Category Archives: HPV & Cervical Cancer

HPV Myths – BUSTED

Myths

There’s an awful lot of misinformation out there about HPV and the HPV vaccine. Let’s see what I can do to clear up the confusion. Here are eight myths I find myself having to continually address with my patients. Let’s bust ’em!

Myth#1 – HPV is forever

Wrong. 90-95% of the time, HPV infections clear without any treatment. For those women with persistent HPV infection, we have pap smears to detect and treat precancerous lesions (dysplasia) years before they become invasive cancer.

Myth #2 – If I’ve had the HPV vaccine, I don’t need Pap smears.PAP

Wrong again. While the HPV vaccine is highly effective against the HPV strains it targets, and those strains together cause in excess of 70% of all cervical cancers, you are not 100% protected. Sorry. Until we have a vaccine that protects against all the cancer-causing subtypes, you’ll need to get your pap smears.

The good news in this front is that both Gardasil and Cervarix are showing cross-reactivity against other cancer causing strains of HPV so we may be getting a bigger bang for our buck than we initially thought. Stay tuned..

Myth #3 – The HPV Vaccine is dangerous.

danger

Actually, it’s quite safe. A recent comprehensive review of HPV vaccine safety studies to date, some with over a million subjects each, found no serious health risks from the vaccine.

Like all vaccines and injections, HPV vaccination can cause some local irritation on the arm, and some young girls faint afterwards. This is not serious.

Myth #4 – The HPV Vaccine is a Scamscam

No, it’s not.

There are valid arguments to be made as to whether the HPV vaccine is the most cost effective approach to eradicating cervical cancer in the US, where most women are already getting pap smears, and where those at highest risk (women who can’t afford pap smears) probably can’t afford the vaccine either. And we won’t get into the ridiculously high cost of the vaccine, or how fear mongering and politics have been used to market the HPV test and its vaccine. (I’ve written enough about this before). But that doesn’t make it a scam. The vaccine is real and it works.

Some have raised legitimate concerns that the vaccine’s efficacy could wane over time, effectively just delaying but not preventing cervical cancers. Fortunately, this has not panned out to date – the vaccine has shown no decline in immunity for up to 9 years. Time will tell on this one, but so far, so good.

Bottom line is that the HPV vaccine is safe and effective. I see no reason why young women should not get the vaccine. (My kids have gotten it, by the way.)

Myth #5 – The HPV Vaccine causes sexual promiscuity lips2

Nope. It doesn’t. (Research reference here)

Myth $6- If I have HPV there is nothing I can do about it.http://www.dreamstime.com/stock-images-emotion-2-image597604

You’re not powerless – there are some things you can do.  In addition to getting your pap smears, you can help your immune system clear the virus in three ways –

  • Use condoms. By decreasing the exposure of your body to more virus, you’ll free your mmune system up to clear the virus you already have.
  • Get 4-6 servings of fruits and vegetables a day. Women who do so clear the virus sooner than women who don’t.
  • Don’t smoke. If having HPV is your wake up call to quit the cigs, then so be it. Ask your doc for help if you need it to get off nicotine.

Myth #7 – All HPV Tests are the same.

technology

Not true. Some are FDA approved, some are not. Ask your doc which test he/she uses, and be sure its an FDA approved test.

Myth #8- I can’t get the HPV vaccine if I’m over age 26.

Actually you can probably get it if you really want it. But you may not need it.

The vaccine is only FDA-approved up to age 26. That’s because by that time, most women have had one or more HPV infections already. From a public health perspective, it doesn’t make much sense to vaccinate a population against a virus that most are already immune to.

But on an individual basis, the vaccine could be effective if you’ve had very few sexual partners and have never been infected with the HPV strains targeted by the vaccine or had genital warts. Even if you have, there’s no way to know what HPV strains you may already be immune to – the HPV test is not strain specific. (Although one test does detect HPV16/18). I do not recommend getting HPV tested just for this purpose.

I’m hearing that some insurers will pay for the HPV vaccine even in women over age 26. And if they don’t, you can pay for it yourself. Talk to your doctor and make your own choice.

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More TBTAM posts on HPV

Last updated 08/17/15

The Not So Scary Truth About HPV

http://www.dreamstime.com/stock-images-emotion-2-image597604There’s a downside, I think, to educating the public about the link between HPV infection and cervical cancer.  And that’s scaring the bejesus out of every woman who happens to find out she has HPV.

It’s not surprising that you’re scared.

You see, we want you to know that HPV infection is linked to cervical cancer, and that we have a vaccine against HPV that can prevent cervical cancer. So we’ve been doing our best to get the word out. (With no small bit of help from the HPV test and vaccine manufacturers.)

But in our zeal to get you screened and vaccinated, we sort of forgot to tell you something equally important. And that something is this –

Pretty much everyone – 80% of US adults- will get HPV at least once, if not more than once, in their lifetime. At any given time, 20-30% of US women ages 14-59 have HPV. That’s right – a third of the female population. If you include men, there are about 20 million persons at any given time in the US who have HPV.

The overwhelming majority of HPV infections do NOT lead to cervical cancer. Around 95% of the time, the infection clears, usually within 1-2 years, without you, or anyone, doing anything

Yes, the problem with HPV disease awareness is that it ultimately makes every woman feel like she have a bull’s eye on her cervix. Which may a good way to get her in for HPV testing and vaccination, but is actually misleading women about an infection that basically everyone gets at some point in their lives.

The Not So Scary Truth About HPV

The truth is that while having HPV is a necessary precondition for getting cervical cancer, it’s also true that almost all HPV infections DO NOT lead to cancer

Think of it this way. Getting in a car is a necessary condition for having an automobile accident, but in fact, most of us will make it to our destination alive. Same thing with HPV. The chain of events that ultimately leads to cervical cancer starts with HPV infection, but almost all the time something intervenes to prevent cancer. That something is called your immune system.

If for some reason, your immune systems doesn’t do the job, and you’re in the 5% of women with HPV who don’t clear the infection, we have ways to monitor you closely so that if a precancerous lesion arises, we can treat it. Years before it becomes cancer.

But I have “High Risk” HPV 

So does everyone else with a positive HPV test.

“High risk” HPV subtypes are called that simply to distinguish them from the “low risk” types that cause genital warts.  Current HPV tests only screen for the “high-risk” types. So by definition, if you’re HPV positive, you have a “high risk” strain. (Someone really needs to change the name of that test…)

But if everyone has HPV, and most infections clear without treatment, then why do we test for it? 

