Pap test smeared

Next to finding a lump in her breast, every woman’s greatest fear is that her annual Pap smear will come back positive for pre-cancerous cells on her cervix.

Stacey Jones has lived that nightmare.

In April 1998, the 26-year-old Jones received a call from her primary care physician informing her that she had an irregular Pap smear.

“Immediately, your heart just goes into your stomach,” Jones said recently, from her new home in Davis.

Roughly 5,000 women die from cervical cancer each year, according to the American Cancer Society.

While her doctor downplayed the possibility of Jones having cancer, she did tell Jones it was possible that a sexually transmitted disease was responsible for the irregular Pap reading, and she referred Jones to an OB-GYN.

HPV, shorthand for the human papillomavirus—a sexually transmitted disease known to cause cervical cancer—is one of the most prevalent of all STDs in young women. But Jones, who was in a long-term, monogamous relationship, didn’t understand how she could have contracted the virus, nor how this irregular Pap would upset her life.

“I was completely freaked out; you think about it every day,” Jones said of the intervening three weeks between the time of her initial diagnosis and her first exam with the OB-GYN.

During those days, Jones did considerable research on both cervical cancer and HPV. And while she said she was comforted by her doctor’s initial belief that she didn’t have cancer, she found it disconcerting to discover that HPV, in addition to causing cervical cancer, also could cause complications in pregnancy.

“You can have problems getting pregnant and, if you do, you could possibly pass it on to your children. It was scary,” Jones said.

But the diagnosis was wrong.

In fact, despite four months of worry, several visits to the doctor and a painful biopsy, Jones did not have pre-cancerous cells or HPV. Simply put, the test was at fault, causing a false-positive reading. Unfortunately, roughly 60 percent of all women who get annual Pap tests receive either a false-positive reading or an inconclusive one.

But Jones need not have had that experience. Had she had access to an advanced Pap test, known as the ThinPrep, her doctor could have ordered a re-test, which would have also tested for HPV and had the results back within two weeks. Without another visit to the doctor’s office. Without the typical rounds of additional Pap tests, set six months apart, until a negative reading was received three consecutive times, thus ruling out the existence of irregular cell formations. Without a biopsy. Essentially, the ThinPrep technology cuts the time frame for receiving conclusive results from 18 months down to two weeks.

“No one, once, ever told me that this test could be wrong,” Jones said of the traditional Pap test used by her doctors. “The most harrowing part of the experience was the biopsy and the anxiety. Had I known how prevalent the inaccuracy of the [Pap] test was, I would have waited and retested, instead of having the biopsy.”

Developed by Cytyc Corporation, the ThinPrep differs from the traditional Pap test in the way the specimen is processed once it is collected from the patient. While the traditional Pap uses roughly 20 percent of the sample collected and is literally smeared onto a slide, the ThinPrep preserves the entire sample in a special liquid, enabling lab technicians and doctors to go back and perform additional testing when a Pap test comes back either inconclusive or positive.

According to the National Cancer Institute, some 3.5 million Pap tests annually are found to be inconclusive. As a result, not only are women subjected to retesting every six months, many have had to undergo such invasive procedures as colposcopies and biopsies as well—many of them unnecessary.

Cervical cancer is the second most common cancer among women worldwide, but, if detected in the pre-cancerous stage, virtually all cervical cancer is preventable and nearly 100 percent curable, scientists and doctors with the National Cancer Institute (NCI) report. Doctors and scientists lay the blame for the 16,000 new cases of invasive cervical cancer and 65,000 cases of pre-cancerous conditions diagnosed annually at the feet of the traditional Pap test—the technology for which is about 60 years old.

“Over that period of time, it certainly has been a beneficial test and many have [credited] its helpfulness in diagnosing cancer and saving lives,” said Dr. Paul Wertlake, chief medical officer for Unilab—currently the only laboratory in California that processes the ThinPrep Pap test. Unilab has a testing facility in Sacramento.

An NCI-trained pathologist, Wertlake asserts that the traditional Pap testing procedures, however, can also miss critical identification marks of disease and, in many cases, misreads cell data, resulting in millions of inconclusive readings.

