Friday, February 6, 2015

National MS Society FAIL! Repeatedly Refuses to Fund Only Ongoing FDA Approved MS Stem Cell Trial…

The National Multiple Sclerosis Society (NMSS), by far the largest MS nonprofit organization in the US, has three times rejected grant applications from the Tisch Multiple Sclerosis Research Center of New York, which were submitted in an effort to procure funding for what is now the only FDA approved regenerative stem cell trial being conducted on MS patients in the nation. The trial in question uses a very sophisticated approach to this experimental therapy, arrived at after over a decade of development in the laboratory, in an attempt to repair nervous system tissues damaged by multiple sclerosis (click here). The failure of the NMSS to help fund this trial is, at the very least, extremely disappointing, and should be of great concern to all those who support the organization.

The goal of nervous system repair and regeneration has long been a Holy Grail of MS research, and investigations into using stem cells to achieve this end hold terrific potential. MS patients around the world are eager to see stem cell research accelerated, as dissatisfaction with current treatment paradigms runs rampant in many segments of the MS population. Patients with the progressive subtypes of the disease are especially desperate for innovative new treatment approaches, as no existing therapy has been shown to put a dent in these especially insidious forms of multiple sclerosis.

The level of desperation felt by many members of the MS community has fueled a rapidly growing medical tourism industry largely comprised of unregulated offshore clinics offering unproven stem cell therapies at prices that can easily amount to many tens of thousands of dollars. The lure of copious bundles of cash to be made by offering such therapies has attracted at least one despicable con artist into the fray, as I wrote about in my last Wheelchair Kamikaze entry (click here). I fear there may be many more lurking in the weeds.

Given the current "Wild West" atmosphere surrounding the commercial MS stem cell industry, it is vitally important that precious research dollars be expeditiously directed to legitimate, scientifically valid stem cell studies being conducted by the best of the best, scientists with proven track records of academic and scientific achievement in the fields of MS and neurodegenerative diseases. Just last week, the Canadian MS society announced that it was providing $4.2 million in funding for a 40 patient trial to be conducted by some of Canada’s most respected MS neurologists (click here). While the American NMSS provides funds for preliminary research inquiries into the use of stem cells to treat MS, most of them using animal or test tube models of the disease, the organization has inexplicably chosen to reject grant proposals submitted by the Tisch Center, despite the fact that the Center’s trial received a hard won FDA approval – the lack of which was cited by the NMSS as reason to reject the first grant proposal submitted by the Tisch Center – and is using a more sophisticated approach than any other regenerative MS stem cell trial to date.

Most previous attempts at using stem cells to repair MS damage have involved intravenously infusing a basic type of stem cell (called mesenchymal stem cells) back into the patient from which they were taken. The Tisch Center is taking this approach several steps further, using proprietary methods to transform raw mesenchymal stem cells into a type of stem cell known as neural progenitors, which are specific to the central nervous system. The cells are then injected directly into the spinal fluid of trial subjects, where, in theory, they should be more effective at effecting repairs and combating the disease. The first phase of this trial is now underway, and many of the trial's human subjects (including Richard Cohen, noted journalist and author – click here) have started receiving their stem cell injections.

I am a patient at the International Multiple Sclerosis Management Practice (click here), which is the clinic closely associated with the Tisch Research Center. I am therefore very well acquainted with the principal investigators running in this trial. I’ve been aware of their arduous efforts in the area of stem cell research almost since the day I became a patient at the clinic, in the summer of 2004, under the care of Dr. Saud Sadiq. The Tisch Multiple Sclerosis Research Center (click here) – which is funded entirely by a private, nonprofit foundation that is unaffiliated with any hospital, academic institution, or government agency – worked extremely hard at getting the FDA approval before embarking on their trial, submitting applications to the regulatory agency several times before finally getting the coveted approval in August 2013.

