FDA Should Expand HPV Vaccines' Age Limit

The next few months will be a very significant time, not only for women but for the Gardasil vaccine as well. This is because the FDA (Food and Drug Administration) is holding hearings into whether or not to extend the use of the vaccine. Currently, Gardasil is approved for administration between the ages of nine and twenty-six. When all is said and done, that high age range will be extended to forty-five.

Gardasil is administered in three doses with the cost hovering around $350 for the series. You can often find a physician who is willing to administer the vaccine “off label”, meaning outside of the standard protocol. As a result, the patient ends up having to carry the cost. So why would anyone really care?

Ultimately having girls immunized prior to the onset of sexual activity would be optimal but what about the teenagers and women in their early twenties, the ones who have the highest incidence of HPV infection? Their immunizations would require knowledge of the vaccine in addition to the ability to cover the expense (although Merck does provide financial assistance under certain criteria). Until age twenty-six, insurance would continue to pick up the cost of the vaccine.

So what then becomes of those women over age 26? The highest incidence of cervical cancer occurs in a woman’s thirties and forties. Presumably she has been exposed to the virus for some time, at this point, and if she continues to remain HPV positive (persistent infection), carries a much higher chance of developing cancer. By this point in time, if a woman is going to have HPV she would have shown symptoms by now, say some. Not necessarily. Symptoms of high risk HPV are often so minimal that they are missed or attributed to something else. Because many of the initial signs resolve rather quickly, the woman usually doesn’t give it a second thought.

It is important that the FDA decide to extend the use of Gardasil beyond age twenty-six to the proposed forty-five. A vast majority of women are married and have had children. They no longer need to be concerned that a pregnancy may set off an HPV infection. Having been in a monogamous relationship, their chances of having acquired the human papillomavirus are less than that of those having had multiple sexual partners during that time frame. However, what happens when this couple now divorces? When after fifteen or twenty years of marriage, the woman suddenly finds herself back on the dating scene? Is she not entitled to receive the same protection from this cancer causing virus as younger women? The answer to that question is a resounding yes, and hopefully before year’s end, the FDA will agree.

HPV and Anal Cancer

In the 1980s, we still had not been introduced to the Internet. Who would have thought everyone would spend countless hours playing solitaire for the sole purpose of watching the cards spring from the page. There was no electronic mail or GPS devices, no iPods, iPhones or iPads and no “Google.” There was however one very significant discovery. After decades of devoting his life to research, Professor Harald zur Hausen, MD (photo featured above) discovered that it was the human papillomavirus (HPV); more specifically HPV strains 16 and 18, which were responsible for 70 percent of cervical cancers.

Unlike bacteria, a virus is capable of remaining dormant in the body for months or even years and it does not respond to antibiotics. By the close of the 1980s, medical science was able to test for the virus along with the Pap smear and also to do more in depth studies to determine just which strain of the virus a person had. The request had been made by Professor zur Hausen to work on the development of a vaccine against this virus but was declined.

It was October 1991 when I was diagnosed with HPV-induced cancer even though my initial diagnosis was in 1987. From 1987 until 1991 the precancerous lesions caused by this virus had remained localized mainly to the vulva though there was the occasional vaginal and cervical lesion. Imagine my utter shock when I was informed, after what was to be a routine hemorrhoidectomy after the birth of my daughter, that I had invasive anal cancer.

As an RN I had very close ties to the medical community, I even managed a local radiology practice in Northern New Jersey making physicians in New York within easy reach. My boss became my radiation oncologist as I endured both radiation and chemotherapy. I was 33.

My treatment was complicated by the fact that there was no vast wealth of knowledge regarding HPV related cancers nor was the information which existed, easily accessible. Never-the-less, that treatment, along with surgery and regular post-treatment follow-ups, kept me cancer free – at least temporarily.

In 2008, seventeen years later, I was once again diagnosed with invasive anal cancer. I thought that now things would surely be different. We had the Internet, a means of disseminating all the research results culminated in the almost two decades prior. A means for the average individual, in the comfort of their own home, to “Google” for HPV and cancer.

