New HPV Test to Detect Greater Cancer Risk

On April 20, 2011 Roche Diagnostics announced the FDA’s approved of 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 however between cobas and the other HPV tests currently on the market.Roche’s test will check for fourteen of the high risk HPV strains. The Hologic test, Cervista, also tests for these same fourteen strains, while the digene test checks for thirteen.

Once this is completed, the Roche test will then concurrently genotype the specimen for HPV types 16 and 18. These two HPV strains are shown to cause approximately 70 percent of all cervical cancers.

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 18genotyping had precancerous lesions despite having a negative result on their Pap smears.

Roche representatives, Christoph Majewski , Head of HPV molecular science and Dr. Catherine Behrens, Director of Medical Affairs, state that 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 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 peer review articles with respect to its methods. Both Hologic and Roche have a bit of catching up to do in that respect.

Cervista (the HPV test from Hologic and also approved by the FDA) like cobas, also tests for fourteen high risk strains. While Cervista does not concurrently genotype for 16 and 18 like cobas, 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.

Some Things Never Change

"We believe that medical attitudes serve to create a climate of emotional and physical estrangement, to reinforce the attitudes of acceptance and self-blame for the situations we find ourselves in. This makes it impossible to ask questions or challenge what is happening around our own health and increases the feelings of despair and feeling of not being in control. What happens in hospitals can have damaging and permanent physical and emotional effects on women's lives and basically, what we ask is to retain our dignity."

I'm sure most would agree that this is a reflection of how we women feel today with respect to the treatment we receive. The interesting thing however is, that this comment was made by a member of The Women's Health Cooperative at hearings regarding activities at National Women's Hospital in New Zealand and, that it was made in 1989. Some things never change as evidenced by the twenty-two year interval since this comment was made.

When it comes to the subject of HPV, the most common sexually transmitted infection, a virus known to cause at least a half-dozen invasive cancers, these comments are even more significant. The ways in which women are treated when it comes to a cervical or anal cancer almost 100% of which are caused by HPV, this is much different than how a woman is treated who has a diagnosis of breast cancer. The former being viewed as something for which the patient is "to blame". No one can "blame" a woman for having breast cancer.

We are heading down a very slippery slope if members of the medical community begin determining the treatment a patient will receive based upon whether or not they can be "blamed" for their condition, cancer or otherwise. It is interesting because even patients with lung cancer which has long been associated with smoking and for which the patient could be blamed because it was after all, their behavior which brought about the disease, we have not seen this type of disparaging treatment.

When one's behavior becomes part of the criteria for treatment of disease then we are all in trouble. What of the patient whose heart attack was caused by their obesity and high cholesterol?

Until now, with research showing an ever enlarging group of cancers resulting from the human papillomavirus, we have not seen such bigoted perspectives by members of the medical community. Obviously when reading these initial comments it is evident that these bigoted perspectives have been long held when it comes to sexually transmitted infections and the gynecologic conditions they cause.

Hopefully with more women advocating against just this sort of behavior and for the education of women regarding their health, these attitudes will not continue for another two decades.

The World's New "Natural Disaster"

I don't know about the rest of you but it becomes very frustrating when our own country cannot balance it's budget, spends money like drunken sailors and places the ramifications on the backs of hard woring Americans.

Then come the natural disasters, earthquakes, floods, tsunammi's. I don't have an exact number on just how much the US provides to other countries but I know it's quite an extraordinary figure. On top of that, we see fundraisers for the victims of this tragedies to which celebrities in particular (but others as well) contribute literally millions of dollars. Does anyone who has contributed to Haiti actualy think any of that money will ever get to the people? Pleeease!

Meantime, there is a growing natural disaster in this country to which most are oblivious except of course those living it. It's called CANCER and it can turn a person's life upside down just as fast as an earthquake or a flood. It's ramfications can leave you homeless, jobless, having to make choices between eating and obtaining often vital medications, many to alleviate agonizing pain.

If course I see fundraisers for various cancer "research", but what about fundraisers to actually help the patients? To help them to rebuild their lives, alleviate the near constant daily stress which only causes further deterioration of their condition because we all know what stress does to the body and the immune system.

I'm glad Sean Penn and others think that Haiti has the potential for such vast improvements. Potential perhaps, likelihood not so much. The American Cancer Society doesn' t provide financial assistance either, much to the surprise of most people, instead they just give you a list of phone numbers which you can call and repeat your story to over and over again trying to receive assistance, as if that isn't traumatic.

