Monday, October 19, 2015

Video: Promising FDA Approved Stem Cell Trial, Repeatedly Rejected for Funding by NMSS, Featured in TV News Segment

The only FDA approved Multiple Sclerosis stem cell trial currently underway in the US was featured last week in “The Big Idea”, a monthly segment seen on the local New York Fox Network affiliate’s evening newscast. The segment features the study’s lead researcher, Dr. Saud Sadiq (full disclosure: he’s my neuro), detailing the trial, and highlights a patient currently enrolled in the study who appears to be benefiting from the treatment.

The stem cell trial is being conducted by the Tisch Multiple Sclerosis Research Center of New York, and utilizes proprietary methodologies unlike those being used in any other stem cell study or treatment center in the world. As is detailed in the below video, raw mesenchymal stem cells are extracted from a patient’s own bone marrow and are then transformed in the laboratory into Neural Progenitor cells, stem cells specific to the central nervous system. The cells are then introduced directly into the patient’s central nervous system via intrathecal injection. Unlike HSCT, the type of stem cell therapy that seeks to stop or slow down MS disease progression by rebooting the immune system after ablating it using chemotherapy drugs, the Tisch Center’s trial is aimed directly at regenerating and restoring the damage done to brain and spinal cord tissues by the MS disease process.

Regular Wheelchair Kamikaze readers will recognize this as the very same trial that the National Multiple Sclerosis Society has repeatedly refused to fund for reasons that can only be deemed suspect, as I’ve detailed in several previous blog posts (click here and here). The Tisch Center’s trial is currently an early phase 1 study and is in urgent need of additional funding in order to expand into a larger and more comprehensive phase II trial.

As the Tisch Center is not affiliated with any academic institution or hospital and is a completely independent nonprofit organization, its research efforts are entirely reliant on private donations and institutional grants for continuation. Due to funding shortfalls, the trial is currently on precarious financial footing despite showing tremendous potential and promising early results. One would hope that the NMSS would see fit to reconsider its previous withholding of funds and do its part to help further the only FDA approved Multiple Sclerosis stem cell trial in the USA.

As is evidenced by this news segment, the Tisch Center stem cell trial has the potential to dramatically change the MS treatment landscape. I’d urge all who feel that the National Multiple Sclerosis Society should reverse course and support the Tisch Center to contact the Society and voice their opinions. The  email addresses of the Society’s executive staff can be accessed by (clicking here), and the phone number of the NMSS is 1-800-344-4867

Please keep all communications polite, as the NMSS may in this instance be misguided, but it is not an adversary. As my grandmother used to tell me, you can catch more flies with honey than you can with vinegar…






42 comments:

  1. Let us keep pushing. I will renew my correspondence with the nmss, now that I have a thing or two to add to an email chain that ended with a polite brick wall. Brick walls are always polite; they can be...
    Thanks Marc

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    1. Thanks for keeping up the pressure, Tom. I'm sure you'll only meet with another brick wall, but hey, even the walls of Jericho eventually came down…

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  2. Marc, Thanks for posting this, my wife is going through this process for leukemia (when they find a donor) and I could see my self doing the same IF and when it's approved. Thanks again for doing such a kick ass job on keeping us 'MSers' current. Tom

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    1. Tom, the process your wife is going through is probably more like HSCT, the stem cell therapy in which chemotherapy drugs are used to wipe out the immune system, which is then rebooted using the patient's own stem cells. The difference being that for leukemia the cells come from a donor, not from the patient themselves. If you have enhancing lesions and are experiencing relapses, I would encourage you to look into HSCT. It can be an EXTREMELY effective treatment for people with active inflammatory multiple sclerosis.

      Please send my best wishes to your wife, and of course save some of them for yourself as well…

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  3. Excellent. Thanks, Marc, for once again doing some spot-on sleuthing and reporting on behalf of the MS community. I think we all need to take an active role in getting stem cell therapy funded in order to create an avalanche of wellness to MS patients.