HPV testing is better at finding precancerous lesions that Pap smear alone, so what the Pap misses, the HPV test will find. It’s so good that it’s being considered as a replacement for the pap smear as the first line test for cervical cancer screening.

The HPV test is also good for weeding out the false positive Pap smears. A mildly abnormal pap (ASCUS) can be safely ignored and repeated in a year if the HPV test is negative. This saves a lot of women unnecessary testing.

The other good thing about HPV testing is that if it’s negative, you’re really in the clear. So much so that if both the Pap and HPV test are normal, the risk for cervical cancer plummets, and you can safely wait up to 5 years between pap smears.

The problem with HPV Testing

The problem with HPV testing is that it has a very high false positive rate. Most of the women with HPV  actually do not have precancerous lesions. They just have HPV.

That’s what happened to NYC Councilwoman Melissa Mark-Viverito, who then went public with her HPV diagnosis on Twitter. Ultimately, when she had additional testing after her HPV diagnosis, she found out that she was fine.

Of course, you don’t want to ignore the fact that you have HPV.

You should take it as a sign that you, of all people, need to get your pap smears regularly. Or , if your doctor recommends it, have a simple office procedure called a colposcopy – a magnifying lens that looks for tiny abnormalities on the cervix that are too small to be seen by the naked eye, but if found, can be treated so that you never get cervical cancer.

But know that it would be exceedingly unusual for you to actually have cervical cancer just because your HPV test is positive. This is about finding precancerous lesions, and ultimately, preventing cancer.

So if you have HPV, don’t be scared. But be smart.

If you have HPV, odds are overwhelming that you’re going to be fine.  Between the HPV test and the pap smear, if you have anything precancerous, we’ll find it and we’ll treat it. Years before it becomes cervical cancer.

In the meantime, there are things you can do to help your immune system along. Things like not smoking, using condoms, getting enough sleep and getting 4-6 servings of fruits and veggies each day. Women who do these things clear the virus faster, although ultimately most will clear it anyway.

So do be smart and get screened. And follow through on whatever testing is recommended based on that result.

But please. Don’t be scared.

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More good info on HPV and cervical cancer.

A slightly modified version of this post first appeared on WebMD.

Last updated 09/11/14

New Pap Management Guidelines – Balancing Benefits and Harms of Cervical Cancer Screening

Sunrise over the Mississippi - NOLA
Mississippi Sunrise in NOLA

It’s fitting that this year’s ACOG meeting was held in New Orleans, because navigating the 2013 ASCCP Pap Smear Management Guidelines presented there feels like trying to make my way through the Mississippi bayou. The guidelines include 18 different algorithms encompassing almost any combination of pap and HPV abnormality we docs are likely to encounter among our patients.  But all tributaries lead to the same place, where we achieve optimal reduction in cervical cancer with minimal harm.  

Cervical cancer prevention is a process with benefits and harms. Risk cannot be reduced to zero with currently available strategies, and attempts to achieve zero risk may result in unbalanced harms, including over treatment. …optimal prevention strategies should identify those HPV-related abnormalities likely to progress to invasive cancers while avoiding destructive treatment of abnormalities not destined to become cancerous. Adopted management strategies provide what participants considered an acceptable level of risk of failing to detect high-grade neoplasia or cancer in a given clinical situation.

I’m not even going to try to spell out everything in the guidelines, which come from the American Society of Colposcopy and Cervical Pathology (ASCCP), except to say that they represent further movement away from aggressive screening and treatment of pap smear abnormalities, especially in younger women, in whom treatment carries small but real childbearing risks. The guidelines are increasingly reliant upon HPV testing to determine who and how often to screen, and when to treat.  They also acknowledge the role of testing for HPV 16 and 18 as a way to be sure that those women with adenocarcinoma of the cervix (which is less likely to show up as cancer on a pap smear) are identified and treated. From the guidelines –

 ASCCP CHANGES2

What should you expect?

  • Less pap smears, for sure. Women should start screening at 21 and have paps every 3 years until age 65 (assuming, of course, that her paps remain normal).  There is no place for HPV as routine screening in women under age 30, as most of these women will acquire HPV one or more times by that age, with little consequence.  HPV testing is used in this age group to manage abnormal paps and to follow those with prior pap abnormalities, but that’s it.  Women age 30 and over have the option of pap with HPV co-testing – if both are normal/negative, she may go up to 5 years before her next pap.
  • Little treatment of CIN1. CIN 1 represents HPV infection but is not a true pre-cancer and usually will resolve within two years. (If it does not resolve by then, treatment is an option.)
  • Less use of colposcopy in younger women with mildly abnormal paps, even if HPV testing is positive. In women ages 21-24, one may repeat the pap with HPV testing at 12 months rather than go to immediate colposcopy for mild pap smear abnormalities (ASCUS and LGSIL).
  • Continued decline in treatment for CIN2. Most CIN2 will resolve without treatment. (I’ve been backing off on cin2 treatment for some time now in younger women and indeed most lesions resolve.)
  • The option to observe CIN3. I don’t know how often any of us are going to use that option, though I admit to having already taken it occasionally in younger women with focal CIN3 lesions that were removed at colposcopy.
  • Increased interval pap followup in women who have had colposcopy or treatment for CIN2-3.
  • Increasing use of HPV 16/18 testing to identify those women with mild pap abnormalities who may need immediate colposcopy.

Confused? There’s an App for that! 

IMG_8137

In a very smart move, ASCCP has launched an app for providers wondering just what to do with those abnormal pap results. It’s called ASCCP Mobile, it costs $9.99 and it’s really cool.  Let me show you how it works-

Let’s say you have a 27 yo, non-pregnant patient with an LSIL Pap and HPV+. Just enter the info, click next  and, as Emeril would say – Bam! You’ve got the appropriate algorithm for her right there on your screen!

IMG_8138

 Click next steps, and enter her colpo result, which let’s say was CIN3 and Bam!  You are advised to treat her, and to perform 12 month pap/HPV co-testing for follow up.

IMG_8139

Of course, you could have pulled out the guidelines and found the right algorithm there, but this is a lot more fun.

