FDA Approves New Device for Brain Tumor Treatment

Does the story adequately discuss the costs of the intervention?

Not Satisfactory

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?

Does the story adequately quantify the benefits of the treatment/test/product/procedure?

Not Satisfactory

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.

Does the story adequately explain/quantify the harms of the intervention?

Not Satisfactory

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.

Does the story seem to grasp the quality of the evidence?

Not Satisfactory

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:

• “Failing to meet its primary endpoint of improved overall survival, the company attempted to show the device was not inferior to chemotherapy, but the FDA and the advisory committee members rejected the company’s follow-up studies because there was no agreed-upon pretrial plan to test for noninferiority. The lackluster data caused the panel — which was dominated by neurosurgeons and radiologists — to be lukewarm about the efficacy of the device. Initially, the panel split evenly on the questions of efficacy, but the chair added his vote, which made it 7-6, advantage NovoTTF. Panel members were more enthusiastic about the device’s safety.”

Does the story use independent sources and identify conflicts of interest?

Not Satisfactory

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.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The news-release-driven info dances around the edges of what we want to hear, but never really delivers.

Excerpts:

• the tumor is highly resistant to standard treatments, such as surgery, radiation, and chemotherapy

• The FDA says the device should be used only after other treatments have failed.

• Novocure chief medical officer Eilon Kirson, MD, PhD, says in a company news release that the device allows for continuous treatment without the “debilitating side effects that chemotherapies inflict on recurrent [glioblastoma multiforme] patients and indirectly on their families.”

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?

Does the story establish the true novelty of the approach?

Not Satisfactory

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.

Does the story appear to rely solely or largely on a news release?

Not Satisfactory

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.