Getting Med access prior to FDA approval

[GrandOak]

Someone had posted a link (in Aug-Sept time frame if I recall correctly) to information on how one might gain access to meds (ex. VX950) prior to full FDA approval by signing waivers and such. Does anyone still have it or point me to the thread to which it was posted?

I can't quickly find it in the archives and the MH search engine does not apparently apply it's keyword search to post contents, only the subject lines.

Thanks in advance to anyone who can help here!!

[orphanedhawk]

This isn't that far fetched as it  may seem. I had an herbalist/MD tell me she could get zadaxin from Panama, legally. I'd love to get my greedy paws on vx950.

[jmjm530]

Don't want to burst anyone's bubble, but I *hightly* doubt if at this point Vertex is going to release their drug to anyone except those running authorized trials. A call or email to Vertex would be the quickest way to confirm.

[nitramog]

maybe thay have some test studys you can get into but that has its prows an cons to it

[NYgirl]

Yeah it doesn't make any sense really if you think about it...that is what trials are for.

I remember they were a bit out of orbit and didn't read anything real about it.

[GrandOak]

If I recall correctly the med had to be in Phase III or pending approval and there were liability waivers which had to be signed, etc..

[GrandOak]

The game WAS afoot. The link to the thread, started by none other than DougV, is:

http://www.medhelp.org/forums/Hepatitis/messages/42543.html

For those interested, the links he mentioned were:

http://www.fda.gov/cder/cancer/access.htm
and http://www.fda.gov/cder/cancer/singleIND.htm

[FlGuy]

And, I don't recall a link with it.  If there was a link I would have opened it and might remember it better.  Keep going, Sherlock.

[jmjm530]

On second thought, maybe at some point in the future, one of the Vertex trial doctors might allocate some VX-950 to his/her private patients with such a release. This is total speculation on my part but anything and everything reasonable is worth pursuing. Just can't see Vertex authorizing anything like this right now as I imagine they would want to control all Vertex data at this important juncture in their trial and approval process.

[FlGuy]

Shows how good my memory is.  What clinched it for you?  Was it the ashes of a singular variety or perhaps the shape of his ears, which are not easily disguised.

[bobbyullc]

IS THIS WHAT YOU WANT?

http://www.fda.gov/cder/cancer/access.htm

[GrandOak]

Naw, it is the good memory I have always been blessed with.  I don't always recall the particulars, more so it seems these days thanks to Brian Fog, but do recall the overall concept I've read or heard.

I also recalled that the post was about the time of my last follow-up visit, so using Eyedeas' Friday Fight songs and RockerforLife's Sunday poems, was able to narrow in on posts around that time.

Funny thing is that despite using FDA as a keyword search, it failed to pull the desired thread in question up despite FDA clearly being in the subject header of the thread.  It really makes be suspect as to how reliable the archive search engine is when it comes to locating old threads and post.

[FlGuy]

I remember the gist of that post and thinking at the time that it was an 'out there' kind of a comment.  Don't recall the poster person.  Can't narrow down the time frame for you either.