ASCCP Mobile is not so much a recipe for patient management as it is a navigator through a complex algorithm that requires a lot more than just tapping a screen to understand and execute. I encourage you to read the actual guidelines article (links below), which provides the background and summarizes the evidence supporting each of the recommendations.

And lest you think we’ve just distilled gynecology into an app, remember that not every patient fits an algorithm. Not all patient populations are suited to follow-up, particularly those who may have spotty or intermittent care. Fortunately, most of the algorithms provide options for management that will allow almost any woman and her provider to come to a management decision that’s right for her.

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Last updated 06/5/13

Is Your HPV Test FDA Approved?

bd sure pathSome doctors and their patients will be surprised to learn that the test they are using to screen for HPV may not be FDA approved, according to a special investigation by the Arizona Republic/USA Today.

HPV Testing can be performed on the same specimen as the pap smear, often after the pap result is found to be mildly abnormal, in a process called HPV co-testing.

But if your pap smear has been obtained using Becton Dickinson’s Sure -Path pap collection system, you and your doctor need to know that the specimen it is not FDA approved for HPV co-testing, due to higher than acceptable false negative HPV results resulting from specimen degradation in the SurePath media over time.

This has not stopped some of the nations largest labs, including Quest Dignostics, Lab Corp, Aurora Diagnostics, Sonic Health, Bio-Reference Labs and ARUP labs, from using the Sure-pap specimen off label for HPV co-testing, based on studies each lab has done to confirm the validity of the test in their hands. Although such off-label use is perfectly legal, the FDA and the manufacturer issued a letter in June warning the labs that they should be using an FDA-approved system test and not the SurePath for HPV testing.

BD LETTER

That letter, however, was only sent to the laboratories and not to the doctors using the Sure Path system, meaning that physicians and their patients were unaware of the issue until it was reported this week in the press.

You should know that the BD specimen is just fine for the pap testing itself, comparing favorably to its competitor, the Thin Prep System, and perhaps having lower rates of unsatisfactory specimens than Thin Prep. SurePath is also FDA-approved for co-testing for gonorrhea and chlamydia. But not HPV co-testing.

How big is the potential problem?

Just how high the false negative rate is with SurePath is not clear – since the FDA applications for HPV co-testing with SurePath were withdrawn, the data are nowhere in the public domain. The Republic article tries to estimate the potential impact, but they do not cite the study they are using to make their estimates, so I quote this with some reservation update – see reference in comments –

SurePath accounts for about a third of the HPV tests, or about 3 million a year, estimated Michael Farmer, a market analyst who specializes in the pathology and histology laboratory markets. … extrapolating from the findings of a Johns Hopkins University study (unfortunately, not cited – MMP) suggests a thousand or more women tested each year using SurePath may be told they are HPV-free when they are not.

Why would a lab use a non-fda approved test over one that is approved?

Most leading national labs would not explain to The Republic why they use SurePath despite the warning. But each kit costs labs between $1 and $2 less than alternatives that are FDA-approved for HPV tests.

Both Quest and ARUP labs reported doing their own internal validation before using the SurePath for HPV testing, and Quest’s validation included patient samples, as if they were running their own little FDA trial. BIo Reference Labs states they switched 90% of their clients to an fda-approved test when they got the warning from the FDA. ARUP apparently sent letters to clients in October notifying them of the FDA’s warning.

There appears to be support in the pathology community for using the SurePath system for HPV testing, since the College of American Pathologists states the following  –

Non-FDA approved off-label methods for hrHPV DNA detection are commonly used in laboratories, and are acceptable under CLIA ’88 assuming appropriate self-validation studies are performed. Such off-label use most commonly consists of approved methods (Qiagen or Hologic) used with different non-FDA approved transport medias ( e.g., BD SurePath). In addition, non-FDA approved methods such as polymerase chain reaction (PCR) and in situ hybridization have been used for high risk HPV DNA detection. Because of the high volume of hrHPV testing performed and the implications for clinical management of patients based on the results, guidelines for validations have recently been published and include both analytic and clinical components.

However, Phil Castle, PhD, a cervical cancer researcher who was interviewed for the article, had this to say in his blog about using the BD pap for HPV testing –

Currently, there are 4 FDA-approved HPV tests for cervical cancer screening. However, none of them have approval for use with a liquid-based cytology (Pap) buffer called SurePath. Many pathologists like SurePath for Pap testing. But there is no approval for HPV testing because the buffer degrades the quality of the HPV DNA very quickly. A manufacturer of one FDA-approved HPV test has failed to get FDA approval for use of SurePath several times. Even the company that makes SurePath, BD, is urging clinical labs to stop this practice.

What is disconcerting is that there are plenty of alternative choices for valid HPV testing. So it is unethical to offer women less than optimal care just because a pathologist wants to use SurePath.

I myself would not be satisfied with a lab’s internal validation of a non-FDA approved test when an FDA-approved alternative exists. I had always assumed (naively it seems), that any test a lab uses must be FDA approved. If not, then the result I receive from that lab should indicate to me what test they are using, why it is being used and what issues exist with that test.

I do not use the BD Pap Collection Kit

My patients can be assured that the pap collection system I use in my office (Thin Prep) is FDA approved for both Pap and HPV co-testing.

What should you do with this information?

Ask your doctor what Pap smear collection kit he/she uses – it will be prominently labelled on the collection vial for you to see. If it’s BD’s test, and you need HVP testing, make sure a separate specimen for HPV is taken using an FDA-approved collection device.

If you’ve had a recent negative HPV test, ask your doctor how the specimen was obtained. If it was done using the BD pap system, ask your doctor if there is a need for repeating the test using an FDA-approved collection device. If your doctor thinks it is prudent, then retest. In most cases, so long as your pap was normal, simply doing a pap and repeating the HPV at your next checkup will be all that is needed. If the negative HPV was used, however, to triage an mildly abnormal pap, then a sooner repeat pap or repeat HPV test might be indicated.

Logistically, not being able to to an HPV on the pap vial is problematic, since we often do not know until after the pap is read whether or not HPV testing is needed.  By default, then, docs may end up either moving to another pap system or getting HPV routinely with every pap using an FDA-approved collecting system.

Kudos to Bob Ortega at the Arizona Republic for some of the best health reporting I have ever seen.

His article not only gives me almost everything I need to know on this issue as a clinician, but includes information on how the article was complied, and excellent info for patients wondering what to do themselves with this information. Unfortunately, however, he did not link to the Hopkins study that he cited, and I’ve been unable to find the study myself. UPDATE – see reference in comments. Thanks, Dr Austin!

