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US Lags Behind Again in Protecting Women: Editorial

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Several weeks ago, the ACIP (Advisory Committee on Immunization Practice) finally changed their position on the HPV vaccine use for boys and young men from allowed to recommended. This after delaying for six years after having recommended the vaccine for girls and young women.

Despite the research which has been conducted regarding the HPV test itself and using it in conjunction with cytology (Pap testing), the FDA continues to restrict its use to women thirty and older.

The Roche cobas test is the only U.S.- and globally-approved test for 14 high risk strains of HPV as well as for the genotype of the two most aggressive strains (16 and 18). Strains 16 and 18 are responsible for 70 percent of cervical cancer occurance. Data taken from the ATHENA study (stands for Addressing The Need for Advanced HPV Diagnostics) used to assess the cobas test accuracy indicate that cervical cancer was identified at a higher rate than with cervical cytology (Pap) testing alone in primary screening.

The Netherlands is one of the first countries in Europe to begin utilizing the cobas test as its primary screening tool. The United States however continues to lag behind when it comes to incorporating cobas into primary screening and continues to restrict it to women 30 and over.

While the newly proposed screening guidelines for the United States are being finalized subsequent to open comment by the public which ended last month, that portion of the guidelines continues to remain "up in the air" as it has for years, continuing to claim they are in need of more information before making any final conclusions.

Obviously the Netherlands found sufficient research to draw conclusions allowing the use of cobas in the primary screening of its women while those of us in the United States must wait an additional10 years.

Knowing if the patient had either strain 16 or 18 at the initial time of diagnosis would alert the physician to the fact that this patient will require more close follow-up. With the likelihood that the new guidelines will solidify obtaining a Pap every three years follow-up is already being compromised across the general population. Refusing to appove the use of genotyping until age 30 only further compromises the ability to obtain the earliest diagnosis possible.


"Benefits Of Cobas® HPV Test For Primary Screening, England." Medical News Today: Health News. N.p., n.d. Web. 30 Nov. 2011. http://www.medicalnewstoday.com/articles/238255.php

"U.S. Preventive Services Task Force: Draft Recommendation Statement." U.S. Preventive Services Task Force. N.p., n.d. Web. 30 Nov. 2011. http://www.uspreventiveservicestaskforce.org/draftrec4.htm

" HPV Genotyping Clinical Update." ASCCP is the national organization dedicated to the study, prevention, diagnosis, and management of lower genital tract disorders. N.p., n.d. Web. 30 Nov. 2011. http://www.asccp.org/ConsensusGuidelines/HPVGenotypingClinicalUpdate/tabid/5963/Default.aspx

Reviewed November 30, 2011
by Michele Blacksberg RN
Edited by Jody Smith

Add a Comment6 Comments

EmpowHER Guest

Cervical cancer has always been rare in the developed world, and was in steady decline before screening started. In Australia it was 15 women in 100,000 affected, now it's 9, but other factors are also having an impact on the incidence and death rate...more women have had hysterectomies, fewer women smoking, better condoms and hygiene, less STD (Dr Gilbert Welch included those last two in his book, "Over-diagnosed") So some women have benefited from pap testing, but no one seems to care about the vast over-detection and over-treatment of healthy women...made worse by the serious overuse of the pap test.
Finland and the Netherlands have shown that there was no need to harm so many, with screening based on the evidence...now we can identify the roughly 5% who are HPV positive at age 30 or older, they are the only women who have a small chance of benefiting from a 5 yearly pap test...95% of women aged 30 or older are HPV negative and not at risk, they cannot benefit from pap testing. So who benefits from all of this pap testing, excess biopsies and over-treatment, certainly not women? I think women's healthcare needs to be refocused on what's best for women. It seems few countries are able to keep high emotion, vested and political interests out of women's healthcare.

September 16, 2012 - 8:00am

HPV cancers are NOT rare and speaking about cervical cancer alone account for half a million cases with approximately 250,000 deaths per year worldwide. This doesn't even include those cancers involving the anus, vulva, vagina and oropharyngeal. I wish people would stop referring to HPV related cancers as rare since they are far from it and increasing steadily especially with respect to head/neck cancers which at the current rate are expected to exceed cervical cancer cases within ten years.

