What about boys?

HPV vaccination programme - What about boys?

The Mouth Cancer Foundation, while welcoming the government’s introduction of a human papilloma virus (HPV) immunisation programme for girls aged 12 - 13 years of age against cervical cancer, is concerned that boys are not being vaccinated.

This decision follows the advice of the Joint Committee on Vaccination and Immunisation (JCVI) which, based on a detailed review of evidence surrounding HPV vaccination, did not consider it to be cost-effective in preventing cervical cancer.

But according to an article recently published in the British Journal of Cancer, researchers from Finland using mathematical models of human papillomavirus (HPV) type 16 virus infection to determine the optimal age to vaccinate individuals as well as different approaches to introducing the vaccine into the general population concluded that:
  • Vaccination generates the greatest long-term benefit when administered prior to the first sexual contact.
  • Vaccination of males as well as females has a greater impact when administered at an early age.
While males cannot get HPV-linked cervical cancer, they make up half of the equation when it comes to spreading the sexually transmitted virus. This is a viral infectious process, and the majority of the time it is passed through heterosexual contact. Men can pass on the virus to their sexual partners, so it makes sense to vaccinate boys against HPV, and it would also protect them from throat cancer as the virus is also a leading cause of throat cancer, which affects both sexes.

The MCF is concerned that the JCVI may not have given due consideration to the vaccine's cost-effectiveness in preventing anal and throat cancers, plus genital warts, among boys.

Recent mounting evidence is confirming that infection with HPV via oral sex is by far the leading cause of throat cancer. This threat of throat cancer is especially troubling because doctors traditionally only look for these malignancies in long-time smokers and drinkers. And while girls and women typically see a gynecologist for their Pap smear to look for cervical cancer, not many boys and men are going to go to a doctor and ask them to look at their throat.

Historically, at least 25% of those diagnosed with mouth cancers are non-smokers. The other 75% of those diagnosed have used tobacco in some form during their lifetimes. But today the research into the relationship of HPV and mouth cancers gives us clues as to the origin of cancer in those 25% of diagnosed individuals who did not smoke, and also into changing behaviors both in tobacco use and sexual practices. The age standardised incidence of oral cancer in British males stayed at around 7 per 100,000 males between 1975 and 1989, but since then, the rate has steadily increased to reach 9.8 per 100,000 in 2004, an increase of 40% since 1989. While female oral cancer rates have remained significantly lower than male rates, their incidence trends have been similar with an average increase of 2.5% each year since 1989.

Given the decline of tobacco use over the last ten years, (the historic primary cause of the disease) and the increasing rate of incidence of oral cancers, particularly those of the posterior mouth, it is likely that the ‘75% – 25%’ statement which has been made by everyone is no longer an accurate representation of the situation. There have been large increases in the incidence of oral cancer diagnosed in men in their 40s and 50s whose rates have doubled from 3.6 to 8.8 per 100,000 for men aged 40-49 and from 11.5 to 24.9 for men aged 50-59. These rising trends of oral cancer in young and middle-aged men, particularly of cancer of the tongue, have also been reported in other European countries and the USA. This increase in a cancer that is often difficult to treat and sometimes debilitating and disfiguring, is alarming.

In general it appears that HPV positive tumors occur most frequently in a younger group of individuals than tobacco related malignancies. They also occur more in white males, and in non smokers. The rising incidence and mortality rates in young and middle-aged adults is incontrovertible. There has been debate over the causes of this increase but in recent years, there has been mounting epidemiologic and experimental evidence of a role for human papillomavirus (HPV) as the etiologic agent of a subset of head and neck cancers. The association is strongest for oropharyngeal cancers, especially those of the tonsil. The HPV group is the fastest growing segment of the oral cancer population.

