Why There is No HPV Test for Men

There has long been a frustration, upsetment and for some a feeling of discrimination because there is currently no available HPV test for boys and men.

We are the ones burdened with the diagnoses, having to inform partners, shouldering feelings of shame and guilt and ultimately if persistent and progressive having to deal with all the physical and emotional ramifications of treatment.

The medical community has not been falling over itself in a race to make available a test for men and so the predominant question becomes - why not?

To begin with the current HC2 technology used in testing for HPV does not discriminate. It knows not whether the specimen is from a male or a female. PCR, or polymerase chain reaction, is a test which has been used long before the digene HPV test and most currently used was approved by the FDA. This is also true of the tests available through Hologic and Roche's new cobas test.

It is often heard that there is no consistently reliable test for men, yet PCR is typically used in the majority of research studies, including those on men. If it were so unreliable, then the research study results should also be in question but they're not. These same results are used to develop policies and guidelines relative to things like screening, so obviously it isn't because the test is unreliable.

According to Joel Palefsky, MD, of the University of California San Francisco, who deals with infectious disease and HPV related anal cancers, the unfortunate fact is, that it doesn't serve a purpose. Unless a man has some type of lesions which can be further tested simply knowing that he has HPV is not going to change anything. He states that most individuals are not tested in advance of sexual involvement with a partner but typically are dragged in by a partner who has been diagnosed with HPV. By that time, it is too late to undue transmission for any strain of virus which may have been acquired.

I know many are now adamantly disagreeing with this. It's unfair that women cannot have their partners tested in advance, it is unfair to put the burden on women and essentially result in women taking the blame for HPV transmission and a host of other reasons women typically consider.

Many may be surprised to know that the current test is only approved by the FDA for use with cervical specimens despite the fact that HPV can also be found in vaginal, vulvar and anogenital tissue. Once again, the test cannot distinguish from where the sample originates and would work just fine on any of these other areas.

Many of you may have heard of the anal pap. This is usually performed more on men than on women so of course one would wonder how this would work. Simple really, the origin of the specimen would simply be changed prior to submission to the lab for analysis. While this can be highly dangerous if it were done with a biopsy, for the HPV test which is simply looking to detect HPV DNA the sample area isn't significant. Either the DNA is present or it's not.

So why is it considered of no use in men? Well because while a urethral swab could be taken and perhaps a penile swab there is nothing that can be done for the patient if it were to reveal him to be HPV positive. Just as with women there would have to be some type of lesion which could be biopsied to check for dysplasia and/or cancer and penile cancer is very rare and there are rarely if ever visible penile lesions (unless of course they are genital warts which are the low risk type of HPV and not what we're talking about here). You don't need a test to tell you that genital warts are present, they're pretty obvious. It's the high risk oncogenic strains we're talking about here.

Tests are not typically performed by a physician unless there is the ability to then DO something based upon those results. There isn't anything that can be done for a man who is diagnosed as HPV positive other than to provide the standard precautions regarding the spread of the virus and using condoms and this information can be given even without an HPV result.

Even with condoms, HPV is so contagious and often exists in the tissue around the penis, testicles and perianal area that transmission is highly likely even with condoms and the only thing that will really make a difference would be if the man were to become a cloistered monk.

So its not that there isn't a test able to detect HPV in men, it's just viewed as pointless in testing for it. When it comes to the blame and shame which falls almost exclusively on women, what will make a difference is the FDA changing their current position regarding male vaccination against HPV. Right now vaccination is only recommended for women. It is approved for boys and men but not recommended. That recommendation carries all the difference, it says that protecting against HPV is just as important for men as women and levels the field when it comes to people's perception that women are to blame. Having the FDA make it a recommendation says that men are equally involved and accountable when it comes to the transmission of the virus and helps to lift the burden currently placed solely on women.

So in summary, it isn't that a test doesn't exist because it does. It is just not embraced for use by the medical community because knowing if they are positive is not going to really change anything and if their HPV is dormant at the time resulting in a negative test it would only be misleading. anyway.

