Monday, April 28, 2014


I have a ton of questions.  Maybe not a ton but definitely several.

There seems to be an underlying theme going on in my life.  Cervical stuff.

I wrote a blog post for the Share Those Moments project baring my soul and sharing, among other things, the need for the removal of my cervix when my hysterectomy was done in 2010.  There was a revival of the ethics of those cervical cancer studies in India.  Hell, I even sat in the doctor's office with a family member to discuss cervical spinal issues.

And now this??

The FDA has approved the first new alternative to the PAP smear.  It is a test for HPV that was designed by Roche.  For first line screening of cervical cancer? Quick everyone, call your stock broker if you have one.....

I'm still trying to wrap my brain around this so bear with me.

Let's start with the quote from the FDA:

"Roche Diagnostics conducted a well-designed study that provided the FDA with a reasonable assurance of the safety and effectiveness when used as a primary screening tool for cervical cancer."

And now, let's start with the big question from the big mouth advocate and in this case, activist.  Can I see the "well designed study?"  It may very well be that this would satisfy my concerns by answering all of my questions.  As of this moment, the whole thing seems ass backwards.

Reasonable assurance?  WTF does that mean?  Don't insult me by using that kind of terminology.  Show me the data.  Give me the numbers that are behind this so called reasonable assurance.

Should we not screen for cancer by actually looking at the area to see if cancer or pre-cancerous cells are present?  Testing for a virus does not equate to cancer screening.  First of all, are they CERTAIN they have identified all cancer causing HPV strains? I'm going with, probably not.

Once again, enter Dr. Eric Suba.  I was already a big fan, I'm officially elevating him to hero status.  He saw the post on my Facebook page and provided me with a link to a blog written by a pathologist.  Quest Labs was present at the FDA hearing and provided some interesting comments.  The post written on the Pathology Blawg contains a ton of information and lots of links. Read it and then please, rage along with me.  Join me in my armchair activism.

Bottom line, only examination of cells can detect if there are abnormal cells present.  The real bottom line, Quest provided the FDA with solid numbers.  Using information from over 3.7 Million women, they found that nearly 5% of the women with advanced dysplasia or cancer were HPV negative.

In their estimation using information from this vast database, this now FDA approved for primary screening tool, could miss 13.5% of those with cervical cancer.  The American Cancer Society estimates that 12,360 women are expected to be diagnosed with cervical cancer this year.  In other words, 1670 undiagnosed women.  In MY words:  UNACCEPTABLE.

A few notes.  The PAP test is much less expensive than the HPV test although I suppose the logic is that less testing would be done if someone tested negative?  The thing with HPV?  It spreads pretty easily and the use of condoms do not guarantee protection against the disease.  Read the CDC fact sheet.  It's worth mentioning if I test negative for HPV today, I may have a sexual encounter shortly thereafter and become infected.  I may have that encounter with a person with whom I THINK I'm in a monogamous relationship.  Shit happens.  There are too many damn uncontrollables.

I already did lots of investigating on HPV when I had my own cervical cancer scare.  Yes, I have one of those two bad strains.  I think they identified four different strains when they did my HPV test which was done AFTER my PAP returned those crappy cells.

Just because the FDA approved the test does not mean this is the law of the land.  Five major medical professional organizations are opposed to this recommendation or whatever the hell it is.  Those would be the US Preventative Services Task Force, the American Congress of Obstetricians and Gynecologists, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology and the American Society for Clinical Pathology.  Their objections were dismissed by the FDA in favor of the "well designed study."

Yes, I want to see the study.  I want to see a transcript of the FDA hearing.  I want a list of those who voted (unanimously) in favor of this test.  It's all out there.  I haven't had the chance to read it but I'm pretty sure I'll remain unconvinced.

Also, in a 24 hour news cycle, even though this first hit my twitter feed last week, the approval was over a month ago.  I'm losing my edge.

Actually, I'm not surprised.  Too many distractions.  Now that I've seemingly emerged from income tax hell, I'm jumping into annual doctor season.  Tomorrow is my annual oncology follow up.  I have no scanxiety since the appointment is going to amount to a chat.  There will be no blood test, there will be no scans.  Makes me wonder about the need for the appointment.  Thursday, I have an MRI to check the implants.  Next week, the dermatologist (remember, the increased risk for melanoma thing...) and then the plastic surgeon.

Come to think of it, I have to find a new gynecologist.  I think it's been a year.  I wonder what s/he will do about a PAP test since my cervix is in that big old medical waste field.  I wonder if s/he will recommend the new Roche test.  Stay tuned.....

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  1. Did you try following the links at the bottom of the FDA press release?

  2. This test is news to me as well. Thanks so much for all of this great analysis. You are totally amazing! Good luck with your doc appointments next week!!! Love to you.

    1. Thanks, Idelle!! Miss you tons -- so glad to see your face.

      One appointment down, four more to go. At least I think it's four.... ;)

      Discussion about need for something for ongoing bone loss. Infusion is the only option. Remembering to take another pill daily or worse, MONTHLY.... yeah... that's expecting far more than my brain can handle!



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