The story relies soley on two press releases and as a result falls short on providing important details about the device and of the trial. The company presentation to the FDA is readily available (http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/NeurologicalDevicesPanel/UCM247168.pdf ) and could have been used to provide readers with more context as well as quantitation of benefits and harms with the device.
Given that this is a relatively common type of brain cancer and that it can be resistant to other treatments, readers deserve more information than that provided in news releases to be able to judge the potential of this new device and how it compares with other approaches.
NO discussion of costs – even though the story allowed a company spokesman (from a news release) promote the potential for the device. Why not ask that company directly for the cost?
No quantification of benefits – only this: “The FDA says the study showed comparable overall survival rates in patients in both groups.”
Does that mean a week? A month? A year? Longer?
Answer – not in the story: Both treatment groups had a median survival of about 6 months.
The story stated: “The agency says patients treated with the new system experienced a slightly higher incidence of neurological side effects, including convulsions and headaches, than patients receiving chemotherapy.”
What does slightly higher incidence actually mean?
What is the baseline incidence – in actual numbers?
And how much higher was the incidence with the new system?
Give the numbers and let readers/consumers decide what’s “slightly higher” and what that might mean in their own lives.
There was no scrutiny of the evidence – not surprising given the story’s reliance on company and FDA news releases.
By comparison, look at how MedPageToday reported the back story when it reported last month on an FDA advisory’s committee’s struggle with the issues:
The story appropriately frames the target population: “is meant for adults with glioblastoma multiforme that recurs or progresses after chemotherapy and radiation treatment. Glioblastoma multiforme is a common type of brain cancer, and the tumor is highly resistant to standard treatments, such as surgery, radiation, and chemotherapy, the FDA says in a statement.”
As already stated, no independent source was quoted about the evidence, about the benefits or harms. Even the news-release-lifted quote from the FDA official said only that the approval shows FDA’s “commitment to innovative new devices that provide patients with other treatment options.” That’s more of a self-promotional statement about FDA than it is a helpful comment about the role of this particular device.
This is indeed unfortunate given the availabilty of the information about the pivotal study in toto from the FDA website. But the online story didn’t even link to that information.
The news-release-driven info dances around the edges of what we want to hear, but never really delivers.
But we’re not given any meaningful, substantive, data-backed comparison. It wouldn’t take much space to do so. How often do other treatments fail? How often do debilitating side effects occur from surgery, radiation, chemotherapy?
The purpose of the story was to announce FDA approval of the new device, so it’s clear that it’s not widely available yet.
We’re only told that this is a new device, newly approved by the FDA. But its unique place in the treatment of this brain tumor type is not clearly defined. In reality, the use of weak electrical fields to interrupt cancer cell growth has been known for some time. But we’re not given any of that context.
The story admits it drew its information from a company news release and an FDA news release.
Was it that urgent that this be published before a live person could actually be interviewed?
And if we accept the FDA as the primary source, then the only source was the company spokesman, who is not an independent voice on this product and its potential.