Osiris Therapeutics has halted registration for the Phase III trial evaluating Prochymal for Crohn's disease due to flaws in the study methodology. Apparently, there was an overly large percentage of people taking the placebo who reported positive results. There has been some speculation that patients may have underreported their symptoms if they felt they were getting the real medication possibly because if they were on the medication in the Phase II trials and were experiencing good results they would be given the medication in the Phase III trials.
My opinion - being that Crohn's disease is totally effected by stress and emotions (at least in my experience it is) is is also possible that people in the trial who started to feel better assumed they were on the real drug and then the euphoria of having a potential miracle cure helped them to feel even better.
Osiris stops enrollment in Crohn's disease trial
This news is very disappointing not only for investors in Osiris, but for Crohn's patients like myself. This will push back the approval for the drug to treat Crohn's and a whole new set of study parameters will be devised to try to make sure they have a true result with no problems with an overly large placebo effect.
I find this news very ironic given the squabble that some Crohn's patients had with Osiris regarding the ability for people who got the placebo in the study to get the real drug in a follow up study.
Wall Street Journal Reports: The FDA is Killing Crohn's Patients
I think that this is a lesson for us all in terms of letting the scientific double blind study methodology take its course and try to keep human emotions out of the process as much as possible.
We want to know if the drug is effective and if it is safe. There were no problems with adverse reactions or safety issues in the studies - they simply need to be redone to be able to prove the drug works better that no treatment.
I am very sorry to chide Gideon Sofer, who I vastly admire. I sincerely hope that he is doing better, as I know his Crohn's is very severe. I think he would understand my *shock value* headline, which is an homage (and a criticism) to his piece in the Wall Street Journal. I do think it is possible to both admire and criticize someone.