The reason other vaccines have such a high compliance rate compared to HPV is because they are mandatory, typically required if a child is going to be allowed into school. Being "recommended" as HPV currently is certainly doesn't prompt compliance and since most doctors do not discuss HPV with patients they typically only learn about it as part of their positive diagnosis.

Since there are so many other means of transmission now being discovered and even kissing being suggested by those at Johns Hopkins doing research on HPV oral cancers then what is to prevent a child from transmitting it to another child by sharing a drink in the cafeteria. This is how Hepatitis B is transmitted very often and that results in cancer as well. Those against mandatory vaccination say that since it is an STI and younger children are not engaging in sex it isn't necessary, but if indeed it is as simple as sharing a drink or kissing (HPV has been identified in saliva) then it can easily be transmitted even without the sexual component in that age group.

Given the fact that male oral cancers from HPV have doubled from 1973 to 2004 is all the more reason for the FDA to make vaccination recommended in boys and men. Perhaps then this will lessen the stigma so often placed upon women and educate others to the fact that men are just as responsible for HPV transmission as women.
HPV Oral Cancers on Rise as Oral Sex Becomes More Popular, May Spread Human Papilloma Virus - ABC News." ABCNews.com: Daily News, Breaking News and Video Broadcasts - ABC News. N.p., n.d. Web. 5 Sept. 2011. http://abcnews.go.com/Health/ReproductiveHealth/hpv-oral-cancers-rise-oral-sex-popular-spread/story?id=11916068&page=2

Joel M. Palefsky, MD - UCSF Helen Diller Family Comprehensive Cancer Center." UCSF Helen Diller Family Comprehensive Cancer Center. N.p., n.d. Web. 5 Sept. 2011.
http://cancer.ucsf.edu/people/palefsky_joel.php

HPV and Anal PAP Testing, Health Facts For You, UW Health, University of Wisconsin Hospital, Madison ." UW Health, University of Wisconsin Hospital, Madison . N.p., n.d. Web. 5 Sept. 2011. http://www.uwhealth.org/healthfacts/B_EXTRANET_HEALTH_INFORMATION-FlexMember-Show_Public_HFFY_1126667028463.html

FDA Approves New Cobas High Risk HPV Test

On April 20, 2011, Roche Diagnostics announced that the FDA has approved its new HPV test, cobas. This new test detects the presence of DNA for fourteen high risk strains of the virus. There are a few differences between the Roche test and the current digene HPV test. Roche’s test will check for fourteen of the high risk HPV strains while the digene test checks for thirteen. Once this is completed, the Roche test will then concurrently genotype the specimen for types 16 and 18. These two HPV strains re shown to cause approximately 70 percent of all cervical cancers.

Roche representatives, Christoph Majewski , Head of HPV molecular science and Dr. Catherine Behrens, Director of Medical Affairs of the women involved in the ATHENA study with a Pap result of ASCUS (atypical squamous cells of undetermined significance) 90 percent were shown on biopsy to have CIN2/3 lesions. Of those, 46 percent were CIN3.

The National Cancer Institute indicates that 10 percent of women who are positive for HPV types 16 and 18 have been shown to develop CIN3 (cervical intraepithelial neoplasia grade 3) within three years. CIN3/CIS (carcinoma in situ) is the most severe type of abnormality prior to the lesion becoming an invasive cancer.

The ATHENA study was utilized to determine the effectiveness of this new test, cobas. The study was conducted throughout the United States and involved a total of 47,000 women. It showed that one in ten women who tested positive for types 16 and 18 genotyping had precancerous lesions despite having a negative result on their Pap smears.

The current digene HPV test in existence for over ten years does not, at this point, genotype within its 13 panel assay. It has however since its inception performed over forty million tests and had over three-hundred pier review articles with respect to its methods.

