FDA rejects Avastin as breast cancer therapy

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

Not Satisfactory

The article meets the standard here by presenting data for progression-free survival and explaining that none of the trials showed a survival benefit for Avastin compared to standard chemo. (The quantity 0 seems implied.) While it’s notoriously difficult to explain the ins and outs of cancer studies in such a short space, we nonethless criticize the article on this criterion because, although most of the messages were generally accurate, readers could’ve benefited from more clarity on one of them and a little help overall in squaring up some potentially contradictory messages. We’ll explain in 3 acts.

Act I: Story Highlights. One of these summary bullets states that “Subsequent studies showed no greater survival benefit.” In isolation this statement may be misleading. It seems they mean it to refer to progression-free survival. But that doesn’t jibe with the practical meaning of the term “survival benefit” as actually used in the body of this article: overall survival. And in fact, as we learn, all 4 studies showed no survival benefit compared to standard chemo.

Act II: Dr. Sparano’s zinger. In his opposition to the FDA decision, the source notes that one-year survival for Avastin was consistently better in all studies. How is a reader to reconcile that message with the message that survival was not better for Avastin in ANY study? What was needed was not just quantification but qualification. Perhaps it would’ve been as simple as giving us the timeframe for Dr. Woodcock’s conclusion that there was no survival benefit in all studies, or more context about Dr. Sparano’s point. Without some explanation somewhere, we think Dr. Sparano’s line should not have been quoted, since it’s essentially out of context and it somewhat throws the messages up in the air for a reader, perhaps with consequences on the balance of the story.

Act III: Mixed messages? The story gives us 2 messages that, taken together, may also seem contradictory for lay readers:

1. Later trials showed that Avastin offers a small increase in progression-free survival compared to standard chemo — but still an increase.
2. The 4 studies together shown no survival benefit.

How is a non-clinician to make sense of these messages? How can it slow tumor growth — and lengthen the time people lived without progression — but not lengthen the time people lived? These head-butting messages might’ve been reconciled by clarifying, as the FDA press release starts to, how these data show that Avastin’s effects on tumor growth were temporary enough that people taking Avastin didn’t live any longer, on average.

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

Not Satisfactory

Harms are not quantified, and it would’ve been very helpful to know how frequently these serious side effects occurred in the trials. Were they exceptionally rare? Utterly rampant? The point of our criterion is that without quantifying the harms, readers can’t evaluate the risk/benefit trade-off for themselves.

That said, we could almost award the story credit on the spirit of this criterion because it gives the serious harms, and their implications in the FDA decision, a solid amount of time in this article. The point from the ACS medical officer that some women “have not only not benefited, they’ve been harmed,” conveys the big picture.

However, true to the definition of this criterion, we must grade this as unsatisfactory.

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

Not Satisfactory

There was some room for improvement here. Two independent sources were used: an interview with a cancer doctor and a statement on the ACS website.  The story neglected to point out that the former, Joseph Sparano, has served as a consultant and speaker on Avastin for Genentech, as WebMD acknowledged when they interviewed him for their story.

See “Quantifying Benefits” for our request for more information about Dr. Sparano’s quote regarding 1-year survival.

On a side note, it may have balanced Dr. Sparano’s quote had the story included a little more of the ACS statement that spoke directly to the FDA decision, such as their conclusion that until we have a better way to determine who will derive the most benefit from Avastin, “giving all women with metastatic breast cancer [bevacizumab] may harm more women than it helps.”