Some would say this has been true since 2006, when the FDA approved Gardasil for exclusive use in girls/women, and finally the FDA agrees. Last week Merck received FDA approval for Gardasil to be used as a genital warts vaccine in boys/men (ages 9 to 26 years old). However, yesterday, the CDC Advisory Committee on Immunization Practices voted for only “permisive” use in boys, rather than voting for the stronger recommendation of “routine use,” as they had for Gardasil’s use in girls/women.
As reported in Bloomberg.com, this decision had been predicted by some experts:
William Schaffner, chairman of the department of preventive medicine at Vanderbilt University in Nashville, Tennessee, said the panel will be asking itself “if we vaccinate all the girls, how much additional benefit will we get by vaccinating the boys?”
The Atlanta Journal-Constitution cited a similar argument from a different expert:
Debbie Saslow, director of breast and gynecologic cancer at the American Cancer Society, agreed with the findings. “If we can vaccinate a high enough proportion of young girls, then vaccinating boys is not cost-effective,” she said.
This line of reasoning and the ACIP’s conclusion are problematic on two levels. First, there seems to be a privileging of female health over male health. There are compelling reasons “ other than the prevention of cervical cancer” for the ACIP to recommend “routine use” of a safe and effective male HPV vaccine. Second, there seems to be a heterosexist assumption in the ACIP’s decisions — that all boys/men are sexually attracted to (and sexually active with) girls/women and vice versa.
Maggie Fox of Reuters offered a more complete assessment in her article published yesterday:
The main reason the vaccine was approved was to prevent cervical cancer, which kills 4,000 women a year in the United States alone. But various strains of HPV also cause disfiguring genital warts, anal and penile cancers and head and neck cancers. “We know that the later the cancer is discovered, the lower the chance of survival is,” David Hastings of the Oral Cancer Foundation told the committee, asking for a recommendation to add the vaccine to the standard schedule for boys. However, ACIP decided only to consider its use based on its ability to prevent genital warts.
Did the ACIP adequately factor in the clinically proven causal links between certain strains of HPV and potentially life-threatening oral cancers — which do not discriminate on the basis of sex? This seems important, particularly if, “The death rate for oral cancer is higher than that of cancers which we hear about routinely such as cervical cancer” (Oral Cancer Facts)?
A recent New York Times article reports that the committee will “take up the issue of the vaccine’s effectiveness in preventing HPV-related male cancers at its next session in February, when more data should be available.” But data has been available since 2007, when results of clinical studies were reported and the Oral Cancer Foundation issued a press release urging male HPV vaccination?
If the FDA believes Gardasil is safe and effective, then we deserve a more thorough explanation of why the vaccine’s potential to protect against oral cancers — in both men and women — is not reason enough for the federal advisory group to issue as strong a recommendation for male vaccination as for female vaccination.
Comments 17
Brian Hill — October 23, 2009
The financial arguments against vaccinating boys (The most current one is from two number crunchers at Harvard) miss the point on either one or both of these points. Men are vectors of the virus to women. We carry it and give it to women. Men are a significant reason that the reservoir of the virus is so high in the US, and why HPV is so ubiquitous in our population. Those points are why in most other countries that use the vaccine, it is not given on a gender basis when considering just cervical cancer. The second is errors in the core numbers that the published articles are drawn from. Using the most recent one out of Harvard, their cost analysis was based on an gross under estimate of how much of the oral cancer population is coming to the disease from HPV16 these days vs. tobacco, the historic risk factor. They used articles from almost a decade ago to estimate HPV related incidence. Today it is believed that as many as 50% (some think higher) of oral cancers are HPV16 etiology. This alone would make their conclusion wrong. But in addition to this, they estimated the cost for treatment of oral cancer at about 43,ooo dollars. The articles that they used to come up with this number are referring to very early stage anterior of the mouth tongue cancers, which usually are treated with a surgical only solution. HPV+ oral cancers affect the posterior of the mouth, and are routinely found as late stage disease, and the patients require radiation, chemo, and sometimes additional surgery and the use of expensive monoclonal anti-body drugs. The average cost for treatment of these patients is between 200,000 and 250,000. The study is so far off, that even though it included oral cancers in the benefit analysis, they worked from bad facts to reach their conclusion that the cost/benefit was not worth vaccinating boys.
The Oral Cancer Foundation has been an early sponsor of research at Johns Hopkins and elsewhere related to all this, we have chronicled the rapid rise (11% increase in 2007 alone) of the HPV+ oral cancers for about a decade. A Swedish study in the last year shows that 60% of oral cancers there are HPV+
Young, non smoking individuals are increasingly the dominant group in newly diagnosed oral cancers. The vaccines are our best hope IN THE NEXT GENERATION of turning this around, as they are only effective in individuals that have not been exposed to the virus. This means that young children who are pre-sexual are the group that most needs to be vaccinated. Without the vaccine there is no methodology for reducing the incidence rates or the mortality associated with the disease in the near future.