Cervista*, the HPV test from Hologic, approved by the FDA, like Roche, tests for fourteen high risk strains. While Cervista* HR does not concurrently genotype for 16 and 18 as cobas does, they do offer a separate test to genotype for both 16 and 18.

It may seem more convenient to have all testing done relatively simultaneously in one HPV test. However, since much of the cost of testing is ultimately determined by the laboratories performing them, it will be interesting to see just which test will take the lead.

*This blog has been changed (with our apologies) to correctly reflect the name of the Hologic HPV test which is Cervista and not Cervarix as previously mentioned. Cervarix, along with Gardasil is one of the two FDA approved HPV vaccines.

Is Cancer Contagious? The ACS Says No, but is This the Truth?

In an article by the American Cancer Society titled “Is Cancer Contagious”, the comment is emphatically made that it is not. It goes on to say,

“If cancer were contagious, we would have cancer epidemics just as we have flu epidemics -- cancer would spread like measles, polio, or the common cold. We would expect a high rate of cancer among the families and friends of cancer patients and among health professionals to reflect their exposure to the disease. This is not the case.”

In the case of the human papillomavirus I would have to disagree. HPV is known to cause numerous cancers including cervical, vaginal, vulvar, anal and oral, as well as penile. Its main method of transmission is through intimate skin-to-skin contact. It does not require intercourse however this only increased the chances of contracting the virus especially for women through small tears or abrasions in the vagina during intercourse.

Family members don’t have intimate relations with each other and they don’t typically have them with their friends either. And it’s obvious that they aren’t having intimate relations with their physicians. So the theory as related in this article borders on nothing but the absurd.

While HPV does not transmit cancer in the literal sense of the word, it does introduce the precursors known, under the right conditions, to cause cancer. We know that HPV is a sexually transmitted disease and can also be transmitted through oral sex and some have indicated that kissing is not beyond the realm of possibilities as well as through foamites (inanimate objects, fingers, sex toys etc).
The article goes on to state:

“There is no evidence that close contact or things like sex, kissing, touching …… can spread cancer from one person to another.” On the contrary, more and more research is confirming that transmission of HPV is far more complex and involves multiple modes of transmission and one is certainly more likely to develop one of these cancers if they have been exposed to HPV than not.

Today, 99.9% of cervical cancers are the result of HPV and over 90% of anal cancers. Oral cancers continue to rise, particularly in younger men, at a staggering rate which has already exceeded the number of cervical cancers on an annual basis.
As with other HPV related cancers, it is not a difficulty in diagnosing these cancers that are the problem, but a lack of education on the part of physicians and the lack of public awareness and early screening opportunities.

Cancer in the broader sense of the conversation, or shall I say the potential for cancer, has shown to be very much contagious as it relates to HPV. The Hepatitis viruses have long been known to result in liver and pancreatic cancers. Perhaps we may ultimately find that all cancers are the result of various viruses, but until then, perhaps the ACS should take a bit more pragmatic view on its current position.

" Is Cancer Contagious? ." American Cancer Society :: Information and Resources for Cancer: Breast, Colon, Prostate, Lung and Other Forms. N.p., n.d. Web. 28 Aug. 2011. http://www.cancer.org/Cancer/CancerBasics/is-cancer-contagious

"Hepatitis B Foundation: Hepatitis B and Primary Liver Cancer." Hepatitis B Foundation. N.p., n.d. Web. 28 Aug. 2011. http://www.hepb.org/professionals

The Oral Cancer Foundation. Web.28 Aug. 2011. http://www.oralcancerfoundation.com/

International Conference Update

The schedule for this year's International Papillomavirus Conference in Berlin Germany has been finalized. My presentation, HPV - The Patient Experience is the first in the experience of the conference given by a patient and I commend the organizers of this conference in recognizing the need to include the voice of those most affected by HPV - the patients.

