Tuesday, September 27, 2011

When Vaccines Trump Sex Ed, or Do They?

As a parent myself, I’ve had those often uncomfortable conversations with my children regarding sex. Today, these conversations can become quite complex in an attempt to warn our children against the risks which accompany sexual activity especially with respect to sexually transmitted diseases and infections.

Many parents are not well educated themselves with respect to many of the sexually transmitted diseases and infections which exist thus making the education of their children even more difficult.

As parents, we are certainly not comfortable with the thought of our children engaging in sexual activities in uncommitted relationships and at early ages. However according to Bill Albert, a spokesman for The National Campaign to Prevent Teen and Unplanned Pregnancy. "Teenagers, by and large, have sex episodically, It has much more to do with opportunity than it does with a vaccination, for heaven's sake."

When it comes to the HPV (human papillomavirus) infection however, even celibacy until marriage cannot prevent one from contracting the virus. Recent studies have shown that half of all adult males in the U.S. may be infected with HPV, most unknowingly as it typically has no symptoms and is highly contagious. It is also transmitted through skin-to-skin contact and intercourse is not even necessary to become infected.

HPV is easily transmitted from males to females which his why it is important for not only girls but boys to be vaccinated as well. In addition, recent studies have shown that 75 percent of oropharyngeal cancers are the result of HPV, the majority of these are affecting younger men.

As parents, we do our best to educate our children not only with scientific knowledge but based on our own moral and religious beliefs as well. If we are confident in what we teach our children, a vaccine is not going to change that. If anything, it may very well save their lives.

" Why Teens Have Sex (Hint: It's Not About Vaccines) | Rick Perry & HPV Vaccine Controversy | Sexually Transmitted Infections | LiveScience ." N.p., n.d. Web. 27 Sept. 2011. http://www.livescience.com/16061-hpv-vaccine-controversy.html

" Half of U.S. Men Infected With HPV, Study Reveals." CancerCompass - Empowering cancer patients to make informed decisions. N.p., n.d. Web. 27 Sept. 2011. http://www.cancercompass.com/cancer-news/article/35971.htm?c=NL20110302

"Can HPV Vaccine Stop Throat Cancer?." WebMD Children's Health Center - Kids health and safety information for a healthy child. N.p., n.d. Web. 25 Sept. 2011. http://children.webmd.com/vaccines/news/20110623/can-hpv-vaccine-stop-throat-cancer

Monday, September 26, 2011

HPV Cancer Survivor and Advocate Calls for Apology from Bachmann

Michele Bachmann, US Representative and GOP presidential candidate has offended not only women, but cancer survivors with comments she made during a political debate earlier this month.

Bachmann’s comments were based on the current vaccine Gardasil which in her words “results in mental retardation”. She continues to stand by her comments despite the fact that this is disputed by experts, including the American Academy of Pediatrics.

Gardasil, approved by the FDA in 2006, reduces the risk of the two highest cancer causing strains of the HPV virus. It has long been know that HPV is responsible not only for cervical cancer but also vaginal, vulvar and anal cancer as well as penile. Recent research now shows its role in 75 percent of oropharyngeal cancers as well.

While she may attempt to sidestep her comments by stating that she is not a doctor or a scientist, she has perhaps done far more damage with her comments than if she had been. Her comment that she “made no conclusions regarding the drug one way or the other” is clearly untrue when she drew the conclusion that it resulted in mental retardation.

It is just this type of uneducated comment made by Bachmann that has mothers questioning, if not outright refusing the HPV vaccines for their children. Perhaps Congresswoman Bachmann needs a history lesson herself before she attempts to make history as this country’s first woman President.

Cervical cancer affects approximately 12,000 women each year in the US. This figure is down 70% since cervical screening guidelines in addition to the development the HPV test has allowed for early intervention and treatment. However these interventions are not without physical and/or psychological damage, can require mutilating surgery and in some instances result in a woman’s loss of fertility. It continues to be responsible for half a million cancers per year globally with approximately 250,000 deaths.

We now have two vaccines, Gardasil and Cervarix which protect against the major cancer causing strains of HPV which can make things one step better by eliminating the physical and psychological ramifications of the treatment needed to address these precancerous and cancerous lesions.

HPV is responsible for 99.9% of cervical cancer. It is also responsible for 90% of anal cancers and to a lesser extent vaginal and vulvar cancer in women and anal and penile cancer in men. Now 75% of oropharyngeal cancers (mainly in men) are being found to be caused by HPV. Those parents who insist that their child will remain celibate until marriage only further exposes the complete lack of understanding regarding HPV because celibacy will not protect her from getting HPV from her husband when studies show that one out of every two men unknowingly has HPV.

