Monday, May 7, 2012

Avastin Continues to Impress for Eye Use

A while back I posted on the controversy about the drugs Avastin and Lucentis:

Quick recap: Eye specialists found out almost by accident that a drug intended for cancer, Avastin, was really good for a particular eye condition, wet macular degeneration, and was also quite inexpensive. The maker, Genentech, then marketed a newer cousin of Avastin, called Lucentis, which of course they priced up the wazoo, and tried every trick in the book to get doctors to use it instead of the cheaper Avastin, which remains officially off label for eye use. (To their great credit, the retinal community refused to go along.)

In the earlier post away back in 2007, I noted that a trial was just beginning that would provide the definitive scientific answer to whether Avastin was as good as Lucentis for eye use, contrary to the interested claims of Genentech that Lucentis was superior. Genentech, quite naturally, refused to fund a head-to-head comparison trial of the two drugs to find out the answer, so an NIH-funded study was launched.

The first results of that study showed that the two drugs worked equally well, as did a more definitive follow-up report from the same study, as now helpfully summarized at Merrill Goozner's blog:

So in case you wondered, we now have sound evidence for what the retinal specialists had all along believed based on the older evidence plus their impressive clinical experience--a cheaper version of the drug works just as well as the much more expensive version.

If the world were just, the FDA would now revise the labeling for Avastin to make it clear that it's indicated for wet macular degeneration, removing Genentech's claim that Lucentis is the only drug so approved. But to the best of my understanding, the world is not fair, and only Genentech can initiate such a label change at the FDA, which of course they would only do over their dead bodies. (If others know the FDA rules better please chime in.)

1 comment:

Bernard Carroll said...

We should keep in mind that the remit of the FDA does not include regulation of the practice of medicine. The agency was established by Congress to regulate the claims and practices of manufacturers.

Lately, as in the case of Avastin, corporations have turned to deceptive equivocation in marketing by implying that only FDA-approved drugs may be used, ignoring a professional consensus on the utility of alternative treatments.

Corcept Therapeutics, the company associated with Dr. Alan Schatzberg at Stanford University, has used this strategy for years to promote interest in its drug-under-development Corlux for psychotic depression. They beat the drum about there being no FDA-approved treatment for psychotic depression while glossing over the fact that such patients are routinely managed successfully with standard antidepressant treatment approaches.