Cure 101/ Lobby Info

[Varian]

WE are always stronger in groups we should advertise the chat room on rutgers more aggresively on here. If a pack of us frequently talk in a chat room it would help us move in a type of lench mob with specific daily goals more effectively.

For instance having a master list of all political leaders email addresses on a web site for ease. I believe face to face is ultra key. But it would seem wise to stake out the offices of the politians and catch them to their cars from teh office. Or buying them lunch. Delivered by you or the restuarant with a card emphasizing the need for a cure.

[Don D. 73]

I would like to see more examples of really good "fill in the blanks" letters. Composing really effective letters can be a real challenge for us. Literally, the act of folding a paper letter, inserting it into an envelope, and applying the postage, all can be a real challenge for some of us. It's just another bitter pill to swallow for many of us unable to achieve even the slightest bit of independence.
So anything that the more able-bodied members of our community can do to facilitate the type communication to our various elected officials would be greatly appreciated by myself and other high quads.

[wysong417]

I have an idea , why doesn't someone write a letter all of these polititians trying to get votes for office and let them know thats its not a question if theres a cure but just a matter of time and let them know how many votes they'll be missing out on if they don't make an effort to address this problem and fund research and get as many of us with sci's to sign it as we can. I mean the power is in numbers, and if we all get together and take serious action I know we can make something happpen. I'm not the only one who's tired of being paralyzed and ignored by everyone who can make a difference. If we can put our heads together we can definately raise some eyebrows.

[Han Solo]

Thia question is for Dr. Young. Dr. Young, I'm curious what would be a reason for the FDA to put a hold on a clinical trial. If theres sufficient data on therapies and it is shown to work in laboratories, like Dr. Davies decorin research, then whats the next step in getting the ball rolling? Is it the funding, or if its shown to work will they give a grant. I'm curious because I was at working2walk 08 and I spoke with Dr. Davies and he all but assured me that clinical trials were on the horizon. Also if his work is as great as it seems then how come it will take 2-3 more years to be approved. If you could shed some light on this subject it would be appreciated. Thanks.

[Wise Young]

Originally Posted by Han Solo

Thia question is for Dr. Young. Dr. Young, I'm curious what would be a reason for the FDA to put a hold on a clinical trial. If theres sufficient data on therapies and it is shown to work in laboratories, like Dr. Davies decorin research, then whats the next step in getting the ball rolling? Is it the funding, or if its shown to work will they give a grant. I'm curious because I was at working2walk 08 and I spoke with Dr. Davies and he all but assured me that clinical trials were on the horizon. Also if his work is as great as it seems then how come it will take 2-3 more years to be approved. If you could shed some light on this subject it would be appreciated. Thanks.

Han Solo,

At the level of phase 1 trials, the FDA is primarily concerned with safety. If you can prove that a treatment is reasonably safe, the FDA will generally permit the trial to go ahead. By the way, the treatment does not have to be completely "safe" to be tested in clinical trial but the risk should be balanced by potential benefit. Much depends on the therapy.

Usually, the FDA is cautious when it comes to new therapies that have never been applied to humans. In such cases, they require a full set of studies in small animals (rodents) and one large species (cat, rabbit, dog, pig, monkey) showing safety. What is safe? Mostly, the FDA requires that the proposed treatment dose and route will not cause cardiac, liver, kidney, and brain damage, or cancer. There is a separate requirement to rule out teratological effect, i.e. effects on developing fetuses, before they will allow the treatment to be used in pregnant women.

If the risk is significant, then the risk must be balanced by potential benefit. Of course, if the risk is low, the FDA does not require as much proof of benefit. For example, in a disease where the person will die without therapy and there is no therapy, a treatment that has potential of slowing or reversing the disease will be allowed despite significant risks.

In a condition where the risk of death is low, the FDA may be reluctant to approve a risky therapy without convincing evidence of efficacy. For example, I suspect that this may be the reason why the FDA put on a hold on the Geron study because the risk of life-time immune suppression is high and the potential benefits of the therapy for ASIA A patients may not have been convincing. The FDA may be more willing to approve a trial on SMA (spinomuscular dystrophy) or ALS (amyotrophic lateral sclerosis).

I am not sure of the status of decorin. I do hope that we will hear more about it because I have invited Stephen Davies to speak at the Third International Spinal Cord Injury Treatment and Trials Symposium, which will be held in Beijing on October 30 to November 2.

Wise.

[Wise Young]

I moved this thread to the FLA forum because it is more relevant here and was not getting many views in the Cure Forum.

Wise.

[mswestfall]

I am trying, without much luck to find out if there is an update to legislation and advocacy for spinal cord injury? The media attention is focusing on raising money privately; however, what is being done to increase government funding? It seems the current administration is giving money away to just about any organization. Other than the Reeve Foundation is there an advocacy group? I understand we should be writing to our governmental officials; however, to me, I don't feel that's enough. The last update regarding legislation via this forum was 2007-08...to me that should be an ongoing action item if a cure is a top priority.

[Karen M]

Check out Unite 2 Fight Paralysis www.u2fp.org