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Recommended Reading

 

Last updated 01/17/13

HPV in Menopause – Old Infections or New Relations?

Menopausal couple cropped
New love comes at all ages.
So can HPV.

When HPV occurs in the menopause, is it due to reactivation of a previous HPV infection or a newly acquired infection?  That’s the question asked, but not properly answered in this doc’s opinion, by a new study published this week in the Journal of Infectious Diseases.

Researchers performed HPV testing in 843 women age 30-60, and found an increased prevalence of HPV infections among women in the peri-menopausal age group who also reported having had >5 lifetime partners, but not necessarily a new partner within the past 6 months. They concluded that this second lifetime peak of HPV infections (the first peak occurs in the second decade) was due, not to new HPV infections, but to infections acquired in the earlier years that were now re-emerging with older age and waning immunity.

The fact that we have not seen this peri-menopausal HPV peak in prior population-based studies, they say, is because most women in this age group until now have not had so many sexual partners.

The study’s findings contradicts what we are now telling women, which is that most HPV infections permanently clear within two years of an initial infection that occurs primarily during the second and third decades.

Erroneous conclusions based on a flawed study design

I take strong issue with the study’s conclusions, based on over two decades taking care of peri-menopausal women in a country where 50% of marriages end in divorce.

The flawed conclusions of this study stem from what I believe to be a flawed methodology – namely using 6 months as a cut off for defining women as having had a recent new partner, an artificial categorization that makes no sense socially or biologically. As a result, the researchers may have missed much of the important new sexual activity in their cohort that could explain an increase in HPV infection around the age of menopause.

Sex, HPV and the Middle-Aged Woman

Many women in their middle years have new relationships through divorce, dating and often, remarriage. HPV infection can occur at any time in a recent relationship, not just in the first 6 months (a part of which time many couples use condoms). These infections can persist up to 2-3 years before they clear and be diagnosed any point in that time frame.

In my own clinical practice, the overwhelming majority of HPV infections in this age group occur in women who have had a clear change in partnership within the past 1-5 years. Not surprisingly, theses HPV infections clear in the same 12-36 month time frame as the infections I’m diagnosing in the younger crowd.

Remember too, that it is at middle age that some of the husbands will start to wander – bringing home a new infection to a woman who has not had a new sexual partner in decades. The study does nothing to address this possibility. Not that any study can, of course, but you get my point.

A better study design would have been to ask how long the subject has been in her current relationship , and correlate that with HPV prevalence.

Bottom Line –

The study raises interesting questions, but unfortunately its design limits its conclusions, which to this clinician don’t make sense given what we know about HPV infection and the social lives of women.

While we cannot completely discount the possibility of reactivation of dormant HPV, this study, in my opinion, does little to answer the question it raises.

Unfortunately, the publicity around this study is sure to drive anxiety among every menopausal woman out there, especially as we are now telling them that they can back off on pap smears if theirs have been normal up till now. (I myself am not 100% comfortable with the new pap recommendations, by the way...)

What if you have a positive HPV and have not had a new partner?

I see two possible ways that a women can have HPV and not have a new HPV infection.

One is a longstanding persistent HPV infection that is only now causing precancerous changes, which as we know can take decades to appear. Is this reactivation of a dormant HPV infection or just delayed detection? After all, we only recently began testing for HPV, so unless we have a prior negative test, it’s hard to say, isn’t it?

The second is that menopause itself can lead to low grade pap abnormalities related to estrogen deficiency rather than true pre-neoplastic changes.  In women without HPV, these are so called false positives. But in women who may have a persistent HPV infection, this estrogen-deficient pap may be the first time she has ever had an HPV test.

The important point with these two scenarios is that not every HPV infection necessarily comes from a new partner (or a wayward husband).

Which is good to know.

Last updated 12/14/12

Reacting & Adapting to the New Pap Smear Screening Recommendations

Pap Smear (image from Wikipedia)

Cervical cancer screening used to be easy – they came once a year, I did a pap.  High risk patients with abnormal paps stayed at the top of my radar because they came more frequently or had procedures. If they managed to slip under the radar, we caught them at their annual.

Easy.

Now, with new consensus guidelines for pap smear screening, every patient is different. (Of course, they always were, but you get my point).

  • Under age 21 – No pap. No HPV Testing. (That one’s easy…)
  • Age 21-29 – Pap every 3 years. No HPV unless pap abnormal.
  • Ages 30-65 – Pap every 3 years, or Pap + HPV every 5 years.
  • Age 65 and older – If no history cervical pre-cancer, we can stop paps.
  • Cervical pre-cancer at any age – Manage individually.

How I feel About the New Pap Smear Recommendations

Overall, I think we are moving in the right direction, but I must admit that I am not entirely comfortable with every aspect of the new guidelines.

I do like the “no paps before age 21” recommendation. Cervical cancer is exceedingly rare in this age group, and has not declined appreciably with increased screening. And there is nothing less fun for patient or doctor than a colposcopy in a teenager. Which does not mean I won’t slip in an occasional pap a year or two early in a young woman who initiated sexual activity at a very young age (like before age 16). These kids worry me.

I’m not so enamored with jumping right into every 3 year screening (as opposed to having three normal annual paps first) starting at age 21. That recommendation is based mostly on modeling and not real world results, and accepts a small increase in the number of cervical cancers in return for less colposcopies.  I also worry that an every three year pap will turn into every five years, especially as we move towards longer acting contraceptives at the same time. This could increase the rates of cancers further in this group. Finally, I’d also argue that we’ve already made huge strides towards decreasing over-treatment by observing rather than treating low grade lesions in this age group. If it had been up to me I think I would have kept annual paps in this group, at least for three years before heading off to every three year paps.

This stands in contrast to the expected outcomes in women ages 30-65, where adding co-testing for HPV leads to better pre-cancer diagnosis and less cervical cancers – I like that a lot.

I also admit that I am having a bit of a problem thinking about stopping paps in healthy 65 year olds who are having new sexual partners and may be acquiring new HPV infections. The guidelines advise not to take sexual history into consideration in this age group, but I wonder if this is based on data from a world before the baby boomers found Match.com. In having discussions with such women about stopping paps, I find myself ordering an HPV test for reassurance before backing off. And thinking about readdressing the question in 5 years or so based on interval sexual history.