The Oral Cancer Foundation (our sister organisation in the U.S.) strongly believe that in a younger population of non smoking mouth cancer patients, that HPV will present itself as the dominant causative factor. We both believe that since the historic definition of those who need to be screened is now changed by this newly defined HPV etiology, and no longer valid, it is NOT POSSIBLE to definitively know who is at risk for the development of the disease, and who is not. Simply stated, today ANYONE OLD ENOUGH TO HAVE ENGAGED IN SEXUAL BEHAVIOURS WHICH ARE CAPABLE OF TRANSFERING THIS VERY UBIQUITOUS VIRUS ARE AT RISK. For this reason we are concerned that boys are not being vaccinated.

It is hoped that the new cervical cancer vaccines approved for use in pre sexual individuals for the prevention of cervical cancer being developed and marketed by Merck and GlaxoSmithKline, will have a positive collateral impact in the world of head and neck / mouth cancers in the next couple of decades, as these young, vaccinated individuals do not develop HPV related malignancies in sites far removed from the cervix.

The Mouth Cancer Foundation is a strong supporter of the use of the vaccines, and encourages their use in young males as well as females in the U.K.

References:
Original Post
Edited to allow addition of new link to replace dead link above for: government’s introduction of a human papilloma virus (HPV) immunisation programme for girls aged 12 - 13 years of age against cervical cancer
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The Mouth Cancer Foundation and NALC have started a petition to the Prime Minister to widen the planned HPV vaccination programme to include both sexes.

Please support it by going the HPV petition site. To sign the petition, you will need to give your name, address and email on the form provided. Once you have signed the petition, you will receive an email asking you to confirm that you wish to add your name to the petition by clicking a link. Once you have done this, your name will be added to the petition.

Thank you for your support.

Best wishes

Vinod

--
Dr Vinod K Joshi
Founder & Chief Executive
Mouth Cancer Foundation
from
Drinking And Smoking Don't Boost HPV-related Cancer Risk


quote:
New Brown University research, however, shows that alcohol and tobacco use doesn’t further increase the risk of contracting head and neck cancers for people infected with HPV16. This finding, published in the Journal of the National Cancer Institute, is the strongest evidence to date that these major cancers have two distinct causes — and may represent two distinct classes of cancer — and would require different prevention and treatment strategies.

Karl Kelsey, M.D., a Brown professor of community health and pathology and laboratory medicine and the director of the Center for Environmental Health and Technology, said the research has public health policy implications.

While the Centers for Disease Control and Prevention recommends that girls and young women receive the HPV vaccine to prevent cervical cancer — HPV16 causes about half of all cervical cancer cases — boys and men cannot get the vaccine. An estimated 20 million Americans are currently infected with genital HPV and 50 to 75 percent of sexually active men and women are infected with HPV at some point in their lives, according to the National Institutes of Health.

“Our current HPV vaccine recommendations should change,” Kelsey said. “Head and neck cancers, regardless of their cause, are predominantly male diseases. If boys and men received the HPV vaccine, a lot of these cancers could be prevented.”


Ref: Brown University (2007, November 27). Drinking And Smoking Don't Boost HPV-related Cancer Risk. ScienceDaily. Retrieved November 28, 2007, from http://www.sciencedaily.com/releases/2007/11/071127164933.htm
HPV also blamed for oral cancer in men


BEIJING, Feb. 2 (Xinhuanet)--
quote:
Human papillomavirus, or HPV, the leading cause of cervical cancer in women, is also a major cause of oral cancer in men, according to a new study in the United States reported by media Saturday.

The sexually transmitted virus causing cancers of the mouth and upper throat is probably the result of an increase in oral sex and the decline in smoking, the study said.

The new study looked at more than 30 years of National Cancer Institute data on oral cancers. Researchers categorized about 46,000 cases, using a formula to divide them into those caused by HPV and those not connected to the virus.

They concluded the incidence rates for HPV-related oral cancers rose steadily in men from 1973 to 2004, becoming about as common as those from tobacco and alcohol.

However, the only available vaccine against HPV, made by Merck & Co. Inc., is currently given only to girls and young women.

Now Merck plans this year to ask government permission to offer the shot to boys.

In related research, Penn State University scientists reported that cigarette smoke may aggravate HPV and raise the risk of cervical cancer.

