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As stem cell industry explodes, can a static FDA keep up?

There are legitimate arguments about the degree to which the FDA should regulate stem cell clinics and the point-of-care, for-profit stem cell industry. I’ve held debates about that on my blog with argument on both sides including a very valuable debate between Dr. Chris Centeno and Doug Sipp. However, increasingly it is looking like the …

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Meet the real, not so charming Paul Ryan: an extremist out of touch with most Americans

Mitt Romney announced on Saturday that his running mate would be Congressman Paul Ryan of Wisconsin. Ryan is a handsome, charming guy who American’s can tell already is much more at ease campaigning than Romney. However, Ryan’s voting record is extremely troubling and far from charming. In fact, it is downright ugly. The Chronicle of …

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Court empowers FDA to regulate stem cells as drugs

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Are stem cells drugs? At least for today, a federal court unambiguously ruled that the answer to this question for manipulated stem cells is “Yes”.  The story has been reported in the media at New Scientist and Scope Blog. You can read over the key issues here. The court ruled in favor of the federal government and FDA and against …

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Testimony in supermodel stem cell fraud case: “I lied to patients”

“I lied to patients,” testified a weeping, young woman in court related to a fraud allegation involving stem cells. She had worked as an office assistant at a company that injected bogus and potentially dangerous cow-based “stem cell” treatments into human patients. This company, which in different incarnations went by various names including Biomark in …

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The dangers of direct to media reporting of unpublished, non-peer reviewed science: the Higgstery case

I was critical earlier this week in a post of what I perceived to be the over-the-top reaction to the whole Higgs Boson situation and press fest. I went so far as to call it “hysteria” or one could say “Higgstery“. In turn, I was criticized for that blog post for being too critical and spoiling people’s …

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Korean stem cell clinic sued by patients in U.S. for fraud

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For the first time to my knowledge, patients have sued a dubious stem cell clinic (RNL Bio) for fraud. As one stem cell expert has put it (see below), now there is “blood in the water”. RNL Bio of Korea has reportedly (hat tip to Leigh Turner) just been sued for fraud by patients related to stem …

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What’s next for Celltex? Texas adult stem cell provider that treated Rick Perry has uncertain future

Celltex is that adult stem cell company that treated Governor Perry and upwards of 80 other people with stem cell products that they grew in their lab in Texas. I wonder what the leadership of Celltex is thinking right now about its FDA audit, their future, and that pesky professor/blogger in California…what’s his name? I …

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Celltex responds in press release: FDA problems result of their Texas lab being run by Koreans, not Texans

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Celltex has issued a press release (PR), entitled “Company Pioneering Regenerative Medicine Services Invited FDA to Inspect Lab” on their FDA audit in response to the reaction in the media and stem cell community about it. I view this PR as a step in the right direction–more openness! There is a lot of info in …

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