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Stem Cell Firm May Have Administered Unproven Treatments 221

Posted by samzenpus
from the snake-oil dept.
ananyo writes "With Texas pouring millions of dollars into developing adult stem-cell treatments, doctors there are already injecting paying customers with unproven preparations, supplied by an ambitious new company. Celltex Therapeutics 'multiplies and banks' stem cells derived from people's abdominal fat and its facility in Sugar Land opened in December 2011 and houses the largest stem-cell bank in the United States. But Nature has uncovered evidence that the company is involved in the clinical use of the cells on US soil, which the FDA has viewed as illegal in other cases."
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Stem Cell Firm May Have Administered Unproven Treatments

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  • by icebike (68054) * on Wednesday February 29, 2012 @11:15PM (#39204957)

    The company is injecting patients with their own stem cells after massive multiplication of “minimally modified” stem cells.

    This seems to be something of a loop hole in current regulation.

    Some advocates of the treatments argue, however, that preparations based on a patient's own cells should not be classed as drugs, and should not therefore fall under the FDA's jurisdiction.

    ...

    The legal standing of stem-cell treatments is currently being debated in a court case brought by Regenerative Sciences of Broomfield, Colorado, which was ordered by the FDA in 2010 to stop administering mesenchymal stem cells to patients5. One of the key issues being debated is whether the cells are “minimally manipulated” before being reinjected into the patient. Treatment with the patient's own, unprocessed tissue does not always require FDA approval.

    I'm betting this gets reigned in somewhat, if not by the FDA, then by Texas, as the state has already made it clear it wants some oversight.

    This whole thing sounds like several bad made for TV movies I've seen.

    • by Dr. Tom (23206)

      Nobody is asking the obvious question, "did the treatments work?"

    • by Jawnn (445279)

      The company is injecting patients with their own stem cells after massive multiplication of “minimally modified” stem cells.

      This seems to be something of a loop hole in current regulation.

      This here's Texas, y'all. We don't need or want no dang gubamint regulations that would keep us from makin' money off'n our snake oil business. Stop messin' with corporations', er... private citizens' rights to turn a profit. It's just un-American.

  • Consent (Score:4, Insightful)

    by Jazari (2006634) on Wednesday February 29, 2012 @11:19PM (#39204977)
    The only question should be: "Were the patients fully informed?" If I have a terminal or otherwise untreatable condition, I want to be able to decide for myself whether or not an unproven treatment is worth the risk.

    Some people need "protection" or "hand-holding"? No problem. Protect them. But I also want the right to opt out of the government's protection.
    • As long as you get your children, grandchildren, great grandchildren, great great grandchildren to sign off as well, go for it. Otherwise your child becomes the end of life Jenna McCarthy.

      • by msauve (701917)
        "As long as you get your children, grandchildren, great grandchildren, great great grandchildren to sign off as well"

        Are you willing to do the same every time you eat a greasy hamburger, drink a beer, or sit on the couch watching TV instead of jogging around the block?
        • Sure, because none of them claim to cure anything but my hunger, soberness, or boredom. Health is another issue entirely.

          • by msauve (701917)
            So, you claim that diet, drugs, and exercise have nothing to do with health. You're obviously one of those who can't make healthy decisions for themselves.
            • Nice extrapolation. Any other words you would like to put in my mouth? "Every time" might be once in a life. To put words in your mouth, are you claiming that one beer is going to negatively effect your health? And in any event, my medical behaviour doesn't effect effect my fourth+ generation.

              • by msauve (701917)

                my medical behaviour doesn't effect effect my fourth+ generation.

                Thank your for repudiating your earlier statement.

                • If anything I confirmed it. My medical behaviour won't effect my 4th+ gen. What the great+ grand parent wants is unfettered drugs without consequences. My comment was a legal one. Not a health one.

                  do you think Timmy is not going to sue when Dad scarfs down an experimental drug that kills him?

                  • by msauve (701917)
                    "My comment was a legal one. Not a health one."

                    You're lost. This is a discussion on health, not torts.
    • Re:Consent (Score:5, Insightful)

      by Anonymous Coward on Thursday March 01, 2012 @12:12AM (#39205275)

      I worked with a non-practicing MD. He loved to tell stories about his days working with patients, and one of the things that stands out in my mind is when he told us "Informed consent is a joke. I know what's best for my patient, and that's what they're going to choose. It's impossible for me to actually make them understand the pros and cons, so it's all in how I explain the options."

      It's true enough. People tend to trust their doctor, and in general don't have the necessary knowledge to make informed decisions.

      • by msauve (701917)
        "People tend to trust their doctor, and in general don't have the necessary knowledge to make informed decisions."

        If people follow the advice of their doctor, and they're not making informed decisions, then they need a new doctor.
        • by artor3 (1344997)

          I suppose you always check the blueprints before driving across a bridge? As a friend of mine likes to say, you can't make a truly informed decision on what to have for breakfast. For every Cheerio you put in your mouth, you're trusting that hundreds of people did their jobs right and that there won't be any mold or arsenic or broken glass in it.

    • Re: (Score:3, Interesting)

      by artor3 (1344997)

      You need protection and hand-holding just as much of the rest of us. Moreso, since you don't seem to realize it. If you're diagnosed with some terrible disease, you're not going to be thinking rationally. No one ever does.

  • Hell, I've seen "stem cell treatment" clinics advertising all kinds of BS therapies for years. Last I heard the only approved treatment was for repairing damage done from chemotherapy - and that has been going on for decades.

  • by Okian Warrior (537106) on Wednesday February 29, 2012 @11:42PM (#39205113) Homepage Journal

    In order to form an opinion on the matter, it would be useful to know if the treatments have any effect.

    You know... evidence based science?

    Model-based science is all the rage nowadays, and that we can't allow anything to happen unless we have a clear understanding of why it should happen before we try.

    The debate as to whether these people should be labelled snake-oil salesmen or experimentalists would seem to rest on this. Is this government intrusion into people's right to choose, or a regulatory agency stepping in to keep people safe?

    We need to know the risks and potential benefits in addition to the opinions of an insular, jargonized profession.

    It's not always about trusting the experts.

  • by 93 Escort Wagon (326346) on Wednesday February 29, 2012 @11:47PM (#39205141)

    Celltex Therapeutics's patented "Stem Cell Rejuvenation Nostrum and Relief Cream" cures the Colick, Goiter, Dropsy, Issues of Women, Fatigue, Consumption, Black Blood, Great Pox, and Chillblains. It can be boiled in water to create an Efficacious Drench for All Manner of Stomach Ailments. It is 100% Safe and Guaranteed by CellTex to Improve Disposition of Children.

    When purchased with the optional Nasal Applicator Sponge, this cream can also be used to relieve Nasal Congestion and Dryness as well as treat all manner of Nasal Infection.

  • by Brad1138 (590148) <brad1138@yahoo.com> on Thursday March 01, 2012 @12:23AM (#39205319)
    Texas is pouring millions into stem cell research? OK it is official, the world is coming to an end.
    • by tunapez (1161697)

      I just assumed they were talking about Austin. Sugar Land is nowhere near Austin! The Mayan prophecy is almost complete.

  • Apparently Texas may have advanced technologically, but not socially. They still sell snake oil and execute the innocent and the retarded.
  • Do whatever you want with U.S. laws. It won't make a difference. Ban it here and people will just drive to Mexico to buy the treatment, usually from other Americans over there. In fact, they already do. I'm not advocating that stem cell treatment should be legal in the U.S. Just saying that whether it is legal or not won't affect people's ability to buy it when they want to.
  • In other news, water is wet.

    -- Terry

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