I’m still waiting to see what ACOG comes up with. They wrote in support for the new recommendations, but have yet to publish their own.

Doing less paps sounds simple, but the reality is that it takes more time

Not a lot of time, but in the era of the 15 minute office visit, every minute is precious.

Actually doing the pap takes a few seconds. But deciding whether or not to do the pap takes much longer. In order to determine which screening group a given patient falls into, I now have to go back and look at all her paps, review her history and figure out where we are in a given year on her screening scedule. That takes a few minutes.

Asking women to keep track is not always so helpful. You’d be surprised how many don’t know what their pap results were or how they may have been treated for abnormalities in the past. Getting old records is not always easy. The annual pap was always a great fallback position when there was uncertainty in the history.

At this point in time, my EMR has no ways of flagging the pap screening interval for me. (It still thinks I’m on an annual screening schedule with everyone.) So I’ve come up with little notes to myself in the assessment and plan – thinks like a macro that says “no hx abnormal paps, HPV neg, paps every 3-5 years”.  Next visit I can see this and carry it forward. Or putting a pap flag in the problem list – though it really isn’t a problem, is it? Until I get off schedule because I’ve lost track, that is.

Patients have their own issues with the new recommendations

Some are thrilled to have one less test. Others, not so much. Needless to say, we’re having a lot of conversations during visits about the new guidelines, which takes – let’s say it shall we? – time.

I’m not arguing that we need to to go back to one size fits all annual screening

Every woman is an individual, and deserves to be treated as such.   The new recommendations demand that we consider each woman’s risk of cervical cancer and weigh it against the harms of over-treatment in her age group. Overall, the risk-benefit ratio is favorable, but it does accept a small increase in cervical cancers in the age 21-29 age group, and a very very  small number of expected cancers in the over 65 crowd without allowing for consideration of other risk factors such as sexual activity. I’m not convinced that’s a trade off worth making. Unlike mammograms, which have had a limited impact on breast cancer mortality and none on its incidence, pap smears actually prevent cancer.  I wish we could have moved just a tad more slowly before making such sweeping changes.

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How do you feel about the new pap recommendations?

If you’ve come up with any little tricks for using your EMR to track individualized pap intervals for your patients, let us know in the comments section.

Last updated 07/30/12

Jade Goody – Are There Lessons to be Learned?

Dr Crippen, aka The NHS Blog Doctor, has written a very thoughtful response to my recent post on Jade Goody’s cervical cancer. Dr Crippen practices in the UK, and corrects my misperceptions of how low-income folks get care in his country.
No Margaret. You are confusing the UK with the USA. God knows, the NHS is creaking, and we have problems enough, but we do not have “public clinics” for the impoverished poor. In the USA, the impoverished poor, aka the unemployed working class, predominantly black and Latino, may need “public clinics”. In the UK everyone is entitled to a “primary physician” as of right, independent of status and means. Yes, yes, before someone, or no one, or “angry from Tonbridge” writes in, a few people slip through the net, and a few people have incompetent GPs, and there is a difficulty with the homeless who are of no fixed abode, and so on and so forth but by and large most people have a GP. God knows, I do not hold back on criticising the failings of the NHS, but I become amazingly protective when people try to suggest that we have problems akin to those experienced by the medically uninsured in the USA.

I encourage you to head on over and read his post, which includes a description of the cervical cancer screening program in the UK.

Dr Crippen also thinks I went too far in hoping that someone

personally called, warned, cajoled and hollered at [Jade] countless times, until finally, as a last ditch effort, they sent her a certified letter.

You know what? He’s right. I doubt I would have called “countless times”. I was being a bit hyperbolic, probably because I was feeling particularly saddened and frustrated by the fact that a preventable death was about to occur in a young mother of two children.

But I like to think that I would have called Jade at least once if she failed to respond to her letter. Probably twice if I know myself well. And I suspect from reading Dr Crippen’s post that he would have done the same.

So don’t worry, Dr Crippen – you and I are in full agreement that the medical profession does not need anyone breathing down our backs to force patients to accept medical care that they have been duly informed that they need. I was in no way trying to insinuate that the medical profession bore any legal responsibility in Jade’s tragedy. They sent her a letter, she ignored it. Her bad.

That said, the question that remains is simply this – Did anyone call Jade when she failed to follow up on that last abnormal pap smear?

Which is not to imply that they were required to do so, or that the government should mandate it. I’m just speaking as one human being to another. It seems like it would have been the right thing to do.

And I hope someone did it.

That was really all I meant to say.

Last updated 09/9/10

The Tragedy of Jade Goody

Jade Goody, the controversial star of British reality TV, is dying of cervical cancer at age 27. This young woman, who has lived her life in front of the camera for the last 7 years, will die for the camera as well, having sold the rights to film her last days in an ongoing reality show.

Whatever you think of Jade, the publicity generated by her illness has led to a 20% upswing in the number of women getting Pap smears in Britain.

And this is a good thing. Because if Jade’s story causes even one young woman to get the smear that saves her life, it will mean Jade’s death will not have been in vain.

The Irony

Unlike Eva Peron, whose death from cervical cancer occurred in the years before we had access to screening, Jade did get pap smears.

Jade had more than one pap smear, starting in her teens. At one point, she was even treated for precancerous changes of the cervix. And went on to have more follow up smears after that.

But when those follow up smears showed a recurrence of abnormal cells, Jade ignored letters that were sent to her advising her to come in for follow up and treatment.

Why? Because she was scared..

“They had sent a letter to me ages ago, telling that I needed to go in for an operation, but I had been too scared to do anything about it,” Goody confessed.

So Jade put the whole thing out of her mind and pretended it never happened. Until repeated episodes of pain and hemorrhage became symptoms she could no longer ignore. But by then, the tumor had spread beyond the cervix to her uterus. And while a radical hysterectomy and chemotherapy staved the cancer off for awhile, it returned this past month with a vengeance.

And now Jane Goody is going to die.

Let me stop beating around the bush

What has been on my mind all week since I first read about Jade’s story, and what I want to ask is simply this –

Did any health professional ever actually call Jade and try to get her in for treatment in all that time after her Paps came back abnormal? A nurse? A doctor? Anyone?

Please don’t tell me the only contact ever made with this frightened young woman was a series of letters, each one scarier than the next. Please tell me someone called her personally and tried to get her in.

Look, I know Jade was stupid.

