No more Pap smears?

By Diana Zuckerman, PhD

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.


A version of this post appeared in Huffington Post and Maria’s Country Kitchen.