National MS Society FAIL!

barbara

Pioneer Founding member
Click on link to read comments:

http://www.wheelchairkamikaze.com/2015/02/national-ms-society-fail-repeatedly.html

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 country. 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 the 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 cells 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 trials 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 people fully dedicated to the cause.

Although I also know 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, 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…
 

barbara

Pioneer Founding member
National MS Society FAIL: UPDATE – The NMSS Responds

I really have to admire the Wheelchair Kamikaze taking on the MS Society.

2-10-15
http://www.wheelchairkamikaze.com/2015/02/national-ms-society-fail-update-nmss.html?spref=fb

First, I’d like to thank all who helped contribute to the online dialogue (some might even call it a brouhaha) spurred by my last post on this blog (see my original post in this thread) which detailed the American National Multiple Sclerosis Society’s repeated refusals to fund the only current ongoing FDA approved stem cell trial being done on MS patients in the nation, at The Tisch Multiple Sclerosis Research Center of New York. Your response has been a personal inspiration to me, and your comments and sharing of the article on social media have definitely been noticed by the powers that be.

Several readers have forwarded me statements they received from the NMSS in regards to phone calls or emails they sent to the Society in response to that Wheelchair Kamikaze post. The body of each example of the Society’s feedback includes identical text, apparently written by the Society’s communications department. Nothing wrong with that, per se, as any large organization needs to fashion a coordinated response to any issue of concern, but I do feel it necessary to make some points about the reply sent out by the NMSS. Here’s the heart of the text sent by the Society to those who inquired about the organization’s repeated lack of funding for the Tisch Center’s ongoing stem cell research efforts:

“Regarding stem cell research, the Society is currently funding 15 research projects exploring various types of stem cells, including cells derived from bone marrow, fat and skin. We have supported 70 stem cell studies over the past 10 years. We have also convened international meetings on the potential of stem cells to drive new, effective MS treatments.

The Society’s research funding decisions are determined with advice from internationally renowned scientific experts who review the more than 500 research proposals received each year. These volunteers bring a broad range of knowledge in different MS specialties, including stem cell research and clinical trials expertise. They help us determine each proposal’s scientific merit and relevance to MS, assess the originality of the proposed project, and evaluate the experience and scientific track record of the applicants.

The decision to not fund the Tisch MS Center stem cell clinical trial was based on the advice of a review committee comprised of experts with experience in stem cell research and clinical trials as well as perspective from individuals living with MS. The lead investigator, Dr. Saud Sadiq, received written feedback regarding the scientific evaluation of his proposal and was invited to reapply for funding to address the specific concerns. We are pleased to receive proposals from Dr. Sadiq and to work with him. In fact, the Society has collaborated with his research team on an innovative pilot project to understand one of the biological pathways in MS.

There is exciting progress being made through innovative research related to the potential of many types of stem cells for both slowing MS disease activity and for repairing damage to the nervous system. With the urgent need for more effective treatment for MS, especially progressive forms of the disease, we believe that the potential of all types of cell therapies must be explored.

Additional information about Society funded stem cell studies and stem cells research underway internationally can be found on our website http://www.nationalmssociety.org/Research/Research-We-Fund/Restoring-What-s-Been-Lost/Repairing-Damaged-Tissues/Stem-Cells-in-MS”

Although my own professional expertise on any of the matters outlined above is infinitesimally small compared to that of the internationally renowned scientific experts who decide which research efforts the NMSS will fund, I’ll take the liberty of commenting from my position of expertise as a patient being forced to slowly watch himself disappear courtesy a horrendous brain and body eating disease. I've also been a patient at the MS clinic that works hand-in-hand with the Tisch Center since 2004, and being the pain in the ass that I am I’ve become quite familiar to and with many of the doctors and researchers involved.

I’ll start my comments on the statement put out by the NMSS with a short, general critique of the Society : Too Much Pharma!

Now, I know that this criticism may sound simplistic, hyperbolic, and even a bit trite at this point, but the influence of Big Pharma on all aspects of medical research has been terribly corrosive, and not because the pharmaceutical companies are staffed by evil ogres intent on hiding cures from a nettlesome population of sick people. No, I honestly believe that the vast majority of pharmaceutical company employees are good people doing their jobs to the best of their abilities, and therein lies the crux of the problem.

