There’s good news and bad in what looks like the soon-to-be FDA approval of a new drug specifically for lupus, the first such targeted drug, according to The New York Times , since 1958. Lupus is an autoimmune disorder that largely strikes young women, causing a myriad of symptoms, from the unpleasant to the truly debilitating. The new drug, Benlysta, is a therapy made possible by the genomics revolution. This sounds as if we are finally starting to get the miracle cures promised by this information explosion. But when you read the accounts of the drug approval process, you realize just how hard it is to conjure up a miracle. The drug, taken as a monthly infusion is expected to cost upward of $30,000 a year. I actually don’t begrudge the manufacturer what sounds like an outrageous sum. If Benlysta is approved this will be the first drug brought to market by the small biotech that developed it, Human Genome Sciences, in its 18 year history. If drug companies can’t make a killing when they succeed, there is no incentive to burn through the millions it takes to try to come up with a treatment.
It would all seem worth it if Benlysta returned lupus sufferers to health. But it turns out, as The Wall Street Journal reports, the drug provides a measurable impact, but not a “dramatic” one. FDA staff scientists said the effect was “modest”, and expressed concern that African-Americans showed a worsening of symptoms – and black women disproportinately suffer from the disease. The Times also reports that “about 11 patients would have to be treated in order for one to benefit.” It’s looking more and more as if Benlysta is the revolution – a terribly expensive drug that’s modestly effective for some people, but better than nothing.