Far too many cancer organizations think that the patient's need ends when treatment ends. This couldn't be further from the truth and actually is just the beginning for most of these folks. They've previously been caught up in their treatment schedule, doctors appointments, appointments for CT scans and PET scans, chemotherapy etc and have no time to even focus on "daily life" because this has become their daily life. But when treatments ends, daily life is never the same and too many patients find themselves financially destitute, lacking emotional support as well, needing help because side effects complicate what were once simple everyday chores. These are the forgotten. I think survivor is an incorrect classification because often they are not even surviving they're barely existing. And, while it's nice that the ACS provides a beauty sessoin with free make-up to help women feel better about themselves, personally I'd rather have a check to pay my electric bill or put food on the table.

Perhpas it's long past the time when we should be looking within our own countries to those who have been just as ravaged and just as emotionally and financially devastated as the others they so quickly rush to support. Perhaps it is time for these same people to contribute to a fund which will provide houses to cancer victims who have lost theirs, or funds to pay their electric bills, medical bills, be able to obtain their much needed medications and even buy food.

I think I speak for many victims of cancer, especially those whose cancer is HPV related. A virus which 80% of us will be affected by, but far few that have even heard of. Bring the compassion home to care for those Americans who are struggling every day but for whom nobody is putting on a fundraiser to assist their needs. Charity begins at home and far too many have forgotten that very simple slogan.

Negotiating Medical Bills

Cancer cannot only devastate the body , it can devastate the pocketbook as well. I know from personal experience. So in this entry I would like to educate people on something few know about but certainly anyone with cancer should regardless of its origin.

There is a federal law referred to as Hill-Burton. Within this law, hospitals are allowed to maintain tax-exempt status in return for providing a certain amount of services to patients who could otherwise not afford them.

Virtually every hospital has a Financial Services Department. This is the department you should be communicating with, not the billing or collections or any other department!

Request financial aid/charity forms and let them know about your situation. There are guidelines and unfortunately, there are maximum incomes as with most programs but for many, this could be a Godsend. Many hospitals, once approved, will then waive any co-pays, deductibles and co-insurances beyond what your insurance will pay. This is one way to keep more of the money that YOU desperately need. You will need to get past any ego issues about asking for charity but most people in this situation are far beyond that anyway.

You will need to provide documentation but it isn't really all that complex and certainly nothing compared to what you need to provide to file a bankruptcy.

In the coming weeks a number of other financial topics will be discussed here, including negotiating COBRA payments with your hospital, ways to obtain medications at no cost, and yes that dreaded subject - bankruptcy. I hope you will join and contribute any programs or organizations so I can compile them within the website www.thehpvsupportnetwork.org. It certainly would be much easier to do a "one stop shopping"now wouldn't it?

FDA Approves Gardasil to Prevent Anal Cancer!

When Merck released the Gardasil vaccine it was initially touted as the preventative for cervical cancer. Unfortunately all these years later this is all that most people associated both the vaccine, and the virus (HPV), with.

What most people don't know, is that in the interim, the FDA approved the revision of the insert provided along with the vaccine to include protection/prevention of VIN (vulvar intraepithelial neoplasia) and VaIN (vaginal intraepithelial neoplasia). It has been a struggle to get the FDA to recommend revision yet again to include AIN/anal cancer. The FDA wanted four years of data before making such a decision something which only became available last year.

In November of last year, the FDA held hearings to determine whether or not to include anal cancer along with it's prior revisions. Luckily and thankfully, they made the right decision. Having gone through two cases of invasive anal cancer caused by HPV I have long known that if the virus strains which caused the other dysplasias/cancers could be thwarted by this vaccine that so should anal cancer. I didn't need four years of data to know that. But, the FDA being what it is seems to rush some things to market too quickly and linger too long with others. This should have been a slam dunk years ago and I seriously must question the thinking of those overseeing these decisions. They also approved Gardasil for use in boys which was another good sign.

Now, the final hurdle which remains is getting them to extend the age for which both women and men can obtain the vaccine which now tops out at 27. Many individuals married for decades may find themselves divorced and back on the dating scene. Why should they not be offered this same protection? While the decision has not been denied, it has been pushed back and is expected this summer. Let's hope they remain consistent with these prior two decisions and extend the age, which in my opinion should be open-ended and not just 45. Only time will tell.

Children and the HPV Vaccine

It has been decades since children heard the words, “Don’t go outside and play”, or “You cannot go outside and play with your friends. As a matter of fact, it has been so long, that parents of young children today have probably never heard those words, nor did their parents – perhaps their grandparents though.

