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This is not only allowed, it's encouraged by legislation called the Bayh-Dole Act. The general thought is that there would be no incentive for anyone to do cli
by skosuri 12y ago
This is not only allowed, it's encouraged by legislation called the Bayh-Dole Act. The general thought is that there would be no incentive for anyone to do clinical trials on the drug, which can get quite expensive, if they don't have some protection for exclusive use. Many, if not most drugs proceed starting from academic research funded by governmental support.
- _craft 12y agoThanks for the informative response! Do you know how expensive clinical trials would be for this kind of drug?
- skosuri 12y ago$100M-500M gets thrown around [1] but it's hard to find good data. This might seem not too high, but many drugs fail, and often fail at the most costly step (phase III). So you have to be sure to factor that failure rate in. [1] http://www.manhattan-institute.org/html/fda_05.htm http://www.manhattan-institute.org/html/fda_05.htm
- refurb 12y agoDepends on what indication they are trying to get. A handy estimate is that a phase III trial costs $15K/person/year. If they aim for a 1000 person trial of 6 month duration, you're looking at $15M just for the phase 3 (I doubled it since they typically run two). However, that's a small trial.
- Fomite 12y agoFidaxomycin, which was developed by Optimer Pharmaceuticals to treat C. difficle, was relatively inexpensive to run. I want to say in the vicinity of $100 million
- refurb 12y agoI'll also add that the educational institute who received the government funds out-licenses the drug while maintaining a royalty interest in it. Lyrica came out of Northwestern and they build a brand new, shiny chemistry building out of the royalties.
- s_q_b 12y agoWhy is that bad? Shouldn't the discoverers of pregabalin, who helped millions in excruciating incurable chronic pain, receive a portion of the profit from the sales of the drug to build facilities for future research? That seems like a well-formed feedback loop to me.
- _craft 12y agoHow much of that goes to the actual researchers vs the school?
- skosuri 12y agoDepends on the school. The general rule of thumb is about 1/3rd to the inventors themselves, 1/3rd to the department, 1/3 to the school.
- scott_karana 12y agoCynically, even if the school gets 100% of the profits, the feedback loop of "encourage drug development, get paid" functions properly. They would only have to pay their researchers just enough to continue working...
- refurb 12y agoThe guy at Northwestern who discovered Lyrica is a multimillionaire. The incoming royalties are usually split between the researcher and school.
- refurb 12y agoI'm not saying it's bad at all! I'm just pointing out that the academics who invent something and pass it to a biotech company for development get something in return!
- s_q_b 12y agoTotally agreed. I misread your tone, which can be tough to perceive over the interwebs sometimes. My apologies :)
- throwaway2048 12y agoDo note companies have a very strong incentive to make clinical trials as expensive as possible for this, and other reasons.
- cyrus9020 12y agoCompanies have a very strong incentive to make it expensive? Can you expand on that?