Live from Working 2 Walk 2011!

[Jawaid]

Kate any news from Neuralstem?

Being lumbar injury patient interested what is going on for lumbar injuries.

Will Neuralstem be taking old injuries in trials? I mean 10 years or old?

I guess they will start trial with lower injuries which is good news for us

[cheesecake]

Thanks nrf! My insurance is out. They pay for nothing! I guess I need to check back with RTI. FWI, didn't Dr. MacDonald help start this?

Dr. McDonald is no longer part of the company. If you want grant info, PM me and there may be some grants that will help fund the bike.

[kate]

Conversation with Jerry Silver

Me: What I heard you say earlier is that you're not here to troll for dollars.

JS: That's right. What I have seen is that people do these small lesions in animals and get them to do a small task better than if they hadn't got my special treatment after that lesion . . . and then try to extrapolate that and spread false hope about what that means for humans, you're not being completely honest.

The preclinical data is not strong enough to justify the claims you're making.

I have a strong feeling that we should not create false hope . . .

Q: but isn't there a difference between creating false hope and stimulating discussion?

Sure, but it's wrong to say that because we've fixed this lesion in a rat, we're going to fix all of you. The next step should be to fix a huge lesion and therefore I'm going to fix all of you. And then lets get the funds shunted to chronic injury. We need money channeled into legit injury models. Neilsen, Reeve, NIH -- there's a lot of money, and you should get some. If anybody can do this, it's you guys. w2w, unite2fight. you guys have influenced ME.

Can we make incremental steps? Damn right, and we can do it now.

Q: but what about the business side of this thing? does that get in the way of progress?

The company with the patent is Acorda. . . let's get them to use their money to start helping people.

The most important thing I said this morning is that in your cord there is a slow and steady plasticity . . .the fibers are all looking for whoever is left to tell them what to do. When we put ONE injection of Chase into an animal that had had a c2 hemisection for a full year, that animal recovered nearly normal breathing. That animal recovered BETTER than an acute. In a single week. We found something that works better in chronics than in acutes.

Okay, so that was a conversation that went on for about 45 minutes, and what's written above is obviously just a snitch of it. The thing Jerry kept repeating over and over is that u2fp is positioned (finally!) to really get traction -- that the tools and the drugs have been studied enough -- that it's time to get to human trials, and he's willing to help us figure out how to get there. It won't be easy, or necessarily quick, and of course there are no guarantees about what the results will be. That said -- and this is just me talking -- something has changed in a really good way in this effort.

A lot of us know that when Wise Young put this site together, he thought that it would be a natural next step for the community to use the space to organize and work for the cure. To his surprise, that never happened -- until the death of Chris Reeve. CR's death was the catalyst for a few CC members to organize the 2005 rally in DC. The following year that little group organized the first Working 2 Walk science symposium, and this is the 5th iteration of that event. I wish you all could have been in the room with Jerry Silver . . . he's an old guard kind of guy, someone who's been in this game for decades. He was -- my impression -- stunned in a really good way to find himself surrounded by knowledgeable, passionate, articulate people in chairs. He'd never seen anything like it.

I'm not saying this to be bang the drum for u2fp, but to say that finally, finally, there is traction. We -- the sci community through the efforts of our friends at u2fp -- have the attention of people who can help us, and we're in a position to ramp it up to another order of magnitude.

[kate]

Michael Werner, Executive Director, Alliance for Regenerative Medicine

This morning all that's left to do is prep people for their visits to Capitol Hill. A lot of people are still here, getting ready to go make their appointments and because it's the first time for a lot of them, they need some talking points.

Michael Werner: It's fantastic that you guys are here . . . I know it's physically challenging for a lot of you, and even if not, you've obviously dropped what you were doing to show up.

If you live in DC, you kind of know that people have to disrupt their whole lives to get here. When you meet with your representatives, know that you bring a power that no paid lobbyist can match. When I talk with them, they always ask who in their district cares about this.

When I was in Senator Klobuchar's office, they wanted to know who in Minnesota cares about this . . . they hadn't heard from anybody in Minnesota who wanted this to happen. They weren't going to consider it until they heard from somebody in Minnesota. (I'm laughing, thinking of Sue Maus and her army of family members rolling into that office. "Hello! We're all from Minnesota.")