While the ThinPrep technology has been available since 1992 for non-gynecological procedures, such as analyzing urine and spinal fluid, it was not approved by the Federal Drug Administration for use in Pap testing until 1996. Since then, use of the advanced Pap test has been limited, many say, because of administrative struggles in determining reimbursement rates for doctors and HMOs. Unilab reports that, when purchased by HMOs, the advanced test costs about $23 more than the traditional one. Individual purchases, however, may run as high as $60 more, Wertlake said.

Although the test isn’t proprietary to Unilab, the company is the only one in California currently processing the test.

“I’d say that’s significant because we’re statewide and that means more women and their doctors have access to it,” Wertlake says. “But it’s not our property; any lab can buy this [technology] from Cytyc. My main concern is getting the word out that this test is available and to show people why it’s superior to the traditional Pap.”

A typical collection sample taken from a woman’s cervix during her annual exam contains about 1 million cells, Wertlake explains. With the traditional Pap smear, about one-fifth to one-fourth of those are placed on a slide, and the rest are thrown away. With the newer liquid collection method, all 1 million cells are placed in liquid preservative material, disbursing the cells uniformly throughout the process so when a sample is taken from the tube and examined, it’s from the full collection. Additionally, because the cells are better preserved, they’re much clearer in their appearance, rendering inconsequential additional matter in the sample such as red and white blood cells, bacteria and mucus.

As a result, scientists maintain, cervical cancer in its pre-cancerous form is caught at a 65 percent higher rate with ThinPrep than with traditional methods.

Since annual Pap screenings are essential to a woman’s health, Wertlake contends it only makes sense to use the newer liquid collection method, which produces more accurate results, thereby catching any problems at the early stages when treatment is less complicated and expensive.

“Women and their doctors need to know this exists,” he added.

But many women, including Stacey Jones, are just finding out about it.

Coverage uncertain
Area doctors varied in their knowledge of the advanced test when polled informally by the SN&R, and many HMO representatives were unclear not only on the procedure but also on whether the test would be covered if specifically requested as a substitute for the traditional Pap. This is no small issue in California, where 23.5 million residents, some 85 percent of the population, are covered by an HMO.

Daniel Zingale, director of the nascent state Department of Managed Health Care, told the SN&R that his department will be surveying plans statewide to determine how many do, in fact, cover the new test.

[This test] would help our fight for better preventive care and reduce patient visits, patient anxiety and overall health-care costs,” Zingale said.

Charged with regulating the 113 health maintenance organizations operating statewide, 54 of which are considered full-service HMOs, Zingale vows to require health plans to cover the ThinPrep in the future if they don’t already.

“We can require them to do that … if it’s a full-coverage health plan, then they cover cervical cancer screening, [and] that means they have to cover [this],” Zingale contends. “Given that the success of managed health care depends on a genuine commitment to preventive health, it would be a bad sign if the plans were not following that principle.”

It seems as if some clinics geared toward uninsured women are ahead of the game, however. Planned Parenthood Mar Monte, which covers the Northern California region, has already approved the test in various areas, including sites in San Jose and Sacramento, where the test will be rolled out within two months. Additionally, Medi-Cal and Medicare have also authorized coverage for the ThinPrep.

“I think that the rate of accuracy for the ThinPrep is just higher,” said Lisa Johnson, regional health services director for Planned Parenthood. Because the [interfering] material is able to be removed, you’re left with a thin layer of cells, versus multiple layers, and that lessens the margin of error.”

Planned Parenthood, which has yet to determine how much women will be charged for the improved test, performs between 800-1,000 Pap tests per month at its North Highlands clinic alone.

Jones, now 28, is incredulous when told that the advanced Pap test was available a full two years before her false diagnosis.

“I mean, it’s been available for years, and it’s just being used now? Obviously, raising women’s awareness about this is important, but I think it’s more important to ask why doctors and health [insurance] companies aren’t making this routine," Jones said. "I just don’t understand it. … If you’re going in for any other kind of test, would your first question be, ‘Is this the very best test I can get?' Why is this our responsibility?"