Slow Track on The Fast Track

[Upbeat]

These new Hep-c drugs were put on the fast track. I see no difference from normal drug approvals. If there was a real need then you should be able to forgo phase three and use phase two data.  The FDA must figure there is so much risk with the new PI's that they want full term data.

                                                                                                                                                               Ron

[epiphiny]

Perhaps I am naive but I would like to think that the world is some what more enlightened than it was 20 years ago and that governments no longer see HCV as a "junkies" disease in the same way that the world, for the most part, no longer sees HIV as a "gay" disease.  Of course there are still going to be narrow-minded bigots who will have this viewpoint but surely these people must become the minority in our informed and educated world...

The fact is, HCV is a serious world health problem and we need to halt it.  More people have it than any one knows as many people don't even know they have it.  It is the major cause of liver cancer and the number one reason for liver transplant.  Since the awareness of the virus and testing blood for donation the infection rate has definitely slowed.  But people are still getting the disease, and if they are not treated they can spread it.  There have been instances THIS YEAR of infected blood still being given in transfusion.  Many people have been infected by working in the medical profession, trying to help other people, some babies get it at birth.  Some people NEVER use IV drugs and get it.  Many people were infected by their own governments and health systems via vaccination programs, through NO FAULT of their own.

It makes me angry to hear people still think of this as a junkie's disease.  We need to change that way of thinking, particularly those of us who have it.  Is that how YOU think of yourself, as a 'dying junkie"?  Well, shame on you!  That's not the way we change the world...

Epi.

[pjhep80]

it doesnt make me wonder, i know why and fret said it , the system dont care... about a bunch of dying junkies

sorry i know there are people who got it other ways but i think thats the general consensus when it comes to the general poplulation and the government

ron said -  The FDA must figure there is so much risk with the new PI's that they want full term data....the 'fast track' with the fda might only be 'ok after you do all the trials we will decide in  2 years'... as opposed to 5 or 10 or whatever the hell timeframe it takes to get a drug approved

whats the deal with rest of the world??  are they all waiting for the phase iii results also?  i thought it was differnet in europe im wondering if we will see the new drugs available there first.  

[fretboard]

I don't think the government is that concerned about HepC.  They have SOC approved and that's it, I feel they feel that they've done their job.  You may hear of a medical device receiving approval without completion of clinical trials, but not a drug.  You would think that with Fast Track, doctors should at least be able to use these drugs in compassionate situations but no, the system don't care.  Which makes one wonder?  

[can-do-man]

From what i was told vertex decided to for-go fast track approval and have this phase 3 trial, so the FDA is not involved yet. But i wouldn't want to place any bets on that.

cando