It is my hope that this will set a new standard by which future conferences will continue to include the voice of the patient. There is much that can be learned from the patient's input however for too long the medical community has not appreciated that they could learn anything useful from them aside from the results provided regarding physical research. But HPV is not solely a physical condition but a psychological one as well.

In finalizing my presentation I realize just how much of the psychological aspects of an HPV diagnosis is relevant to the development of guidelines currently only focused on scientific physical evidence. While this is certainly a significant factor, the psychological aspect simply cannot be ignored if the patient is going to be treated as a whole.

We are not just physical nor just psychological beings but a delicate combination of both. It is important for me to dispel the myth that providing the patient with information will only result in hysteria and upset. In my experience it is exactly the opposite. It is that lack of education of the patient which results in psychological distress. The feelings of not only the unknown but the loss of control over their bodies as well The loss of control is especially true in the case of persistent disease in which the patient cannot in many instances effectuate a change in the progression of precancerous lesions. Younger individuals, once feeling invincible with the world ahead of them are now fearful and concerned about the potential for loss of future fertility and possibly death - something which, because of their age they typically would never have had to face if not for HPV.

It is also important that women not continue to have to bear the burden of HPV diagnosis themselves and a test for men must be developed. In addition the development of a therapeutic vaccine for those already infected with the virus is paramount. The percentage of individuals who actually complete the three doses of the current vaccine in the US is only 30% and without a widespread public education campaign far more individuals will become infected than those protected.

This will certainly prove to be a precedent setting conference.

Comparisons Between AIDS and HPV

Both HIV/AIDS and HPV are viruses. Just as with HPV (Human Papillomavirus) which has been in existence for centuries, HIV/AIDS (Human Immunodeficiency Virus/ Acquired Immune Deficiency Syndrome) has also existed as an unidentified condition decades before it’s identity as a retrovirus was discovered in the early 1980s. This is the same time frame during which HPV was identified as being responsible for cervical cancer. Actually the retroviruses responsible for AIDS were discovered in the very same year, 1984, as was the connection between HPV and cervical cancer.

According to information from those who researched AIDS in the earliest years, the time of onset of symptoms could be ten years or more. Similarly, while the incubation period for HPV is usually three months, symptoms are usually absent and actual progression to an invasive cancer takes a similar amount of time, approximately ten years.

Dr. Robert Yarchoan of the National Institute of Health, made the following comment regarding the early days of AIDS diagnoses, “I remember doing a rough mental calculation of the number of gays in the country and the percentage who were likely to be HIV-infected, and estimating that there were half a million to a million people infected with this lethal virus who did not know it.” With HPV estimated to affect over twenty million Americans and more than six million more acquiring the virus each year, still few people are even aware of what HPV stands for.

By the mid-eighties however, far more extensive research was being conducted with respect to pharmaceuticals and vaccines and more so after the United States Congress allocated additional funding in 1986. Within ten years of the identification of the AIDS virus there existed medications which could control the disease, yet it took another two decades for the first vaccine to become available for HPV in 2006. Even this vaccine is limited and does not cover all cancer-causing strains of HPV.

While the Pap smear and subsequent HPV test has resulted in a dramatic reduction in the number of cervical cancers this is the result of early identification, the treatment for which is typically some form of invasive tissue removing procedure, but certainly not a medication which would be far less traumatic and result in fewer consequnces (physical and psychological) for women, including potential infertility.

So why is AIDS so familiar to the majority while HPV remains relatively unknown? It would appear that the governments direct involvement as well as its massive funding for AIDS research may be the answer. The media also played more of a role in educating the public than they do today with HPV. Yet, high risk HPV has now been identified as being necessary for the progression to a minimum of five different cancers; cervical, vaginal, vulvar, anal and oral, with other conditions resulting from low risk strains.

While HPV may not be fatal within a short period of time as AIDS was, it is ultimately still responsible for millions of deaths throughout the world each year. The question remains, just how many cancers will need to be attributed to HPV before the government decides to involve itself both in education and funding? Despite all the similarities, the difference in how each has played out since discovery appear quite disturbing.