She speaks to exposing our “young girls” to such a vaccine, yet few parents of infants give a second thought to having their child vaccinated with the MMR (prevention for measles, mumps, rubella) or dTAP (prevention for diphtheria, tetanus and pertussis also known as whooping cough) or polio. It is well known that the best time for any child to be vaccinated is before they are exposed to these viruses.

There are always going to be those with unforeseen allergies or other medical conditions resulting in untoward effects whether it be to a vaccine, or peanuts, sesame seeds or antibiotics. Shall we ban Penicillin because of the large number of individuals allergic to it. Birth control pills are long known to cause blood clots which can result in death yet that hasn’t resulted in the type of backlash that these vaccines have and that is more directly connected to sexual activity than the receipt of any vaccine.

As the mother of a 20-year-old daughter, I didn’t think twice about having her vaccinated when Gardasil was released. Why? Because I have lived with the severe ramifications of what this virus can do. I am the survivor of two invasive HPV-induced cancers having endured the mutilating surgeries, chemotherapy and radiation as well as the unfortunate complications and side effects of those treatments. I cannot conceive of my daughter having to go through even a small portion of what I did because I chose not to get her vaccinated. I wonder how many other parents could watch their child suffer the ravages of this virus knowing it was a result of their decision not to have them vaccinated.

Now, women having survived a variety of these HPV-induced cancers, those with precancerous lesions and even those diagnosed with HPV are outraged. At a time when they are desperately trying to spread the word about HPV and the importance of vaccination, Bachmann’s comments are simply untenable.

As President of The HPV Support Network Inc, a non-profit organization which advocates for awareness and education of both physicians and patients, I personally call for an apology from Representative Bachmann. She has done a tremendous disservice to all of us not to mention future generations of women (and men)who may remain unvaccinated and suffer HPV related disease. It is particularly painful to those of us who are HPV cancer survivors.

Hopefully when she begins to hear the voices of these women, she will comprehend just how devastating HPV is to their lives, how important vaccination is for future generations, and that inaccurate statements regarding this most valuable vaccine, used for the purposes of a political ploy, will not be tolerated.

Complaints can be made to: MicheleBachmann.com/contact/

Hughes, Sarah Anne. "Michele Bachmann’s HPV claims just latest in Gardasil debate - BlogPost - The Washington Post." The Washington Post: National, World & D.C. Area News and Headlines - The Washington Post. N.p., n.d. Web. 25 Sept. 2011.

"The HPV Support Network: Jul 26, 2011." The HPV Support Network. N.p., n.d. Web. 25 Sept. 2011. http://thehpvsupportnetwork.blogspot

"Can HPV Vaccine Stop Throat Cancer?." WebMD Children's Health Center - Kids health and safety information for a healthy child. N.p., n.d. Web. 25 Sept. 2011. http://children.webmd.com/vaccines/news/20110623/can-hpv-vaccine-stop-throat-cancer

"Gardasil." U S Food and Drug Administration Home Page. N.p., n.d. Web. 26 Sept. 2011. http://www.fda.gov/BiologicsBl

"Pediatricians Fact-Check Bachmann's Bashing Of HPV Vaccine : Shots - Health Blog : NPR." NPR : National Public Radio : News & Analysis, World, US, Music & Arts : NPR. N.p., n.d. Web. 26 Sept. 2011. http://www.npr.org/blogs/health/2011/09/13/140445104/pediatricians-fact-check-bachmanns-bashing-of-hpv-vaccine

Wednesday, September 14, 2011

HPV - Beyond Cervical Cancer

HPV was first identified as the cause of cervical cancer in 1983 when Professor Harald zur Hausen, MD discovered HPV16. In 1984, he discovered HPV18 which, between the two strains were shown to be responsible for approximately 70% of cervical cancers.

In 2006, the first vaccine to prevent cervical cancer as a result of these two strains, Gardasil, was approved by the FDA. The vaccine protects against two high risk strains, those known to potentially cause cancer, and two low risk strains that typically result in genital warts.

Since that time, the usefulness of the vaccine has expanded. The vaccine which initially was approved as useful only with respect to cervical cancer was approved by the FDA for the prevention of vaginal, vulvar and most recently anal precancerous and cancerous lesions resulting from these two strains of the virus.

Because Gardasil was initially approved for use only in preventing cervical cancer, its manufacturers, Merck Pharmaceuticals, was initially forced to limit its advertising to cervical cancer prevention and genital warts only to avoid any compliance and regulatory issues. As a result, the majority of individuals who have even heard of HPV typically make the connection to cervical cancer. It is almost as if the two have become synonymous.

