The study presents important evidence that could help many babies in the future and will likely lead to future studies. The article got the gist, yet there were some lapses in its presentations of the benefits, harms, and comparator treatments. We think these gaps combine to tilt the story into Avastin promotion, and addressing them would have centered the keel.
It gets credit for discussing the costs of Avastin.
In this review, we’ll keep coming back to the lack of context for the comparison to Lucentis. This article doesn’t discuss the use of Lucentis in this condition. Is it a real, off-label alternative or a hypothetical one? Since the study compared Avastin and a laser, the latter’s price tag would’ve been more relevant instead.
Consider this rating a partial credit. We were happy to see some results in absolute terms and the important subgroup result for babies with type 1 disease. But the article gets enough dings to withhold a satisfactory grade.
First are the qualitative summaries. “An injection of Avastin stopped blood-vessel growth.” That’s a bit vague for such a zinger. For one thing, one of Avastin’s apparent advantages was that it doesn’t stop vessel growth in the peripheral retina. For another, does this sentence mean Avastin cured all babies? (Retinopathy came back in 4 of 70.) Or does it mean Avastin universally stopped vessel growth at the outset? (The main endpoint of the study was recurrence of disease. Maybe the laser also stops vessel growth at first.)
And we think the story could set a neater table before comparing the benefits of Avastin and the laser therapy. It names 3 downsides of laser therapy, but efficacy (50% recurrence in zone I disease) wasn’t one. Since the study was designed to compare recurrence rates, we assume this downside of the laser is prominent. Another downside of the laser was given: some babies need several treatments. But, in comparison, we’re told that “in many cases” Avastin only needed one treatment. “Some do” means the same thing as “many don’t,” so a cleaner comparison would’ve been nicer.
Here’s a final aside, not of the same magnitude as the prior comments. In an ideal world, the article could’ve addressed the different types of retinopathy of prematurity. Indeed Avastin was superior in the overall cohort, especially in Zone I disease, and the article accurately quotes the editorial as suggesting Avastin should become the treatment of choice in Zone I. But absent is the fact that this study showed no significant benefit in Zone II disease, the larger group of enrolled babies. There was a trend towards benefit, but it wasn’t statistically significant. The message from the editorial is that Avastin is possibly superior in Zone II, but we’ll need more studies. This thread would’ve added some nice balance to the story’s conclusion that Avastin “far surpassed” laser therapy in treating this disease, and would allow them to be more specific about the 15 hospitals that stopped using the laser (for whom? all zones?).
Room for improvement. We give the article credit for noting that Avastin has limited safety information in this setting and that the investigator has noted no significant side effects in this cohort. It also gives some theoretical reasons to be optimistic. But what’s missing from the story is the key line from the study: it “was too small to assess safety.” You know the saying about absence of evidence and evidence of absence?
As noted, as readers we are unclear why Avastin is sparring with Lucentis. The article elevates Avastin because it “can’t easily travel outside the eye,” while Lucentis has a theoretical concern of systemic effects. That paragraph gave us several itches:
The article states that the 7 deaths in the study were unrelated to either treatment. We don’t see that conclusion in the publication or editorial. Perhaps it was based on an interview with the lead researcher? If so we’re unable to verify, since we can’t interpret the raw mortality information on the 7 cases in the study report ourselves. With that caveat in mind, we note that, to us, the study report seems to suggest that their study was too small to determine whether Avastin is associated with more deaths than is laser therapy. Since there were more deaths in the Avastin group (5 vs 2), we would’ve liked more clarity around this topic.
The story provides lots of good details on the study design, including the publication status, size, randomization, multicenter nature, comparator, number lost to follow-up, and a qualitative description of the follow-up period.
See the “Harms” criterion for a critically important limitation of the study size. A bit more specificity on follow-up wouldn’t have hurt.
A quibble: The article says that the study enrolled “About 150” babies, but then it discussed them in groups of 143 and 7. Isn’t that exactly 150?
There’s no real mongering here.
As a side note, the article cites statistics regarding the disease in general. Since the study only enrolled a subset of babies with this disease, it would be interesting to know how representative its sample was.
The independent source was the NEJM editorial. We prefer to see more outside analysis of a study, but the editorial is an important source.
General conflicts of interest are identified. (Although the sources made some additional disclosures to the NEJM, none were overwhelming.)
The study itself compared Avastin to standard therapy, and the story reports enough of the comparison to earn a score. However, we see a few ways the comparisons in this story could’ve been sharper. (See our comments under the “Benefits” criterion for a related critique.)
We’ve logged confusion about pitting Avastin to Lucentis. There may be a good reason, but we don’t think WSJ readers get it. The only use of Lucentis discussed is in grown-up eyes. Is it compared to Avastin just because they’re “similar” drugs and because Lucentis has at least some eye indication? Or is Lucentis actually used off-label, or such use has been proposed, in this disease? Without that missing piece of the narrative, it’s kind of difficult to weigh the meaning of Avastin’s cost and pharmacologic advantages over Lucentis.
It may be hard to find perfectly balanced patient testimonials for a story like this, but it’s worth pointing out that the Henry family’s experiences may not be the most level illustration of this study’s results. Evelyn had a great outcome from Avastin. Her sister Grace had the laser and a very regrettable outcome, losing an eye from glaucoma. For one thing, it’s only implied that the culprit was the treatment, not her disease, which, we’re told is associated with retinal detachment as opposed to glaucoma — but the article could’ve been clearer about causality here. More importantly, the relative side effects of these two procedures were never discussed in the scientific portion of the article, and we don’t see any discussion of the potential for very serious side effects from the laser. If it is such a distinguishing factor as to color the entire testimonial section, we would’ve liked to hear about it in the discussion of pros, cons, and research.
It’s clear that we’re talking about an off-label use of an available drug.
The novelty in the approach is well described. We’re told how the drug works and some differences with the laser therapy, for instance, related to the type of anesthesia.
We didn’t find signs that the article relied on a news release.
Systematic, Criteria-Driven
A lot of interesting workshops are happening now at the #NBCCSummit! @garyschwitzer, the publisher of @HealthNewsRevu, is discussing new cancer research news. #BeBold
Comments
Please note, comments are no longer published through this website. All previously made comments are still archived and available for viewing through select posts.
Our Comments Policy
But before leaving a comment, please review these notes about our policy.
You are responsible for any comments you leave on this site.
This site is primarily a forum for discussion about the quality (or lack thereof) in journalism or other media messages (advertising, marketing, public relations, medical journals, etc.) It is not intended to be a forum for definitive discussions about medicine or science.
We will delete comments that include personal attacks, unfounded allegations, unverified claims, product pitches, profanity or any from anyone who does not list a full name and a functioning email address. We will also end any thread of repetitive comments. We don”t give medical advice so we won”t respond to questions asking for it.
We don”t have sufficient staffing to contact each commenter who left such a message. If you have a question about why your comment was edited or removed, you can email us at feedback@healthnewsreview.org.
There has been a recent burst of attention to troubles with many comments left on science and science news/communication websites. Read “Online science comments: trolls, trash and treasure.”
The authors of the Retraction Watch comments policy urge commenters:
We”re also concerned about anonymous comments. We ask that all commenters leave their full name and provide an actual email address in case we feel we need to contact them. We may delete any comment left by someone who does not leave their name and a legitimate email address.
And, as noted, product pitches of any sort – pushing treatments, tests, products, procedures, physicians, medical centers, books, websites – are likely to be deleted. We don”t accept advertising on this site and are not going to give it away free.
The ability to leave comments expires after a certain period of time. So you may find that you’re unable to leave a comment on an article that is more than a few months old.
You might also like