducing cancer was NOT tested or measured.
Dr. Harper explains during her radio interview that it is unknown whether or not the HPV vaccine prevents cancer. That discussion begins with her explaining how the HPV vaccine testing process worked. She said (emphasis mine):
It’s important to first understand what are you going to ask the patients to do. From the company’s perspective, [the participants] are going to get three shots, and the company has to know whether something bad happens to them immediately, after getting the shots or not. And then the company has to have some measure to say whether the vaccine is worthwhile or not. And the question then becomes what are you going to measure. And in this particular case, we can’t let women, it’s not ethical to enrol women in a trial, and let them proceed on to develop cancer, and another group, intervene, and ...by giving them a vaccine, potentially not letting them get cancer. So obviously cancer was not an ethical endpoint to use, to determine whether or not the vaccines would be effective or not. …So the first obvious end point that we would think about would be, “Well let’s show whether or not people got infected with the virus. If the vaccine’s supposed to prevent you from getting infected with it, then we should be able to see that you don’t get infected.” So that was the first end point.
And on this topic, in the Huffington Post article, Dr. Harper also states:
Gardasil is not really a cervical cancer vaccine. The vaccine prevents HPV infection, not the development of cervical cancer.”
In the radio interview with Dr. Harper, she alluded to the difference in performance between the Cervarix and Gardasil vaccines. She said (emphasis mine):
..."one of the major concerns, is that the two vaccines that are currently released are similar, but yet very different. And there’s the major concern that the formulation within Gardasil will not give women protection that will last their lifetime, and therefore, even though it prevents them from getting an HPV infection early on, it’s not going to prevent them from getting an HPV infection later, and in effect, all we’re doing is delaying when they would get cancer...when you look at the data from Merck [for Gardasil] at the end of four years, and you look at the spread of antibody titers across all the people in the population, there’s a thousandfold difference in the way individual people respond to the exact same shot. So, I think that’s really powerful to say that, “You know we really just don’t know how long and what level of protection people are going to have."
In the Huffington Post article, Dr. Harper made the following statements (emphasis mine):
Cervarix is the superior cervical cancer vaccine, in that it prevents five types of cancer causing HPV infections. Gardasil is the superior vaccine in preventing HPV types causing genital warts." She also stated, "Regarding wart protection promotion, there is no mention [to the public] that the data showed protection against genital warts in men for only a 2.4-year period of time."
Gardarsil received licensing approval first. The first drug brand that is licensed, usually becomes the favoured brand that doctors rely upon, even if newer more effective drugs enter the market later. Such was the case with Gardasil. Dr. Harper has repeatedly expressed that the most effective HPV vaccine on the market is the Cervarix vaccine, however it is very rarely used. She says the following:
Cervarix induces antibody titers for HPV 16 and 18 that are at least ten fold higher than natural infection titers; the antibody titers for the other three cancer causing types (HPV 31, 45, 33) are also significantly higher than natural infection titers, and the titers stay high for at least 7.4 years - lasting the longer of either vaccines.
Gardasil only maintains antibody titers for HPV 16 (not 18, not 11, not 6) at five years, making the true long lasting (five years) coverage of Gardasil only for one type of cancer causing HPV.
If duration of efficacy is less than fifteen years, then no cancers are prevented, only postponed.
To explain Gardasil's length of protection further, I would like to bring your attention to an interview that Dr. Suzanne Humphries gave. In it, she explains how long the Gardasil antibody levels last. She stated the following (emphasis mine):
Here’s [a study] where they checked the titers… they show you the antibody titers, and what you can see here is that…in the nine to fifteen year old girls... when it comes to the HPV 6 titer, there’s nothing left at month 48, that’s four years. There’s nothing left, and look how quickly [titers] drop, 929 in month seven, 156 in month 24. [For HPV 11] 1304 goes down to nothing, so it goes 1300 to 218 in two years. These titers are dropping like gravity.
Below is the table she is referring to, taken directly from the Gardasil package insert.
