Drug Development Cost to Soar?!
Healthworld IT is reporting that Steven Paul, executive vice president at Eli Lilly is stating that the cost to develop drugs could top $2 BILLION by 2010 if changes are not made.
Drug Costs Nearing $2 Billion, Warns Lilly Executive
Other than mentioning the FDA’s Critical Path Initiative there isn’t much else new here. The one point that always seems to get mention is the need to reduce the attrition rate in phase II. Currently only 20% make it to phase III studies (one on five). Biomarkers may help with this but I still think that your are always going to have phase II as the place to make go-no go decisions. This makes sense if you stop and think about it. This is the first place where it is tested in humans for the disease indication and the first time it is tested in more than a few people. It should be expected that this is where potential drugs are going to fail. Until we develop much better animal models, this will continue to be the case.
I do think the talk of allowing the use of biomarkers and possibly allowing drugs to go onto market for those identified with certain biomarkers after a successful phase II study could help. However, I don’t see this happening anytime soon as a lot of processes and procedures would need to be put into place before it could be eliminated.
I do find the following quote from the article to be interesting:
The effective patent life of blockbuster drugs is approaching 10 years, said Paul, who contrasted that short lifespan with the 50 years of copyright protection enjoyed by Mickey Mouse! “We should start the clock when the drug reaches market,” Paul suggested.
I think pharmaceutical executives tend to forget or overlook the current attitudes of consumers. There is already much talk about how expensive drugs are and this seems to play right into the view of some consumers of pharmaceutical companies being greedy. While increasing potential income is one approach, I think there is much more room for improvement with the lead discovery to phase II stages.
Technorati Tags: drug development, drug cost
Related Posts:
Bookmark it with:
| 
del.icio.us
| 
Digg it
| 
Furl
| 
Simpy
| 
Spurl
| 
My Yahoo!
|
