FDA Slaps Down Genentech On Eye Drug
The saga of Avastin and Lucentis -- two Genentech drugs used to treat a blinding condition called age-related macular degeneration, even though one is about 50 times cheaper than the other -- is one of those stories that just gets better the longer it goes on.
A quick recap: Avastin, a cancer drug, is biochemically very similar to Lucentis, which Genentech specifically developed to treat AMD. Several years ago, before Lucentis was approved, some enterprising retinal specialists realized that Avastin might work against AMD as well -- which it seems to, although it hasn't yet completed a formal trial. The catch: Because cancer patients take large doses of Avastin, the amount needed for injections into the eyes of AMD patients is tiny, and thus dirt cheap.
Avastin apparently now holds roughly half the market for AMD treatment, even though it isn't approved for such use. Cue corporate panic at Genentech, which last year announced plans to end shipments of Avastin to "compounding pharmacies" that divided large vials of Avastin into filled syringes that could be used in eye treatment. Although it later backed off somewhat, Genentech continued to insist that it was acting in the best interest of patients, even noting that it had destroyed four lots of Avastin because FDA inspectors didn't think it met quality standards for use in the eye.
Today, though, leaks from Sen. Herb Kohl's office suggest that Genentech was lying through its teeth when it offered that explanation. From Pharmalot (emphasis added):
As a result, Herb Kohl, the Wisconsin Democrat who chairs the Special Senate Committee on the Aging, began investigating the cost to Medicare if Avastin usage was restricted. In an FDA letter sent to his staff, the agency writes inspectors "identified deficient practices and the lack of of effective processes to know what was in those four lots. Consequently, the agency recommended that those lots should be considered unfit for use for any indication."Genentech, of course, denies the FDA's version of events and says it believes the lots in question would have been fine for use in cancer treatment. Meanwhile, the company has declined to participate in a major head-to-head trial of Avastin and Lucentis funded by the National Eye Institute, even though the company commonly donates drugs for studies it wants to see carried out.The letter was referred to in a memo written by Kohl's staff about the Avastin controversy. The memo, which we have reviewed, also notes that a separate issue concerning the FDA inspection involved "levels of glass particulates in the Avastin lots in question (which) were a central issue in the ultimate decision to destroy those particular lots or vats of the product."
Another internal agency e-mail from a high-level FDA eye expert stated explicitly that "Genentech has found a way to blame FDA for their decision to limit the distribution of Avastin. The manufacturing problem at their facility that resulted in glass in their product would be an issue for either the on label oncology indications or the off label ophthalmology indications," the senior FDA official wrote to his colleagues, according to the memo.
Looked at one way, it's a no-brainer that a company would want to continue selling its high-priced product as long as it can, and in that sense Genentech's actions are perfectly understandable. But the company wants us to think it aspires to something more -- its Web site, for instance, still commits it to "the best interests of patients [and] the medical profession," in addition to those of its employees and shareholders. How, exactly, throwing up roadblocks to a potentially affordable treatment for a horrible blinding disease of the elderly does either of those things is beyond me.
Further reading: The WSJ Health Blog also has a lengthy post on the subject.
