Gardasil for Boys? The American Cancer Society Doubles Down, for No Good Reason.

August 3, 2016

“. . . the ACS Board of Directors recently voted to make prevention of HPV-associated cancers through increased vaccination a nationwide priority for the organization. The ACS convened and leads the National HPV Vaccination Roundtable, a national coalition of over 70 organizations working together to prevent HPV-associated cancers and precancers by increasing and sustaining US HPV vaccination.”

— Human Papillomavirus Vaccination Guideline Update: American Cancer Society Guideline Endorsement (page 9)

The American Cancer Society (ACS) has recently doubled down on its endorsement of the HPV vaccine (Gardasil 9) for boys and girls aged 9 through 26, according to a recent press release. This amendment to their policy is in response to the December 2015  Advisory Committee on Immunization Practices’ (ACIP) recommendation for Gardasil 9. The ACS press release appears to promote the vaccine without stating the risks, the side effects, the contraindications, or the risk that getting the vaccine can potentially progress an existing HPV infection and cause cancer if left untreated.

I contacted the ACS for comment, and I was directed to a footnote citation aimed at clinicians which details the reasons behind their policy update. However, contraindications were not discussed anywhere in this document, and they punted safety issues to the ACIP and CDC (page 6). Also, nowhere does the press release state that pap tests, the only measure proven thus far to reduce the incidence of cervical cancer, will continue to be necessary. When I asked why that was, I was told that that information is contained elsewhere on their website. When I asked why Gardasil 9 was being recommended for boys when no new data was available, I was referred to the above-mentioned clinicians’ report, which incredibly concludes that “At this time, there is a lack of direct evidence of efficacy for cancer or pre-cancer prevention in average-risk men . . . .” Confused? More on that later on.

Ultimately, the ACS recommendation fails to advise the public adequately with the unbiased, independent information on cervical, throat, penile, and anal cancers contained on its own website. I’m not saying there is a conflict of interest when a nonprofit supposedly dedicated to health endorses a product made by their very generous corporate donor (Merck), but I might be implying it.

One could be forgiven for not knowing which way to turn when it comes to advice on whether or not to vaccinate your 11-year-old boys and girls with Gardasil. Previously, the vaccine had been heavily marketed to girls for prevention of cervical cancer. However, the narrative has been changing over the years, with a seemingly exponential explosion in the number of cancers that HPV is associated with — cancers of the vagina, vulva, penis, anus, rectum, and throat, and now the more general “head and neck” cancers, which doesn’t have the obvious connection with the sexually transmitted nature of HPV infection. As in the ACS press release, we are now hearing the vaccine referred to simply as the “HPV vaccine.” It seems to have been completely rebranded, topped off with the most offensive, egregious TV ad I have ever seen, to ensure that the kids get the message. The fear mongering is at an all-time high for a condition which clears spontaneously, without symptoms, in most people. It’s as if we have all forgotten that HPV is a sexually transmitted infection with no symptoms in over 90% of cases and rarely leads to cancer.

CDC poster boys

So why vaccinate the boys? The reasons given for vaccinating boys vary depending on the source and the marketing tactics used. To ease us into it in 2010 — because, remember, boys don’t have a cervix — we were told it was because of the risk of genital warts (apparently there is a new case every minute!). During the Gardasil trials, the vaccine was never shown to prevent genital warts in men or boys; it was an endpoint in an uncontrolled clinical trial in women aged 27-45 (page 14). Based on this, an assumption was made about efficacy in boys, which I guess could be valid, but it is an assumption.

Merck then sponsored a study, Protocol 020, which was presented to the FDA in 2011 to argue that the vaccine be licensed for men who have sex with men, where genital warts was an endpoint. Merck planned a “long-term extension study” to follow the men for 10 years, but it was without a placebo control, which experts deemed was necessary to conclude effectiveness, safety, and immunogenicity of the vaccine. What is interesting about this study is, it also attempted (but failed) to show efficacy against pre-cancerous anal lesions. More on that in a moment.