Don’t get me wrong, it’s not that there wasn’t information to be found. It’s just that the information I found to often be incorrect, misleading and in some cases downright wrong! Women in particular still were not urged to obtain the vaccine against the two most proliferative strains of the virus which had since been developed, and doctors in general were remiss in their overall knowledge of HPV – frighteningly so.

It was for this reason that I decided to write Any Mother’s Daughter. I was not only upset, but angry over the fact that after two decades it was as difficult for women to find out about the virus and the dangers it posed as it had been initially for me in 1991 and this had to change.

I chose to incorporate my own story into the book, allowing the reader someone with whom to connect, while at the same time learning about the virus, how it causes cancer, the diagnosis, treatments and procedures accompanying the diagnosis of high risk HPV. It became my goal, to educate women and others (men and the healthcare professionals) regarding HPV, as well as, to become advocates for their own healthcare in the process.

Bonnie was recently featured in the Orlando Woman Newspaper:
Any Mother's Daughter~One Woman's Lifelong Struggle With HPV: Page 8: http://orlandowomannews.com/files/091010.pdf

A Need For Change

I have wanted to blog on this issue for some time. I suppose it was a culmination of several things which have made this an appropriate time to do so.

I make clear on my website "The HPV Support Network" (previously Any Mother's Daughter) that HPV is not solely about cervical cancer. When Merck began marketing Gardasil, the vaccine to protect against certain strains of HPV, back in 2006 they were faced with a difficult challenge.

While it is well known that HPV is a sexually transmitted infection, marketing Gardasil as such was not going to get the attention it needed. It was the purpose of the vaccine that needed to be focused on and how better to do so than as a means to protect against cervical cancer.

While the initial indication for use was indeed against cervical precancerous lesions and potentially cancer, the vaccine also protects against two strains of the virus which cause gential warts. Perhaps many have noticed that the commercials talk about cervical cancers and "other" conditions caused by HPV. They never use the term genital warts because once again it focuses on the STI aspect. While understandable from their marketing point of view, it certainly does more damage regarding the self esteme of those who have it.

I am not going to get into a post about those who view the vaccine as permission (for young girls) to engage in sexual activity or intercourse. These individuals aren't capable of addressing the fact that a woman can remain celibate until marriage and still contract HPV from her husband because most men show no symptoms and when eight out of ten individuals already have HPV, chances are he does too. And, that contracting HPV doesn't require intercourse and even a virgin can have HPV because of its skin-to-skin mode of transmission.

What I want to focus on is that there are other things which have taken the back seat, if you will, to cervical cancer. If you were to look at the documentation which came with the vaccine initially, you will see that the indications for use include protection from gential warts and CIN (cervical intraepithelial neoplasia). What most people don't know, is that since then that documentation has changed. The indications for use have broadened to include protection against VIN (vulvar intraepithelial neoplasia) and VaIN (vaginal intraepithelial neoplasia) as well.

Why were these now included? Because research substantiated the fact that HPV effects more than just the cervix and, perhaps more importantly, that these lesions can also develop into cancer. Unfortunately there still remains one area excluded from these indications and that is anal.

Most people aware of the connection between HPV and cervical cancer also know that HPV is responsible for 99% of cervical cancers. Not only are people unaware that HPV involves the anus and perianal area but they are frighteningly less aware that it too (like cervical cancer) is responsible for 99% of anal cancers.

It's time that anal cancer gets the attention that it deserves. Unfortunately this is still an area of the body that people have difficulty talking about, and while I can understand this, overcoming those inhibitions will be necessary to save others from this lesser known form of cancer.

Like other cancers, anal cancer knows no limitations. It effects both men and women although women are effected more often than men. You would think that this statistic would make people realize that it is not limited to the gay male population. It is not inhibited by a person's social status - last June, Farrah Fawcett lost her long battle against anal cancer. I had hoped that it would finally begin to get the coverage it deserved. These hopes were quickly dashed when the death of Michael Jackson overshadowed virtually all coverage relating to Farrah.

What follows may be perceived as graphic and you may decide to stop reading now. I would hope not, because it is the initiative of individuals to push past what is comfortable for them that allows for growth.