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    1. Patient activism is definitely needed. For better or worse, we don't see much activism in the MS patient population because many patients are now seeing their disease kept relatively under control by the disease modifying drugs, even though those drugs don't do anything to cure the illness. And many of the patients on whom these drugs don't work find themselves too sick to do much in the way of activism. The NMSS is extremely good at public relations, also, and have pretty much entrenched themselves in the minds of the public as the face of MS. Let's not completely pillory the NMSS, though, they do some very good work and can be of great assistance to MS patients, but I find their research initiatives very misguided.

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  4. If you have the energy to track down e-mail addresses for the board members, it might be good to contact them in addition to or in place of the NMSS board. There really seems to be a bias towards this researcher. And I thought he was an attending / professor at NYU?

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    1. Dr. Sadiq has no real university affiliation.

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    2. Unfortunately, I fear that politics plays an awfully big role in some of the NMSS is funding decisions, and that many of the board members are among those playing these political games.

      Dr. Sadiq has never been associated with NYU. I believe much earlier in his career he was associated with Columbia University, and then later with Roosevelt hospital. He's been entirely on his own since 2006, though.

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  5. Hi Marc - Dr. Sadiq is my neuro too :-)

    It is disheartening to learn that his stem cell grant has been denied NMSS funding, more than once! This peaked my curiosity/outrage. Since my dx 4 years ago I have been a big supporter of the NMSS. I have raised more than $60K for them. I sure would like to know what they are doing with the money.

    I would like to contact them and inquire about their decision. It would be helpful to have specifics. Do you know how many times Sadiq applied and what there reasons were for denying his requests? Please feel free to contact me directly @kwarendorf@gmail.com.

    Thanks in advance,
    Kyle Warendorf

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  6. Marc, at the MS Symposium last Sunday, Dr. Sadiq gave you and your blog a huge shout out for the time and effort you place in doing your blog. Thanks to your request, I contacted the MS Society and politely asked them to reconsider funding the stem cell trial. Thanks for your hard work.
    Ray

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    1. Thank you, I've heard from several patients that Dr. Sadiq mentioned me at the symposium. I had an appointment with Dr. Sadiq just yesterday, and we talked about his frustrations with the NMSS. He's pretty much resigned to the fact that they will never give them funding, and I must say that he's taking a much higher road than I would have. Glad to know that you are in his capable hands…

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  7. I served on the Government Relations Committee for the Lone Star chapter of the MS society in Austin, Tx. for 3 legislative sessions. I was dxd with MS in 2004 and received stem cell therapy in 2012, with many quality of life improvements. Stem cell therapy was not on their agenda then, nor will it ever be, until the doctors that sit on the National MS Society committees who decide where all the funding goes, stop receiving kick backs from the drug companies. I know you did another post on this very subject earlier in the year. Many of us who served on the Gov.Rel.Co. had either had adult stem cell therapy, or where considering having the treatment. It was a hush hush thing in our advocacy efforts. They couldn't tell us not to talk about it, but they also couldn't tell us to talk about it. Funny thing, it WAS a part of our personal stories, so it crept into just about every conversation we had at the capital! There is major promise in the Tisch MS study and to garner attention to finding a possible cellular cure, advocacy efforts from patients are paramount! I'm a founding member of a group called Patients For Stem Cells. We are pleased to say we have joined forces with an organization founded with the goal of accelerating access to life saving cellular therapy, The Alliance for the Advancement of Cellular Therapies (AACT) Any patient can join in this advocacy effort. We must present as a united front and this group of doctors, scientists and patients can do just that! I'll add the link so you and your readers can check it out. AACT just had it's first conference in Chicago and it was heralded a great success from the attendees and speakers. Cellular medicine will change the practice of medicine as a whole. Your blog is an amazing tool in sharing views and information! Thanks Wheelchair Kamikaze!
    patientsforstemcells.org
    aact.com

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    1. Thanks for all of that info, Jennifer. And thanks for doing all of your advocacy work. We are of like minds when it comes to the influence of pharmaceutical company monies on many of the decision-makers at the NMSS. The corrosive influence of big money has degraded not only our system of medicine, but our body politic as a whole, and much reform is needed.