Another story . . . I heard a staffer say in the course of a conversation about a bill, "If the pharmacists don't like this, they're going to make my life miserable if I support it. They've got me on speed dial and they will not leave me alone until they have a promise that I won't support it."

Some key points about the legislation you're asking for:
1. there is no national strategy to support regenerative medicine
2. there are lots and lots of conditions that cost the country in terms of both social and economic terms -- conditions that are the subject of hundreds of clinical trials, a ton of basic research, etc.
3. there's enough evidence to show that
4. we have a kind of half-assed policy . . .a lot of one-off projects but no coordinated strategy, no sense of urgency
5. why?
6. there's a national strategy for broadband technology, there's a national strategy for alternative energy, there's a national strategy on semiconductors, but not in regenerative medicine

The bill is HR 1862, The Regenerative Medicine Promotion Act -- it contains provisions to launch a national strategy.

It doesn't cost a lot of money, which is really important. The first thing we ask for is for the GAO (government accounting office) to do a strategic assessment . . . what are doing now, who is funding it, are the agencies talking to each other? There are 9 NIH institutes that fund regenerative research. Anybody here from NIH? No. I promise you, they're NOT communicating with each other. (Stephen Davies speaks up to say that only 7% of applications are now being funded.)

So, how would I find out what the NIH -- all of its 21 institutes -- are doing in regenerative medicine? You'd have to call all of them. How would I know who to talk to? You wouldn't. And you know that they're not talking to the Dept of Defense. If you talk to the fda, they'll suggest that it would be great if there was some research . . . and the NIH will say, yeah, but our research agenda is our own thing.

The other thing in the bill is to develop a set of goals and performance benchmarks and prioritize them. Let's get patients and doctors into that conversation. It's remarkable, but nobody's ever done this.

Finally, let's get the NIH to fund collaborative research . . . so that academic investigators can get funding even if they're working for companies. Let's get translation going. The NIH will say, oh, we do that. But they don't spend a lot of money on it, and it's not a focus. And let's go to the fda to get some regulatory research to figure out what the holes are in their understanding of how regenerative therapies work, in the hope that they'll

Okay. Congress is, as everybody knows, bitterly partisan right now. It is. But we've been able to bridge the gap between the parties. We've been able to talk to members of both parties, even in the house . . . when we first went to the hill to talk about this, people were laughing at us. They said we'd never, ever get the parties to cooperate. But we've done that. Part of the message is that it's not a conservative or a liberal; that doesn't matter.

One thing the congress has to do this year is pass a law called the prescription drug user fee act (PPUFA). That bill has been us law for a long time. It's a fee that companies pay the fda to review their applications. That law is set to expire, which means it will have to be renewed, or else the fda will lose 10s of millions of dollars.

This means that congress IS going to pass this law . . . and that means that congress IS going to have a conversation about curing disease. So you can say that you know there's going to be a debate about this, and you want the regenerative medicine promotion act included in this bill.

It's a fact that it's very hard to get congress to do anything. Inertia rules. And yet this is a real opportunity. They're not going to say, "Wow, I'm on board." That would be like catching a foul ball at the baseball game and having a scout run up to you and sign you up for the team.

That won't happen.

But you will have started a conversation, and you will therefore be able to keep that conversation going over time. You want to be the person -- like those pharmacists -- who has that staffer's number on speed dial, who checks in frequently to say, "Hey, are we making any progress?" Things NEVER get solved the first time you talk. Ever.

When you go to the office, you need to have a specific request. It's this bill.

How about the senate? Different deal . . . lots of Democrats are on board with this, but no Republicans . . . so if you're in Republican's office, focus on your situation and ask that they step up and support this.

What's the first question they might ask?
What the heck is regenerative medicine?

Second thing is, we don't have any money.
This isn't going to cost money -- it's going to redirect existing money.

Third thing is "my boss thinks esc is unethical."
That's a tough argument, right? My answer is, we're talking about something that's much, much broader than esc . . . you can support regenerative medicine and still be against esc. This bill is about consolidating and assessing and making a national strategy. Esc is small slice, a single tactic, that may or may not fit in to that national strategy. If they demand that esc be explicitly forbidden, the best thing to say is, "why not let science decide."