No one, even Jade, I suspect, would say otherwise. Ignoring multiple abnormal Pap smear letters was not the first or the last stupid thing Jade Goody ever did. This is a kid who, in front of millions, stripped nude during a game of poker, made an ass of herself shouting racial slurs to an Indian housemate and then gave a blow job under the covers to another housemate. We’re not talking rocket scientist here.

But I’ve seen Jade in interviews that I’ve watched over the past few days, trying to wrap my head around this tragedy. This kid doesn’t hold anything back. She is completely genuine, self-effacing and ready to admit her shortcomings. She’s an idiot, but she knows it. And she is anything but unreachable emotionally. I just can’t believe that someone couldn’t have convinced her to come in sooner if they’d just talked to her.

Please tell me someone tried to reach her.

Jade seems to have had multiple interactions with the health care system during those years between the abnormal smears and her ultimate diagnosis. Times when she visited doctors for pain or gastrointestinal symptoms that were probably related to her growing cancer.

Did these doctors know about her abnormal smears? Did Jade think to tell them? (Probably not…) Were the letters being sent from the NHS cervical cancer screening program separate from Jade’s actual ongoing medical care?

Heck, did Jade even have a source of ongoing care, or, god forbid, a primary physician? I doubt it. This is, after all, a lower class girl from a very rough upbringing – someone, I suspect, whose only contact with the health care system was in public clinics and ERs. She probably bounced around ER’s and hospitals during those years, failing follow up appointments, checking out AMA so she could appear in one or another publicity venue, denying that there was really anything wrong. (Update – Dr Crippen corrects my misperceptions of the British system…)

She even tried to delay her surgery after her diagnosis so she could stay on TV, till they told her she’d be dead in 3 weeks unless she went into the hospital right away.

So maybe I’m completely off base.

Maybe, just maybe, there were docs and nurses who tried to help Jade. Folks who personally called, warned, cajoled and hollered at her countless times, until finally, as a last ditch effort, they sent her a certified letter. Health professional who really cared about Jade and wanted to help her, although ultimately she refused their help.

Maybe Jade was just really that stupid.

I hope so. Because otherwise, the tragedy is not just Jade’s, but all of ours.
______________________________________________________

Update –
Dr Crippen reponds to my post with a very thoughtful post of his own regarding Jade.
I respond to Dr Crippen.

For more information about cervical cancer, see these sites –

Jade Goody Photo from Wikimedia

Last updated 12/13/12

Eva Peron, Cervical Cancer and the Pap Smear

Eva and Juan Peron, October 1951 (Image from Wikipedia)
Fat Doctor writes that she can never think of Argentina without thinking of the music from Evita, the musical that was inspired by the life of Eva Peron.

When I think of Argentina, I too, think of Eva Peron. But there’s no musical accompaniment. Just sorrow.

Because I can never think about Eva Peron without thinking about cervical cancer, Pap smears and HPV. And the tragedy that was Eva’s death, and the deaths of so many women from cervical cancer.

Eva died from cervical cancer in 1952 at the young age of 33 years. Although George Papanicolaou invented the Pap smear in 1942, this life-saving test was not widely used in Argentina until the 1960’s. Thus, Eva’s cancer was at an advanced stage when it was diagnosed after she began having vaginal hemorrhage.  She received radiation treatment to control the bleeding, probably right around the time of that photo up there, and then a radical hysterectomy in November 1951. Despite treatment, the cancer progressed rapidly and she succumbed to it just 8 months later.

Don’t be surprised if you did not know that Eva had cervical cancer

She herself never knew. Her diagnosis was kept from her at her family’s request, and the public never told, even after her death. The subterfuge was so extensive that when they brought in an oncologic surgeon from Memorial Sloan Kettering to perform a radical hysterectomy, he never met his famous patient until she was asleep under anesthesia, and Eva never knew that her surgeon was anyone other than her own doctor.  It’s an amazing story of paternalism and politics.

Eva’s husband, dictator Juan Peron, also lost his first wife to cervical cancer at 28 years.

Did Peron carry a particularly aggressive strain of HPV, the virus that we now know causes cervical cancer, and unknowingly transmit the infection to both his wives?  Or did Evita contract HPV elsewhere, having been sexually active with multiple partners from the young age of 15?  We will never know for sure.

What we do know today is that Evita’s death due to cervical cancer would likely never have happened if she had had a Pap smear. This simple test, in which cells from the cervix are collected with a brush and examined microscopically for abnormalities, can detect precancerous changes up to 10 years before cervical cancer develops. Ten years during which developing lesions can be treated before they become cancerous.

This week is the 125th anniversary of the birthday of George Papanicolaou, the inventor of the Pap smear.

Happy Birthday, George. If there is a heaven, you are surely in it. And thank you for your wonderful Pap smear – one of the most effective cancer screening tests ever created

If only Evita had had one.

_________________________________________________________

For more reading about Evita see –

For more information about cervical cancer, pap smears and HPV see these sites –

 

Last updated 07/10/13

HPV and Breast Cancer? Interesting, but too soon to say

Read a fascinating post in Aetiology regarding the potential role of HPV in the etiology of breast cancer.

Although we are nowhere near proving a direct causation, studies have found HPV DNA in anywhere from 20-85% of tumors studied. (Types 16, 18 and 33 most commonly) However, some studies have found HPV DNA in normal breast tissue as well. So is HPV a cancer-causing agent in the breast or just a bystander? It’s too soon to say. Lots more work is needed on this one, folks.

The data are at odds with known risk factors for breast cancer, such as never having been pregnant. And if there is a link, one should see that breast cancer risk is increased with number of sexual partners, which as far as I know, is not the case.

So be careful before making the leap between hypothesis and recommending HPV vaccination for breast cancer protection. It’s way, way to soon…

Last updated 08/4/10

HPV and Oral Cancer – What Are the Risks?

Increasing evidence suggests that HPV infection of the mouth and throat, presumably acquired through oral-genital contact with an infected partner, can lead to squamous cell cancers of the tongue and tonsils.You know what HPV is, right? Human Papilloma Virus. The same virus that can cause cervical cancer in women and anal cancers in both men and women.

Scientists have been suspecting for years that this virus might be responsible for squamous cell cancers of the oral cavity. Turns out that it is, though it may be a more recent phenomenon related to the increasingly widespread nature of HPV infection.

What is the Evidence?