Unfortunately, receiving FDA approval and procuring the funding needed to proceed with the trial were two separate battles. In today’s tough economic environment research monies are difficult to come by. After receiving their FDA approval, the Tisch Center submitted two subsequent grant proposals for vitally needed research funds to the National Multiple Sclerosis Society, both of which were rejected without any viable explanation. Subsequently, the Tisch Center mounted extraordinary efforts to raise the necessary capital, culminating in a crowd funding effort through the Internet site Indiegogo (click here). The final $300,000 needed to start the trial was raised through this online effort, in large part from donations by patients themselves and those who love them.

With the first phase of the trial now underway, the researchers and administrators at the Tisch Center have their hopeful eyes fixed on phase 2, which is expected to expand the treatment to a greater number of trial subjects using lessons learned during the first phase of the study. This projected expansion will naturally require additional state-of-the-art equipment to be purchased and world-class researchers to be hired, and private fundraising efforts are already underway to procure the financial resources needed to facilitate these necessities, which are expected to require more than $1 million of investment.

I’m fully aware that the NMSS does some extraodinarily good work on behalf of the MS community. The organization not only funds research but also provides education and support to tens of thousands of MS patients in the United States, and has innovated many programs designed to help the MS community in a wide variety of ways. I consider several employees of the National Multiple Sclerosis Society friends, and the NMSS workers with whom I am acquainted are wonderful, bighearted, talented people fully dedicated to the cause.

I also know, though, that the NMSS – which has become THE face of multiple sclerosis to the American general public – has grown into a multi million dollar a year many tentacled behemoth, too entwined with and reliant on mainstream medical dogma, the pharmaceutical companies, and, perhaps on institutionally subconscious level, an increasingly unacceptable MS status quo; and that it can play unnecessarily rough when working with other, smaller MS nonprofits, which are often left to scramble for the fundraising scraps the NMSS leaves behind. That said, it is the knowledge of the power and potential for good represented by the NMSS that makes its repeated rejections of the Tisch Center’s vital research so discouraging and disheartening. One can only question the decision-making processes involved within the Society that would lead to the withholding of much needed funds from the Tisch Center, a transparent, fully certified nonprofit organization staffed by world-class researchers and some of the most caring physicians I’ve come to know, who are conducting cutting-edge stem cell research that has the potential to completely transform the MS treatment landscape.

As a patient with progressive MS who is watching himself slowly circle the drain, I’m outraged at the NMSS’s actions (or lack thereof) in regards to the Tisch Center’s ongoing stem cell trial, and as a human being who knows firsthand the dedication of some of the national organization’s staff I find myself confused and deeply saddened by the Society’s behavior in this regard. If there are politics at work, well, get over it, and if there are some other tangible objections the NMSS has to the Tisch Center’s research, by all means, state them loud and clear so they can be properly addressed. Time, and brain, is wasting…

For more info on the Tisch Multiple Sclerosis Research Center of New York (click here).

The contact number for the National Multiple Sclerosis Society is 800-344-4867. A list of the NMSS senior leadership team, including email links, can be found by (clicking here).

44 comments:

  1. I am circling the drain too. Few big, long-established non-profits will fund efforts that will lead to their disappearance. Pharma doesn't want to cure MS, it wants to manage it over every patient's lifetime. They're profit seeking companies. Non-profits aren't, of course, but I've never seen one that's really interested in putting themselves out of business. They should be...

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    1. Yes, the pharma industrial complex is wary of stem cell therapy cutting into their profits. If the NMSS wants to discourage "medical tourism" for bogus stem cell therapies they need to support reparative stem cell studies at reputable institutions. Stem cell science will proceed with or without support of the NMSS - its potential has numerous medical applications in addition to spinal cord repair.

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    2. The NMSS lost supporters when it caved to pressure to investigate CCSVI, with much the same rhetoric behind the criticisms. Now, I do not think that was money wasted in that it hopefully prevented people from cutting their necks open for no reason. I think Dr. Zamboni was well-intentioned and not a scam artist. I think the same of those researching HSCT. I hope that the NMSS provides funding because of how tantalizing the efficacy is in the data coming out of Chicago. However, I also hope that we can fast track some of these medications and procedures like Herceptin was for breast cancer sufferers. Our litigious climate does us no favors who have the SPMS clock ticking, and losing functionality and dignity every day.

