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First 2018 Stem Cell Update

First 2018 Stem Cell Update

We’re now beginning the second month of 2018, and we are a few months past the FDA’s issuance of the final stem cell guidance documents which are intended to dramatically limit the availability of stem cell treatments outside of FDA approved clinical trials. See my prior post at: http://wp.me/p7pwQD-bB So what’s going on so far in 2018? FDA Inspections? Rumor has it that there already have been several facility inspections this year. What I can say is that it’s more…

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FDA sends a Happy New Year greeting to another stem cell operation!

FDA sends a Happy New Year greeting to another stem cell operation!

As a prelude to more of what may be coming this year, the FDA has issued its first warning letter to a for-profit stem cell entity, on the third working day of the New Year. As per previous posts, expect more to follow in the coming weeks and months, targeting the most visible stem cell only entities. Here is the warning letter: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm591225.htm Same ol, same ol, but with a twist The letter is largely the FDA’s standard form warning…

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Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

Happy New Year! Last year review, and what’s coming this year/ ACCME/Cali. Vaccine /Homeopathy/Supplements/Antitrust/Obamacare

As we start the New Year, let’s look back and forward: CAM’s ACCME problem The biggest challenge facing the CAM community in the coming years is that CAM organizations are under direct attack by ACCME, the main CME accrediting agency. In the last year or two, the ACCME have initiated a process to revoke several CAM organization’s CME credit provider status. See my post: http://rickjaffeesq.com/2017/04/04/bad-day-cam-patients-first-cam-group-caves-accmes-extortionre-education/ If ACCME succeeds, the result would be devastating to these groups because they are financially…

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The year in review and some predictions about next year/ Part One: Stem Cells

The year in review and some predictions about next year/ Part One: Stem Cells

It’s time to look back at what happened this year, and make some predictions about next year. Part One will focus on stem cells. We started 2017 awaiting the FDA’s final guidance documents on HCT/P’s (“stem cells”). In late August, the FDA foreshadowed the guidance documents by issuing warning letters to two of most high profile (or infamous) stem cell clinics in the country. Both clinics were warned that their use of HCT/P’s were in violation of the FDA trifecta…

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Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

Update on the Green Pharmaceuticals Homeopathy Case/You Do What You Can

To recap and expand on my prior post on the case: (http://rickjaffeesq.com/2017/11/05/big-trouble-ahead-companies-selling-homeopathic-remedies-california-revised/) Green Pharmaceuticals which makes SnoreStop was sued by a bottom feeding (IMO) plaintiffs class action law firm for false advertising and unfair business practices in California. The theory of the case was that homeopathy is unscientific nonsense and none of the product’s ingredients have any possible effect on snoring. What made the case harder for the plaintiffs’ lawyers was that unlike most homeopathic products, the claims supporting SnoreStop…

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I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’m flattered but this is what the stem cell clinics are up against; To me it’s all about personal freedom

I’ve just had the distinct but perhaps questionable honor of being quoted extensively by the Grand Inquisitor of all things unconventional (medicine wise). here is his post: https://respectfulinsolence.com/2017/11/21/fda-cracks-quack-stem-cell-clinics/ Like M.C. Escher so brilliantly explains in his pictures, it all depends on your perspective, whether you think the the FDA final guidance documents are a good or bad thing. But, one thing I’ve never been able to figure out about the other side is why the obsession with the stem cell…

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Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

Big Surprise: FDA’s Final Stem Cell Guidelines Threaten the Existence of Stem Cell Clinics

As widely reported yesterday, the FDA finalized the draft guidance documents concerning stem cells, or as the FDA refers to the category broadly, HCT/P’s. The draft guidance documents proposed a couple years ago made it very hard for what I call unregulated stem cell clinics to operate. Based on recent FDA action against a couple of these clinics (see my prior post at http://rickjaffeesq.com/2017/09/22/sleeping-giant-awakens-fda-starts-final-push-eliminate-practice-medicine-stem-cell-clinics/),the tea leaves weren’t looking good for the FDA loosening-up the rules in the final version. Well,…

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Saturday Night Gala for Brain Tune-ups for TBI Vets

Saturday Night Gala for Brain Tune-ups for TBI Vets

This Saturday night, I’m going to the Brain Wellness Gala at the Army/Navy Club in DC. The organization raises money for funding veterans with TBI (traumatic brain injury) to get treatment with an effective but completely non-invasive treatment involving micro current stimulation. It’s a form of Neurofeedback. Here is info about the event. http://www.brainwellnessfund.org/ Neurofeedback for therapeutic or lifestyle purposes isn’t new. But these folks have are using the technique on TBI’ed vets with some dramatic results. Sounds a little…

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Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

Dr. Bob Sears Medical Board Case Update: LA Times tries to squeeze, shame and goad the California Medical Board to go after Bob Sears and other vaccine exemption writing Docs harder and faster

We recently received hearing dates in late May, 2018 for Dr. Bob’s hearing before an administrative law judge. The case is primarily about his writing a note excusing the child from vaccination due to two prior severe vaccine reactions. But May, 2018 apparently is not soon or severe enough for the LA Times which today published a story complaining that Dr. Bob and many other doctors are still writing medical exemptions that don’t meet the standards of medical exemptions by…

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Big trouble ahead for companies selling homeopathic remedies in California (revised)

Big trouble ahead for companies selling homeopathic remedies in California (revised)

Last month, the California Court of Appeals came out with a decision which should scare the bejesus out of companies selling homeopathic remedies in California. The case is Rosendez vs. Green Pharmaceuticals. Here is the decision: https://www.leagle.com/decision/incaco20171004089 First horrible thing: It was a class action You want to get a company’s attention: file a class action. It’s more time consuming and expensive for plaintiff’s counsel to obtain “class certification” as opposed to filing a case for just one or two…

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