We were then told that Gardasil could be used to prevent many penile, anal, and throat cancers. I think Merck’s marketing people were getting brave and decided we could handle casually mentioning “penile” and “anal” cancer as if we’ve always been worried about them — just so long as no one mentions the uncomfortable fact that the most at-risk population for these cancers is the gay and bisexual population. However, just like genital warts, Gardasil has not been demonstrated to prevent penile, anal, or throat cancer. In fact, a quick control-F on Gardasil 9’s package insert does not even come up with the word “throat.” I’m not sure why ENT doctors all over the country are collectively losing their minds over this vaccine and pushing to mandate it, hoping it will reduce incidence of throat cancer. Is smoking all of a sudden off the hook? There are many recent studies citing HPV 16 as a possible suspect in throat cancer, but it’s not the overriding culprit in 80% of cases per this large international study. However, in this study, conducted by a Sanofi-Pasteur MSD (European distributor of Gardasil) consultant, the results were quite different and showed a large number of head and neck cancers relating to HPV. It should be noted that neither study has said that a vaccine can prevent throat cancer, and only the latter mentioned that it was theoretically possible.

Next we see that any claim about prevention of penile cancer was eliminated following the original trials for Gardasil when Merck admitted in the original package insert (Page 16) that the results were statistically insignificant:

Efficacy against penile/perineal/perianal intraepithelial neoplasia (PIN) grades 1/2/3 or penile/perineal/perianal cancer was not demonstrated as the number of cases was too limited to reach statistical significance.

Just like “throat,” the word “penile” is not even mentioned in Gardasil 9’s package insert. Why is penile cancer even mentioned by doctors with regard to this vaccine, especially given the average age of penile cancer diagnosis is 65? There are only 2,000 cases a year in the U.S., only about half of which are associated with HPV infection, with an 85% survival rate. This is hardly something 11-year-old boys and their parents should be worried about.

Finally, let’s look at anal cancer, for which the average age of diagnosis is mid-60s. The (composite) endpoint used in the trials for anal cancer was stage 1, 2, or 3 of Anal Intraepithelial Neoplasia in a cohort of 200 16-26 year old boys and men in an uncontrolled clinical trial (Protocol 020), i.e. the placebo was not saline or an inert substance, it was the adjuvant and vaccine excipients (page 13). The efficacy came out at around 75% for the quadrivalent vaccine. According to Medscape, Dr. Diane Harper noted that of the five cases of AIN lesions reported in Protocol 020, only two were possibly carcinogenic and three were not. However, combining the results is how investigators arrived at statistical significance and were able to report a positive finding.

Furthermore, buried in the Gardasil 9 package insert, we see that Merck could find no association with incidence in the other five HPV types in the vaccine, rendering the “upgrade” to Gardasil 9 unnecessary: “Efficacy of GARDASIL 9 against anal lesions caused by HPV Types 31, 33, 45, 52, and 58 was not assessed due to low incidence.”

In this press-release-disguised-Gardasil-commercial, the ACS also claims that “Studies now show that vaccination in males is effective in preventing HPV infection. New evidence has also allowed the ACS to make recommendations for vaccination through age 26.” There are two problems with this statement, for which there was no footnote citation:

One, I know of no such “new evidence” of safety or efficacy for males beyond the paltry uncontrolled clinical trials I have described above, none of which focused on safety beyond the 14-day follow-up period. The ACS did cite 10 studies in its addendum for clinicians at the bottom of the press release but it’s a few clicks in and you really need to know what you’re looking for. The studies they rely on to base their recommendations can be found on page 13 here, which are all Merck-funded and show no new data.

Second, if the ACS is now recommending that the vaccine be given to an age group which is sexually active, then people in that age group should know that Gardasil vaccination might increase their risk of developing cancer should they already have an HPV infection of the type they were vaccinated for. Merck showed this “negative efficacy” (a 44.6% increase in pre-canercous lesions in women who received the vaccine; men were not studied, but if we can assume prevention of genital warts based on the women’s result then why not assume increase in cancer risk based on the women’s result?), in Protocol 013 in the original trials (table 17, page 13).

When I asked the ACS why they did not raise the alarm on the outcome of study Protocol 013 when universally recommending the vaccine for everyone up to the age of 26, they merely quoted the Center for Biologics Evaluation and Research’s (CBER) assessment (which I provided to them) on page 14 that stated

This demonstrated a limitation of the evaluation of small subgroups, where subgroups might have imbalances in baseline demographic characteristics. In this case it appeared that subjects in this subgroup of study 013 who received GardasilTM might have had enhanced risk factors for development of CIN 2/3 or worse compared to placebo recipients. (emphases mine)

The key word here is “might.” What does that mean? It “might” mean that they are presuming that some risk factors present contributed to the progression of the infection. And what exactly are those risk factors? Arguably, the very ones that exist in the real world: smoking, a history of STDs, and an irregular pap smear test, which makes complete sense and should not be disregarded! When a package insert lists ingredients as “approximate” and words like “might” are used to explain away a highly significant safety signal, I have a hard time believing that the proper testing and controls that should be in place for such a complex medical product as this one, actually are.

