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2 Treatments for Retinas Make Gains

Rating

3 Star

Categories

2 Treatments for Retinas Make Gains

Our Review Summary

This was a story that deals primarily with an experimental new drug called VEGF Trap Eye that treats age-related macular degeneration (AMD), the leading cause of blindness in older adults. (The story also diverges briefly into discussion of a second drug based on embryonic human stem cell research, but this is not the main focus of the story and will not be an emphasis in our review.) Since the study’s findings about the new drug appear to have come directly from Regeneron, the manufacturer, without any external scrutiny, we feel it was incumbent upon the story to provide some independent expert analysis of the results — something which it failed to do. The story also wasn’t detailed enough in its description of which specific patients might benefit from the drug, what harms they might experience, and what other treatment options may be available to them.

 

Why This Matters

The “wet” form of macular degeneration and Stargardt’s retinopathy — the two eye diseases discussed in this story — are serious causes of vision loss with few if any effective treatments.

Criteria

Does the story adequately discuss the costs of the intervention?

Satisfactory

The story does mention the cost per dose of two competing drugs, Lucentis and Avastin (which are actually two different formulations of the same drug that are made by the same company, Genentech). Lucentis is the version of the drug meant for the eye, whereas Avastin is approved and sold as a cancer treatment. However, doctors can use Avastin off-label in the eye with much smaller doses than cancer patients need. The result is that the cost per dose is vastly lower for Avastin than it is for Lucentis. A head-to-head trial of Avastin and Lucentis is now underway that will probably have important implications for pricing and prescribing of these drugs. (If Avastin works just as well as Lucentis, more doctors will presumably switch to it at much lower cost to patients.) Moreover, allegations have surfaced recently that Genentech is providing questionable financial inducements for doctors to use the more costly Lucentis instead of Avastin. Given the significance of these developments for anyone who needs or may need treatment for AMD, we feel the story could have and probably should have gone into a bit more detail about why these two drugs have such wildly different costs.

We also think that if the story is interviewing a company about its plans to seek marketing approval in just a few months, they certainly could get some kind of pricing estimate from them. Nevertheless, by at least mentioning costs, the story accomplishes more than most other health articles that we review and does enough to satisfy the minimum for this criterion. We’ll award a satisfactory.

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

Satisfactory

A pretty good job here. The story notes that the major benefit of the new drug over existing treatments would be the potential for less frequent dosing and follow-up visits. It also quantifies the benefit in terms of the numbers of letters and lines that were legible on any eye chart — a metric that should have “real-world” significance for most readers.

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

Not Satisfactory

The story cites a company assurance that the new drug is “equally safe” compared with its FDA-approved competitor. To which we respond: How safe is that?  Injecting substances into the eye is associated with rare but potentially serious risks such as infections of the interior eye. There’s also some evidence that Lucentis is associated with increased risk of stroke. Does the new drug carry the same risks? The story should have provided more details.   With over 2000 patients in the trials the company could have reported on the minor and major complications that were observed in the 2 trials.

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

Not Satisfactory

Two major problems here:

  • The story never specifies that the trials included only patients with so-called “wet” AMD and that the drug is effective only for this form of AMD. Since about 85% of AMD patients have the “dry” form of the disease, this omission may create confusion among some readers.
  • The story never cautions readers that the results were reported by the company and that they haven’t yet been subjected to peer review by other eye experts. Companies obviously have an incentive to cast their findings in a positive light.

Does the story commit disease-mongering?

Not Satisfactory

We feel that the story crosses the line when it diverges briefly into discussion of a potential new treatment for Stargardt’s macular dystrophy, another retinal disease that causes earlier-onset macular degeneration. In its coverage of the experimental therapy, which just received approval to start human testing, the story solicits a comment from the father of a 10-year-old boy who, according to the father, “basically went from normal vision to legally blind in seven months.” This anecdote represents a worst-case scenario for this disease, and its inclusion with almost no context seems to serve little purpose other than to create undue fear in the reader. The child would not even be a candidate for the trial, according to the story, since enrollment in the study is limited to adults.

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

Not Satisfactory

The only expert source quoted in the story was an investigator on the study of the new drug. Although the story disclosed that he was a consultant for the drug’s manufacturer, Regeneron, it should have sought out a comment on the findings from somebody with no stake in the research. This is especially important considering the findings were not published in a journal and presumably have not been vetted by other researchers.

Does the story compare the new approach with existing alternatives?

Not Satisfactory

Laser surgery and photodynamic therapy are other potential treatment options for wet AMD. The story did not mention them.

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

Satisfactory

The story calls VEGF Trap-Eye “experimental” and says the drug’s developers plan to apply for approval of the drug in the first half of 2011.

Does the story establish the true novelty of the approach?

Satisfactory

The story does not try to oversell the novelty of the new treatment.

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

Not Applicable

The story seems to have relied on the company for the substance of this story and quoted only one researcher who was affiliated with the study (not counting the father of the child with Stargardt’s macular dystrophy, which, as discussed above under the Disease Mongering criterion, was not the main focus of the story). Since no independent sources were referenced, we can’t be sure to what extent this story may have relied on a release. We’ll call it not applicable.

Total Score: 4 of 9 Satisfactory

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