The HPV is the fastest growing sexually transmitted disease in the nation. Cervical cancer is a leading cause of cancer-related death in women in developing countries.

According to the American Cancer Society, it was estimated that 11,150 new cases and 3,670 deaths would be reported in the U.S. from cervical cancer in 2007.
Hello Joy

Yes it is possible to be tested for HPV. See:HPV Test.

The current vaccines,Gardasil and Cervarix, are preventative (rather than therapeutic) vaccines and so recommended for women who are 9 to 25 years old and have not contracted HPV. There is work being done on developing therapeutic vaccines but nothing to report yet.

Hope that helps.

Best wishes
Vinod Coffee


Oral sex a factor in oral cancer increase
3rd March 2008
quote:
The cases of oral cancer caused by a virus transmitted during oral sex appear to have increased drastically over the last 30 years, according to a study by US researchers.

The number of tongue, mouth and throat cancers due to the sexually transmitted human papilloma virus (HPV), which can also cause cervical cancer in women, rose by about a third from 1973 to 2004, say researchers.

The team – led by Maura Gillison at Johns Hopkins University in Baltimore, Maryland, US – studied trends in oral cancers recorded by US National Cancer Institute registries.

Earlier work had established a link between certain strains of the common sexually transmitted virus and oral cancer.

The latest study, which looked at nearly 46,000 cases, is the first to quantify an increase in mouth and throat cancers due to sexual activity.

‘What we do know is that the prevalence of HPV is high, particularly among young people and this shouldn't be a surprise given that, since the sexual revolution, people have been having more sexual partners,' a New Scientist article quoted Lesley Walker, director of cancer information at Cancer Research UK.

The rise was largest among young white males, suggesting this group is more likely to have oral sex at a younger age now than it was 20 years ago, says Gillison's team.

Although, oral cancers linked to HPV infection have risen, the study notes the incidence of oral cancers in parts of the mouth or throat not linked to HPV infection remained constant until 1982, and then started to decline.

Gillison called for a need to consider giving boys the HPV vaccine, to protect them from the disease.

A Merck vaccine is presently licensed for use in young women and girls to protect them against the most common cervical cancer-causing strains of HPV.

‘We need to start having a discussion about those cancers other than cervical cancer that may be affected in a positive way by the vaccine,' Gillison said.

The study is published in the journal of Clinical Oncology.

The Mouth Cancer Foundation and NALC have started a petition to the Prime Minister to widen the planned HPV vaccination programme to include both sexes.

Please support it by going the HPV petition site. To sign the petition, you will need to give your name, address and email on the form provided. Once you have signed the petition, you will receive an email asking you to confirm that you wish to add your name to the petition by clicking a link. Once you have done this, your name will be added to the petition.

Thank you for your support.
Dr. Joshi,

I am very interested in this, as I have 3 boys and I have head and neck cancer. I have been preaching to everyone to have the HPV injection even if you are over 25. To not have it is just insane. Anything to protect yourself against this awful cancer. But my question is this, I am in the US and was wondering if you know where I can go to see about boys getting vaccinated here in the states.

Leann
Wow! That's wordy.
I get the general gist though and it will be great if effective vaccination of boys and young men is implemented. In the news this week we have had talk calling for the introduction of Gardasil injections for boys. I guess that means it is still many moons away but at least it's in the news.
Cheers
Deborah
Vinod,

Thanks for this. Related - do you know whether path reports in the UK routinely identify whether head and neck cancer tumours are HPV+ or not? Patients in the US seem to know whether their cancer is HPV related or not and some posters on the oral foundation site seem to suggest that this knowledge could (eventually) affect treatment decisions. Non smokers whose tumours are HPV+ seem to do better than patients who have likely developed H&N cancer as a result of smoking. Thus some argue, although it is contested as there have not been proper clinical trials, that non smoker HPV patients may not require as radical treatment programmes as smokers.

