Roswell Park Cancer Institute Justifies Expanding Gardasil to Boys

Is HPV Neck and Head Cancer Connection the Camel’s Nose Under the FDA’s Tent?

A recent press release from Roswell Park Cancer Institute (RPCI) in Buffalo, New York caught my attention. I have been following the HPV-vaccine debate since 2005. I’ve read thousands of press releases, research papers, articles and websites. I’ve observed what I consider an interesting information interpretation phenomenon. Two or three research bodies can look at the same set of data and come to several, sometimes diametrically opposed conclusions. I think it is important to read everything, even the material I don’t agree with — actually, especially the information I don’t agree with. Insight is always helpful, even if I disagree with the conclusion.

Several recent studies have pointed to an increased incidence of cancers of the head and neck. A decade or so ago the network news executives decided that the sexual preference of a sitting president was fine six o’clock news fare. Along with the great debate of what the meaning of “IS” is, the notion that oral sex wasn’t sex came into the national consciousness. Followed quickly by reports from news broadcasters that increasing numbers of middle school kids had been observed on both school bus and school security cameras engaging in oral sex.

What ‘IS’, is. As oral sex became an “accepted” practice of being sexually active while maintaining “technical virginity” incidences of oral HPV infections in teens and young adults grew to the point, that the trend was noted by STD researchers.

Today a number of those researchers have concluded that certain cancers of the head and neck are strongly linked to HPV 16, a specific strain of the human papillomavirus (HPV). According to Thom Loree, MD, Chair of RPCI’s Department of Head & Neck Surgery the types of cancer associated with HPV 16 occur mostly at the back (base) of the tongue, in the tonsils, and in the soft palate at the back of the throat. Over the past 10 years, members of RPCI’s Head & Neck Department have seen a threefold increase in the number of throat cancers they treat.

In 2007, Roswell Park researchers began testing all head and neck tumors treated at the Buffalo-based comprehensive cancer center for the presence of HPV DNA, says Saurin Popat, MD, FRCSC, FACS, Attending Surgeon in Head & Neck and Plastic & Reconstructive Surgery, RPCI. RPCI is one of few institutions in the nation to do so. Data from the ongoing testing have been combined with data from archived tumor samples to provide a clearer picture of how many head and neck cancers treated at RPCI test positive for HPV. To date, the total is around 50 to 60 percent.

The American Cancer Society estimates that 35,310 new cases of oral and oropharyngeal cancer are diagnosed every year—25,310 of those in men—and 7,590 people, including 5,210 men, die of those cancers. The American Cancer Society still implicates smoking, the use of chewing tobacco, and heavy alcohol use as the leading causes of cancers of the head and neck. The resent RPCI HPV research may change that view, or not.

Human papillomavirus (HPV) that is one of the most common sexually transmitted diseases in the United States. It is estimated that approximately 70% of Americans, both men and women, will be infected with HPV at some point in their lives. RPCI researchers compared HPV with the common cold. There is no cure for HPV, just as there is no cure for the common cold. In most people, those with a healthy lifestyle and a resilient immune system, an HPV infection will resolve on its own, but it can be passed on to other people during the infection period — just as with the common cold.

There are more than 100 identified, numbered, types of HPV—but only 70 have been described so far. Some HPV viruses, including 16 and 18, are transmitted sexually—not just through sexual intercourse, but also through any skin-to-skin contact involving the mouth, vagina, vulva (the external female genitalia), penis, anus, or fingers.

HPV 16 and HPV 18 were previously identified as the cause of most cases of cervical cancer in the U.S. HPV has also been implicated in the development of some cancers of the vulva, vagina, anus, penis, and perineum (the area between the genitals and anus).

In some cases, the person may continue to be infected for decades without any symptoms. During that time, the infected person can infect others without knowing it. Over time, this “silent,” chronic HPV infection increases the risk of developing certain cancers.

In 2006, the FDA approved the use of the HPV vaccine, Gardasil, for girls and young women ages 9 through 26. The rational for vaccinating school girls was to protect them from the HPV 16 and HPV 18 identified as the cause of most cases of cervical cancer; and immunize them from HPV 6 and HPV 11 which can result in the STD, genital warts, BEFORE they were exposed to HPV through sexual contact.

The Merck & Co, INC Gardasil product sheet gives some valuable doctor/patient information.

However, it is supplied on an 11 X 22” sheet, printed both sides, using 6-point Helvetica light, justified type, print production speak for really hard to read. The sheet is folded down to approximately 2.75 X 5.50-inches, and glued into the marketing brochures Merck’s drug reps leave in Doctor’s offices.  The important information, to which I refer, is in the section called:
GARDASIL is a prophylactic vaccine

  • There was no clear evidence of protection from disease caused by HPV types which subjects were PCR positive and/or seropositive at baseline.
  • Individuals who were already infected with 1 or more vaccine-related HPV types prior to vaccination were protected from clinical diseases by the remaining vaccine HPV types.

So this brings me back to my original quandary concerning the red hot hurry to vaccinate all schoolgirls.

