Women's Health

Controversy Surrounds PapSeek, a New Diagnostic Test

Controversy Surrounds PapSeek, a New Diagnostic Test

What is PapSeek?

PapSeek is a 3-part test designed to identify certain reproductive cancers that aren’t usually caught until they’ve advanced. The test itself is groundbreaking in terms of cancer research and early prevention, but there has been a lot of controversy surrounding the test for a number of reasons. When scientists and researchers are conducting medical studies, conflicts of interest and bias are supposed to eliminated to avoid inaccurate results and testing. When these issues aren’t eliminated, the medical study can be discredited due to faulty results, which is one of the cases in the PapSeek controversy that caused so much uproar.

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The test is designed to test for cervical, ovarian, and endometrial cancers using three different tests: Pap smear, Inner uterus smear, and blood tests. The test was initially thought of as groundbreaking because, to date, there are no accurate tests that help diagnose ovarian or endometrial cancers before they have spread beyond the reproductive system. Any test that offers patients and doctors the potential ability to diagnose any of these three cancers early is going to be widely used, which is where the controversy comes in. According to the Health News Review, “The story falters in very important ways. There’s no mention that 27% of the study’s authors could benefit financially from the administration and sale of PapSeek tests, doesn’t appear to incorporate independent experts’ perspectives on the study and its significance, and skips over any discussion of costs or potential harms.”

What they did right

Before discussing the things that could be considered controversial, let's first talk about the many things they did correctly. The benefits of the test were clearly outlined and reiterated to physicians within the field. The release of the study talked about how effective the test is for identifying cancer cells early. The PapSeek test is, per the study, 63% effective in identifying cancer cells as opposed to the 33% effectiveness of the recommended Pap smear. The study also boasts how the endometrial identification percentage went up from 81% to 93%, quite a jump for any test. This test gives doctors the chance to help them accurately identify endometrial cancers early on, a test that hasn’t previously been available.
The study didn’t commit any “disease mongering,” which is frowned upon in medical studies. It clearly outlined the lethality of cervical cancer, endometrial cancer, and ovarian cancer, as well as the current survival rates for the three cancers. The study does an accurate job at comparing the current preventive test, the pap smear, with the new test, PapSeek. It outlines the current benefits of both studies and how PapSeek could benefit the patient by gathering more cells and testing. The study does not discredit the effectiveness of the current pap smear test, it praises how that test is incorporated into theirs to provide an even higher effective identification rate.
The study describes the current backend testing done using the pap smear, and where that test lacks in its ability. The study talks about where their test picks up the slack and uses a different type of testing known as “liquid biopsy,” that they believe to be the future of all cancer detection in the future. The study also includes all original content. Nothing within the study was copied from other medical news journals or sites, meaning the content was created originally and is unique to the study.

What they did wrong

Now for the bad. Although some studies may contain features that readers might determine as discrediting, PapSeek might have more than most. A big factor in helping patients determine whether or not the test is for them is the cost. Pap smear tests are generally free of charge for individuals with insurance because it is considered a “preventive screening” measure. Because the PapSeek test is so new, many insurance companies aren’t yet covering it, leading to high costs for the patients. Many patients will opt out of the test if it isn’t considered “necessary” and if their insurance doesn’t cover it.

The study also didn’t go in depth on the high prevalence of false positives that the test issues. For patients undergoing routine testing, they may be falsely diagnosed with cancer when in reality, it was only a false positive. This would result in lawsuits to the doctors office and is a huge liability to doctors offering the test to patients.

The study didn’t stress the small test groups that were used. Instead, the study talked about the high rates of success in finding cancer in the preliminary stages, but didn’t talk about about the groups were under 300 people, a tiny portion of the population. Another discrediting factor is that the test was only administered to patients who were already confirmed to have cancer. The test did not provide “true” detection; it only solidified the diagnosis already in place by previous testing done prior to the test.

According to Health News Review, one of the biggest shortcomings of the entire study was the lack of independent resources. The sources used were directly involved in the study, and everyone that was interviewed had some sort of financial gain from the study. Almost half of the authors received monetary rewards from the use of the study through patents, equity, and royalties. Studies often have financial incentive to researchers, but when the incentive is much higher than normal, not mentioning it can discredit the study and be off putting to other journalists.

Another controversy is the lack of information on where women can receive the test. Because of the relatively new nature of the study, information on where to obtain the test would be helpful and relevant to readers. There is also little information on how the test is going to impact the declining necessity of pap smear testing. Pap smears are recommended every year for women who come back clear, so if this test becomes a staple in preventive screening for reproductive cancers, there is no discussion into how often the test will be required and how it’s going to take the place of current pap smears - critical information for newcoming studies.

Overall impression

The overall impression other researchers and journalists had on the study was unfavorable after its release. Researchers stated there was too many negative indicators to ignore and too much was left undiscussed. Ambiguity in studies is not something that is looked upon lightly, especially in relation to such a sensitive topic. In fact, Health News Review gave the study a 5 out of 10 on satisfactory score. When the story was released in the LA times, there was a lot of information that was not discussed or simply glazed over, information that was critical to the studies credibility.

In the future, we can hope more information about the study and the potential new test will be released, along with the information that the LA times story and professional study lacked in disclosing.

If the study is true in it’s ability, this could be a revolutionary test that could single handedly cut down the mortality rate on patients with endometrial cancer, ovarian cancer, and cervical cancer. It’s an exciting time for cancer research and studies like this, although missing information, gives hope to future cancer patients and current patients undergoing cancer treatment.

Reference

https://www.healthnewsreview.org/review/significant-conflicts-of-interest-not-disclosed-in-la-times-story-on-modified-pap-tests/