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    3. The medical industrial complex is rife with conflict of interest issues. The fact that pharmaceutical companies are publicly traded entities beholden by statute to their shareholders, not to the end-users of their products, means that a drug company CEO could be considered to be in violation of his mandated duties by guiding his company to investigate potential products that could negatively impact his bottom line, as a cure for many chronic diseases almost certainly would. Nice system of medical research we've developed…

      Just to make sure there are no misconceptions, CCSVI therapy did not involve people getting their neckes cut open, rather the procedure used was similar to minimally invasive balloon angioplasties that are one of the most common surgical procedures done. Not that CCSVI therapy was necessarily effective, but it has led to some investigation into the role of vasculature and neurodegenerative diseases, which may bear some scientific fruit. At one point there were some offshore clinics offering open neck jugular vein surgery, but I don't think any of the "mainstream" CCSVI advocates or practitioners ever embraced this approach.

      HSCT certainly holds tremendous potential, and the recent trials were funded, in part, by the National Institutes Of Health. Having spoke& to some of the neuroimmunology team at the NIH, I can tell you that they are very optimistic about HSCT, some even suggesting that it may become the standard of care for many MS patients in the not-too-distant future.

      I do agree that work on drugs for the progressive forms of the disease should be fast tracked, but as these forms of the disease are even less understood than RRMS, the prospects of finding an effective pharmaceutical solution may not be all that bright, especially for patients whose disease is past the active inflammatory stage. Still, it is encouraging that at least investigations have started, as progressive disease was ignored for way too long…

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    4. Marc, I believe the business relationship the NMSS has with a stem cell company is the reason they won't support the Tisch study. I regret I do not remember the name of the company, but they issued a press release in 2011 or so and I remember looking into it then. The product was going to be an-off-the-shelf stem cell injectable that pools cells from 1000's of donors. Like gamma globulin. Pharma is pushing this over using your own mesenchymal stem cells and having them expanded. So they can profit off of stem cell technology. Otherwise you are using your own cells to cure disease and they are shut out. The NMSS loses too, so they hooked up. This is also, as I understand it, the crux of the CellTex lawsuit. FDA allegedly changed one word in the stem Cell regulation without due process (underground regulation) that makes mesenchymal stem cells a "drug" and therefore under their jurisdiction. Otherwise it was up to the states. Rick Perry (Gov. of TX) had a great result for a bad shoulder, so he allowed CellTex to operate. They are supposedly doing trials soon with Baylor. They licensed Korean technology similar to what we use every day in veterinary medicine, and it sounds not too far off from Tisch. They thought that they could open centers across the country until that one word change. I'd have to do a bit of research to get the specifics, I believe there were SEC filings. not sure if court documents are public yet. But if you want them I will search public records.

      I hope they work it out and get FDA backing because it looks like good technology, similar to Tisch. I'm all for FDA supported research but they need to lighten up a bit, open up, and work with companies who are trying new technology for horrible diseases. I firmly believe our only hope is right-to-try legislation and government funded research. I believe we can get bi-partisan support. We also need to demand that all research results be published and access be opened up. Let the sun shine in. let's go to D.C. and statehouses and crash the NMSS-Pharma party! You Rock, thank you for speaking truth to power.

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  2. it seems that we are left to our own devices. i am not a very accomplished searcher of the web, and reading all of these astories is frightening. thank goodness for you, Marc. I appreciate the fact that you do much in the way of research for so many of us.

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    1. Hey Veronica, nice to "hear your voice", it's been a while. Hope things are going as well as well can be for you. I very much appreciate your kind words, doing all of this research is kind of therapeutic, helps me hold onto my sanity and serves as sort of an umbrella against the storm. If that makes any sense…

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  3. I think the USA is circling the drain. Power, political agendas, profit. Humans are expendable. What is the polite term...collateral damage. ? And, MS is a war. Never understood the art titled "The Scream". Now I do. Keep your voice loud, Marc.
    Hilda

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    1. I always loved "The Scream", identified with that even when I was healthy. Now, I don't think the character depicted is looking anguished enough…

      The world certainly does seem to be coming loose at the seams. I find myself wishing more and more that the news I'm watching on TV was fiction. Much love to you, Hilda…

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  4. I second Veronica's comments. As a person with PPMS, I rely on you, Marc, to keep me informed and you never let me down.

