Cure 101/ Lobby Info

[alpentalic]

Dr. Wise sews it up on what can be done to speed a cure:

What can you do now? I recommend the following:
1. Take the time to understand spinal cord injury and the various treatments. I am here to answer questions and there are many people here with a great deal of experience. You need to understand things well-enough to make rationale decisions concerning clinical trials that will be coming.
2. Participate in lobbying your government to fund more spinal cord injury research and clinical trials. This can be in the form of letters or telephone calls. It is a long-term effort but it has to start.
3. You must prepare your body for clinical trial. This includes rebuilding your bone and muscle, getting your cardiovascular system up, and weaning down on any unnecessary drugs that you are taking. This will increase the probability that you will respond to whatever therapy.
4. Become educated and earn money. You probably think that I am kidding. I am not. Many studies have shown that the highest correlation with recovery from spinal cord injury is education and wealth.- Dr.Wise Young

Post

I have to admit I didn't follow the spinal cure issue before my injury. Each of the above points struck a "nerve". I wager the average person on this board isn't up to date on treatments or how to lobby local government/public awareness.

Use this thread to compile information, sample lobby letters, addresses, links, basic info, etc. Someone newly injured (like me) or otherwise concerned about SCI Cure could really benefit from a fundamentals crash course.

[antiquity]

Also check out the Funding, Legislation and Advocacy forum. Lots of sample letters and info. there.

/forum/forumdisplay.php?s=&daysprune=&f=24

[Karen M]

If one of your issues is hescr, you might want to visit Don Reed's www.stemcellbattles.com . He is an advocate extraordinaire! He has; who to write to, sample letters, easy explanations and more. There are good links too if that isn't exactly what you are looking for.
If we can't put 20 minutes a week on a few cut and paste letters or a call or fax, we better not be whining about our condition. Cures cost money. Put a donation jar in a liquor store. Do something. Make it happen!

[Wise Young]

Let me start with bite-sized nuggets:

1. Spinal Cord Injury. Spinal cord injury disconnects the body from the brain. The brain communicates with the body through long nerve fibers in the spinal cord, called axons. Axons carry sensory information to the brain and motor information to the spinal cord. Spinal cord injury does not necessarily kill the neurons above and below the injury, only the connection between them.

2. Restoring Function. To restore function, one has to get the axons to grow back to where they once connected. This growth is slow (probably no faster than the rate of hair growth) and may take many months or years. Another way of restoring function is to have surviving axons sprout new connections. Finally, some surviving axons don't function properly because they have lost the insulation called myelin. Thus, some therapies may be able restore function by stimulating sprouting or improving conduction of demyelinated axons.

3. Regenerating the spinal cord. Regeneration has long been thought to be impossible. However, much data collected over the past decade indicate that the spinal cord can regenerate. Almost all neuroscientists around the world agree that the spinal cord can regenerate if we provide a path for the axons to grow, sustained growth factor support, and blockade of axon growth inhibitors that are present in the spinal cord. Many therapies have now been shown to regenerate animal spinal cords and some of these are just beginning to go into clinical trial, mostly in Canada and Europe.

4. Promising therapies. Several cell transplants have been reported to regenerate the spinal cord. At least three classes of axon growth inhibitors have been identified: Nogo, chondroitin-6-sulfate proteoglycan, and ephrins. Blockade of these inhibitors have been shown to result in functional regeneration in animals. Strategies for blocking these axon growth inhibitors include covering the inhibitor (i.e. antibodies against Nogo), blocking the receptor (i.e. Nogo receptor blocker), enzymes to break down the inhibitor (i.e. chondroitinase), and receptor agonists and antagonists. These therapies have been reported to cause functional regeneration in animals and several of these are now beginning clinical trial in Europe and overseas.