Years ago, children were sequestered inside their homes, unable to go outside as they do today and interact with their friends. The reason – disease, but not just any disease, communicable deadly diseases such as polio, typhoid fever, measles, mumps and rubella. These diseases claimed thousands of lives each year.

It was not until mass immunization came into practice, requiring school-aged children to be vaccinated if they were to attend school that things changed. Today when parents visit their pediatricians, they are given a list of required immunizations required by law. If their child does not have these immunizations when it comes time for school, they simply will not be admitted.

Cancer is a disease which has killed hundreds of thousands of individuals during this interval and prior. However, until recently (about thirty years ago) several cancers, in particular cervical and also Hepatitis have been linked to viruses.

Since its connection to cervical cancer in 1984, and the advent of HPV testing, the number of cases of cervical cancer in the United States has decreased dramatically. However, in other less developed countries cervical cancer still remains the number one cancer killer in women. Also since 1984, HPV has been found to cause numerous other types of cancer including vulvar, vaginal, anal, and penile – all genital in nature. HPV is considered the number one communicable sexual disease with 80% of the population being infected with HPV at some time in their lives.

What is alarming is that more recently, HPV has been shown to affect other organs not considered sexual in nature such as the head/neck, mouth/tonsil and even lungs. Who knows how many other cancers are indeed causes by this one virus?

In many states the HPV vaccine was made mandatory for school admission. Many of those states are reconsidering their decisions with some rescinding earlier rulings. Is this a good thing? Not given research showing that the human papillomavirus can be transmitted through means other than sexual contact but via foamites.

Foamites are inanimate objects which can harbor the virus. A virus which is very difficult to destroy even at very high temperatures including those normally found in your washing machine. Many ill-informed parents are refusing to have their children immunized against HPV but it is just those parents who should be asking themselves how often their child may share a drinking cup or utensil with a classmate in the cafeteria.

Most parents would agree that they do not want to isolate their children from social interactions with friends which aid them in becoming well-rounded adults. Nor do they want to expose them to any form of cancer and even with the idea that celibacy can prevent exposure to HPV there is no test for men so a wife can still acquire the virus from her husband even if she has remained celibate.

It is time that parents view the human papillomavirus as the threat that it is and regulated or not, to have their child immunized against this proven cancer causing virus. Speak with your pediatrician or family doctor and research information of HPV at various reputable websites such as thehpvsupportnetwork.org.

We are all concerned for our children’s health, but I don’t think any parent wants to have to answer their child’s question, “Mommy, why can’t I go outside and play with my friends?”

HPV Vaccine

Recently, some state legislators have taken up action against the mandatory administration of the HPV vaccine in young girls. In light of the vaccine’s high success rate in preventing cervical cancer many states passed laws which added Gardasil to the already existing list of mandatory vaccinations required for children to enter school.

A number of things have changed since those laws were enacted. First off, the FDA approved the vaccine for use in boys and young men, a step forward in helping to prevent the ramifications of HPV in that age group. Secondly, there has been much more attention paid to foamites.

Foamites are inanimate objects which can harbor the virus particles and carry them from place to place. An example of this can be as simple as one’s finger but can include other simple objects as well.

People have been asking for some time if the virus can be contracted from such things as underwear or towels and the answer appears to be a resounding yes. The virus has been found on the underwear of women known to have HPV and towels are just another material source through which the virus may be transferred.

Unfortunately, this is a very virulent (strong/aggressive) virus and one that is very difficult to destroy even at very high temperatures. This brings us back again to the question of removing the vaccine from the mandatory vaccination list for school-age children.

One such legislator in Virginia has stated that HPV does not have the likelihood of being transmitted between these children as with other diseases for which we already provide mandatory vaccinations. Apparently she is not considering the significant research pointing to foamites transmission of HPV when considering putting forth this legislation.

HPV has already been found in saliva, amongst other bodily fluids such as urine, breast milk, seminal fluid and others. How often do school-aged children share that can of soda or other drink – a perfect example of foamites. So before considering rescinding this legislation these legislators, most often not medically oriented, need to become far more educated and up-to-date when it comes to HPV vaccination.

It has taken years for the FDA to approve the use of the vaccine in the prevention initially of cervical cancer. This was then expanded to include vaginal and vulvar dysplasia and cancers. They are on the verge of deciding, this month, whether or not to include anal dysplasias and anal cancer onto that list.

With all the progress that has been made in the five years since the vaccine became available, hopefully legislators will not rescind that progress as a result erroneous information and lack of thorough research.