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Generally strong description of diabetic retinopathy drug trial — but more transparency please

Lucentis Proves Effective Against Proliferative Diabetic Retinopathy

Our Review Summary

Eye anatomyThis release describes a study published in the Journal of the American Medical Association on the use of the drug ranibizumab (brand name Lucentis) to treat proliferative diabetic retinopathy (PDR), which can damage eyesight and lead to blindness. The clinical trial at issue found that the use of ranibizumab was at least as effective on vision as laser therapy but with fewer side effects. While the release does a good job explaining a complex trial, it skimps on presenting benefit data, and does not address physician-industry ties or costs, both of which are important factors for consideration with any medical treatment.

 

Why This Matters

According to the CDC, 9.3% of the U.S. population  — 29.1 million people — have Type 2 diabetes. The number rises to 16.2% of adults between the ages of 45 and 64. Among them, PDR is an added burden affecting a great many people with diabetes. A 2010 study reported that the prevalence of vision-threatening diabetic retinopathy in diabetic adults over 40 is 4.4%. It has serious implications for quality of life and the ability to function independently. And with diabetes on the rise in the U.S., rates of PDR are unlikely to decline anytime soon. There’s a significant economic component as well. In 2004, the direct medical cost of diabetic retinopathy treatment was $493 million. Because diabetic retinopathy is the leading cause of vision impairment and blindness among working-age adults in the U.S., there is likely a significant economic burden associated with the condition’s impact on job performance in the workforce. New research findings on a condition this common — and this pricey — are important and worth paying attention to.

Criteria

Does the news release adequately discuss the costs of the intervention?

Not Satisfactory

The story doesn’t mention cost at all. Since Lucentis can cost $2,000 per injection, that’s a significant oversight. It would also be useful to tell readers how Lucentis injections compare with the cost of laser treatment.

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

Not Satisfactory

The benefits are, for the most part, reasonably well explained. But those explanations lack numbers to back them up and are overstated in at least one place.

“One benefit discussed in the release is that study participants who received laser treatment were more likely to suffer peripheral vision loss than participants who were treated solely with Lucentis — although this isn’t quantified. A second benefit was that participants who received laser treatment were more likely to require subsequent surgery to remove blood from the eye — and this was quantified. But the release pushes things a bit when it comes to vision, or visual acuity. The release states: “At two years, vision in the Lucentis group improved by an average of about half a line on an eye chart, compared with virtually no change in the laser group.” But here’s how the journal article puts it: “There was no statistically significant visual acuity difference between the ranibizumab and PRP [laser] groups at 2 years.

The language in the journal article itself stresses that what was being evaluated was whether Lucentis was at least as good as laser treatment — and they found that, after two years, the visual acuity of patients who took Lucentis (and had no laser treatment) was as good as patients who had the laser treatment. The release could have simply stated this and avoided confusion.

In short, this was a close one — but the lack of numbers on peripheral vision and the overstatement of the visual acuity results make this a “Not Satisfactory.”

Does the news release adequately explain/quantify the harms of the intervention?

Satisfactory

The release mentions that one study volunteer in the Lucentis group developed an eye infection and stated that “serious systemic adverse events,” namely cardiac arrest and stroke, occurred at similar rates among the two groups undergoing the two different procedures. We’ll rate that satisfactory for the disclosure although the release might have gone even further by mentioning the other side effects named in the study including inflammation and elevated intraocular pressure which occurred in both treatment groups.

Does the news release seem to grasp the quality of the evidence?

Satisfactory

The release does a good job of describing the study design, the number of participants, and the fact that this was a randomized clinical trial. A few words about the limitations of the study — e.g. the investigators and patients could not be masked to which treatment they were getting, would have be useful as well.

Does the news release commit disease-mongering?

Satisfactory

No disease mongering here.

Does the news release identify funding sources & disclose conflicts of interest?

Not Satisfactory

The release does tell readers that the study was funded by the National Eye Institute. However, it does not make clear that Lloyd Paul Aiello — who is quoted in the release — was also a co-author of the journal article. The release also fails to mention that several co-authors receive research funding or consulting fees from Genentech, which developed ranibizumab and markets it in the U.S., and Novartis, which markets the drug outside the U.S.

Does the news release compare the new approach with existing alternatives?

Satisfactory

The release does a good job of comparing Lucentis to conventional laser treatment for PDR and we’ll award a Satisfactory rating on that basis.

However, we’d note that these are not necessarily the only two options. Lucentis is classed as an “anti-VEGF” (anti- vascular endothelial growth factor) drug — by blocking a protein called VEGF, the drug can reverse abnormal blood vessel growth and decrease fluid in the retina. Other drugs in this category include Avastin and Eylea. Are those drugs under consideration for trials related to PDR treatment? If so, it’s worth mentioning — particularly since Avastin costs around $60 per dose, as compared to Lucentis’s $2,000 per dose.

Does the news release establish the availability of the treatment/test/product/procedure?

Satisfactory

The release notes that Lucentis is already used to treat other diabetes-related eye problems, and “should be considered a viable treatment option for people with PDR.”

Does the news release establish the true novelty of the approach?

Satisfactory

The clinical trial at issue here appears to be the first to look at the use of Lucentis as a treatment for PDR, particularly in a randomized study with direct comparison to laser treatment. However, the release doesn’t tell readers that. On the other hand, the release does make clear that this is the first significant advance in clinical treatment for PDR since the 1970s — that’s good context.

Does the news release include unjustifiable, sensational language, including in the quotes of researchers?

Satisfactory

The release does a good job of avoiding hype and explaining what was a complex study.

Total Score: 7 of 10 Satisfactory

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