The Merck Gardasil Product sheet states in the section:

  • This vaccine will not protect you against HPV Types to which you may have already been exposed.
  • Gardasil works best when given before you or your child has any contact with certain types of HPV (i.e., HPV TYPES 6, 11, 16, 18)

To me the first question we all should be asking before vaccinating is:

How many schoolgirls have already been exposed to the HPV 16 and HPV 18 and HPV 6 and HPV 11?

Allegedly a baby of an HPV-positive mother can be exposed to the virus during the birthing process. Children can be exposed to the HPV by skin to contact, yet another reason to wash hands well after using the restroom.  Researchers have noted that the HPV virus can lay dormant for years. Then there is the HPV exposure risk related to the increased incidence of oral sex experienced by adolescents and teenagers.

  • What questions are health care professionals asking before administering the HPV-vaccine?
  • Will a school nurse, or other public health care provider ask about allergies to the ingredients as required on the product information sheet?

Merck product sheet states in the Section:
Anyone who:

  • Is allergic to any of the ingredients in the vaccine. A list of ingredients can be found at the end of this leaflet

Although how a school girl or her mother for that matter would know if she is allergic to “amorphous aluminum, hydroxyphosphate sulfate, sodium chloride. L-histidine. Polysorbate 80, and sodium borate, is beyond me.

Does the doctor offer a skin scratch to test for sensitivity before administering the shot?

There are as many unanswered questions about Gardasil in 2009 as in 2006. We have thousands of adverse effects reports reported to the CDC. Parents want to know what is happening to their daughters. So far the CDC, FDA and Merck are using the unfortunate but unrelated set of circumstances defense. The CDC still indorses the HPV vaccine as a needed inoculation.

The EU governments are starting to question the rush to vaccinate a generation. The German government is reviewing their HPV-vaccine policy right now.

Will the German scientist deciding against the HPV vaccine policy effect the CDC’s position on Gardasil?  That is a wait and see question.

The publicity around the reported HPV-adverse reactions and the revelations concerning Merck’s lobbyists  ‘carpet-cash-bombing’ federal, state and local government officials and representatives are proving to be a cautionary tale to American parents. Sales of the HPV vaccine Gardasil fell in 4-th quarter 2008 and plummeted in 1st quarter 2009. More folks are looking around and asking, “What is the Rush?”

Now this is what brings me back to the Roswell Park Cancer Institute (RPCI) May 21, 2009 press release titled “Sexually Transmitted HPV Linked to Certain Head & Neck Cancers”
“RPCI Researchers Say Boys Need to Be Vaccinated, Too!”

The RPCI researchers reviewed the increased head and Neck cancers and see a justification to pressure the FDA to expand the use of Gardasil to boys. The FDA has not approved the vaccine for males —yet. The issue of extending approval to males to protect against HPV related cancers is under review, with a decision expected in June 2009.
Loree, Popat, and their RPCI colleagues see compelling evidence for extending the vaccine’s protection to boys. Says Popat, “The side effects of the vaccine are so small, and the potential benefits are great.” He notes that patients with throat cancer “have to undergo major treatment lasting several months, with an additional four to six months of recovery. Their ability to speak and swallow is affected. Generally, they do very well; however, it is a long, challenging road.”

The RPCI’s Loree says that “with increased vaccination against HPV, you’ll see a decrease in cervical cancer and in throat cancers.” He says if everyone stopped smoking and using tobacco in any form, and also got vaccinated against HPV, “we could eliminate head and neck cancers, and I’d be out of business.”

I guess the passing nod to dipping and other tobacco related damage is a scientific homage to the American Cancer Society’s figures that indicate tobacco and alcohol use as the primary cause of throat cancers.

I find the Roswell Park Cancer Institute (RPCI) research compelling. They are dedicated scientist vested in fighting a dreaded disease and I respect their process.  Their stated goal is to banish all cancer. So far we are totally on the same page. I went to their website to find out more about the organization.

The mission of Roswell Park Cancer Institute (RPCI) is to understand, prevent and cure cancer. RPCI, founded in 1898, was one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit RPCI’s website at, call 1-877-ASK-RPCI (1-877-275-7724) or email

However, I still want to know who funded the study.

If the conclusion was to recommend the FDA expanding the HPV-vaccine to boys, we need to know whose money was funding the study.

I’ve emailed RPCI and asked the question.

I’ll let you know as soon as I receive an answer.

Inconvenient Women trust, but personally verify.


Author: H. Sandra Chevalier-Batik

I started the Inconvenient Woman Blog in 2007, and am the product of a long line of inconvenient women. The matriarchal line is French-Canadian, Roman Catholic, with a very feisty Irish great-grandmother thrown in for sheer bloody mindedness. I am a research analyst and author who has made her living studying technical data, and developing articles, training materials, books and web content. Tracking through statistical data, and oblique cross-references to find the relevant connections that identifies a problem, or explains a path of action, is my passion. I love clearly delineating the magic questions of knowledge: Who, What, Why, When, Where and for How Much, Paid to Whom. My life lessons: listen carefully, question with boldness, and personally verify the answers. I look at America through the appreciative eyes of an immigrant, and an amateur historian; the popular and political culture is a ceaseless fascination. I have no impressive initials after my name. I’m merely an observer and a chronicler, an inconvenient woman who asks questions, and sometimes encourages others to look at things differently.