I realise that clinicians are unlikely to advise non smoker HPV patients to undergo less radical treatments until further clinical trials have proved that this is appopriate. However, I just wondered whether H&N tumours currently undergo HPV testing. I have never dared ask our team in Brighton.

BTW I had a coversation with a young GP recently and he had no idea about the link between HPV and H&N cancer. Does this suggest that there is a need for education campaigns targetting health professionals?

Thanks

Cathy
Hello Cathy

Biopsy sample are beginning to be tested for HPV and I am hearing papers being presented at conferences about less need to be aggressive about these cancers but also that there is caution as no one wants to be wrong-footed!

The relationship between HPV and mouth cancer is not that well known - hence there is quite a bit about it in the new leaflet we are getting ready. It will be followed by a press release about HPV and mouth cancer.

Best wishes
Vinod Coffee
Thanks Vinod,

Personally the article is really worrying. Chaz was not given the option of surgery for his tonsil cancer. They just decided to treat him with radio and chemo therapy without telling us the implications. I have no idea whether his tumour was HPV positive and am not sure whether I want to know. He was a smoker for years so this is very unnerving.

Cathy
Hi Lorraine

Most people who get infected will recover from HPV infections with no health problems at all. Many people develop immunity - a natural protection - against different types of HPV. However, some people develop long-term recurrent HPV infections, pre-cancerous abnormal cell changes, or cervical cancer. It's not known why they do. So the advice to partners of those who are HPV positive is to carry on as normal as they have probably already been infected and cleared the infection unless in the tiny minority. The advice would be to carry on with normal life but to be vigilant (i.e. have regular screening - Pap smears, etc.)

Hope that helps put this issue in context.

Best wishes

Vinod Coffee
HPV Vaccines: Cervarix Approval and Gardasil Use in Boys/Men Recommended by FDA Advisory Committee

From Medscape Medical News by Zosia Chustecka
quote:
September 11, 2009 — A second vaccine against human papillomavirus (HPV) for the prevention of cervical cancer — GlaxoSmithKline's Cervarix — has been recommended for approval in the United States; the extended use of Merck & Co's Gardasil, the first vaccine, was recommended for boys and men for the prevention of genital warts.

The recommendations came from the US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee. In both cases, the voting was almost unanimously in favor, with only 1 abstention or no vote, but the meeting heard concerns about the safety of the vaccines and questions about the public-health value of the extended indication.

The voting on Cervarix was carried out by 13 members of the committee. There were 12 votes in favor of and 1 vote against the data supporting its efficacy in preventing precancerous lesions and cervical cancer in females in the 15 to 25 year age group and, from immunobridging studies, the 10 to 14 year age group. One member left the meeting before the vote on safety, but 11 of the remaining members voted in favor of the data supporting the safety of Cervarix in this population; there was 1 vote against.

Eight members of the committee voted on Gardasil use in boys and men. The vote was 7 in favor of the efficacy data supporting the use of Gardasil in males 9 to 25 years of age for the indication of preventing genital warts; there was 1 abstention. The vote was also 7 in favor of the data supporting the safety of Gardasil in this population; there was 1 vote against.

The FDA usually — but not always — follows the recommendations of its advisory committees.

Second Vaccine for Cervical Cancer

If approved, Cervarix would be the second HPV vaccine available in the United States. It is already marketed in more than 100 countries worldwide, including the 27 member states of the European Union. This product has been used in nationwide vaccination programs in the United Kingdom and Australia since it was first approved in 2007. At the meeting, the manufacturer estimated that around 7 million doses have been distributed worldwide.

Ceravix is a bivalent vaccine, active against HPV types 16 and 18, which together are thought to be responsible for about 70% of all cervical cancer cases. However, data from clinical trials presented at the committee meeting suggested that the vaccine also offers protection against other virus types responsible for causing cervical cancer, including HPV types 31, 33, and 45, the next most common cancer-causing strains. In addition, the data presented showed a duration of immunity of 6.4 years.