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    1. Thanks, Melinda. Very glad I can be of some service…

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  5. I once received a NMSS magazine with an extra cover that was an large ad for one of the CRAB drugs.. I ripped it off to find the regular cover underneath. That was the last straw for me as it made obvious the organization's ties to the pharmaceutical company -- so closely tied that they would allow this advertisement to pose as the cover of their periodical.

    I've been cynical about them ever since. I am not a member, I don't make any donations to it, and I don't sponsor anyone on one of those MS bike rides or walks that benefit it. If I'm asked to do so, I tell the biker or walker that I will instead make a donation in their honor to another autoimmune disease organization or association that I do trust. AARDA, for example, or CCSVI Alliance or some individual study that I've heard about such as the Tisch stem cell project that you mention, Marc.

    I, too, am aware of all the good people who are on staff there or on the board. I agree that the organization has done much to support people with MS and that work is to be commended but on research or advanced thinking on cures for the disease, they get a big red F in my book.

    The world will eventually find a way to cure the disease(s) that are MS and also repair the myelin and then where will these organizations be? Gone for lack of need. It's just human nature to hang on to what you have and what makes you feel good/useful/important.
    .

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    1. Daphne, all excellent points. I find myself deeply disturbed when the NMSS magazine arrives and almost every advertisement is for a pharmaceutical product. It's downright unseemly. Having said that, yes, there are very good, dedicated human beings working at the NMSS, and the organization does do a lot of good things. However, as you note, it's very existence relies on there being MS, and therein lies the problem. The individuals I know who work for the society would gladly give up their jobs to see a cure for MS discovered, but institutions tend to have a sort of corporate self-preservation instinct, and the influence of Big Pharma is a poison pill, IMO. And that goes for the medical industry as a whole, not just the NMSS.

      BTW, if you are looking for alternative groups for which to recommend donations, might I suggest the Accelerated Cure Project and/or The Myelin Repair Foundation, in addition to the Tisch Multiple Sclerosis Research Center.

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  6. Hi Marc, who are the people in the Tisch Center?
    I often wonder if there are 'other' reasons why these innovative people don't receive the research support they need?
    And of course there is the 'accounting' of the funding allocations from the MS Society, the staffing costs is one area that is 'dubious'!

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    1. The Tisch center is staffed with world-class researchers and lab technicians with credentials from some of the best academic institutions in the world. I would urge you to check out the link to their website, above, as they are doing much important research in addition to the stem cell trial. It's a very impressive, very innovative organization.

      Of course, the staff at the NMSS does deserve to be paid, but one of the problems is that the organization has grown so large that in order to compete for talent it must pay competitive wages. While seeing a corporate CEO being paid $500,000/year would hardly raise any eyebrows, that same yearly salary does seem just a tad obscene for the head of a charitable nonprofit. Not quite sure what the answer to this particular problem might be…

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  7. Barbara/Stem Cell PioneersFebruary 6, 2015 at 3:16 PM

    Great, well written article Wheelchair Kamikaze. I don't have MS. I have COPD, but understand the frustration here. The American Lung Association is still in the someday in the future "hoping to move forward" stage while at the same time advising people to go to the ISSCR site for information. This from a charity that rakes in millions and millons of dollars annually. Truly unbelievable. http://www.lung.org/finding-cures/research-news/stem-cells-cell-therapies.html

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    1. The fact that so many chronic diseases have effectively been turned into multibillion-dollar a year industries lies at the root of the dysfunction that so many of us patients pick up on. Patients should never be seen as consumers, but unfortunately that's how we are viewed all too often. The problem is compounded by the fact that most people don't care to contemplate such issues until they fall ill, and are thrust into the belly of the beast. And then, it's all usually too little, too late…