Anal cancer is quite a horrific cancer. One might argue that all cancers are horrific but the fact is that some bring with them consequences that other cancers do not. For example, because the use of the anus is required on a regular basis it is not an area kept easily clean which inhibits healing. Radiation therapy for anal cancer causes severe burns to the outside skin and going to the bathroom is a nightmare. Not only is it painful having a bowel movement but urine only causes a burning feeling on the already radiation burned tissue.

It's not as though you can put a clean sterile dressing over the area and that is that. Healing after treatment is often compromised by the development of fissures, splits that occur in the skin around and often directly through the anal sphincter. If that description didn't make you cringe, then I can confirm they are extremely painful especially when pressure while going to the bathroom makes you feel like you're being ripped in two. The pain can become so bad that your body goes into an involuntary case of the shakes.

There is another whole aspect of anal cancer that needs to be addressed. When anal cancer has progressed to a certain point, it requires a colostomy - removal of the anus, suturing shut the opening and connecting the remaining end of the intestines through a stoma (opening) in the abdominal wall. A bag is attached to this stoma and the person loses their normal bodily functions having to forever defecate into this bag.

Not only are there severe physical ramifications as mentioned above but there are also tremendous emotinoal ramifications as well. Having to adjust emotionally to the permanent change in body image, worrying about leakage, smells, and a myriad of other issues. I'm not attempting to "gross" anyone out with these descriptions but rather to educate people regarding just what anal cancer patients may and often do endure as an end result. If this patient was concerned about being able to get into a relationship before, imagine how much more difficult this would potentially be after a colostomy.

I suppose one could argue that they still have their life. This is obviously true but at what cost. Does anyone think these issues can be resolved in a week, or month or even a year? As with any cancer, so much of this will have to do with the support system that the individual has at their disposal.

Anal cancer, like cervical cancer, has a high rate of cure when discovered early. However the medical community is poorly educated when it comes to providing screening by way of an anal pap. They often dismiss patient's concerns stating it is too "rare" to worry about. Yet the rate of anal cancer has continued to rise each year for some time now. Individuals with cancer, regardless of the area, deserve the options and resources that all other cancer patients do but these are sorely lacking for those with anal cancer.

The medical community needs to do more, much more, to educate physicians regarding the dangers of HPV and anal cancer. Doctors must take seriously patient's concerns for anal cancer especially if they have already had cervical issues from HPV. Studies show a 37% increased risk of HPV induced anal issues and cancer if you have had cervical involvement. The media must also work to make the public aware that like many other cancers, this can be cured and screening does exist. The only drawback is - will the widespread use of such screening come in time, and that remains to be seen.

Fighting the Stigma of HPV

Unfortunately HPV, like other sexually transmitted infections, carries with it a stigma. I believe that this stigma is misplaced from the start. HPV is actually transmitted by skin-to-skin contact and it just so happens that genital contact is indeed a form of skin-to-skin contact. However, unlike other STI's, HPV does not require intercourse for transmission. Ongoing research continues to show transmission via other methods with some even suggesting kissing as a potential means of transmission as well as foamites (inanimate objects). So should HPV really be classified as an STI?

Stigmas are not new and continue to inflict emotional pain upon those carrying the label. In the case of HPV, such stigmas can have devastating effects when they function to silence the person infected. The embarrassment may prevent them from speaking to anyone, including those who may be able to shed more light on the virus. In the worst case, it can prevent the individual from seeing their doctor, or by the time they do, it's too late.

The ones that come to mind most often are slut, tramp, hoe, hussy and a host of others all involving the woman's sexual history and number of sexual partners. Just like getting pregnant only takes one act of intercourse so too is true of acquiring the HPV virus.

Personally, I find it very insulting when I hear people on TV joking about STI's. It makes me angry because this person is so oblivious to the harm they are perpetrating. This doesn't have to be only on TV but those people just have such a vast audience to whom they can spread their ignorance. To them it's funny.

Then again there are those who know exactly what they are doing, their actions are intentional, a case of spreading the sentiment that whomever has the humanpapilloma virus got what they deserved. Obviously the underlying message is that those with HPV have done something wrong.