Changes in Immunization Practices May Reduce Oral Cancer

Until now, the ACIP (Advisory Committee for Immunization Practices) has only approved the HPV vaccine for girls and young women through age 26. This despite the fact that the FDA (Food and Drug Administration) itself approved the vaccine for use in boys and young men almost two years ago in 2009.

Since its approval in 2006, the Gardasil vaccine, originally approved only to prevent certain strains of HPV known to cause cervical cancer and their precancerous lesions has been expanded to include vaginal and vulvar cancers and their precancerous lesions as well. Last year, they extended this to include anal cancer.

Until now, including boys and young men would not be cost effective given the low percentage of women who actually go on to complete the three shot series.
Now however there has been an explosion with respect to the number of oral cancers which are predominantly affecting males and which has overall exceeded the number of cervical cancers annually. Previously, smoking and alcohol were considered to be the major causes of oral cancers.

In the time period from 1984 to 1989, 16 percent of oral cancers were attributed to HPV. In comparison, in the time period of 2000 to 2004 the percentage of oral cancers related to HPV had increased to 75 percent and, it is known that the risk of oral cancer increases related to an increase in oral sex and kissing.

During the ACIP meeting of June 22, 2011, testimony was heard from Aimee Kreimer, PhD of the National Cancer Institute. She stated, "At some point ... it is projected that there will be the same incidence of OP cancer in men as cervical cancer in women, If current trends continue, OP cancer in men will pass cervical cancer in 2025."

Many abstinence groups are opposed to the vaccine claiming, like the distribution of condoms in the past, that it was the equivalent of approval to engage in sexual activities. That argument is becoming weaker when simply the act of kissing is considered a risk factor for oral HPV related cancers.

Dr. Dong Moon Shin of Emory University’s Winship Cancer Center stated, “The time is now. For the HPV vaccine, cost is the only issue as side effects are minimal. Routine HPV vaccination has to be implemented very soon, for both boys and girls."

Given the information to date, it is apparent that the sooner the ACIP includes in their recommendations that boys as well as girls receive the vaccine, the greater the impact on all HPV related cancers will be.

Tips for a More Accurate Pap Test Result

Most women have undergone a mammography, perhaps more than once. I myself have never made an appointment without being given specific instructions on what not to do the day of the exam. Don’t use any perfume, powder or deodorant is what someone planning a mammography is typically told.

Most women however are not provided with some also simple instructions when it comes to getting a Pap smear. Whether or not you comply with these recommendations can make a difference in the outcome of your results. In fact, they can interfere with accurate results. Although there has been a 75% reduction in cervical cancer over the past decades, the majority of that decrease today is the result of early treatment for precancerous lesions thus preventing them from progressing to cancer. So following these instructions continues to be important when it comes to your health and obtaining the most accurate results possible.

According to Women’s Health, the following are instructions which all women should be provided when scheduling a visit which will include a Pap test:

1. Vaginal douches are not recommended for the three days prior to the
Pap test.
2. Do not have sexual intercourse two days before your Pap test.
3. Take showers instead of tub baths two days prior to the exam.
4. Tampons, vaginal creams or medications, contraceptive foams and
Jellies are not advised I the 48 hours preceding the Pap.
5. Schedule your Pap one to two weeks after your period.

I’ve been having Pap tests for decades and cannot ever remember being given this information. The recommendations make perfect sense when considering the purpose of the Pap and just what is removed during the test. Any unusual substances such as contraceptive products and those contained in douches can effect the environment surrounding the cervix itself thus preventing removal of the cells necessary to provide a more accurate result. This is true of any outside substance which would include seminal fluid which his why sexual intercourse is discouraged as well.

I hope that you have been provided with this information when you have scheduled your Pap test. If not, you now have the tips which will help you to receive the most accurate results possible, and when it comes to an exam used to detect cervical cancer, we of course want the most accurate results possible.