Remember that these people have meetings all day. It's what they do. All day, every day . . . can you imagine how these things must run together? Your job is to stand out, which is a big challenge. You're trying to make a connection, to be memorable, to be the one meeting that sticks in their mind. I have a friend who never leaves a meeting without asking "So where are you from?" and taking the answer and running with it . . . it's seems cheesy, but it works.

Q: Who is the Alliance for Regenerative Medicine?
A: It's a broad collection of advocacy groups, (Parkinsons Action Network, ALS, Juvenile Diabetes, etc.) and companies, and research organizations.

This is a multi-year project, okay? It's going to take a long time to make all these things happen. But you've got a problem NOW, and every day that it takes the government to do this is another day that you face that problem. What you have to do is understand that it's up to you to create the urgency; to say "I don't want to come back next year and be asking for the same thing. I want to come back next year and be thanking you for everything that's been accomplished and figure out what's next."

[SharonD]

Thanks nrf! My insurance is out. They pay for nothing! I guess I need to check back with RTI. FWI, didn't Dr. MacDonald help start this?

momo3, we had to fight for our FES but we got it. Insurance declined, we appealed and then we reapplied through Mediciad. Our rep at RTI did the leg work, it took some time but was worth it. Good luck!

[Jim]

Did I miss the part on Dr. Steven Davies?

[kate]

Did I miss the part on Dr. Steven Davies?

Dr. Davies gave a breakout session, Jim, but he asked that it not be blogged or broadcast as he didn't want to interfere with getting new work published.

Sorry ~~

[Jim]

Thanks Kate, you did an excellent job once again!

[Johnnie Walked]

whaaaattt ! I dont believe this guy

[Johnnie Walked]

Dr. Davies gave a breakout session, Jim, but he asked that it not be blogged or broadcast as he didn't want to interfere with getting new work published.

Sorry ~~

whaaaattt! I dont believe this guy

[east dragon]

Dr. Davies gave a breakout session, Jim, but he asked that it not be blogged or broadcast as he didn't want to interfere with getting new work published.

Sorry ~~

Maybe dr.Davies have a major breakthrough!!!!!

[Schmeky]

Maybe dr.Davies have a major breakthrough!!!!!

If the past is a predictor of the future, probably not. I was assured back in 2005 there would be results using decorin in a chronic rat. That was 6 years ago, nothing so far for chronics.

Davies alluded to a blockbuster paper that was printed this year, by all measures it was a blockbuster for Davies, not necessarily for people in chairs.

Others have moved past Davies, such as Invivo, Dr. Young, trials in Brazil, China, trials coming to India, Norway, the USA, etc.

[kate]

u2fp just made it into Scientific American!

A new experiment aimed at achieving actor Christopher Reeve's dream of finding an effective treatment for spinal paralysis was announced this week at an international meeting of scientists and people with spinal cord injury sponsored by the United 2 Fight Paralysis Foundation.

And the article features our Irish friend, Martin:

"This is great news—very exciting," says Martin Codyre, of Greystones, Ireland, "but I am frustrated because this [experiments in humans] should have happened 15 years ago."

If you have a facebook page, please link to this article and carry the message out into the world . .. we can create momentum only if people see that we exist, understand that there are therapies that need to be tested, and know that the matter is urgent.

article

[lynnifer]

I know I'm easily swayed by males with charming talk (lol), but I am really liking that Jerry Silver with what he has to say! He is direct and to the point. In fact, I have chosen not to do any of the usual paralzyed options with my flaccid bladder hoping that nerve grafts will be here in less than ten years.

I've been so disappointed by males - don't disappoint me Doc Silver! Hi ho and away!

lmao

Let's hope Acorda doesn't screw this up again (famipridine trials).

[kivi66]

jsilver, sorry for, as lynnifer once characterized it, "impossible question", but nevertheless, how close we are to some "YES, WE CAN" probability? No promises, no predictions, no speculations, but experimenlally founded and well-considered analysis of the current situation.