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Any success with compassionate use of Abiraterone?

franksdaughter
Posts: 1
Joined: Jan 2010

I was wondering if anyone has had success with obtaining Abiraterone by way of the Compassionate Use expanded access program?

Mtavery
Posts: 2
Joined: Mar 2010

I've been in contact with folks at Cougar for more than a year and they have no plans to allow compassionate use of Abiraterone that I'm aware of. Also confirmed it with my dad's oncologists in Detroit. They won't elaborate as to why, it's a very complicated issue, and with Johnson and Johnson buying them , probably even less likely to happen. I'm not telling you to discourage you, but so you don't waste undue time chasing a drug that can't be gotten , except in a clinical trial setting. We've been chasing that clinical trial dog down the alley for almost 2 years, getting into a clinical trial for this drug is extremely difficult. Lots of exclusion criteria, many "unlisted" exclusions on the Clinical Trials website, end up "surprising " you with them after the hosting hospital runs up thousands and thousands of dollars of unnecessary tests before they check to make sure that you're a candidate. Happened twice to us, both times the condition that caused exclusion (heart arrythmia) wasn't listed as an excluding factor,never mentioned at any time during the pre-Clinical Trial work up, then 4-5 months later, after much time and money wasted, was used as the reason for exclusion. This after they already had all the info re: arrythmia up-front. VERY frustrating, excuse my cynicism, just don't want anyone to go thru the same. Eventually this drug will hit market, but for now I'd look elsewhere for treatments already available, that's where we're headed. Good luck to you, Mike

erisian's picture
erisian
Posts: 109
Joined: Dec 2008

It looks like Provenge may be FDA approved within a few months, at last.
I posted some links here: http://csn.cancer.org/node/188308

erisian's picture
erisian
Posts: 109
Joined: Dec 2008

I'm on low-dose daily oral cyclophosphamide. There has been one small human trial with 17 patients, all with docetaxel-resistant HRPC. 9 of the 17 had a PSA response, and there was a very significant increase in survival among those who responded. Good info on wikipedia (I put some of it there):
http://en.wikipedia.org/wiki/Cyclophosphamide

nymets1
Posts: 26
Joined: Sep 2009

Abiraterone, like Provenge, will be approved by the FDA in the near-term (the former next year, the latter , this year). It really is a moral discrace when drugs are so near to approval that one cannot use them sooner under "Compassionate Use." When an individual is near the end, the top societal priority should be to do the most to find something that works.You have nothing to lose and everything to gain.

Mtavery
Posts: 2
Joined: Mar 2010

Unfortunately the FDA and their policing of the pharmaceutical industry doesn't often allow for what an average person would consider "common sense". You have to wonder if it were THEIR father, brother, husband, uncle , nephew or best friend who was close to death from prostate cancer if they'd suddely find a way to get access to promising drug therapies like Abiraterone that are close to approval . A cynical thought, but allowing thousands of our citizens to die a certain death, while potentially promising drug therapies languish in the FDA approval process , is more than a moral disgrace.

There's only one reason I can rationalize why companies like J and J , Merck, Pfizer and others don't push back against the FDA's quagmire of compassionate use provisions . They're just scared and /or intimidated by a fat, slow and ignorant political drug approval process.

I believe we routinely show more compassion to dogs and cats in their last days than we do to some of our terminal prostate cancer patients. My dad spent 3 years of his life fighting for this country in World War II , and in his 80+ years never asked a thing of his government until now. Now he's fighting for his own life, down to his last weeks or days, and the only response I can get from J and J , the FDA or oncologists , is that the compassionate use provisions are "complex" , but that they "sympathize" with our plight. Thanks for the sympathy, but I'd have appreciated a backbone much more.

Just my humble opinion

erisian's picture
erisian
Posts: 109
Joined: Dec 2008

I found out recently that the votes that shot down the Provenge approval at the last possible step a year or two ago were: 17 to 0 agreed that it was safe, and 13 to 4 agreed that it was effective. Then it comes out months later that two of the four had a financial stake in one of Dendreon's direct competitors. (Dendreon is the maker of Provenge) I'll dig up ref's if anyone wants some.

Anyone who died from prostate cancer would have been a candidate for Provenge at some point during their treatment. Before they died, for example.

So if we go with a delay of 2 years @ 27,000 deaths per year, then those four votes caused the early deaths of 54,000 men, by denying them timely access to Provenge.

The increase in median survival shown by the combined Phase III Provenge studies was 4.1 months. Using those numbers, it seems that this decision deprived the prostate cancer victims of about 18,400 man-years of life, or 256 72-year lifetimes. Further, the number of deaths that will result from prostate cancer patients not getting the vaccine earlier in treatment when it might cause long-term remission or even cure is unknowable, and is in addition to the above numbers of premature deaths.

I would have been treated with Provenge immediately after it was approved, so I have a personal interest in this.

I fail to see how the FDA decision protected the public health in any way. It certainly did the opposite to my health, and that of tens of thousands of men.

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