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  8. A few years ago, I was curious why the NMSS would not fund research of GIFT-15 (a potential cure of MS, being researched in Canada). I decided to look through the NMSS website to find out why. After quite some time, I finally figured out that the NMSS will only fund research into "treatments" of MS, not cures. No where in their website do they ever use the term cure. They will not fund potential cures, they do not want potential cures. They are only interested in ongoing "treatments". My wife and I both battle with this disease. After being an ambassador for the NMSS and even going door to door at the Michigan State Capitol to talk to senators and congressmen on behalf of the NMSS, I too no longer have anything to do with them

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  9. Meanwhile, funding goes to things like videos advising MS patients about obvious best practices in living with the disease (i.e. depression can be dangerous, try not to fall down, etc.). It's not that such information has no value. It's that, of course, sufferers need true help: a cure. Thanks for continuing to speak out, WK.

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    1. I do intend to continue to speak out. As regular readers of these pages know, I just love it when researchers conduct studies that determine that MS patients tend to fall down more than healthy people. Oy vey…

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  10. I am surprised the NIH does not help fund this. I am so cynical about the MS society at this point, I don't even want to comment. Edifying as usual, Marc!

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    1. Unfortunately, the NIH has seen its budget squeezed in these days of governmental belt-tightening and funding wars. The price of two or three fighter aircraft would probably pay for enough research to crack some of our most heinous diseases, but, you know, priorities…

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  11. I had violently wobbly legs Monday, terrible vision and depth perception Tuesday, Wednesday I woke up 'fine' and drove 25 miles and made a half dozen stops, exhausting and eventually nauseating. Thursday morning panic attack depressed me all day. A little bleary today. So what is that, about six prescriptions I could be doseing? Eight? That would be a lot of doc appointments too.
    Crowd-sourcing to side step the leeches as possible is positive progress. We need our Michael J Fox...
    Thanks for all the work Marc

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    1. Gee, Tom, you had such an adventurous week! Wobbly, blurry, nauseous, bleary, and anxious. Sounds like the members of a punk rock band.

      Sorry, don't mean to make light of your situation, I hope you don't mind my little attempt at levity to break the tension. Crowdsourcing is becoming a terrific resource, but the fact that we've come to the point where patients have to fund research into the diseases they suffer from makes me want to pull my hair out. While I still can.

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    2. We do have our Michael J. Fox. His name is Richard M. Cohen. Richard is bringing awareness to this disease. Meredith talks about it every chance she gets. He is giving back to the MS community more than we could ever pay him back. Thanks Richard. Just in case you're listening.

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  12. Hi Marc,
    It has been years since I have donated to NMMS. When I needed help with child care when my daughter was young they set me up with a very unreliable service and did nothing to remedy the situation after I contacted them. When we needed funds for a lift to get me up to the second level of my house, they said our income was too high and didn't provide a dime. Fortunately, the Atlas foundation did provide us with $5,000. It is unclear as to why they would not support Tisch. They only report 4% of their donations as coming from big pharma-doesn't seem like enough to be coerced into not supporting a non-pharmaceutical approach. I don't necessarily think Stem Cells would be the answer for someone whose MS is as advanced as mine, but taking the legs out from research as valuable and long standing as this makes no sense.

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    1. Sorry that your experiences with the NMSS have been so unsatisfactory. Unfortunately, I've heard quite a few similar stories.

      Happy to hear that you were able to find the funding that you needed.

      I think that "Pharma only accounts for 4% of our donations" line is a little misleading, as I don't think it takes into account all of the money the Pharma companies pay for the copious amount of advertising they place in NMSS publications. Don't forget, also, that many if not most of the researchers associated with the society are benefactors of pharmaceutical company bribes, um, I mean, consulting fees…

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    2. Thanks for clarifying. I see that it is a tip of the iceberg situation when it comes to their funding. Those of us at the other end are on the Titanic.

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    3. I found it quite curious that when I got a quote for auto insurance they asked if I was a member of any organizations, like maybe the MS Society? That was quite upsetting to me. Are they selling our info as members? I'm a AAA member and AARP also but they asked MS society. Too coincidental.

