The first drug shown to significantly improve the vision of patients threatened by a major cause of blindness in the elderly won federal approval Friday.
This story is about FDA approval of an injectable treatment for wet macular degeneration which is reported to result in improved vision. It is not clear from the story how exactly this treatment differs from other FDA approved treatments for this disease. The article discussed the use of a similar drug (Avastin) which is considerably less expensive but has not been studied for this application and does not have FDA approval for this use. The stoory did not explain how the two similar products made by Genetech might differ. The article failed to mention the other similar injectable drugs (Macugen, Visudyne) which are currently on the market and FDA approved for treating wet macular degeneration. While the article presents the drug as “a major breakthrough” and a “quantum leap forward,” there is very little context given to back up these claims. It failed to present details on both the magnitude of benefit that could be expected and any information on the harms of treatment (harms that are readily found even on the drug company’s website).
The cost – $2000 a dose – was mentioned. The story said that “For those on Medicare without drug coverage, that is an out-of-pocket expense and even with drug plans, there might be a huge co-pay.” But the story did not indicate whether Part D Medicare or other health insurance would pay for this medication. Nonetheless we’ll give it a satisfactory score on this criterion.
The story did not adequately describe the size of the potential benefit from the drug. There was merely a line that said, “The drug works so well that 95 percent of patients had stable or improved vision. And 40 percent, like Frye, could see 3 or more additional lines on an eye chart.” What does that mean in real-life terms?
There were no mention of potential harms from this treatment. Even the drug company’s website lists the risks of serious eye infection, detached retina, increase in eye pressure, blood clots, red eyes, eye pain, and small specks in vision.
Though the story mentioned that Lucentis reversed vision deterioration from macular degeneration, there was not enough information about the clinical trials that evaluated this drug, nor anything about the extent to which vision might be expected to improve, nor anything about how long it took to get an effect and how long the effect lasted. There was merely a line that said, “The drug works so well that 95 percent of patients had stable or improved vision. And 40 percent, like Frye, could see 3 or more additional lines on an eye chart.”
No obvious elements of disease-mongering.
While the article did include quotes from spokespersons for Genentech, the company that makes Lucentis and a spokesman for the American Academy of Ophthalmology, the reader can’t evaluate whether the latter had financial ties with the company. It would have been more helpful to either establish the sources’ objectivity or else to include comments from some objective experts who didn’t have ties to this drug or its manufacturer.
Although there was mention that other treatments have only been shown to stop progression of the disease but not “significantly reverse deteriorating vision,” there were no specifics about these other FDA approved treatments (other injectables, laser treatments, etc.). There was some discussion about the use of Avastain, a drug similar to Lucentis, that has not been approved to treat macular degeneration but is used to do so. For a drug that the story describes as “a major breakthrough” and a “quantum leap forward,” there is very little context given to back up these claims.
The story explains that Lucentis (ranibizumab injection) “won federal approval Friday.”
The story reports on a new FDA approved injectable medication to treat the wet form of macular degeneration. It acknowledged some of the controversy over how “novel” the drug really is when it said, “Many doctors are upset because Lucentis is nearly identical to a Genentech cancer drug called Avastin that doctors have been using without FDA approval to treat macular degeneration at a cost of about $1,000 a year. The company says the drugs are different and Lucentis is the one that has been tested.”
Because the story turned to multiple sources and acknowledged the controversy about how “novel” Lucentis really is, it does not appear to have relied solely or largely on a news release.