December 22, 2011 - 7:48pm
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December 20, 2011 - 6:59pm
EmpowHER Guest

I think over-testing is an issue - many women find pap tests violating, uncomfortable, painful etc - it shows a lack of respect for our bodily privacy to over-screen. Also, over-screening leads to over-detection and few women are happy to leave an "abnormal" result sitting on their file. Australia has huge over-treatment rates as a direct result of over-screening and some women are left worse off with damage to the cervix that can lead to premature babies, the need for c-sections, cervical stenosis etc
Almost all of our referrals are unnecessary - lifetime risk of cc is 0.65% - take out false negatives, less than 0.45% can be helped, while our referral rates are 77% - it's higher in the States.
The Dutch and Finns have programs that provide some protection for the more than 99% who can never benefit - they offer 5 to 7 pap test programs (5 yearly from 30 to 50 or 60) and there are self-test pap and HPV kits. The Dutch are moving to 5 hrHPV PRIMARY tests offered at 30, 35, 40, 50 and 60 and only those positive will be offered 5 yearly pap tests. Those negative and in a monogamous relationship or no longer sexually active might choose to stop all testing and revisit the subject if their risk profile changes in the future.
This greatly reduce the amount of testing and over-treatment and identifies the small number at risk - only 5% by age 40.
Whereas here, a small problem has been turned into a highly lucrative industry in over-treatment - a small problem has a major negative impact on the lives of women not even "at risk" from this rare cancer.
I agree that the over-treatment of women is horrifying - when you consider this is a rare cancer and a small risk, damaging treatments should be avoided, but then women have never received decent information about this testing - most of the information we get is biased and misleading and that means we can't make informed decisions. Most women are not giving informed consent for screening, it's impossible unless you do your own research. I know some women are still having hysterectomies for pre-cancer or dysplasia or CIN 3 (mainly in the States) and that is just shocking...it should amount to professional misconduct. Also, testing women under 30 is unhelpful and harmful, they are excluded for their own protection in many countries - testing doesn't change the tiny death rate, but this group produce the most false positives. (1 in 3 for those under 25)
These women can produce highly abnormal pap tests (false positives) and can end up having damaging over-treatments. The pap picks up as abnormal, normal changes in the maturing cervix or transient and harmless infections.
The Finns have the lowest rates of cc in the world and send the fewest for biopsies etc - they offer 7 pap tests, 5 yearly from 30 to 60.
As a low risk woman, my risk of cc was near zero, it was an easy decision to pass on testing almost 30 years ago now. I did not get the information I needed from my doctor or the screening authorities, I had to do my own research. Its been hard watching friends and family being worried sick and harmed by this program over the years. There are far better ways of dealing with this rare cancer without harming the masses.
I agree - the entire focus is on rare cervical cancer, while other HPV related cancers are virtually ignored. Males were excluded from the HPV vaccination program even though more people die from head, neck and oral HPV-related cancers than rare cervical cancer. It's just that cervical cancer screening is backed by powerful cancer charities, women's groups and those with a vested and political interest in these screening programs. Bowel cancer takes far more lives, but the screening program struggles for funding. The money goes to the loudest voice...

December 4, 2011 - 6:10am

I disagree with you with respect to screening. Yes the medical community needs to loosen its grip when it comes to hrhpv testing and the development of at home testing however the problem isn't necessarily of over screening but over treatment and over testing because doctors do not even follow the guidelines which exist. In addition, when CIN1 is supposed to be followed for 24 months, many doctors are recommending LEEP. CIN1 is shown by the majority to regress by over 70% after 12 months so why are they recommending LEEP.

CIN3 in many cases is being recommended with a hysterectomy as PRIMARY treatment. This is NOT what should be primary treatment yet women are losing their fertility because doctors are performing hysterectomies instead. To some extent society does need to take responsibility because we tend to be of the feeling that we "just want it out" and are willing to do whatever we have to just to get it out of us and not have to deal and worry about it. We are not willing to wait out the course.

The medical community has done a pathetic job of educating its members in all nations and all continents when it comes to HPV. I believe that with respect to vaccination, Australia has a 70% completion rate for the hpv vaccine. This is more than double that of the US and part of the reason is related to a statement above - that this is RARE. It is not rare when you count in all the numbers of dysplasias occurring CIN2/3 lesions requiring treatment and not just the death statistics. But of course there is no database to collect the information on these lesions. I firmly believe that statistics are much higher than quoted overall and most people continue to focus on cervical while excluding all of the dysplasias and cancers involving the vulva, cervix, anus and oropharynx. Recent testimony to the FDA in the US stated that if hpv oropharyngeal cancers continue at the rate they are they will exceed cervical cancers.  Anal cancers are rising at 2% each year. That is a tremendous amount though it may not sound like it.

The majority of women ending up with cancer are those who do NOT get screened. Focusing on too much screening is like shooting the messenger. It is the physicians who for the most part and perhaps also in part are doing the overtreatments they are because of fear of malpractice if they do the watch and wait approach.

December 3, 2011 - 5:09pm
EmpowHER Guest

I fear those with a vested and political interest in these programs block better options for women. The Australian program horribly over-screens which means we have huge over-treatment. Our program calls for 26 pap tests and some women end up having more than that...
Calls for change go back ten or more years, yet nothing changes. Other options are unavailable like hrHPV primary testing and self-test kits. These options would greatly reduce testing and over-treatment and would isolate the small number at risk from this rare cancer.
It concerns me that our doctors remain silent and continue to over-screen women - our program is harmful, yet most women trust their doctors and are being let down badly.

December 3, 2011 - 6:10am
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