5. Combination therapies have been shown to be more effective than individual therapies. Several laboratories have reported that combining two or more of the therapies together have more effect than any of the individual therapies. For example, combining a cell transplants (to bridge the injury site and to remyelinated axons) with drugs that increase cAMP (which tells an axon to ignore growth inhibitorsP) have been reported to produce substantial regeneration. Likewise, combining cell transplants with multiple neurotrophins is more effective than the cell transplants and neurotrophins alone.

Many of these therapies are ready to go to clinical trial. We need more funding for research that would optimize these therapies for human use, to take these therapies to clinical trial, and to asses whether or not they individually and in combination will restore function to people with spinal cord injury.

Wise.

[Wise Young]

What is the current status of spinal cord injury research in the U.S.?

Lobbying Congress requires some facts and figures concerning the current status of funding:

1. Federal Funding of Spinal Cord Injury (SCI) Research. The National Institutes of Health (NIH) is the main source of SCI funding in the United States. The National Institutes of Neurological Disorders and Stroke (NINDS) and The National Institute of Child Health and Development (NICHD) are respectively the lead institutes supporting neurological and rehabitative research on spinal cord injury. In 1997, when Congress decided to double NIH funding from $14 billion to $28 billion, NIH was funding about $64 million per year of spinal cord injury research. This rose to about $84 million by 2003, at the time when the doubling of NIH funding was complete. There was no increase of NIH funding from 2003 to 2006. In 2006, funding for spinal cord injury research declined to about $64 million per year. Thus, the NIH is probably spending less money on spinal cord injury research in 2007 than it was in 1995 (in inflation adjusted dollars) when they spent $48 million on spinal cord injury research.
2. Other Funding Sources of SCI Research. Between 1996-2006, several states decided to fund spinal cord injury research. These include Florida, Kentucky, New York, New Jersey, California, Connecticut, and about a dozen other states that are taking funds from speeding tickets, traffic tickets, driver license penalties for drunk driving, and other sources. These are probably providing about $21 million per year for spinal cord injury fnding in various states. Several organizations raise money for spinal cord injury research, including the Christopher and Dana Reeve Paralysis Association (CDRPA) and the Miami Project. Altogether, these sources probably do not raise more than about $40 millions total for spinal cord injury research.
3. The current funding situation for spinal cord injury is desperate. Many spinal cord injury researchers are either subsisting on state funds or leaving the field and pursue some other kind of research, such as bioterrorism and AIDS research. Since 2001, despite a glut of therapies that have been shown to regenerate the spinal cords of animals, there have been few clinical trials started in the United States. In the area of cell transplantation and stem cell research, which the United States led before 2001, there have been almost no clinical trials at all. Industry is reluctant to invest substantially into clinical trials for SCI research because it is regarded as a small market (approximately 250,000 people in the United States). It is estimated that it takes approximately $800 million to take a therapy from discovery to market. At the current rate of investment by the government and industry, i.e. <$100 million per year that is scattered amongst many therapies, we may not see effective therapies for spinal cord injury in our lifetime unless something is done about this funding situation.
4. A Pitifully Small Investment. The United States spends less than 1% of the costs of care of people with spinal cord injury on the research than can cure spinal cord injury. Several conservative studies have estimated that the United States spends well over $12 billion per year for the care and support of people with spinal cord injury. Yes, it spends less than $120 million per year for research that can cure the condition. A effective therapy for spinal cord injury that restores function to even 10% of the people with spinal cord injury has the potential to saving $1.2 billion every year into the future. It is very likely that research will yield therapies that can restore function to more than 10% of the people. Thus, investing in spinal cord injury research is economically rational and strongly supported by scientific research.
5. The goal of curing spinal cord injury is very worthwhile. For all of human history, doctors and scientists have considered this to be an impossible task. Now, most scientists believe that it can be achieved. The time required will depend on the investment that we put into the research. At our current rate of investment at $120 million per year, it may take us 100 years. If we invest at $1.2 billion per year, it is likely to happen in 5-10 years. The investment would be more than covered by savings on care. The savings of human anguish and suffering are incalculable.

Wise.