1. The incidence of certain oral cancers is rising

Doctors and dentists are seeing increasing numbers of tonsillar and tongue cancers in young men and women, even as rates of other oral cancers and the use of tobacco, a factor typically associated with increased risk of oral cancer, have declined, and rates of oral sex have increased.

Confounding factors may be an increase in binge drinking, another risk factor for oral cancer, and the fact that tonsillectomies are no longer regularly performed. But upwards of one quarter of individuals with oral cancer these days do not have a history of drinking or smoking, suggesting that another risk factor is emerging. That factor appears to be HPV.

2. HPV DNA is found in oral cancer cells

Somewhere between 40 and 75% of tongue and tonsillar cancers contain HPV16 DNA. HPV 16 is the HPV genotype most frequently found in cervical and anal cancers, and is known to be sexually transmitted.

Scientists testing tumor samples from Sweden’s tumor registry in 2007 found that the rate of HPV DNA presence in tonsillar cancers increased from 23% in 1975 to 68% in 2002.

3. The risk for oral cancer increases with number of oral sex partners

Having more than 6 lifetime oral sex partners is associated with a greater than threefold increase in oral cancer risk. (NEJM) This risk appears independent of the risk imparted by smoking and alcohol, which is associated with HPV-negative cancers. Again, this suggests that there are separate pathways to oral cancer, one mediated by HPV and the other via some other factor modified that is by alcohol and nicotine.

What is Your Risk for Getting Oral Cancer?

It’s really, really low. According to the SEER database, the the annual incidence of oral cancer is about 10 per 100,000 annually (6 per 100,000 for women and 16 per 100,000 for men.)
So extrapolating from the research, having had oral sex with more than 6 partners would raise the annual risk of oral cancer in a male to 48 per 100,000.
Of course, that’s just the annual risk. The lifetime risk of getting oral cancer is considerably higher, about 1%, give or take, depending upon how old you live to be.
So, if these numbers hold for HPV related cancers as well, and you have more than 6 oral sex partners, your lifetime risk for oral cancer by age 70 will be about 3 %. Which looks like this –
But, the risk of dying from oral cancer is much, much lower, about 2.5 per 100,000 annually, and ranges from 1.3 per 100,000 in individuals under age 65 to about 12 per 100,000 in those age 65 and older. Since HPV cancers are less aggressive than other oral cancers, I don’t think we can extrapolate historic mortality data, so I won’t. But I would suspect that the risk of dying from an HPV-related oral cancer is even lower than the numbers I just quoted.

(This is rough math, and probably not statistically proper, but it’s the best I can do with the data I have. Others who are better at statistics, please feel free to comment and correct this estimate and I will revise if need be.)

By comparison, the annual incidence of cervical cancer in women is about 7 per 100,000 and the mortality about 2.5 per 100,000. The lifetime risk is about half that of oral cancer in males, due, I suspect, to Pap smear screening in women.

Are There Other Risk Factors?

HPV is only one risk factor for oral cancer, though given the advent of the HPV vaccine, it is sure to be the one that gets the most press.

Smoking, excessive alcohol intake and poor dental care are also very important risk factors, as is a diet low in fruits and vegetables. In one study in Poland, 56% of oral cancers could be attributed to smoking, 31% to excessive drinking, 47% to poor dental hygiene and dental care, and low fruit intake to 12%.

These other risk factors appear to be independent of HPV infection in causing oral cancers, and scientists hypothesize two separate paths to oral cancer, one driven by HPV and the other by these other risk factors. Supporting this idea is the fact that HPV-related oral cancers tend to be less aggressive and have better prognosis than those without HPV. In addition, tobacco and alcohol appear to be synergistic in promoting cancers that are negative for HPV, but not in cancers that test positive for the vurus, again suggesting separate mechanisms for malignant transformation.

What Can You Do Now to Prevent Oral Cancer?

1. Don’t smoke
2. Drink to moderation
3. Brush your teeth and see your dentist regularly.
4. Add fruits and vegetables to your diet.
5. Limit your number of oral sexual partners

Will HPV vaccination be added to that list? I expect it will be. The vaccine prevents HPV 16, the subtype most often found in oral cancers.

Merck, the manufacturer of the vaccine, is conducting clinical trials of their HPV vaccine in young men. I would anticipate a “Tell someone” campaign about oral cancers directed at this population sometime in the near future. Time will tell, and only Merck’s marketing department knows for sure.

In the meantime, be careful out there, okay? Oral sex is a very intimate activity. Why not reserve it for those you love? That would limit your partners quite nicely.

Last updated 06/4/13

Cervical Cancer and Birth Control PIlls

A recent meta-analysis has confirmed that use of birth control pills slightly increases the risk of cervical cancer. But before you stop your pills, take a deep breath, relax and read further.

Because the risk is really small. How small? Well, if you live in a developed country (meaning you have access to Pap smears), use of the pill for 10 years increases your chance of having cervical cancer from 3.8 per 1,000 to 4.5 per 1,000.

Remember that the real cause of cervical cancer is not birth control pills. It’s infection with the Human Papilloma Virus (HPV).

But estrogen metabolites of the pill may make your DNA more susceptible to changes induced by the HPV virus. The pill can also make the glands of the cervix more exposed to infection by the HPV virus. The other big factor may be that women taking the pill may use condoms less frequently, thus making them more likely to get HPV.

The good news is that once you stop the pill, the increased risk of cervical cancer goes away. That means that when you get older and don’t need birth control, you won’t be paying the price for your decision to use pills when you needed them to prevent pregnancy.

Bottom line – limiting your number of sexual partners and getting pap smears regularly are the most important things you can do to prevent cervical cancer. There is also a vaccine to prevent HPV, but remember that it only protects against 2 of the 12 subtypes of HPV that cause cervical cancer, so it’s not a panacea.

And remember, the pill cuts the risk of ovarian cancer, a protective effect that lasts up to 20 years after you stop the pill. It also reduces your risks of endometrial cancer. And keeps your menstrual cycles shorter, lighter and less painful. Not to mention it prevents pregnancy.

A Gynecologist’s Perspective

I’ve been a practicing gynecologist for 20 years now. In that time, I can remember only 1 case of cervical cancer in my private practice, in a woman age 60 who was completely cured with a hysterectomy. (The cancer was so small they could not find it in the hysterectomy specimen because I had removed it all with my office biopsy.)

