We never quite understand the urgency of jumping the gun on reporting on talks not yet presented at a scientific conference – especially when it’s about a device not yet approved by the FDA and when independent perspectives are so crucial. Yes, this story had one independent perspective, but it may have done much better with more informed perspectives if it at least waited until the talk was presented at the conference.
Many women diagnosed with breast cancer are candidates for a lumpectomy, which removes the cancerous tumor and cancerous tissue surrounding the tumor. If the pathology report indicates that the margins were not clear of cancer, the patient returns for a second surgery during which additional tissue is removed. Repeat surgeries are needed by 30% – 60% of patients who have a lumpectomy. Helping doctors know during the initial surgery if they have clear margins could lower the rate of repeat surgeries and could save the patient further distress and cost and save the healthcare system increased costs of a second surgery. Emphasis on “could.”
While the cost of the device in the United States is not known, the story quotes a spokesperson from the manufacturer who points out that the device sells in Europe for 600 euros, or $760. A new device is needed for each surgery.
The piece notes that patients were followed for two months after their lumpectomy. And the story did an adequate job in describing benefits, clearly presenting the proportion of patients in each group who required a second surgery.
The story simply – but inadequately – stated that “researchers said not much more tissue was removed when the device was used compared to tissue removed in the initial and subsequent surgeries among the control group patients.”
It would be useful to have a more quantitative sense of how much more tissue was removed using the MarginProbe device. What does “not much more” mean? Would it mean the same thing to all women? That would help the reader balance the benefit of avoiding a second surgery against the risk of removing more breast tissue when the device is used, which could negatively affect the appearance of the breast after surgery.
There were issues surrounding the quality of the evidence – and the methods/approach – that we think would have better informed readers.
The piece could have noted that patients were randomized in the operating room, that the pathologists were not aware of which arm of the study the patients were in, and that the study was conducted in 21 centers throughout the world.
Another unanswered question is whether the surgeons who made the decision about re-operation were aware of the MarginProbe results in addition to the pathology report. If so, that knowledge could bias their decision to re-operate, resulting in fewer operations in the MarginProbe group.
There is no disease mongering in the piece.
While the story does quote a respected independent source about the need for additional studies, the story should have also indicated that the study was funded by Dune Medical Devices, the manufacturer of the MarginProbe device.
Several times in the story, readers are told about the current method of surgery, which is the alternative to using the MarginProbe. The story clearly informs readers that the new device may reduce the need for repeat surgeries, which are typically needed by 40% of women having a lumpectomy. Patients usually have to wait days, if not a week or more, to find out the pathology report on their tissue. With the new device, surgeons in the operating room have results in about five minutes. Importantly, the story also notes that the tissue is examined by a pathologist after the surgery and that repeat surgeries are sometimes still needed even with use of the device.
Many women who have a lumpectomy are concerned about the cosmetic results of the surgery. The story notes that the lead researcher for the study, Dr. Susan Boolbol, chief of breast surgery at Beth Israel Medical Center in New York City, reported that the volume of tissue excised during the initial surgery using the device was only slightly more than the volume of tissue removed during an initial and repeat surgery or surgeries in the control group.
Readers are told that an FDA advisory panel recommended that the FDA approve the device, which has been used for several years in Europe.
The device is described as new in both the first paragraph and the headline but readers are not told if other devices or methods are currently being used or tested to reduce the need for repeat surgeries for patients having a lumpectomy for breast cancer.
No evidence that the story relied on a news release.