HER2 Support Group Forums - View Single Post - To Joe or anyone, ? about Court of Appeals

rosie · 06-05-2006, 06:34 PM

Dear Loving Daughter

This is very interesting info. What really riles me is that the FDA is making suck a big deal of "making sure the drugs do not cause harm". What for terminal patients who will die? Isn't that harm enough? And besides Abigail Alliance is asking for access to drugs that have already gone through phase 1 or toxicity trials so the safety is known. Instead of shoving all of us patients deemed "terminal" as guinea pigs into the phase 1 trials because no one else will do them, allow us equal access to phase 2's.
And it isn't even a question of terminal but thoise of us who have had too much treatment and might still be in pretty good shape can't get access either.

I did speak with the lawyer involved in this case and the FDA HAS appealed it to the entire Court of Appeals so all judges will hear it not just the 3 selected. The FDA is not going down without a fight. Why? Because this ruling could change the very nature of the way the FDA does clinical trials and could force the pharmaceutical industry to provide drugs to patients but gain no informational benefit like a trial.

so i say, start a separate pool of patients who fit into this ruling and have them signe a liability release and ask them to participate in their own trial.

I am so mad. I have been on 5, count em 5 clinical trials. I have done my time, given of myself for science and have managed to outlive everybody's expectation which is the problem. Because now, darn it, I am still alive, have no more standard treatment options and can't get into an appropriate trial because I have had too much "successful" treatment. Geez, so therefore according to the FDA, it's time to roll over and die. No way, I have kids. But I can't get a break?

Loving Daughter, if you have any ideas, I would love to hear them. I am told hiring and lawyer and filing suit will not work because I don't have time. This ruling was almost 3 years after filing and I don't have 3 years. I am trying to quite it to the drug companies where I am seeing expanded access, so far no go. I guess the next step is to contact Senator Brownback.

Any ideas, appreciated.....

06-05-2006, 06:34 PM	#10
rosie Senior Member Join Date: May 2006 Posts: 26	Dear Loving Daughter This is very interesting info. What really riles me is that the FDA is making suck a big deal of "making sure the drugs do not cause harm". What for terminal patients who will die? Isn't that harm enough? And besides Abigail Alliance is asking for access to drugs that have already gone through phase 1 or toxicity trials so the safety is known. Instead of shoving all of us patients deemed "terminal" as guinea pigs into the phase 1 trials because no one else will do them, allow us equal access to phase 2's. And it isn't even a question of terminal but thoise of us who have had too much treatment and might still be in pretty good shape can't get access either. I did speak with the lawyer involved in this case and the FDA HAS appealed it to the entire Court of Appeals so all judges will hear it not just the 3 selected. The FDA is not going down without a fight. Why? Because this ruling could change the very nature of the way the FDA does clinical trials and could force the pharmaceutical industry to provide drugs to patients but gain no informational benefit like a trial. so i say, start a separate pool of patients who fit into this ruling and have them signe a liability release and ask them to participate in their own trial. I am so mad. I have been on 5, count em 5 clinical trials. I have done my time, given of myself for science and have managed to outlive everybody's expectation which is the problem. Because now, darn it, I am still alive, have no more standard treatment options and can't get into an appropriate trial because I have had too much "successful" treatment. Geez, so therefore according to the FDA, it's time to roll over and die. No way, I have kids. But I can't get a break? Loving Daughter, if you have any ideas, I would love to hear them. I am told hiring and lawyer and filing suit will not work because I don't have time. This ruling was almost 3 years after filing and I don't have 3 years. I am trying to quite it to the drug companies where I am seeing expanded access, so far no go. I guess the next step is to contact Senator Brownback. Any ideas, appreciated.....