      I would urge all readers who would like to foment change to have their voices heard by either contacting the NMSS using the info provided in the essay above, or joining organizations like the ones that Jennifer has provided info on. Here are links you can click on to easily access the organizations Jennifer refers to:

      Patients for Stem Cells<
      Alliance for the Advancement of Cellular Therapies

      Please keep in mind that not all stem cell therapies are created equal, and there are LOTS of practitioners out there offering what amounts to nothing more than snake oil. Make sure to do your due diligence, and yet all sides of the story before committing your health and money to shady practitioners. One good rule of thumb is that if it sounds too good to be true, it probably is…

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  8. I sent an email to the NMSS a few days ago voicing my dismay at their continued refusal to fund Tisch, despite Tisch's promising results. They promptly responded - here is an excerpt from the response:

    The Society pursues all promising paths to solutions for people with MS, and has been actively engaged with the Tisch MS Center regarding their stem cell research. Despite extensive efforts, specific questions regarding the trial remain unanswered. The Society’s thorough research review process requires such answers before any project funding can be provided. We do understand however, that the current trial is fully funded, proceeding, and we look forward to the results.

    Seems like they are implying that Tisch is not jumping thru NMSS's required hoops to get funding. I wish I knew the real story!

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    1. The society is in defensive mode about all of this, and has been defending their not funding the Tisch center trial with the same reasons for quite a while now. Without divulging confidential information, I will say that I've seen at least some of their objections, and IMO they don't hold water. I will say that after Dr. Sadiq submitted his first funding request, the NMSS responded with a list of issues and questions they wanted addressed. Dr. Sadiq addressed all of them, and still his second application was denied.

      Keep in mind, this is AFTER the trial had received FDA approval, a process that took many years and revisions of protocols to get through. So, the trial is up to the extremely high standards of the FDA, but apparently not the standards of the NMSS. Make sense to you? Me neither…

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  9. I read somewhere that 19 cents in every MS Society donated dollar actually goes to research. I used to get there publications but got tired of hearing about how they had acquired a new bank of computers or how the funding for the new club house was. I'm afraid these people have lost their direction or worse are terrified that a cure will crumble the bureaucracy the've created. Same holds true for a number of other charities. I see some drug manufacturers have started advertising now on mainstream television. It's all about the 'buck' Here in Canada millions of healthcare dollars are spent on people who have self inflicted ailments, yet someone with a collapsed neck vein can't get the procedure to fix it. It's the people at Tisch and others who are in the trenches in this war to find a cure, that deserve the money to fund their research. If I ever win the lottery it wont go to the MS Society..

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    1. The MS societies do good work, and do help thousands of MS patients in a variety of ways. When it comes to their research efforts, though, it does seem that they fall short in many areas. The influence of the pharmaceutical companies can't be denied, but that goes for almost all of modern medicine, not just the NMSS… And don't forget, the pharmaceutical companies are only doing what we allow them to do. All of their influence efforts are perfectly legal, so blame the lawmakers who allow themselves to be manipulated more than the entities that are doing the legal manipulation…

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  10. Do you know if Dr. Giovannoni has posted about this research on his blog?

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    1. I follow Dr. G's blog closely, and I don't think I've ever seen mention of the Tisch Center trial…

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  11. Reader Jackie Bruto asked me to post the following comment for her, as for some reason (technical difficulties) she was unable to post it herself:

    "I live in Canada. Do you know if Dr Sadiq and the research bring conducted Tisch Multiple Sclerosis Research Center of New York is similar to the research being conducted by Dr. Mark Freedman (Ottawa Hospital Research Institute, University of Ottawa), principal investigator (PI) at the Ottawa site and Dr. James Marriott (University of Manitoba), PI at the Manitoba site, MESCAMS is part of an international mesenchymal stem cell research effort encompassing nine countries. Thank you for all you do.

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    1. The type of stem cell therapy being done by Dr. Sadiq is entirely different than that being done by Dr. Freedman, who is researching HSCT, the type of stem cell therapy in which chemotherapy drugs are used to wipe out a patient's immune system, and then stem cells are introduced to "reboot" the immune system in hopes of putting the brakes on the MS disease process.

      Dr. Sadiq's trial is all about regenerating and repairing the damage done to the central nervous system by the MS disease process. These are two entirely different approaches, Comparing the two techniques is an apples and oranges comparison….