The job of pharmaceutical company executives, who helm what are almost all publicly traded enterprises, is to make as much money as possible to keep their companies’ stock prices on an ever increasing upward trajectory. This creates a confounding conflict of interest; treating chronic diseases in perpetuity with hyper expensive drugs has become a very successful business model; curing them, on the other hand, kills that business model. Combine this dynamic with the fact that we’ve handed almost all of our mid and late stage medical research over to the pharmaceutical companies, and you have a research model that is dysfunctional to its core, and one which leads many to suspect that the pharmaceutical companies would use a variety of tactics to delay or suppress any potential treatments – like, say, stem cells – that might damage their core business model.

The NMSS has consistently stated that less than 5% of their donations come from Pharma. I’m not sure if this figure includes all of the advertising dollars the pharmaceutical companies spend on NMSS publications and events, but even if it does, it’s too much. I am always astounded by the massive amount of advertising contained in the NMSS’s primary publication, the slick quarterly magazine Momentum, which serves as the face of the organization that serves as the face of multiple sclerosis for most of the general population of America. It’s hardly a stretch to say that every other page contains a Madison Avenue type advertisement for one MS drug or another, the total effect of which makes it easy to perceive the NMSS as a mere extension of the pharmaceutical companies.

If indeed Pharma monies make up less than 5% of the Society’s yearly take, my best advice to them would be to divest themselves completely of these monies. The shortfall would in large part, I’m sure, be quickly made up by donations from people who have long held back from giving because of their perception of the NMSS being locked in Big Pharma’s embrace. The Society could continue educating patients about MS disease modifying drugs, and do so without even the slightest hint of being under the sway of the companies who manufacture them.

In contrast, the International Multiple Sclerosis Management Practice (IMSMP), the MS clinic associated with The Tisch Center, doesn’t even allow pharmaceutical company representatives through the front door. The doctors who work there are not allowed to take any pharmaceutical company largess, and the clinic is one of the few medical facilities I’ve ever visited that doesn’t have the name of one pharmaceutical product or another emblazoned on every pen, sticky note, and wall decoration in the place. You’ll find none of these things at the IMSMP, precisely because the physician who runs the facility, Dr. Saud Sadiq, is fiercely independent and refuses to let the influence of Big Pharma, no matter how subtle, cloud the judgments of the staff who works there.

It is true, as the statement put out by the NMSS asserts, that the society has funded research into stem cell therapy in the past, and is currently funding 15 stem cell trials in the US. The problem is, as best I can tell, all of those studies are early-stage studies being conducted in test tubes or on animals, and even if successful the benefits of these trials will not reach MS patients for at least a decade or more.

The study being conducted by the Tisch Center is a human trial, using living, breathing MS patients to test a technologically advanced stem cell therapy which, if successful, could revolutionize the treatment of multiple sclerosis in a relatively few number of years, not decades. The Tisch Center spent over 10 years doing test tube and animal research before getting their FDA approval, so that work has already been successfully completed. Again, this trial is the only FDA approved stem cell study currently being conducted on MS patients. The only other such trial that I know of was completed by the Cleveland Clinic last year.

The NMSS writes that their decision whether to fund a project depends on “each proposal’s scientific merit and relevance to MS”, assessment “of the originality of the proposed project”, and evaluation “of the experience and scientific track record of the applicants”. I spoke to one of my friends who works at the NMSS's headquarters in Denver, but due to confidentiality agreements between the Society and grant applicants they could not divulge whatever issues the NMSS may have had with the research being done by the Tisch Center. I can say that the research proved safe enough and showed enough potential coming out of the laboratory to be only the second MS stem cell trial to win FDA approval, and the Tisch center applied for NMSS grants on three separate occasions, each application addressing the issues the Society had with the last. I'm not sure what "individuals living with MS" the NMSS consulted with, but from where I sit (since I can barely stand) the research is most certainly relevant to MS.