P.S. I am just typing these as quickly as I can and not stopping to correct typos or grammar.

[Wise Young]

What can Congress do?

Members of Congress tend to be action-oriented and they want to know what they can do for you. If they can do it and it comports with their policies, they will generally do so:

1. National Institute of Health Funding. This is the most important problem that faces us today. The NIH budget has not only been "flat-lined" for four years in a row, which essentially means a 3.5% cut every year due to inflation, but a great deal of NIH funding has been diverted to bioterrorism research and other unfunded mandates imposed upon NIH by Congress. This must stop. The original benefit of doubling NIH has essentially been abrogated by the last four years, since the end of the doubling period. According to NIH's own statistics, funding for spinal cord injury research declined from about $84 million in 2005 to $64 million in 2006. Less than 15% of investigator-initiated grants are being funded. More frightening, less than 2% of investigator-initiated grants are being awarded to investigators that are less than 42 years old. We are not only cutting off crucial research funds but the cut is falling predominantly on the next generation of scientists. Congress must increase NIH funding and stop the diversion of care and cure research funding into bioterrorism and no-child-left-behind research. These research, while worthwhile, should be funded by Homeland Security and the Department of Education.
2. The Christopher and Dana Reeve Paralysis Act. Everybody knows who Christopher and Dana Reeve are. Christopher died in October 2004, from a complication of an antibiotic therapy that he was receiving. Tragically, Dana in April 2006 that she had lung cancer, even though she and Christopher never smoked, and she died less than a year. While he was alive, Christopher lobbied for the Christopher Reeve Paralysis Act (CRPA) that would instructed NIH to fund six paralysis centers and a clinical trial network to develop and assess therapies to reverse paralysis. Although much desired by the paralyzed community, this bill never saw it through committee while Christopher was alive. The bill has been re-introduced in 2005, 2006, and now in 2007 as the Christopher and Dana Reeve Paralysis Act. It enjoys strong bipartisan support and allocates a modest $100 million for the establishment of the Christopher Reeve Paralysis Centers. The Reeve family is continuing to push for the bill. Please, it is time that this bill is passed, not just in memory of Christopher and Dana but for all the paralyzed people of the world.
3. Stem Cell Research Enhancement Act (SCREA). This bill authorizes the NIH to conduct research on human embryonic stem cells derived from blastocyts that would otherwise be thrown from in vitro fertilization clinics. The blastocysts are donated voluntarily by the parents. Human embryonic stem cell research is critical for developing stem cell therapies, for understanding human development, and will lead to important advances in treatments of cancer, neurodegenerative diseases, and many other conditions. The decision to halt all research on human embryonic stem cells derived since 2001 have essentially stripped the United States of its leadership role in stem cell research in the past six years. It has held back not only human embryonic stem cell research but human stem cell research of all kinds. The current restriction of human embryonic stem cell research has not saved a single embryo and in fact is encouraging unmonitored and unregulated use of humane embryos by private companies. It has encouraged abuse and probably misuse of human embryos while allowing the waste of many thousands of human blastocysts. The choice is not between killing the blastocysts or saving them. The choice is between throwing them away or using them to save lives. Congress has twice passed the SCREA by a large margin, only to be vetoed by President Bush.
4. Fund human stem cell research. Almost all scientists agree that human stem cell research is the future of our therapeutic industry and has the potential save many lives and reduce suffering of many millions of people. Yet, the NIH has funded less than $250 million of human stem cell research (of all kinds), less than 1% of its total budget of $28 billion. In fact, the NIH spent more than $10 billion on smallpox and anthraxvaccine, due to unwarranted fear of a terrorist attack using these two agents. If these funds were spent on stem cell research, we would have saved more lives than would ever have been killed by these two agents even in the worst conceivable terrorist attack. Bone marrow and umbilical cord blood stem cells, for example, have the potential to prevent not only all auto-immune diseases such as diabetes and multiple sclerosis, they are the essential first steps to a cure. For example, one would not want to replace the insulin-producing cells in the pancreas or remyelinate the axons in the brain and spinal cords until one has stopped the auto-immune process destroying the cells.
5. Fund science education. The United States has fallen far behind the rest of the world in its science education. At the primary, middle, and high school levels, children are performing so poorly that the United States has consistently ranked less than 40th in the countries of the world, lower than many poorer third world countries and way behind our major economic competitors including Japan, China, India, and Europe. College education has become so expensive that most middle-class families can no longer afford to pay for college education of their children. A majority of our graduate students are from overseas because there are so few American students who apply to PhD programs. For three decades, the United States has essentially coopted the young scientific talent of immigrants to the United States. This source of scientific talent is now staying within their own countries. The United States will have a unsustainable gap of well-trained American scientists to carry on the technology and biomedical research that has essentially fueled the American economic miracle. We have just starved the goose that lays the golden eggs. This situation must be reversed.

