Sandra Kweder of the FDA, in last year's teleconference with patients spoke briefly to the challenge of getting drug companies involved, at least in drug research in the U.S.
"One of the challenges [is] to try and get the companies interested in investing in products to treat a condition.One of the things that we've learned from experience is you've got to be able to define the condition well and they [pharma] need to - they want to know where are the rules about studying it. What am I going to have to show in order to get a drug approved?"Good definition and agreed upon rules on how to measure the effect of the drug so it can be approved.
There are a few good definitions produced by experts but there are also awful definitions that are more well known, certainly more often used, describe a very different set of patients and have resulted in studies that feed gross misperceptions of the disease
As far as how to measure drug effect, there are a number of ways that could be used. But which ones could pharma use with confidence that the FDA would accept it?
Drug research is very high risk, resulting in many dead failures after years of work. If I am pharma with a choice between this disease and some other disease that is more clearly defined and where the methods to measure effect are agreed, I expect I'd choose the other disease.
Yes, I think it's something like that. The company got interested in RA once I had shown the drug seemed to work. But there are a lot of things different now.