Furthermore, the Tisch trial is using proprietary methods to transform raw stem cells into a type of stem cell specific to the central nervous system, a technique far more sophisticated than any previously used in human stem cell trials, and far more refined than the stem cell treatments being offered, at substantial cost, to patients by most offshore clinics. I’d say that accomplishment should tick the “originality” box on the list of NMSS requirements.

As for the “experience and scientific track record of the applicants”, if I were to list the research published by scientists at The Tisch Center in only the last five years, this post might just break the Internet. Okay, maybe that’s an exaggeration, but you can check out just some of the research being done by the Center on their website (click here).

The Society’s response to inquiries about their repeated rejections of the Tisch Center’s research proposals further states that “The lead investigator, Dr. Saud Sadiq, received written feedback regarding the scientific evaluation of his proposal and was invited to reapply for funding to address the specific concerns.” This is quite true. What is also quite true is that Dr. Sadiq submitted not one, not two, but three proposals to the NMSS, attempting each time to address their concerns, to no avail.

The first proposal was submitted before the trial received FDA approval, and one of the primary stated reasons for the NMSS’s rejection of that proposal was the fact that the trial wasn’t FDA approved. After the trial received FDA approval, another proposal was made, which was again rejected. Undaunted, and in need of funding to continue this vital research, the Tisch Center submitted a third proposal, which the researchers involved believed addressed the concerns expressed by the Society's most recent rejection. The third proposal was again rejected.

I’m not privy to the precise concerns expressed by the Society that were used to back up their rejection of the third and final grant proposal submitted by the Tisch Center. However, I do know that the trial did win an extremely rare FDA approval, is using state-of-the-art technology and techniques, is testing methodology that if successful will expand the boundaries of the science, and is being conducted by world-class researchers at a world-class facility in the heart of the biggest city in the nation.

Any safety concerns that the NMSS's experts may have had should have been alleviated by the FDA approval, and unless those experts included soothsayers and seers I'm not entirely sure how they could determine the odds of success for a trial the likes of which has never before been attempted. I may be admittedly biased, but I find it hard to imagine that the Society’s concerns were so dire that three rounds of proposals couldn’t result in a solution. Especially since, even as you read this, hundreds if not thousands of MS patients are flocking to medical tourism sites offering unproven stem cell treatments at facilities of widely varying quality at a cost of many tens of thousands of dollars out-of-pocket.

The NMSS further states that it is funding one pilot project currently underway at the Tisch Center, and this is true. The trial in question was funded back in 2011 to the tune of $44,000, which may seem like a substantial amount of money to the average Joe, but in the world of medical research is fairly negligible (keep in mind that the NMSS receives approximately $100 million worth of donations every year). I spoke with the head of fundraising at the Tisch Center, who told me that the NMSS may have funded another Tisch Center study back in 2005, but she’d have to dig through her files to confirm that. I told her not to bother.

So, there you have it, the National Multiple Sclerosis Society’s response to inquiries as to why they refused to fund a trial that, in my humble opinion, has at least as much potential to change the lives of MS patients as any currently ongoing study, and my reaction to that response. Perhaps I’m partial since I am a patient of Dr. Sadiq’s, but my passion on the subject comes more from the desperation I feel as a human being whose body is being consumed by a relentlessly vicious disease, and not from my allegiance to any medical professional or facility. I promise.

I would urge those who feel similar passion to have their voices heard. 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).

I would also ask that all opinions expressed or inquiries made be done so in as civil a manner as possible, as to a person the NMSS staffers I know personally are truly good people who are fully dedicated to the cause. It’s just the institution they work for that may be misguided…
 

barbara

Pioneer Founding member
Dr Edward Fox enjoying kickbacks it looks like

Thanks to a tip from one of our members. Dr. Edward J Fox, who sits on the National MS board that makes all the decisions for research funding, evidently enjoys quite a few kickbacks (almost $80,000) from major MS drug manufacturers, including Teva and Biogen. Talk about a HUGE CONFLICT OF INTEREST!!


https://openpaymentsdata.cms.gov/physician/104737
 
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