In contrast, Gardasil is a quadrivalent vaccine with activity against 4 HPV types: HPV types 16 and 18, which cause cervical cancer, and HPV types 6 and 11, which cause genital warts. This extra activity means that this vaccine is also indicated for the prevention of genital warts in girls and women, and it has now been recommended for that same indication for boys and men. However, the current data on Gardasil in males extends only out 2 to 3 years, and in women extends only out 5 years.

Is Cervarix Better at Protecting Against Cervical Cancer?

The main purpose behind the development of these HPV vaccines was to prevent cervical cancer, and for this indication, Cervarix is the better of the 2 vaccines, said Diane Harper, MD, from the University of Missouri–Kansas City School of Medicine. She has been involved in clinical trials with both vaccines, and was approached by Medscape Oncology for comment.

Dr. Harper outlined the following reasons for her opinion:

  • Cervarix and Gardasil are equally effective for HPV types 16 and 18 in women with no previous HPV, but Cervarix has proven to have a longer duration than Gardasil (6.4 vs 5 years); there are still no data on how long the protection will ultimately last, and whether booster shots will be needed.
  • Cervarix offers cross protection for 5 cervical-cancer-causing types of HPV, whereas Gardasil offers cross protection for 3. In addition, Cervarix offers protection against the 3 most common types of HPV that cause adenocarcinoma, which is very difficult to detect with Pap testing; Gardasil is deficient in 1 of those types.
  • Cervarix prevents nearly twice the number of excisional therapies as does Gardasil (70% vs 40%), which is one of the harms that Pap screening can cause (excisional therapies lead to reproductive morbidity).
  • The antibody titers induced by Cervarix are superior to those for Gardasil, and are superior for women older than 25 years, should there come a time when the vaccines are approved for optional use by women in this age group. The antibody titers in the cervical mucous are also superior with Cervarix, and it is in the mucous on the epithelial surface that "half the action happens."

"I realize that this may sound like an advertisement for Cervarix, but these are the facts" Dr. Harper explained. "If you bother to vaccinate in countries with screening, then you want to vaccinate with the vaccine that will offer you the greatest cancer protection," she said.

Voting Against the Vaccines

The votes against both vaccines came from the consumer representative on the committee, Vicky Debold, PhD, RN, director of patient safety at the National Vaccine Information Center. She told Medscape Oncology that she has concerns about the safety of these vaccines, and acknowledged that her view is colored by listening to reports of adverse events from members of the public, in particular parents whose daughters who have suffered after vaccination with Gardasil.

"I'm not quite sure what is going on, but there have been too many patients with problems," she said. "There have been reports of demyelinating conditions and also deaths, and I wonder if there is a tendency toward a hyperstimulating of the immune system that results in such catastrophic outcomes." She suspects that there are individuals who might be particularly susceptible to adverse effects, maybe because of pre-existing conditions or genetic vulnerability.

It is very difficult to assess the safety of vaccines, Dr. Debold noted. At the meeting, she pointed out that, in many cases, the trials of both vaccines did not use a true placebo, such as a saline injection. The trials of Gardasil used an adjuvant control, and some of the Cervarix studies used hepatitis A vaccine as the control. "This makes the data very confusing," she said.

In addition, Dr. Debold had an issue with the way the question on the efficacy of Cervarix was worded. She felt the data showed that the vaccine did prevent precancerous lesions (and she would have voted yes for that), but the question also included wording about the prevention of cervical cancer, "and the data do not show this, not yet. The implication is that by preventing the earlier lesions, you prevent cervical cancer, but that is an implication, it has not been shown," she said.

At the meeting, specific questions about the safety of Cervarix focused on an "imbalance" of reports of spontaneous abortions and autoimmune adverse effects, but experts at the meeting were not convinced that these reports were related to the vaccine, with 1 commenting that "there are quirks in the collection of data."

