No More Pap Smears?


By Diana Zuckerman, PhD, president of the Cancer Prevention and Treatment Fund

If you’re a woman over 21, that headline probably got your attention. After all, who likes Pap smears? Wouldn’t it be great to never need one again?

Well, don’t get too excited because the alternative could be worse, if a Food and Drug Administration (FDA) advisory committee gets its way. The committee proposes replacing Pap smears with an equally invasive but less conclusive test, the HPV test, when women reach the age of 25. And then, if the HPV test indicates the presence of HPV (or human papillomavirus, which is very common in sexually active young women and usually goes away by itself), the committee proposes following up the test with an even more invasive procedure called a colposcopy. Patients describe a colposcopy as being like a Pap smear that takes 20 minutes instead of a few seconds.

The purpose of a Pap smear is to test for abnormal cells in your cervix that could eventually turn into cervical cancer. Two strains of HPV virus are responsible for 70 percent of cervical cancers. It’s very common for sexually active women to be infected with HPV, but usually the body gets rid of the virus within a year or two all on its own. HPV can only cause cancer when it lingers in the body for several years and starts to damage the cervix.

Even if a woman has had an HPV vaccine, she could still potentially develop cervical cancer, so experts advise women to get a Pap smear every three years, starting at age 21 and ending at age 65.  Starting at age 30, women are given the option of asking their doctor to use the same sample for a Pap smear and the test for HPV. If nothing suspicious is found, they can get screened using both tests every five years instead of every three for the Pap smear alone.

Current guidelines recommend that if a woman has an abnormal Pap smear and an HPV test indicating that she has the types of HPV that can cause cervical cancer, she should undergo a colposcopy to see if she needs surgery. Most women get Pap smears to screen for problems, and typically only get an HPV test if their Pap results indicate abnormal cells.

That’s why not many women currently get the HPV test. The company that makes HPV tests would like to sell more of them. So it’s asked the FDA to change the agency’s instructions for using the HPV test to screen healthy women. Instead of an optional use with Pap smears, it wants FDA approval to use the HPV test on its own to screen all healthy women starting at age 25.

Unfortunately, the HPV test by itself isn’t very useful because so many young women have HPV that will disappear without any treatment. Having an HPV test without also getting a Pap smear to check for problems is going to scare a lot of women who are not developing cervical cancer.  Instead of waiting a few months to see if the HPV goes away by itself (which it typically does), the company wants those women to get a colposcopy, which is as painful as a Pap smear but the pain lasts longer and the procedure costs more. And like a Pap smear, the test isn’t always accurate.

Otherwise, it’s a great idea.

We’re not the only ones who believe that the current guidelines should not be changed. The unbiased experts at the U.S. Preventive Services Task Force recommend that the HPV test only be used on women 30 and over, and only in combination with a Pap smear. They point out that if the HPV test is used on younger women, the results can’t distinguish between HPV that would go away on its own and HPV that could cause cancer. This would lead to unnecessary worry for young women and many unnecessary colposcopies.

At an FDA Advisory Committee meeting this month, Anna Mazzucco, PhD, from our staff expressed her concerns about replacing Pap smears with HPV tests. She pointed out that Pap smears provide inexpensive and and effective screening. In fact, the women who get cervical cancer are usually women who did not regularly get Pap smears or follow-up.

Research indicates that the way to save lives is to help women get screened with Pap smears, not to put them through unnecessary follow-up procedures. The American College of Gynecologists—the doctors who do Pap smears, HPV tests, and colposcopies—also expressed concerns about changing current policies, since there is no evidence that the proposed changes would save as many lives.

In addition, we believe that the more expensive and painful procedures would discourage women from getting screened or following up after receiving suspicious results.

What is going on at the FDA? Why are they choosing advisors who ignore the research evidence in favor of a new, unproven screening strategy? The FDA needs advisors who focus on scientific evidence and who make recommendations based on facts, rather than embracing every new “innovation” in health care, regardless of whether it will work.

When the “old ways” are effective, let’s not throw them out unless there is proof that the new, more expensive way is better.

Diana_ZuckermanDiana Zuckerman is the president of the Cancer Prevention and Treatment Fund. She received her PhD from Ohio State University and was a postdoctoral fellow in epidemiology and public health at Yale Medical School. After serving on the faculty of Vassar and Yale and as a researcher at Harvard, Dr. Zuckerman spent a dozen years as a health policy expert in the U.S. Congress and a senior policy adviser in the Clinton White House. She is the author of five books, several book chapters, and dozens of articles in medical and academic journals as well as in newspapers across the country.