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    2. Whoops, just realized I spell Jackie's name wrong. It's Jackie Bruno…

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    3. No, Freedman is performing studies on both types of stem cell treatments. See here: https://clinicaltrials.gov/ct2/show/NCT02239393

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    4. Okay, very interesting. I didn't realize that Dr. Freedman was doing MSC trials. From what I can gather, Freedman's trial involves infusing "raw" autologous mesenchymal stem cells intravenously into patients.

      Dr. Sadiq, on the other hand, is taking raw mesenchymal stem cells from patients, using proprietary methods in his laboratory to transform these raw MSCs into a type of stem cell called a Neural Progenitor, which is a stem cell specific to the central nervous system, and then injecting them intrathecally (directly into the spinal fluid) of trial subjects.

      There have been other trials similar to Dr. Freedman's (the Cleveland Clinic and one done by Dr. Neil Scolding in London), but none that have involved the transformation of raw stem cells into neural progenitors. To my knowledge, Dr. Sadiq's trial is the first one that is using this methodology…

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  12. Marc, keep up all the great work you're doing informing all of us on what is happening and not happening. It's a real shame that Dr. Sadiq has received approval from the FDA but no funding from the folks who are supported by us and our families. I hope that all our efforts that go to raising funds to help people with MS, go directly to Dr. Sadiq's research from now on. 5 years ago, I and many other's underwent the procedure for C.C.S.V.I. here in Albany New York. I came away with the gift of LIFE again. I may not be 100%, but I'll take 85% any day. I no longer use the drugs to "slow" the progression and I can still work and play with my family again. But now that the FDA has put a halt on the procedure do to more research needed.......those of us are at the mercy of BIG PHARMA, again! You and I, and everyone else know, they are the road block to any chance we may have at a cure or just plain symptom relief. And you're correct on if we want change, you have to get to those who possibly can make those changes, the politicians. You're not going to get it from the NMSS. If they really cared, they'd take a pay cut and start using more than 19 cents per dollar on helping the cause. Stay well and keep up the good work.

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    1. Glad to hear that you've benefited from CCSVI, and that the improvements stuck. I've heard from too many patients who had little or no success with the procedure, but cases like yours beg for more research to be done.

      The problem with the NMSS is that it's become a very bloated bureaucracy, too big for its own good. It's as big as many large corporations, and unfortunately organizations of that size can start building a negative momentum that is difficult to stop.

      Let's not forget that the NMSS does do good work in helping MS patients in areas other than their research initiatives. Therefore, I don't condemn the organization as a whole, although I do wish they would forgo all pharmaceutical company funding and redefine their mission to focus more intently on finding a cure for this damned disease.

      I also don't begrudge their upper management for making good money. In a perfect world the need to pay such high salaries wouldn't exist, but in reality in order to attract top-notch people to what amount to very high pressure corporate positions you must compete with the private sector. The salary of the head of the NMSS pales in comparison to what other CEOs make, but that's no excuse for some of the egregious decision-making that we see when it comes to many of the NMSS's research initiatives.

      As far as the $.19 per dollar they supposedly spent on research, have actually seen various figures that contradict those numbers. The NMSS is rated quite highly by many of the charity rating organizations, but, again, they have become so big and their organizational expenses so great that they are far from a lean, mean, MS killing machine… And that's what they need to be.

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  13. Good summary of the research which midway through this summer, has shown steady improvement for most of the patients treated. However, I cannot open the email link to email Tim Coetze

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    1. Thanks for the kind words. Not sure what to tell you about the email link, but you might try emailing one of the other higher-ups at the MS Society. Keep up the fight!

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  14. As one of the many in the MS world far into progression with old, still degrading nerves, I have little hope that the politics and business of MS will offer me much hope. Another chapter in the book is written.

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  15. Hi Marc, I found this interesting comment at http://www.thisisms.com/forum/ (General Discussion board)

    "I'm not sure if funding from the NMSS could be enough. Having a look at their current fundings at http://www.nationalmssociety.org/NationalMSSociety/media/MSNationalFiles/Research/New_Research_Fall_2015.pdf, I mainly find fundings from 100'000USD up to 800'000 USD. I don't think, that this is enough to bring a company through a phase II study. For instance, just the costs to take a couple of MRIs during the trial for every participant will probably exceed this amount.