Other Benefits From the Vaccines

Another potential benefit from a vaccine such as Gardasil that is active against HPV types 6 and 11 is that it might also offer protection against other "warty" diseases, including juvenile respiratory papillomatosis. Speaking during the open part of the meeting, Craig Derkay, MD, pediatric otolaryngologistat the Eastern Virginia Medical School in Norfolk, noted that there are about 1500 new cases each year of laryngeal papilloma caused by HPV 6 and 11, with the infection usually acquired from the mother during passage through the birth canal. There are no adjuvant therapies for this disease, and surgery is often not curative, he said. A vaccine that targets HPV 6 and 11 could "substantially reduce" this disease burden, and might also prevent HPV-associated head and neck cancer. If an HPV vaccine is to be used, it is preferable to use one with the broader spectrum so as to also prevent these types of diseases, he said.

Also speaking in the open part of the meeting was Dianne Zuckerman, PhD, president of the National Research Center for Women and Families. She expressed concern about the lack of long-term efficacy data for Gardasil in boys and men. The trial data that were presented were for 2 years, but some of the seroconversion data were for only 7 months, she pointed out.

quote:
The boys of America are not facing an epidemic of genital warts.

The whole point of vaccinating boys 9 to 11 years old is to protect them from genital warts once they become sexually active, but some of the data showed that the antibody titers dropped off during the 2 years of the trial, which raises the concern that any protection offered by the vaccine could have worn off by the time these boys become sexually active. "The boys of America are not facing an epidemic of genital warts and we have time to wait for efficacy data," she said.

In addition, she pointed out that genital warts are not life-threatening, and the male genital cancers that the vaccine offers protection against, such as penile and anal cancer, are very rare in heterosexual men.

One of the committee members highlighted the natural history of genital warts, which he felt was important for the discussion. "While they are ugly and a nuisance, they are also self-limiting and will go away on their own in individuals with a normal immune system," he said.

Approached for comment, Maurie Markman, MD, professor of gynecologic medical oncology at the University of Texas MD Anderson Cancer Center in Houston, who is an editorial advisor for Medscape Oncology, said: "I suspect evidence supporting the protection of males from genital warts will need to be very strong for the FDA to approve [this indication]. There is a very strong theoretical rationale to support vaccination of males to prevent cervix cancer in women, but considering the current cost of vaccination, I would seriously question the cost-effectiveness of this approach, at least in the United States. Further, there may be genuine protection of males against the risk of head and neck and other uncommon cancers, but again, this will need to be demonstrated in the clinical-trials setting."

Also during the open part of the meeting, there were testimonials from 2 mothers whose daughters had suffered adverse effects after vaccination with Gardasil, one of whom died shortly after her third dose. One of these mothers suggested that there was a link between niacin deficiency and adverse reactions to the HPV vaccine, and that individuals with pyruvate kinase deficiency might be particularly susceptible.

Paradigm-Shifting Prevention Strategy

Speaking out in favor of HPV vaccination — indeed, describing it as a "paradigm-shifting prevention strategy for cervical cancer" — was Mark Einstein, MD, MS, director of clinical research for women's health and gynecologic oncology at the Albert Einstein College of Medicine, in the Bronx, New York; he was representing the Society of Gynecologic Oncologists.

Cervical cancer remains a clinically relevant problem with in the United States, he told the meeting, with 11,000 new cases diagnosed annually, and about half a million women affected annually by precancerous lesions that could affect their reproductive health.

"The public-health value of the protection afforded by HPV vaccination overwhelmingly outweighs the self-limiting local side effects and even the rare but more serious effects that may or may not be vaccine-related," he told the meeting.

CDC panel recommends HPV shot for boys
quote:
A US government medical committee has recommended the human papillomavirus vaccine for boys, to tackle the spread of the sexually-transmitted virus.

While the vaccine has been available to boys before, the vote means that injections are now likely to be covered under medical insurance.

Officials said a lower than expected rate of vaccination in girls encouraged them to reconsider the policy.

In boys, the vaccine protects against cancers associated with the virus.

The Advisory Committee on Immunization Practice, which advises the Centers for Disease Control, voted unanimously on Tuesday to recommend the vaccine for males ages 11 and 12.

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