Wise.

[Wise Young]

I am sticking this topic up. People should add their info and I will keep editing and adjusting what I wrote and the supporting data. wise.

[mhinds]

Wise,

Given the sorry state of funding, research, and clinical trials in the U.S., the timeline for anything truly helpful to become available here is devastating. Should we be looking overseas? What do you know about the recently mentioned procedure done in Cologne, Germany by X-cell? It does not sound like a true combination therapy, but it seems to be getting some positive results. I would apprecitate your opinion on that one and anything else that bears looking at. Thanks

[Wise Young]

Wise,

Given the sorry state of funding, research, and clinical trials in the U.S., the timeline for anything truly helpful to become available here is devastating. Should we be looking overseas? What do you know about the recently mentioned procedure done in Cologne, Germany by X-cell? It does not sound like a true combination therapy, but it seems to be getting some positive results. I would apprecitate your opinion on that one and anything else that bears looking at. Thanks

mhinds,

I have no information other than what has been posted here about the X-cell study. I am not sure what exactly the trial will be assessing. There are very few places that are actually doing combination therapies. That is why I decided to focus the ChinaSCINet on combination therapies. But, in order to do combinations, you have to first test the indivdual therapies in phase 2 trials before bringing everything together in a phase 3. The more therapies you have, the more difficult it is to do the trial, to take care of all the regulatory issues, and to design the clinical trial.

So, just to test two therapies, we now have five trials.
• CN100. Observational trial. 400-600 subjects (20 subjects/center). This ensures that everybody can collect data.
• CN101. Phase 1 Open Label Lithium. 20 subjects. This assess safety and feasibility of lithium. I guess we also get an idea of what side-effects or effects lithium may have.
• CN102a. Phase 2 Lithium. Randomized Trial. 60 subjects randomized to a 6-week course of lithium or placeo. 6 month followup.
• CN102b. Phase 2 HLA-matched mmbilical cord blood mononuclear cell transplants ± methylprednisolone. We will transplant the cells into 60 subjects and randomize them to methylprednisolone or not. Animal studies suggest that methylprednisolone markedly increases survival of the transplanted cells and also minimized damage to the spinal cord. So, we want to make sure that the procedure works and whether or not methylprednisolone should be used.
• CN103. Phase 3 Cord Blood Mononuclear Cell Transplant ± Lithium. About 400 patients will be transplanted with mononuclear cells and then randomized to lithium or placebo. The reason why we need so many patients is because we want to stratify the study by ASIA A, B, C. By the way, there will be very few B's and we will probably pool A & B together. This means that there will be approximately 100 patients per treatment/severity group. This will allow us to detect 10% differences in neurological scores.

In terms of the time line, I can only give you my conservative goals. I use to voice my internal ambitious goals. However, when we don't meet these goals, people interpret them as failures.

We are doing CN100 and CN101 now. We need funding for CN102a and CN102b and we are working hard raising that money now. If we get the funding, those trials will likely start in Q1 08. CN103 should start Q3 08. That means it won't finish at least until Q1 10.