I recall many more cases of cervical cancer from my residency, most during my oncology rotation, and all in women who had not had pap smears in years. I remember vividly the woman who presented to the ER bleeding from a large cancer on her cervix. She had not seen a doctor since giving birth to the last of her 7 children, who was now 25 years old. I don’t think she ever took birth control pills.

On the other hand, I’ve lost count of the number of unplanned pregnancies that have occurred among my patients, and the number of my patients who have had abortions for an unwanted pregnancy.

Given this experience, I see no reason for woman to stop taking the birth control pills because of concerns about cervical cancer.

I can think of only one situation where I might tell a woman to stop the pill for this reason. That is the rare patient with recurrent cervical dysplasia and persistent HPV infection that does not clear. I had one such patient, and I changed her to the progesterone-only pill. She is doing well.

Last updated 08/3/10

HPV Vaccine – The Canadian Response

A well-considered position against universal HPV vaccination in Canada has been published in the Canadian Journal of Medicine. The authors, who are part of the Canadian Women’s Health Network, argue the following:

  • Cervical cancer is far from epidemic in their country, with only 400 deaths yearly, a rate that has been steadily declining;
  • Most HPV infections resolve spontaneously;
  • The vaccine was not trialed sufficiently in adolescents, the group being targeted for univeral vaccination;
  • The long-term efficacy of the vaccine against cervical cancer in the population has yet to be proven, in light of the fact that it protects against only two of the subtypes that cause cervical cancer and its duration of effect is not known;
  • The vaccine is too new and the clinical trials were all industry-sponsored;
  • The true costs are not determined.

The Canadian Government apparently had a different opinion on the matter – they recently allocated $300 million for HPV vacination. The Canadian health service is rolling out a mass HPV innoculation campaign with the beginning of this year’s school year, the first such innoculation campaign since the polio vaccine in the 1950’s. (CBC.Canada has a very well-done segment on the vaccine initiative.)

Opponents of universal HPV vaccination in both Canada and the United States are focusing on reports of Guillain Barre syndrome occuring after Gardasil administration, expecially when administered along with the meningococcal vacine Menactra. This is typical of anti-vaccine strategies – to focus on rare adverse events that are unlikely to be caused by a vaccine. Similar publicity around a since-debunked theory that the MMR vaccine causes autism has been blamed for recent outbreaks of measles in Britian.

Here in America, the lawyers are already jumping into the Gardasil fray.

Basically, here is the situation – Merck is frightening women about cervical cancer, then using slick marketing campaigns to sell them their vaccine. The anti-vaccine folks are frightening the public that this vaccine has severe side effects, an approach they basically take with all vaccines.

But well-reasoned and informed views such as those expressed by the Canadian Women’s Health Network deserve attention and discussion. Unfortunately, such views do not lend themselves to catchy slogans or soundbites, and don’t frighten anyone. Which makes it unlikely that anyone will hear them.

My position? (Like I haven’t beat this drum enough already…) I pretty much agree with the position of the Canadian Women’s Health Network. I believe that the HPV vaccine is safe, but not yet appropriate for universal vaccination. Like all new pharmaceuticals, only time will tell if there are rare effects not found in clinical trials. I do offer the vaccine to patients who express interest in it and who understand its limitations, mostly adult women who are having multiple partners over time. I am opposed to universal or mandatory vaccination in young adolescents, and abhor the marketing and lobbying tactics being used to promote this vaccine.

Last updated 08/3/10

HPV Vaccine – Defining the Limits

In a study published today in JAMA, HPV vaccination did not improve clearance of HPV 16/18 in women ages 18-25 who were already infected with the virus.

our results demonstrate that in women positive for HPV DNA, HPV-16/18 vaccination does not accelerate clearance of the virus and should not be used for purposes of treating prevalent infections.

In this study, conducted in Costa Rica, 41.3% of women were infected with HPV at the time of study enrollment. Just another reminder of how common this virus really is.

What do these results mean for patients? If a woman already has an abnormal pap or infection with HPV, vaccination will not be useful in treating her current infection. However, until we have a test to determine which of the 40 HPV subtypes our patients are infected with, vaccination may still be reasonable in such women for preventing future infections with types 16/18/6/11.

The CDC currently recommends vaccination before sexual debut as the most effective means of preventing HPV infection. The older a woman is, the greater the chance she will already have been infected with HPV.

Don’t Misread the Hype

The hype over the HPV vaccine may be misleading, leading some women to believe that the vaccine will make them immune to all HPV infection. Products like the HPV thong (seen below) do little more than promote this misunderstanding.

To be correct, here’s what that thong should look like…

Remember that the currently marketed vaccines only target 2 of the 12 known strains of HPV that cause cervical cancer. Pap smears are still critical in screening for cervical cancer and detecting precancerous lesions before they become life-threatening.

Last updated 06/8/11

Merck Suspends Lobbying for Mandatory HPV Vaccination

Merck today reported that they are suspending their lobbying efforts for mandatory HPV vaccination. (Thanks to Main Mama for pointing this out to me.)

“Our goal is about cervical cancer prevention, and we want to reach as many females as possible with Gardasil,” Dr. Richard M. Haupt, Merck’s medical director for vaccines, told The Associated Press.

“We’re concerned that our role in supporting school requirements is a distraction from that goal, and as such have suspended our lobbying efforts,” Haupt said, adding the company will continue providing information about the vaccine if requested by government officials.

I’m not sure what exactly suspending lobbying means. Merck has been funneling funds through Women in Government, whose members have been the driving force behind mandatory HPV legislation. Both Merck and the WIG have declined to say just how much money has changed hands between them.

If the WIG’s members are the “government officials” Haupt is referring to, then I assume it means the relationship with the WIG remains in place. From what I can see, the majority of Merck’s work with the WIG has been done – boilerplate legislation has been crafted and the WIG members trained to introduce the legislation. At this point, Merck can sit back and let the WIG do it’s job for them, and deny that they are lobbying. (I know, I know. I’m just so cynical…I think I’m just getting really good at reading between the lines of these corporate press releases disguised as news.)

The vaccine, which costs about $360, has been projected to have the potential to generate $3 billion a year in sales. According to that pie up there, that’s almost $2 billion in profit for Merck. Gardasil revenue in 2006 totaled $155 million (The vaccine was approved in June 2006).

Pie Data from Baltimore Sun.

Last updated 08/3/10