The ACS should also be asking, since Gardasil only has four HPV types, how is Merck allowed to say that Gardasil 9 can protect against the additional five strains they claim lead to more cancer in males? In fact, they can’t say this at all. In the package insert, buried on page 14, Merck admits that during the uncontrolled studies they conducted

The effectiveness of GARDASIL 9 in girls and boys 9 through 15 years old and in boys and men 16 through 26 years old was inferred based on a comparison of type-specific antibody GMTs to those of 16 through 26-year-old girls and women following vaccination with GARDASIL 9.

For all endpoints, the efficacy against the HPV Types 31, 33, 45, 52 and 58 in GARDASIL 9 was evaluated compared with GARDASIL. Efficacy of GARDASIL 9 against anal lesions caused by HPV Types 31, 33, 45, 52, and 58 was not assessed due to low incidence. Effectiveness of GARDASIL 9 against anal lesions was inferred from the efficacy of GARDASIL against anal lesions caused by HPV types 6, 11, 16 and 18 in men and antibody responses elicited by GARDASIL 9 against the HPV types covered by the vaccine. (emphases mine)

However, the ACS did provide some additional information based on a review of Pubmed research they performed to find support for endorsing this vaccine for boys. Incredibly they admit that they found no evidence it would be effective in preventing cancer in boys at all, which leaves us scratching our heads. In the supporting citation, under “Discussion,” paragraph 9, linked (buried) in its press release it states:

For average-risk men (excluding men who have sex with men and immunocompromised/HIV-positive men), there is no direct evidence of efficacy for cancer or precancer prevention because of the small number of disease outcomes. There is also no evidence for prevention of oropharyngeal cancers in males or females; however, there is limited evidence of prevention of oral HPV infection. (emphases mine)

In fact, in addition to the assumed but not demonstrated prevention of rare cancers in males, the only reason the ACS can come up with to vaccinate the boys is to support “herd immunity” which “may” provide protection for girls:

“Modeling results suggest that vaccination of males, through herd immunity, may provide additional protection to females in addition to providing protection against HPV-associated cancers in males.” (emphases mine)

And is vaccinating their boys to possibly protect girls the reason why parents are agreeing to give this vaccine to their children? Shouldn’t the ACS and doctors be telling parents that they are putting their 11-year-old boys at risk of vaccine injury in order to protect a girl they have not yet met or had sex with at some point possibly in the future? But given the tone of the new TV ad, that’s not what they’re saying, is it?

“Did you know, Mom? Dad?”

If “herd immunity” existed in the female population then there would be no need to vaccinate heterosexual boys to protect them. The problem arises when there is only 30% uptake in girls and 18% in boys, as we currently have in the US. However, this type of narrative provides a dangerous argument for mandating this vaccine for 11 and 12-year-olds, something that will be a disaster for every state that implements such a law. It would put thousands of children in harm’s way for a perceived, unproven benefit, decades into the future, based on incomplete studies which are without proper inert placebo controls.

Incredibly, the American Cancer Society has chosen to promote a vaccine for boys, without demonstrating a benefit for any but a very small minority of the population. It’s hard to imagine why universal vaccination is the preferred path over pap tests (for women) and better sexual health education (for all), considering the magnitude of the possible risks and the groundswell of resistance that exists in the public mindset as regards this vaccine. And we haven’t even discussed the cost. Why are doctors not listening? Well, to answer that I would have to go all conspiracy-nut on you, so I won’t.

Welcome to a world where parents are losing their right to make these important medical decisions for their children. Welcome to the era of vaccine mandates and pharmaceutical dominance over our government, where conflicts of interest are now the norm. Welcome to an incredible new vaccine paradigm where doctors and the trusted American Cancer Society will tell you a vaccine prevents cancer, even when the manufacturer has never shown that it does.

Caveat emptor, for as long as you still have that right.

~ ShamROCK

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