Until Wednesday, no new treatment for lupus had been approved, not for lack of trying on the part of those in the lab, in over 50 years. Daniel Wallace, the rock star of lupus researchers, told with frustration of how one company had recently carefully followed all the FDA’s guidelines and had spent many many millions of dollars, only to be told that the third FDA president since they’d started had now decided to shelve it for reasons that many felt were very wrong. (And I personally know a patient who went from the normal person I knew to severe brain damage symptoms akin to late-stage Alzheimer’s, to being blessedly, miraculously normal again during the trials of that drug that is now denied to her and her good, supportive husband. I have not seen her since.)
There was an outcry. And the FDA finally paid attention to the disease.
So now there is Benlysta, and great hope–and more new drugs in the pipeline, at long long last.
One of the people who testified before the FDA for Benlysta’s approval was on a panel that spoke today. Another was a patient who’d been in its trials.
What I didn’t expect, though, was to get to have several minutes of private conversation, after most the others had left, with a gentleman (and I use that word to convey my very great respect and admiration for him) whose name I missed, the head of the California Institute for Regenerative Medicine.
He in his own remarks to the group made clear that stem cells can now be made from adult cells. No embryos need be involved. This goes far beyond lupus; this is everybody. Californians voted for this, the State of California will get 50% royalties on all patents from this, and it is already returning $4.50 for every $1 spent on it.
The state isn’t exactly swimming in cash and the funding was to be re-voted on after ten years. That will be 2014. He wants the word out: there is great hope that we could cure many diseases and that treatment will bring down medical costs, as well as vastly improving the lives of those treated–and their families by extension.
First they had to build the buildings; they did. Then they had to hire the researchers. They have been. Talent has come in from all over the world to pursue their dream jobs of doing real and lasting good for one’s fellow man.
Sixteen million people in California with chronic diseases, he said. And all those others who will get a disease that could become treatable. We can do this.