    Moreover, I assume that they have an upper limit of funding that they donate per project.

    Also, if an organisation provides a larger amount of money to progress with the development of therapies, they should be able to invest the money and not just donate it. If the product is successful, they should be able to participate in the success and, therefore, to make a profit. This additional cash could then be needed to support further projects. However, a non-profit, which is freed from taxes, is not allowed to invest and make a profit ( ;-) well, that's probably why it is called non-profit), even if a potential profit is used to support others non-profit projects. At least that is the way how it is handled here in Switzerland.

    These and a couple of others are all reasons, why I think that an investment company held by MS-patients and their relatives could make sense (as described in this thread http://www.thisisms.com/forum/general-discussion-f1/topic26945.html or on http://butterflyeffectproject.jimdo.com/) and is something that I really would like to discuss."

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    1. While the society certainly couldn't provide all of the funding needed for the Tisch Center study, every little bit helps, and $100,000 or $200,000 is far from a little bit.

      I agree that some other form of funding medical research is vitally needed, as handing off almost all late stage medical research to the pharmaceutical companies obviously only leads to pharmaceutical solutions. Expecting much help from the government in these days of "all government is bad government" austerity is unrealistic also.

      As you note, a private sector solution would be terrific, but organizing such an entity would be difficult at best. After all, that's what the NMSS is supposed to be, a private-sector solution for funding medical research into MS. Human nature being what it is, whenever large sums of money are involved, there is always a good chance for coercion or otherwise tainted motives. I don't believe the NMSS is acting in a malevolent fashion, rather the society has evolved into such a large, multi-tentacled organization that a self-preservation instinct takes hold.

      Thanks for your comment…

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  16. It seems that Dr. Sadiq's work is featured on FOX News and by Dr. Oz, a total shill. Research done at the MSRCNY isn't published in the best journals either. None of the researchers there come from top universities. Dr. Sadiq himself is a product of the University of Nairobi. Unfortunately his reputation has suffered because there has never been a rigorous clinical trial for the intrathecal methotrexate. Working with a naturopath doesn't help much either. Dr. Sadiq is not considered to be a practitioner of evidence based medicine, and that hurts his ability to get grants from the NIH and the MS Society.

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    1. Aside from that Mrs. Lincoln, how was the play?

      Terrific job of character assassination, kudos on that. Unfortunately, most of it disingenuous, at best.

      Yes, Dr. Sadiq’s stem cell trial was featured in a local FOX affiliate newscasts, and he has appeared on the Dr. Oz show. While I’m no fan of Fox News, the local newscasts are far different than the national newscasts, and Dr. Sadiq’s stem cell trial is only the second human MS stem cell trial to get an FDA approval, making it truly newsworthy, no? The same can be said for his appearance on Dr. Oz. Though Dr. Oz can certainly be considered a shill, Dr. Sadiq’s stem cell study rises far above magic coffee beans or some of the other “remedies” caulked by the dubious Dr. Oz.

      Yes, not much of the Tisch Center’s research has been published in major medical journals, but much of their research threatens the status quo, and pharmaceutical company dominance over the MS treatment paradigm, and it’s been well documented that the pharmaceutical companies have at this point assert undue influence on the editing of major medical journals. The researchers in Dr. Sadiq slab do indeed have degrees from prestigious universities, and Dr. Sadiq was raised in Kenya, thus his graduating from the University of Nairobi. No shame there.

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    2. There has never been a rigorous clinical trial of intrathecal methotrexate simply because methotrexate is an old, off patent drug which holds very little profit potential for the companies that make it. Many other older compounds that show promise in treating MS and other diseases have fallen into the same black hole, victims of their lack of potential blockbuster status in a medical research world dominated by Big Pharma. This is a huge problem that is being recognized as increasingly troublesome by researchers around the world.

      Somehow intimating that the fact that Dr. Sadiq has an on staff naturopathic physician is a negative reveals your biases more than anything else. Dr. Bates, the naturopath at the clinic, is a full ND, having gone through a training program as vigorous as that of any medical school. It’s not as if she received a nutritionist certificate from an online diploma mill. Dr. Bates is among the sharpest physicians I’ve ever worked with, and if the medical field were filled with doctors as diligent and cerebral as Dr. Bates the world would be a much better place.