Deciding on the use of the drug is an individual issue, and the foundation does not advocate for mandatory vaccination. But we hope that the CDC and the FDA will take an approach to this that considers all the possible benefits to the vaccine outside the current approval for cervical cancers alone. Anal, oral, naso-pharygeal, cervical, and cancers of the penis are all directly caused by persistent HPV16 infections, which the vaccines protect against.
Right now, the drug manufacturers have to conduct a trial in young boys that will provide evidence of what the scientific community already believes, before the FDA is going to allow them to even talk about these other cancers in the same breath as the vaccine. This will take years. The good news is that with a current approval for the vaccines to prevent genital warts in men, pediatricians can vaccinate boys without using the vaccine "off-label". And while we do not believe that benign genital warts are a significant health hazard, the collateral benefit of protecting against the oncogenic versions of the virus will take place at the same time.
Chloe Bird — October 23, 2009
While it is possible that we could achieve herd immunity by only vaccinating girls, boys won't end up with immunity if they are exposed. Can you assume all your kids partners ever will be from the US and vaccinated? Can we ignore that boys can expose girls? And can we assume that there won't be any spread (or any sexual activity) among boys or among men?
gwp_admin — October 27, 2009
Chloe, I completely agree with your points and would like to see the CDC answer all of the questions you raise.
Brian, I appreciate your additional information from the Oral Cancer Foundation. Given the position of the OCF and the research results you cite, is now the time for the OCF to join forces with a sexual health organization (e.g., Planned Parenthood) to launch a full-scale 'safer oral sex' campaign in the U.S.? This campaign could spell out that oral sex is which barrier methods can reduce the risk of skin-to-skin contact that transmits HPV, while clarifying the connection between HPV and oral cancer. I agree that mandatory HPV vaccination is not the answer. Today, we do not have a vaccine that (1) provides 100% protection against the strain(s) of HPV that have been causally linked to oral and other cancers, (2) is approved for use in males and females of all ages, (3) is affordable to all who need it, and (4) has full social acceptance. So, it is vital that we empower the public with all the information they need to make informed decisions to best protect their health and the health of their children.
(For more about HPV, please visit me online at www.adinanack.com)
Brian Hill — October 30, 2009
Adina,
Our most recently published peer reviewed article from Gillison et. al, (Johns Hopkins) co-sponsored by the National Cancer Institute, determined that oral sex is likely not the only mechanism of transfer, though a highly effective one. Even deep kissing (French kissing) is a possible transfer mechanism. Given this, it is hard to come up with a recommendation that is gong to completely prevent transmission. Even the use of condoms, while they help, do not completely cover all portions of the male anatomy during intercourse and are not 100% effective in blocking skin to skin contact and transfer. It is a difficult paradigm. Therein lies our desire to see this vaccine used more aggressively. Changing the behaviors of our adolescent hormonally driven youth, is not likely. And thinking that we are going to prohibit passionate kissing, that is even more remote. This has to be approached from another angle, biological pre-protection.
As to your other points, while well thought out, there are also no absolutes when looking for reasonable answers to them.
1. No matter what vaccine you look at, from polio to the most contemporary, there is has never been a vaccine that is 100% effective in any given population. We are all unique biological entities, and while we have things that protect the majority, nothing is ever going to be 100% effective in every person. 2. The approval process for males exists now, but FDA allowed claims still restrict what manufacturers can talk about. So we hope that the open public dialog will help drive this. At the very least, reasonable people that understand the science of all this, have to counter the viral spread of BAD information about the vaccine on the web, which is hurting the opportunity for progress. 3. While the cost for the vaccine isn't low, Merck has in place programs for people of low incomes, and in under-served populations to get the vaccine at hugely reduced costs. Their web site has links to mechanisms to apply for subsidies. In foreign, third-world countries they are working within governmental bodies to provide the vaccine at reduced costs. 4. Social acceptance in our country will never be 100%. You have push-back from people that still believe that vaccines cause autism, something that there is no proof to substantiate. Most of their arguments are based on mercury containing preservatives that have not been in vaccines for decades. Even since those preservatives have been removed, the incidence rate of autism still rises. You also have push-back from social conservatives that erroneously believe that this will cause their daughters to engage in sexual activities earlier in life. There is no evidence to support this. In fact there is evidence to the contrary. Liver cancers are primarily caused by hepatitis B and C, which is a virus that is sexually transmitted. We have been vaccinating our children for this for years. There was no push back on this, and there has been no indication that this vaccination program which is mandatory, has changed the sexual desires of young girls. This would be the same as saying that our youth , once vaccinated for tetanus, would desire to go out and step on rusty nails.... ridiculous.
Given these issues, we expect that it will take several generations to drastically reduce HPV 16 induced disease, and to see the death rate first stabilize and quit climbing, and eventually fall. We are a small organization, and we are working on this problem daily, with the micro funding that we currently have. (This economy has not helped benevolent giving, especially to small non-profits). But it will take more public awareness, more viral spread of good and scientifically accurate information on the web, and it will take a government and medical/dental professionals to become actively involved in seeing progress made. http://www.oralcancerfoundation.org/hpv/index.htm
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