As I point out above, we will probably carry out some other phase 2 trials with other treatments in 08. I am going to start organizing trials in the United States. Even though things are more expensive, if the money is available, the trials can faster in the United States. In China, timing is less predictable.

Wise.

[Doug Wilburn]

dr young, i have not seen, and that doesnt mean i did not miss it, a response from you on the ricci kilgore video where she stated she had recieved treatments by the medra group. i would like your comments on this, please. also, what is the risks in having the treatments offered by medra? i mean if there is nothing to loose? other than $ why should one not try it?...... i continue to look for a way to get better while trying to be skeptical of offers in which medra seemed to be one of those and then comes the ricci kilgore tape on utube. so any input you have would be appreciated. thanks.

[artsyguy1954]

This is a good idea to put all the major sci and cure issues in a nutshell in one sticky thread. Otherwise it is very easy to loose sight of the "big Picture" due to the complexities of the individual issues. Good work, Wise.

[Wise Young]

dr young, i have not seen, and that doesnt mean i did not miss it, a response from you on the ricci kilgore video where she stated she had recieved treatments by the medra group. i would like your comments on this, please. also, what is the risks in having the treatments offered by medra? i mean if there is nothing to loose? other than $ why should one not try it?...... i continue to look for a way to get better while trying to be skeptical of offers in which medra seemed to be one of those and then comes the ricci kilgore tape on utube. so any input you have would be appreciated. thanks.

Rather than answering your Ricci Kilgore question (which I should not because an anecdotal case is not meaningful), let me answer the generic question, what do you have to lose? I put it in a separate topic: /forum/showthread.php?t=82828

Wise.

[Doug Wilburn]

thanks for your response dr young. it is very hard to continue to wait when your living with an sci. i hope to make the best decision i can and you do help lots with all your post and info. please continue and thank you for your hard work.

[TheRainman]

I got an email from barbera today from Stepnow asking us to email the president about his coming veto on the Stem Cell Research Enhancement Act. It gave us 3 options on what to say. The 3rd one was the only good one. Write your own.

The first two had no teeth. The president knows their is a large communty out there that could be help with this Act. So I emailed him a letter like this one.

Mr. President Bush. I'm a registerd voting republican and I would like you to pass the Stem Cell Research Enhancement Act. Until you do I will not vote for any republican that dose not support it. You forced me to vote for the democrates that do support it. And I belong to a large community that feels the same way.

Can anybody else think of a better way of telling these Yahoos. I'm tired of them supporting the religious right idiots.

[TheRainman]

Dr. Wise

Are you as surprised as I am that there was no replies to my last post. You would of thought you would of seen a few saying they have sent emails or letters using their vote as leverage.

I have seen others asking the communty to send letters with recommendation on what to say. And they all have no teeth to them.

This is a great communty for CARE but not for CURE. Everybody wants to act like sheeps. We need to act like lions.

These politicians care about one think. Staying in office. If Bushes advisers told him that it would cost him reelection two years ago if he vetod the stem cell act the first time he would of passed on it.

Dr.wise, I don't know how many members you have here. But if you want to get the sheeps to help pass the initiatives we need passed so we can walk again you need to direct them in the right direction.

And I'm just saying you need to come right out and tell them they can't vote for anyone that doesn't support our cause. Really how weak can some of these people be by voting for Bush, and you know who you are.

Why do you people think sharpten, jackson and falwell to name a few have so much power. They carry votes. Well this communty carries votes too. But you got to stand up(well you know what I meant).

Dr. Wise, you said in a prior post that we should send letters and emails. And I agree with you. I'm guessing that theirs 10,000 members here. If we sent 10,000 emails to these presidential candidates that don't support us and tell them that they are not getting our vote and the other guy is because he supports stem cell research. Thats like 20,00 votes to him. That will wake them up.

I know a lot of members are not going to like what I wrote, but it's the truth. You can keep complaining that they don't pass this and that. But they really don't care about us. They care about their jobs.