Packed House at FDA Stem Cell Hearing – Public Can Comment Through Tuesday

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stem cell therapies


What should be done about stem cell treatments? Are stem cells safe? Do they work? Do stem cell clinics need more regulation, or less?

With some studies reporting encouraging results from using stem cells to treat a number of diseases, including multiple sclerosis, the number of clinics around the world offering some sort of stem cell treatment is increasing. In the United States there are an estimated, 500 or more, of these clinics. Many of them charge thousands of dollars for treatments that may, or may not, use the kind of stem cells that researchers have been studying, and many, or may not, be helping patients.

This concerns the U.S. Food and Drug Administration. With many patients and doctors demanding easy access to stem cell therapy, and others in the medical community warning “no, not yet,” the FDA is studying proposed guidelines that would strengthen its control over those treatments. The FDA’s goal is to ensure that stem cell treatments are safe and effective.

More People … Bigger Room

There was so much interest in this subject that a hearing, first scheduled for April, had to be pushed back to September; rescheduled in a much larger location and with more time for witnesses.

The hearing covered two days, and the hearing room was packed. About 90 speakers were on the agenda. About 500 people were in the audience. Some patients and doctors told the FDA panel about significant improvements they’ d seen in medical conditions. Stem cell clinics argued that they’re exempt from current FDA regulations, because their patients are being treated with their own fat cells and only “minimally manipulated.” But other speakers raised red flags, telling stories of patients who were harmed by their stem cell therapy and warning of “shady” clinics and unproven treatments.

What everyone seemed to agree was that FDA guidance needs to strike a balance: Allow patients access to stem cell treatments while ensuring that those patients aren’t harmed or hoodwinked. That’s a tough order to fill.

Have Your Say on Stem Cell Regulations

As it deliberates, it seems obvious that the more opinions the FDA receives about stem cell treatments, the better. And there’s still time to have your opinion considered before the Sept. 27 — Tuesday — 11:59 p.m. deadline. There’s even a weblink provided on Click the blue “Comment Now” button in the right corner of the page and have your say.

There’s been no word from the FDA on when it expects to issue the final version of its stem cell guidelines. So, stay tuned.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today, or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

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Ed Tobias is a retired broadcast journalist. Most of his 40+ year career was spent as a manager with the Associated Press in Washington, DC. Tobias was diagnosed with Multiple Sclerosis in 1980 but he continued to work, full-time, meeting interesting people and traveling to interesting places, until retiring at the end of 2012.
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  1. DONNA BIRD says:

    The FDA will keep dragging their feet for as long as they can so the pharmaceutical companies can keep making money while we suffer everyday and wish we were dead.

    • Carol says:

      I have never thought of it being that way before, but now that you have brought it to my attention, it is blatently obvious. As a person suffering with MS, my father and I have done YEARS of research about stem cells and how they can help people with MS. However, with what you have posted and thinking about it, I am currently on the MS drug Tysabri. The medication alone costs $84,000/year. Thousands of dollars are charged every 28 days when I receive a Tysabri infusion, as I have to be in a medical center to have nurses administer the drug and for an hour following my infusion, observe me to be certain I do not have a bad reaction to the drug. It’s rather sickening that people and insurance companies can charge so much money that certain patients do not have certain treatments as an option. I am very lucky that I have primary and secondary insurance. Otherwise, I would never be able to afford this medication. Big pharma, with their outrageous prices are literally forcing some patients to go without the best treatments, and in some cases, any treatment at all. MS, as much as I hate to discuss it, is life or death for many patients. I lost my aunt (dad’s sister) to MS complications back in 2006. It’s quality of life as well. Should we have to be disabled? Should we have to suffer through the pain of MS, any all the many symptoms other than pain? The answer is no. There are things that can be done about that today. We do not HAVE to remain sick, but if we cannot afford the treatments that would help us, we’re screwed. Big pharma is literally screwing many MS patients, as well as many patients with other health issues. Thank you for helping me understand this.

      • Phil Mayeaux says:

        I hate to say it, but you dead on right. There is zero profit in finding a cure or a real beneficial treatment. Just keep people hanging on and suffering, so FDA and others can continue to make billions (with a B). No one is interested in be a Louis Pasteur anymore, they would rather just rake in the money while acting as if they are really looking for a CURE.It’s really sad to think this way, but why would anyone want a CURE when we can all just muddle along and pay through the nose for “hope”?

  2. Bill Harrison says:

    I had stem cell therapy Aug 18/16 in Vancouver BC Canada.
    Great experience! Well worth the cost!
    Why wait for the FDA to approve it? Your conditions won’t!
    I recommend this to anyone with neurological symptoms!

    • Ed TobiasEd Tobias says:

      Hi Bill,

      Thanks for your comments. Would you be willing to share some details of your treatment, e.g. was it for MS, what kind of stem cells did you receive, what improvement have you seen, etc?


      • Bill Harrison says:

        Hi Ed,
        I was diagnosed with “Peripheral Neuropathy” ,but I have many more symptoms closer to MS. I can’t have the MIR’s that would be further required, due too having a pacemaker that isn’t conducive to MRI’s.

        Bottom line my conditions were getting worse by the month!
        I chose to have (fat stem cell treatment) in at 10:Am out at 2:00 Pm the same day. I didn’t notice any big changes until day 2 and its been all positive since, played 9 holes of golf a couple weeks ago! My energy is great & my dizziness has disappeared, need to get some water therapy on my legs, my gait is still compromised due to weak muscles. I have noticed improvement in other areas as well.

  3. DONNA BIRD says:

    I’m so happy to hear the stem cells are working. I am going to Mexico this month and get fetal stem cells. The pharmaceutical companies can sit back and watch everybody go out of the country while they make nothing

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