If you look at the different age groups shown in the table, you can see that the 9-15 year old population has the strongest anti-body response initially, seen at month seven, one month after all the groups received the third and final dose of vaccine. However, in all groups their titers drop rapidly and drastically in the subsequent months.
The insert states, "studies in 9- to 15-year-old girls were planned to end prior to 48 months and therefore no serology samples were collected." The 9-15 year old girls had their titers tested between month 7 and month 36, a 2.5 year window, and during that time the girls anti-body levels dropped 87-92%.
In the Huffington Post article, Dr. Harper stated that anti-body titers measured at year five showed memory against HPV 16 only, not 6, not 11, not 18. Because the package insert states that 9-15 year olds were not tested after 36 months, I infer that Dr. Harper's statement was specific to the older women only. And based on how the manufacturer's table above shows that testing occurred for the older women at 24 months, 36 months, and 48 months, I will assume that the older women were tested again at 60 months (year 5). So, recognizing Dr. Harper's statement, one could then speculate that maybe 9-15 year olds also retained some HPV 16 anti-body levels at year five. But considering how significantly and consistently titers were shown to drop, in all HPV strain types and across all age groups, it's reasonable to assume that in the 9-15 year age bracket, the HPV 16 antibody titer would also return back to zero shortly after year five, if their titers even lasted into year five in the first place.
Also in the radio interview with Dr. Harper, she goes on to talk about a third, newest HPV vaccine. She gave this interview in 2013, which was the year before this newest vaccine was approved for use in the USA and Canada. She had the following to say (emphasis mine):
I should mention that there’s rumour that Merck is going to come out with another vaccine, where they are going to put more types in it, to say, “We’re even better now because we cover more types.” And I think people should just be really really cautious about that, because we don’t have any idea that it’s going to really prevent HPV infections. We don’t have any idea that it’s going to prevent them for a long time, we don’t know which types it will or won’t protect.
The newest HPV vaccine is called Gardasil 9, because it is supposed to protect against nine strains of HPV. If you look at the titer data in the Gardasil 9 package insert on pages 28-33, the manufacturer provides a comparison of Gardasil 9 to the original formulation of Gardasil. What's missing in the comparison is a listing of the titer levels in subsequent years. The only titer levels listed were those measured one month after receipt of the final vaccine doses, which were given at either month 6 or 12 (depending on the various schedules tested).
What's critically important about this titer information is that in Canada and the USA, Gardasil is the vaccine of choice. Some Canadian provinces administer this vaccine as early as grade five to children aged nine and ten. In the USA, Gardasil is given at age 11. Does it make any sense to administer the HPV vaccine to children aged 9-11 years old, when the data shows that anti-body levels wear off in four to five years, which would make these kids 13-16 years old. The most critical age bracket when these kids are likely to acquire an HPV infection is between the ages 16-24 years. The short duration of antibody memory means that this vaccine will not offer any protection to the children who receive it.
In the Huffington Post Interview, Dr. Harper stated (emphasis mine):
If Gardasil is given to 11 year olds, and the vaccine does not last at least fifteen years, then there is no benefit - and only risk - for the young girl.
...the [Gardasil] marketing campaign was designed to incite the greatest fear possible in parents, so that there would be uptake of the vaccine. If parents and girls were told the benefits and harms of Pap screening and HPV vaccines as described above, an informed and valued decision would have been able to be made. Many may have chosen to continue with a lifetime of Pap screening and forgo the vaccines, with the unknowns of duration of efficacy and safety unable to be answered for many more years.
CONTINUE to the next article: Ch6: Article 3
Article Sources Here
Radio interview with HPV expert, Dr. Diane Harper Here
One More Girl Documentary excerpt - statement by Dr. Harper Here
Huffington Post Interview with Dr. Harper Here
Dr. Suzanne Humphries explains the Gardasil Package Inserts Here
Gardasil Package Insert Here
Gardasil 9 Package Insert Here
Cervarix Package Insert Here
CDC - vaccinated long term health outcomes have never been studied Here