I’m a big fan of Minnesota Public Radio and usually a big fan of their health care news coverage. They’ve done some bold and innovative coverage in recent years. But when I heard (on the radio) and saw (online) MPR’s story, “Prostate cancer scan advance helps Mayo doctors with early detection,” I saw and heard some red flags immediately.
What initially jumped out at me were some of the often-seen claims of exclusivity, which, in this case are legitimate (although with some asterisks):
We don’t systematically review MPR health news stories. That is, we don’t check them regularly and apply our 10 criteria to the review of their stories. But if we had in this case, this story would have been graded unsatisfactory for failing to discuss costs, failing to report any independent perspective, failing to provide any meaningful data about benefits/harms/outcomes, failing to adequately compare with any existing alternatives or anything else in the research pipeline. It would have taken little time to address these concerns. MPR has lots of time, unfettered by the commercial interruptions of commercial broadcasting operations, right? Choices are made about how to use that time.
Disclosure: I was the founding editor-in-chief of MayoClinic.com in 2000. I don’t know these Mayo physicians.
Because I live in Minnesota, and because I might be seen as being too close to local health care news coverage, I asked Harold DeMonaco. who lives in Massachusetts, and who is our most active expert story reviewer and guest blogger, to analyze the story. Here are his comments:
Having reviewed hundreds of news stories about medicine, new medical devices, drugs and diagnostic tests for HealthNewsReview.org, I have seen many that only look at half the story. This story on Minnesota Public Radio about a prostate cancer scan advance at the Mayo Clinic looks like one of those. But, let me be clear, the following critique is on the reporting and not on the technology.
Prostate cancer presents a bit of a conundrum at the moment. We know that many men who have it will live a long life without ever knowing they have the disease. With the unbridled enthusiasm of routine PSA screening in men, there are now many more men diagnosed with the disease than in the pre-PSA era. While many would rightly argue that knowing allows for better surveillance, it also introduces anxiety and a sudden switch for healthy to unhealthy.
Depending on the level of concern, men with a diagnosis undergo routine surveillance. The intensity of the surveillance depends a bit on the presumed risk. The PSA test, originally developed specifically for this purpose, is routinely used. We know that the test is imperfect with both false positive and negative results. As the story points out, what the next step should be after an elevation of the PSA levels is unclear. And a way of identifying additional disease that is reliable is clearly desirable.
Enter the Mayo Clinic and the newly approved Choline C11 PET scan imaging test. The test takes advantage of the need for choline by cells. Breast cancer and prostate cancer cells apparently need a good deal of choline and can therefore be differentiated using a carbon-11 or fluorine-18 radioactive tag. Very clever indeed. By the way, others are working on a Choline F 18 test (something never mentioned in this Mayo-only story.)
The Food and Drug Administration approved the use of Choline C 11 as a biomarker to be used with PET scanning in September 2012. Apparently, the test is only available at the Mayo Clinic and “As a result, patients from around North America have flooded the clinic with requests to use the scan because it’s much more sensitive than other available techniques.”
Hopefully, the folks at Mayo provide a bit more disclosure than is provided in the story. The FDA News Release provides some detail that MPR didn’t know about or chose to leave out. Just how good is the test? Here’s what the FDA said:
“The safety and effectiveness of Choline C 11 Injection were verified by a systematic review of published study reports. Four independent studies examined a total of 98 patients with elevated blood PSA levels but no sign of recurrent prostate cancer on conventional imaging. After PET imaging with Choline C 11, the patients underwent tissue sampling of the abnormalities detected on the PET scans.
In each of the four studies, at least half the patients who had abnormalities detected on PET scans also had recurrent prostate cancer confirmed by tissue sampling of the abnormal areas. PET scan errors also were reported. Depending on the study, falsely positive PET scans were observed in 15 percent to 47 percent of the patients. These findings underscore the need for confirmatory tissue sampling of abnormalities detected with Choline C 11 Injection PET scans.”
The test was approved after being studied in just 98 men with prostate cancer and had a false positive rate of 15 to 47% so a tissue biopsy is necessary to confirm the presence of prostate cancer. 15-47% of men means many men undergoing biopsies unnecessarily due to a false positive test. And along with those biopsies come risk. Would it not have been useful to the reader to have this information before trying to schedule the test and the Mayo Clinic?
The folks from the Mayo Clinic presented three studies at the last annual meeting of the American Urologic Association. One of the abstracts notes an 11% false negative rate with the test.
So significant false positive and false negative rates were reported by the investigators.
I am constantly reminded that the patient perspective is important and the decision to undergo testing or any medical intervention is really up to the patient. As an advocate for informed decision making, I believe that all relevant information should be available consistent with the patient’s health literacy. I am not suggesting that patients should not have the test performed if recommended. I am suggesting that the reliability of the test and the likely next steps need to be thoroughly vetted. That is not the job of journalist but rather of clinicians. However, don’t journalists have an obligation to provide a balanced perspective on a story about a new technology?
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