Until people are educated regarding the facts about HPV nothing will change. Education needs to emphasize that HPV is contracted via skin-to-skin contact and that most importantly, the cancers caused by the most common strains of HPV, are preventable. Perhaps if people understood that HPV is also responsible for cancers of the lung, head/neck, throat and other non-sexual organs, they would be open to a more meaningful discussion.

Take advantage of any opportunity to correct those with a misperception about HPV. Learn as much as you can yourself about HPV so you can correct those misperceptions. It is alarming the number of women who still have never heard of HPV. If you are reading this then you are ahead of many others.

Research Shows Gardasil Effective in Preventing Anal Intraepithelial Neoplasia (AIN)

Most people are familiar with the connection between HPV and cervical cancer. Merck Pharmaceuticals, makers of the Gardasil vaccine focus mainly on HPV as the causative agent in cervical cancer. However, what most people do not know is that it is also the causative agent for vaginal, vulvar and anal cancer.

Since it's approval by the FDA for use in protecting against CIN (cervial intraepithelial neoplasia) and potentially cervial cancer, the FDA has also approved Gardasil for protection against both VIN (vulvar intraepithelial neoplasia) and VaIN (vaginal intraepithelial neoplasia) and the potential cancers which result if left untreated.

There is a long standing connection between AIN (anal intraepithelial neoplasia) and anal cancer to HPV. In fact, HPV is considered to be responsible for 99% of anal cancers. Since the publication of this new research, hopefully the FDA will quickly approve the inclusion of AIN in the indications for the Gardasil vaccine. This research showed a 74% protection rate against the development of AIN lesions.

While an HPV connection was never mentioned, most people are aware that Farrah Fawcett died last June of anal cancer. In the subsequent documentary no public service announcement was made letting people know that this is a preventable cancer. Individuals with HPV and more specifically those with anal involvementfrom HPV were sorely disappointed that a PSA was omitted.

Doctors and other healthcare providers need to be more proactive in educating patients not only about HPV and cervial cancer, but about its connection to these other cancers as well. Unfortunately because of the lack of medical organizations such as the Society for Colon and Rectal Surgeons to educate their members on this connection, it fails to be conveyed to patients. This makes obtaining an anal pap for HPV (similar to the cervical pap) is almost impossible to obtain.

One of the ways that will bring about change is for patient's to continue to request the anal pap. Eventually, providers will realize the significance of offering this service. Professional organizations however must get on board and focus on educating their members. These are preventable cancers, and more needs to be done to bring this into awareness.

So Much For Responsible Journalists

In researching the internet over this past week for new information regarding HPV and HPV research, I came across the equivalent of an "Ask Abbey" section in the Montreal Gazette written by Josey Vogels. The question and answer were framed under the heading of: Three in Four Sexually Active People Infected With HPV. The link is below:(http://www.montrealgazette.com/about-montreal-gazette/contactus.html)

Anyone writing for public consumption including myself, has an obligation to research the information we provide and to be diligent in our research. It matters not the subject, whether the current oil spill in the Gulf of Mexico or HPV we owe it to those who read our words to convey accuracy and above all, the truth.

Ms. Vogels states that there is currently no vaccine available for men. I might have accepted that if it were not for the fact that this issue of the paper was dated May 12, 2010, only two days ago. If it had been written last summmer, the statement would have been true for the United States. The FDA only approved Gardasil for use in boys and men last September. Gardasil was approved in the US, by the European Commission and has been in use in Canada since 2006 for girls. But, on February 23rd of this year, Health Canada approved Gardasil for boys and men. A simple Google search would have revealed this information. Instead, many Canadians, as well as international readers such as myself, are being lead to believe there is no vaccine for males. There is and it is approved in Canada.

Why is this irresponsible, because a young man who may be interested in receiving the vaccine will think he cannot. Use in men is also limited to those under 27 as it is in women. Some physicians will provide the vaccine beyond the age limits imposed by the FDA and insurance companies although the patient typically must pay for this themselves. This is true for women as well.

Given the prevelence of HPV, something Ms. Vogels WAS aware of, being so lax in the dissemination of this misinformation is one of the problems, especially when the facts are so readily accessible. Shameful.