Just Spoke To Vertex

[Magnum]

I have a contact at Vertex. We spoke at length about Telepravir and the "compassionate" use. That means use now (without placebo) for Cirrhotic victims. While he couldn't give me a definite time line for the compassionate release, he did say that telepravir being in Phase III, they are seeking approval by the FDA in the second half of 2010, and making it available through prescription instead of the current clinical trials.

Interestingly, he added a comment that we could hopefully expedite the "compassionate" use approval by the FDA if we write them an email stating the urgency for those who need this NOW.

Here is a direct link, with phone number to the FDA: http://www.fda.gov/comments.html

Write to them and continue to bombard them with emails until they give in. This is a battle to be sure, but if the government sees that we are desperately seeking a compassionate release of Telepravir, they could rethink this whole matter. Write an email now...

Magnum

[can-do-man]

Why does a good thread like this have to turn to polictics??? Its quite clear from the response tippyclub got from the FDA it can still be done. Its just up to the drug company and your doctor.

FROM THE FDA

There is a mechanism to
access products that have not been approved.  However, this would
involve a physician willing to file a single patient or emergency
Investigational New Drug (IND) application and this must be done with
the cooperation and permission of the drug supplier

[fretboard]

"It was the pummeling, no let up persistence that forced both the FDA and the drug companies onto a fast track release". Otherwise, it's up to you...

So true, the pummeling plus a lawsuit that was won.lol  The clip I leave gives one the idea that "compassionate drug use" is limited.  I'm sure other people/drugs have been approved, but off of wikipedia, this was all I could find.  The compassionate drug use idea was made possible in 1978 when this man was trying to get medical marijuana from his pharmacy for use on his glaucoma.  Oh, the article says the program was shut down by George Bush.  If he shut it down, I don't think it's shut down anymore.  latr

The settlement in Randall v. U.S. became the legal basis for the FDA's Compassionate IND program. Initially only available to patients afflicted by marijuana-responsive disorders and orphan drugs, the concept was expanded to include

HIV-positive patients in the mid-1980s. However, because of the growing number of AIDS patients throughout the late 1980s and the resulting numbers of patients who joined the Compassionate IND program, the George H. W. Bush administration closed the program down in 1991. At its peak, the program had thirty active patients.

[can-do-man]

I agree with you, vertex is the one to pressure,

As for the FDA to "pressure" a drug company into early release with NO data on people with cirrhosis......... Hmmmmm

[Magnum]

Yes, but can the FDA persuade the drug companies to simplify this request for "compassionate" release. Let's be careful to not lose thought of what we’re trying to achieve and instead look at all the down sided negative possibilities. I keep referring back to the AIDS crisis. It was the pummeling, no let up persistence that forced both the FDA and the drug companies onto a fast track release. Otherwise, it's up to you...

Magnum

[desrt]

That would certainly make the reference to "a definite timeline for compassionate release" in the original posting make more sense. The FDA can't give off-label approval to something doctors don't have access to. I guess all these letters should have been going to Vertex instead of the FDA.

[can-do-man]

Seems everyone is thinking only about the FDA or the doctors, I'm not so sure the drug company would be real interested in this and really why should they??? They are just now doing trials on us cirrhotics, they have a lot of money tied up in this drug. At this point do they really want to risk maybe tying this FDA approval for what could be years if just 1 case went bad whether it would be the drugs fault or out of their control? I just don't see the benifit to the drug company when they are just now testing cirrhotics.

Plus what insurance is going to cover it, showing the shelf life of telaprevir, pricing of the drug, alot of things involved in this when their into trials and about two years out for FDA approval................. Just my thoughts.