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Looming ruling on breast cancer drug splits patient advocates


4 Star

Looming ruling on breast cancer drug splits patient advocates

Our Review Summary

In December, an FDA advisory panel will decide if it should revoke the approval of the drug Avastin for treating metastatic breast cancer based on the results of two major trials suggesting that the serious side effects outweigh the time that patients live without the disease getting worse. This story met many of our criteria, but failed to provide important details about the trials, including the patient population and how many women developed serious side effects in each treatment group. While the story included various viewpoints on whether this drug should continue to be used as a first-line therapy for metastatic breast cancer, it focused largely on the drug’s success in just one patient. This personal story is misleading to readers.


Why This Matters

Two major trials found that Avastin is not particularly effective for treating metastatic breast cancer and it causes serious side effects. The story missed this main issue by devoting an extraordinary amount of space to just one woman’s success story.  Metastatic disease is very difficult and one treatment is not likely to work for everyone; however, it is not compelling to argue that the FDA should approve every drug because not all patients will respond to the same treatment regimen. It would have been more insightful if the story suggested that the median is not the message and that if this or other drugs work for a subset of women, then researchers should find markers to help predict which patients will benefit from which therapy.

This is another example in which an honest application of our criteria may render a score out of whack with our general impression.  We urge journalists and consumers not to fixate on "the star score" but to read our full reviews.


Does the story adequately discuss the costs of the intervention?

In addition to noting that the cost of Avastin is more than $8000 a month, the story discussed how FDA approval affects insurance coverage. 

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

As the story points out, compared to women who received placebo, those in the RIBBON-1 study who received Avastin increased their progression free survival by less than 3 months. In the AVADO trial, Avastin only improved progression free survival by 24 days. Readers may have found it useful to know the total progression free survival time for each treatment.

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

Not Satisfactory

The story mentions that Avastin is associated with serious side effects, such as high blood pressure and internal bleeding; however, it did not provide data on how many women in each treatment arm experienced these side effects.

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

Not Satisfactory

The story briefly mentioned the two trials, RIBBON-1 and AVADO, on which the FDA will base their decision whether to revoke approval of the Avastin. The story could have mentioned that both were double-blind, randomized, placebo-controlled trials and enrolled women with HER-2 neu negative tumors. It also would have been helpful if the reader knew that the women in the trials received another chemotherapy agent in combination with Avastin or a placebo.

But a bigger issue is that the first trial, which won this drug preliminary FDA approval, had a huge impact on survival compared to much more modest results in these subsequent trials. This begs the question of why there is such a discrepancy. We think the story should have pointed this out.



Does the story commit disease-mongering?

The story did not exaggerative the prevalence or seriousness of metastatic breast cancer; however, the piece included inflammatory statements that are unsubstantiated and exaggerated, (e.g."If the [Avastin] label is not upheld, it sets a new standard. We’re not going to see another first-line drug for another 10 years, at least").

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


The story includes interviews with individuals who are for and against revoking Avastin’s approval, providing some counterbalance; however, the focus on the personal success story of one patient tips this balance.  Because of the strong comments by people like Fran Visco and some of the physicians quoted, we’ll give this story a satisfactory score on this criterion.

However, if you’re going to play the personal anecdote game, we think you have an obligation to balance the glowing positive story with the more representative story of people who didn’t benefit. The plural of anecdote is not data.

Also, from a balance perspective, why wasn’t the statement of Senator David Vitter – who has politicized breast cancer a number of times without showing a concern for evidence – balanced by a statement from a politician who is more evidence-based?  Again, if you’re going to play the politics game, how about leveling the playing field a bit?

Does the story compare the new approach with existing alternatives?

Not Satisfactory

The story briefly discusses radiation and other chemotherapy treatments for metastatic breast cancer; however, there are many other treatments that could have been mentioned.  It would take just a few more words. 

Does the story establish the availability of the treatment/test/product/procedure?


It’s clear from the story that Avastin received preliminary approval for treating metastatic breast cancer in 2008 and formal FDA approval is currently pending.

Does the story establish the true novelty of the approach?


The story makes it clear that the FDA gave this drug preliminary approval in 2008 for the treatment of metastatic breast cancer.

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


This piece does not rely on a press release.

Total Score: 7 of 10 Satisfactory


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