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12 Responses to No More Pap Smears?

  1. Alice Green March 25, 2014 at 8:20 pm #

    Maybe what’s going on at the FDA is the same thing going on in many of our governmental agencies. Big Corporations, intend on making their CEO’s even richer then the 1% use their fat wallets to ‘urge’ our different agencies to change the rules – not because it will help the people who have no choice in the change, but because it will bring in more bucks for the Corporations! When will this type of behind the scenes lobbying end??

  2. Sarah Lyn March 26, 2014 at 9:51 am #

    One of my biggest concerns is for the women who are already afraid of getting pap smears who would definitely not submit themselves to a colposcopy if they receive a positive HPV test. Money seems to be motivation over health and practicality, here.

  3. Anna March 26, 2014 at 9:56 am #

    This test also will miss non-HPV cervical cancers! But pap smears can detect both! Doing an HPV test without a pap would just be throwing critical information into the trash!

  4. Maura March 26, 2014 at 11:33 am #

    Great article! Why would we make cervical cancer screening more complicated, more expensive, and more uncomfortable for women when we already have an effective screening method? Let’s hope the FDA comes to its senses and realizes that in this case, new technology is a step backwards.

  5. Melanie March 27, 2014 at 11:29 am #

    Thanks so much for sharing this! Having a new test may seem like a good idea at first, but now I can see how using the HPV instead of the pap could have negative consequences. Colposcopies are invasive and slightly painful procedures that women shouldn’t have to undergo unless absolutely necessary.

  6. Jay March 28, 2014 at 12:12 am #

    Honestly. No studies? No data? I know we all want to believe the entire world is one giant corporate conspiracy but the entire reason this expert panel took place is so the FDA didn’t appear biased. It was a such a big change that they invited unbiased experts in the field, none of whom were identified to the corporate sponsor and had them review the data and give their opinion. They voted UNANIMOUSLY in favor for safety, efficacy and benefits vs. harms. That’s right 13-0 x 3. Now you can bash the FDA, you can pretend that it is impossible to make money AND deliver better ways of doing things, but these experts sit on professional medical associations like ASCCP, etc. and gave their opinion. Where was all the concern when they voted?

    No data? What do you call the 47,000 woman trial they reviewed the data from? How about the 50+ publications that were cited in the presentations? Are all those investigators from all over the world in someone’s pocket too?

    Why do you act like colposcopy is only related to the HPV test? You want to tell me you know something about cervical health and you aren’t aware that every woman with an abnormal pap is reflexed to a colposcopy? The new algorithm uses specific genotyping of the viral types as well as pap smears as a triage for some positives to determine who goes to colposcopy. The result? More disease is caught earlier and without sending more women to colposcopy than current practice with cytology. And that…is why the panel of independent experts voted unanimously to offer this as an OPTION.

    You are either willfully misleading the readers of this blog or you haven’t done due diligence reading the literature yourself. Either way it is as irresponsible as those who scare parents out of vaccinating their children because they need something to blame autism on, even though there isn’t a shred of scientific data suggesting there is a link. Note sure how you sleep at night but you should be encouraging these women to read up from multiple sources and not take medical advice from a blog.

    Let the experts do their jobs and if you want to present yourself as one do your homework first. As it is I am more inclined to believe you are the one with financial interests here that are keeping you from presenting a fair story on a change that is going to save thousands of women from cancer.

  7. Jay March 28, 2014 at 12:14 am #

    Here is a more balanced view rather than this obviously biased one.

  8. Elizabeth (Aust) April 10, 2014 at 5:51 am #

    Actually following the evidence is easy if you take the decisions FAR away from vested interests, something Australia & the States have been unable to do. This cancer was always rare in the developed world and in natural decline before testing even started, there was never a need to worry and harm so many. (0.65% is the lifetime risk of cc;
    77% is the lifetime risk of referral for colposcopy and usually a biopsy, the States would be similar if not higher)
    HPV primary testing should always stand alone and only be offered to those aged 30 to 60. The Dutch are the ones to watch. They’ll scrap their 7 pap test program, 5 yearly from 30 to 60, and offer instead 5 HPV primary tests at ages 30,35,40,50 and 60. (or women can self-test with the Delphi Screener, already being used there and elsewhere)
    ONLY the roughly 5% who are HPV+ will be offered a 5 yearly pap test. This will save more lives and takes most women OUT of pap testing and harms way. It will also, see colposcopy, excess biopsy/over-treatment rates PLUMMET. Of course, this also, means medical profits will plummet, and that’s why women will have to fight for access to evidence based testing. (or seek it out for themselves)
    America has ADDED HPV testing TO pap testing which creates the most over-investigation for no additional benefit to women. The HPV test should always stand alone as the primary test.