What is unfortunate, is that despite the FDA expanding its use for prevention of three additional cancers, Merck has not developed any new advertising campaigns to update the public regarding the increased risk from HPV. Even its website fails to provide any more than a single line of information and even this fails to include anal cancer.

More recently, a second vaccine, Cervarix was developed by Glaxo Smith Kline also for the prevention of cervical cancer but not protecting against genital warts. Its use has not been expanded to include any other cancers nor has it been approved for use in males as Gardasil was in 2009.

With over 20 million Americans infected with HPV at any one time, according to the CDC, and over six million new cases per year, one would think that there would be far more information distributed to the public.

With more recent studies identifying HPV as the cause of oral cancer as well, it probably will not be long until Merck applies to the FDA to expand once again the usefulness of Gardasil to include oral cancers as well.
The CDC however recently reported a decline in the number of those eligible for the vaccine and who are choosing to take advantage of it. The rate of vaccination from 2009 to 2010 rose only 5.2%. This brought the total overall vaccination rate, considered to be an individual receiving all three of the shots required to complete the series, to an abysmal 32%. The CDC is concerned, and rightly so, that unless it can turn its vaccination campaign around, there will be another entire generation of women having to deal with the ravages of dysplasia and cervical cancer.

The CDC has a right to be concerned. However, until the government as well as the medical community and the vaccine manufacturers alike begin an all out effort to educate the public regarding the extensive cancer causing potential for HPV, it is unlikely that much will change.

CDC Media Relations - Press Release: August 25, 2011." Centers for Disease Control and Prevention. N.p., n.d. Web. 12 Sept. 2011. http://www.cdc.gov/media/releases/2011/p0825_hpv_vaccine.html?source=govdelivery

http://www.gardasil.com/ Web September 12, 2011

Thursday, September 8, 2011

Is Your Risk for HPV Greater Than You Think?

It has long been reported that the risk of HPV progressing to a significant level of precancerous and subsequently cancerous lesion are very low. I have long been concerned regarding just how accurate this information may be.

The rates of cervical cancer over the past half a century have dropped dramatically as a result of cervical screening programs which can identify abnormalities in advance of their becoming cancerous. As a direct result of these programs, high-grade lesions (CIN2, CIN3 and CIS also known as carcinoma in situ) are routinely treated and removed in an attempt to eliminate the potential for cancer.

HPV however, like many other contagious conditions, is not a reportable infection like Chlamydia or Hepatitis. There is the potential for far more of these lesions to exist because there also is no repository from which to study and track the numbers of these high-grade lesions.

However HPV is known to cause multiple other cancers aside from cervical. One of the most significant is anal cancer. While this cancer has an extremely high cure rate if identified and treated early in its course, all too often it is misdiagnosed as bleeding hemorrhoids thus delaying a true diagnosis for months or even years.

Just like cervical HPV, anal HPV progresses from small changes within the cells and over time increasingly abnormal changes which eventually will result in cancer.

For the most part, HPV and the associated conditions has long been a “woman’s disease” while recent studies in both North and South America have shown that 50 percent of men have HPV. Obviously this information is something which the public needs to know and for which men need to take responsibility since they can transmit the virus to women.

In recent studies referenced by Dr. Joel Palefsky, one of the leading HPV researchers and infectious disease specialists in the United States, anal HPV infection was shown to be present in 60 percent of normal healthy women while only 50 percent were shown to have cervical HPV infections. This indicates that anal HPV infection is more prevalent than previously thought.

Dr. Palefsky intends to initiate a study which would also create a repository for specimens relating to anal HPV. This could be used to study for an early signs of transition to higher grade lesions and cancer which may be useful in the future in determining those most in need of treatment. Dr. Palefsky will be presenting this proposal to the National Institutes of Health early this month.
What has long been needed is such a repository to adequately determine the risk for high-grade cervical lesions as well. Hopefully someone will follow Dr. Palefsky’s innovative and forward thinking in creating just such a repository.

Webcasts | Joel Palefsky, MD — ." Sexuality, Reproduction & Menopause. N.P., n.d. Web. 7 Sept. 2011. http://www.srm-ejournal.com/srm.asp?id=7285

"Anal Cancer: Statistics | Cancer.Net." Doctor-approved cancer information from ASCO | Cancer.Net. N.P., n.d. Web. 7 Sept. 2011. http://www.cancer.net/patient/Cancer+Types/Anal+Cancer?sectionTitle=Statistics

"Cervical Cancer Prevention." THE MEDICAL NEWS | from News-Medical.Net - Latest Medical News and Research from Around the World. N.P., n.d. Web. 7 Sept. 2011. http://www.news-medical.net/health/Cervical-Cancer-Prevention.aspx

Tuesday, September 6, 2011

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.

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

Thursday, September 1, 2011

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.