I agree Jim, but I really believe people suffering with terminal diseases deserve not only the right to try experimentation, but also need to sign off on documents deemed legally binding that eliminate the possibility of suing after a negative experimental outcome.
To my way of thinking the FDA is completely wrong in making drugs like Provenge await further data. Drugs need to be approved with conditions that through use will prove they work, or the don't. If they don't the patients trying them are out of choices anyway, other than perhaps some clinical trial, but many people can't or won't go into clinical trials.
In many cases the reason patients choose not to go into clinical trials is they're not being conducted where they live. When someone's given the choice of perhaps living months, or maybe years longer, but treatment is away from family, the real question often becomes, how do you want to spend the remaining time. More sights where such trials can be done might solve some of the issues, perhaps running trials where the family oncologist could administer the treatment all but once every month, or two months, etc would work. I just think that there are better way of getting more people involved in trials or experimentation.
I'm very big on permitting experimentation for those willing to accept it. I don't know if you're familiar with IMGN. If not it's IMGN901 has been in trials for SCLC for years, though right now they believe MM is the quickest course to approval. Preclinically the drug in combination with a Taxane worked extremely well for SCLC, but it's a trial that hasn't been run. IMGN's like so many biotechs, short on funds, running trials slowly to hold down expenditures, however if in an experimental setting this combination were tried, even in a single patient, it might lead to additional trials.
Gary |
