The Prostate Health Index is an FDA-approved diagnostic test designed to help patients avoid undergoing unnecessary biopsies. But the journal Prostate Cancer and Prostatic Diseases has made waves in the cancer research community after it published a letter to the editor about the omission of crucial data. The letter has drawn the ire of urologists and concern from biomedical executives, Stat News reports.
In 2018, two scientists at Memorial Sloan Kettering Cancer Center wrote a letter to the editor of the prestigious journal noting that a study it published in November 2017 about the Prostate Health Index had left out data showing how many aggressive cancers might have been missed. The letter asked the study authors to publish those numbers. The two study authors who responded to the letter outright refused.
A few months later, a biostatistician who had helped develop a competing product asked the test’s manufacturer, Beckman Coulter, which funded the study, to release the missing data. Beckman Coulter also refused and advised the researcher to talk to the company’s lawyers.
So why is this such a big deal? According to more than 10 experts unaffiliated with either side of the controversy, including oncologists, epidemiologists, biostatisticians, and bioethicists, the company’s refusal to publish pertinent study information was scientifically and morally questionable. Furthermore, some say this is just another example of science being spun for the benefit of companies marketing clinical tests.
In fact, in 2013, a review of over 100 diagnostic accuracy studies found that nearly a third misrepresented their findings, often making techniques seem more beneficial than was accurate. In the case of the Prostate Health Index, which was approved by the Food and Drug Administration in 2012, researchers at Memorial Sloan Kettering noted that the study did not disclose how many patients had been found to have more aggressive cancers and therefore should have received biopsies. Sloan Kettering’s researchers calculated that the data that had been omitted revealed that one potentially dangerous cancer went undetected for every three biopsies not done after the test.
In a published reply on the failure to report the data, two of the study’s authors, Ronald Tutrone, MD of Chesapeake Urology Associates, and Jay White, MD then of Carolina Urology Partners, said the missing data were collected but that the study was “not powered” to address that question. They also added some sparring words to the Memorial Sloan Kettering scientists who called them out, calling them “a bunch of statistician wonks [who] took a bunch of numbers out of context.”
However, a lot of cancer experts remain unconvinced. “Unless the authors can offer a principled reason for refusing to provide this information, it’s not up to them to declare by fiat that these data are irrelevant,” said Jonathan Kimmelman, PhD, a bioethicist at McGill University in Montreal and vocal critic of the study.
To learn more about the controversy, and the ins-and-outs of the Prostate Health Index test, click here.