News Story: Full Text
Sponsored By
Orbus Therapeutics Inc Clinical Trial for Recurrent Anaplastic Astrocytomas
Please Click On The Above Banner For More Details
Braintumor Website


FDA agrees to let patients get controversial drug

Al's Comment:

 I have mixed feelings on this one. On the one hand, I am all for patients being allowed to try experimental treatments, especially when all approved options have run out and they are not eligible for clinical trials.  On the other hand, some protection of the patient is needed.

I would propose a few things before I allowed this to be made available:

1. Release all of the data on the clinical trials that have been run.  They have not been published. Unofficial sources have said that there were over 100 trials of this treatment, and 99 of them showed negative results. 1 showed good results.  Statistically, at the level of proof most commonly used, .05%, if you ran 100 trials, you would expect 5 of them to come out positive by chance alone.  Having only 1 positive and 99 negative trials leads me to believe this is not the miracle drug it is touted to be.

2. I understand a traditional clinical trial can not be run on this group of patients, however, that does not mean that their experiances should go to waste.  All patients who use a compassionate use treatment should be tracked.  Our "Brain tumor virtual trial" is a perfect vehicle for this.   An individual success is meaningless.  About 10% of kids and a higher % of adults with brainstem gliomas do well for a long time on the standard treatments. If you take 3 patients, there is a good chance that 1 of them, and a small chance that 2 or 3 of them, would do well no matter what you did to them. However, if you had 50 patients tracked from before they start the treatment, the chances that 25 of them do well is pretty low if the treatment is not working.  Not as convincing proof as a randomized blinded trial, but good enough for me and the people who have no other options. 

IF the story does not appear below, Click HERE to view the text of the story!
Note: The original website is displayed below - we have no control over it and are not responsible for the content of it, we just report it! IF you click on anything below, it will take you off of our website!
Original Source:

(Everything below this line is from!)

Click HERE to return to brain tumor news headlines

Home | Brain Tumor Guide | FAQs | Find A Treatment
Noteworthy Treatments | News | Virtual Trial | Videos | Novocure Optune® | Newsletter
Donations | Brain Tumor Centers | Survivor Stories | Temodar®
Fundraising For Research | Unsubscribe | Contact Us

Copyright (c) 1993 - 2020 by:
The Musella Foundation For Brain Tumor Research & Information, Inc
1100 Peninsula Blvd
Hewlett, NY 11557