      The fact that she’s on staff at Dr. Sadiq’s clinic speaks volumes of his willingness to do whatever it takes to help his patients. Certainly, there is a place for complementary and alternative medicines in the treatment of MS, as standard medicine has a long way to go in terms of treating multiple sclerosis. Advances have been made, yes, but the only people who can possibly be satisfied with the status quo can only be the pharmaceutical companies, making billions of dollars a year selling drugs that treat but don’t even begin to hint at a cure. Of course, there are also those neurologists happy to line their own pockets with pharmaceutical company largess, of which Dr. Sadiq is not one. Pharma reps are not even allowed into his clinic, much less pay him or any of his associates “speaking” or “consulting” brides, on the, I mean, fees…

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    3. Claiming that Dr. Sadiq does not practice evidence-based medicine is ludicrous, and again only reveals your own biases. Sadiq is an accomplished clinician and research director, who cares deeply about his patients. The man is far from perfect, but I've seen a variety of MS specialists, and though many of them appear to be brilliant human beings, the care they afford their patients can sometimes be seriously lacking. In many cases this is due to restrictions on their time and efforts placed by insurance company requirements, which is why Dr. Sadiq doesn't take insurance. I routinely spend 60 or 90 minutes during my appointments with Dr. Sadiq, whereas my experience with some of my previous MS neuros was limited to very short appointments during which not much give-and-take was offered. Especially once it was determined I have progressive MS, and thus no easy answers were to be had. Sadiq has his own privately funded research laboratories, which allows him to pursue lines of research with a freedom that other doctors only dream about. He is obsessively committed to ending the scourge of MS, and also doesn't accept any monies from the pharmaceutical companies in his clinical practice. Too few MDs can make the same claim.

      If Dr. Sadiq's independence and proclivity for thinking outside the box is somehow keeping him from getting funding from the NIH and the MS Society, something is systemically wrong with those two institutions. As I noted, his stem cell trial has full FDA approval. As I'm sure you are aware, getting such an approval is no small feat, requiring an incredible amount of laboratory work and documentation, but this same trial is somehow not worthy of MS society funding? Something's rotten in Denmark….

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    4. Sorry about the typos and assorted strange words included in the above responses. I'm using voice recognition software, which is less than 100% accurate, and did a poor job proofreading. Actually, I did no proofreading at all. My bad…

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  17. This wasn't intended as a personal attack. Neil Cavuto is one of Dr. Sadiq's patients, which may account for the attention from FOX; I'm sure Dr. Oz is a connection of Meredith Vieira and Richard Cohen.

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  18. Hi Marc,
    I read about Dr. Sadiq, Dr. Bates, the Tisch clinic, their work with ms patients and your blog posts through one of the many ms newsletters I subscribe to. I live in the UK and was diagnosed around 1991 with rrms at the U of Rochester where I had an MRI. I took no drugs then and never have. Later an ex-medical person suggested that it was actually a serious allergic chemical reaction to solvents. Later I found to be true and found this proof: http://www.ncbi.nlm.nih.gov/pubmed/8153592 . With enough prolonged exposure to solvents, it can change to ms for some people. It was for me. It was quite benign between solvents exposure attacks for over 25 years, but started to change a little to spms when I turned 59 last year. Last summer I went to Massachusetts to have ordinary stem cell treatment that gave good results after a week or so. I’m VERY eager to be in Dr. Sadiq's stem cell work study. How could I go about applying?

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    1. Hi Judy, thanks for the info on the environmental toxins, very interesting. I myself think my disease was kicked off by exposure to toxic mold in a "sick building" I worked in from 1993-95. I definitely believe that environmental agents can and do act as initiators of the MS disease process.

      Unfortunately, I don't think there is a way for you to apply to be part of Dr. Sadiq's study. He's using patients that attend his MS practice, and between Dr. Sadiq and the three other neurologists that work in his practice, there are probably well over 1000 candidates for them to choose from. Dr. Sadiq recently received FDA approval for phase 2 of his study, so hopefully things will progress rapidly and his methodology will be proven successful sooner rather than later.

      Wishing you the best…

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