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  13. I gave up on NMSS years ago. Worthless organization for me, personally, though I'm sure their are many good individuals in it. I seem to have transitioned to one of the "expendables", and am tired of waiting around for the organization to find me, and people like me, worthwhile. I'm tired of the phrase "5 more years". I'm just tired.

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    1. Yes, the "five more years" line becomes quite poisonous once those first five years are up. It does indeed feel at times like patients with progressive disease are treated as "expendables". Horrifying, yes. I suppose I'm lucky in that my neuro is especially intrigued by progressive MS, and is not the "diagnose and adios"kind. I am aware, though, that he is not typical of most neuros…

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  14. This is a very upsetting situation. I am just astounded that the NMSS would refuse to support this trial, and I agree with you- this only encourages patients to leave the country to seek treatment from untrustworthy sources. Very disappointing, indeed- but thank you for the information. I will be flooding them with emails, myself- maybe they will get the message if all of us join in the fight.

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    1. I wish I was astounded that the NMSS wouldn't fund this trial, but most of their sponsored research is focused on treatments, not cures. Finding treatments for the disease is, naturally, very important, but I would think the NMSS powers that be might want to rethink their research priorities. I'm sure a poll of MS patients would reveal an overwhelming majority would favor research into potential cures rather than treatments.

      I hope many of your fellow patients will follow your lead in flooding them with emails, phone calls, and other expressions of dissatisfaction. You know what they say about the squeaky wheel…

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    2. I will certainly be forming a campaign to do so. I am sure they are in bed with big Pharm and the almighty dollar is in the drivers seat.

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  15. Marc, as always I thank you for putting an intelligent and informed voice into the conversation and drawing from facts and not innuendos. Tisch Center will accept donations without having to go through their campaign. Their last newsletter issue says they are stopping the print version so they can save that money and it will be available online. It appears they continue to be good stewards of their money. Their link, once again, is http://tischms.org/home-news, and I encourage everyone to let their fingers WALK a few dollars over to Tisch and support their efforts.

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    1. Thanks, Laura, for the kind words, and for reminding folks that they can donate directly to the Tisch Center. To make it all the easier, here's a clickable link for people who would like to donate: Donate to Tisch

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  16. My brother has MS and unfortunately quickly progressing. It's very frustrating to read about clinical trials being halted due to the FDA or not being able to be funded. I have been seriously racking my brain to think of a way to start raising funds...

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    1. The pace of trials is frustratingly slow, and the fact that many promising therapies die very early in the research process because they are deemed to not have much profit potential makes me want to strangle someone. Please see my above comment for a link to donate directly to the Tisch Center. Thanks for your comment…

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  17. It's obvious the NMSS would rather pay their employees huge salaries, instead of helping the MS Community. Plus, they send their top fund raisers on trips, what about the patients...

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    1. The issue of paying the employees of nonprofits is a tricky one. In order to attract top talent, these organizations must pay competitive wages. I've no problem with people earning decent money as long as they guide the organization correctly. In this case, I honestly believe the Society has drifted off course…

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  18. Cheer up, WK. If the stem cells work as well as you think they will, the NMSS will cough up, and you are sure to be on Dr. Sadiq's short list.

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    1. Well, we sure would find out a hell of a lot faster if the NMSS would cough up before we discover whether or not the cells work.

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  19. Thank you WCKK again for this much needed piece. You are the voice for us, saying what needs to be said, providing real information and all without inhibition. Before the interenet, always felt that I was alone in thinking the NMSS was in the way of letting the truth out. I will write to them. What is your thought on what people should do? Can I post this on Facebook? I have well meaning acquaintances that want to do good, but they are feeding the problem without knowing.. The do gooders will be dressing in orange and climbing stairs in March for another well coordinated and youth appealing challenge that raises thousands, not knowing exactly what they support.

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    1. Thanks for your very kind words. You certainly can post this to Facebook, and urge your friends to do so as well. I've heard through the grapevine that all of the phone calls and emails are getting through. Honestly, I would advise that you tell your friends what I tell mine. If they want to donate to the cause, some of my favorite MS nonprofits are: The Myelin Repair Foundation, The Accelerated Cure Project, and The Tisch MS Research Center of New York…

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