    Women under 30 do not benefit from pap testing and that’s why they are excluded from evidence based programs found in the Netherlands and Finland, sadly, the same rare cases occur whether you screen or not. Excluding young women protects them from over-treatment, young women produce the most false positives. HPV tests are not recommended either because around 40% would test positive, transient and harmless infections that will clear in a year or so, by age 30 only about 5% will test HPV+.
    So we can identify the small number of women actually at risk and exclude all others from pap testing and the fairly high risk of excess biopsies etc. MOST women are having unnecessary pap testing that simply risks their health.
    It’s horrible to see the damage this testing has done in reckless hands, it’s overuse and inappropriate use has caused worry and harm to huge numbers. Almost all of this damage was avoidable as the Finns and Dutch have shown. Damage to the cervix can mean miscarriages, c-sections, cervical cerclage, premature babies etc.
    HPV Today, Edition 24, sets out the new Dutch program.

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  10. Teresa June 27, 2014 at 2:49 pm #

    A year ago I went to the doctor for my normal Pap smear check up. I was not told I was getting any special testing, I was just there to get a Pap smear check up. I am 52 years old and not sexually active outside of my marriage, and have never had any irregular Pap smears or other troubles.
    I got my lab tests back several weeks later, and saw that they had charged me an arm and leg for what I thought should’ve only been like $50 for the usual Pap smear. Instead it cost me about $190, but they would give me a 20% discount if I paid it by a certain date. What in the world??? I called the lab, only to find out they had done a HPV testing and that it is normal procedure now.
    Well… because of that, I will not be going to get my check ups any longer unless they will let me come in just to get a Pap smear. I should not be charged for anything that I was not first notified about getting done. And I should not be required to get anything done that I don’t want to get done. Just like when I’m a shopper at a store, I buy what I want to buy and nobody’s going to force me to buy something I don’t want…so… Buyers beware!

  11. Elizabeth (Aust) August 29, 2014 at 10:54 pm #

    Teresa, if you’re HPV- you could also, consider re-testing for HPV in 5 or 10 years time. If you’re confidently monogamous and HPV- you might also, consider forgetting about more testing. You can even test yourself for HPV using the Delphi Screener or Tampap. (both are available online in most countries)
    Not many doctors will give you this information, they simply push pap testing and excess, doing both a pap and HPV test as we see in the States provides no additional benefit to women, but leads to the most over-investigation. The HPV test should always stand alone.

    Doctors also, consider it safer to assume all men will stray, so no one can be sure their marriage/partnership is monogamous, I think that should be our call. Give us the information we need to make our own decisions.
    At 52 and a history of normal pap tests and in a monogamous relationship, I’ll bet you’re HPV- and that means you can’t benefit from pap testing (but you can get a false positive and be referred for excess colposcopy and biopsy) Menopause is a time (and post menopause) when false positives are more common due to natural/hormonal changes.

    HPV primary testing should not be used before age 30, in evidence based programs in the Netherlands and Finland they don’t offer pap tests either before age 30, but then the evidence doesn’t really come into it in the States, Australia and elsewhere, too much money is made doing unnecessary testing and inappropriate testing that leads to excess biopsies and over-treatment which leads to more health issues…it’s a win:win for vested interests.

  12. Shelli October 3, 2018 at 7:23 pm #

    We do not need “routine” gyno care. This is a patriarchal white male construct. Cervical cancer is rare; we are far more likely to die of pancreatic cancer than cervical cancer. Why then are we not demanding that our pancreases be surveyed annually? This obsession on surveying women’s genetalia yearly is systemic oppression of women and opportunistic money-making. Scare women – make money. Will there be casualties if we give all this testing up? Yes, a few, just as there will be casualties with women dying of pancreatic cancer (which no one routinely tests for.). What is most likely to kill us in the end? Heart disease. Whereas about 4 in 100000 women will die of cervical cancer, 1 in 3 will die of heart disease. We are obsessing over the wrong body organ.

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