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Hot off the press: The other shoe drops on stem cell clinics

Hot off the press: The other shoe drops on stem cell clinics

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The Washington Times reported today that the FDA has filed permanent injunction lawsuits against the two most high profile U.S. stem cell clinics. Here is the article: https://www.washingtontimes.com/news/2018/may/9/doj-moves-shut-down-two-stem-cell-clinics/ Both of these clinics received FDA warning letters last year indicating that their operation violated federal law. Today’s action by the FDA in the logical and inevitable conclusion of the FDA’s multi-year effort to eradicate stem cell clinics using autologous stem cell treatments. See my end of year post, laying out what…

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The CME certification powers-that-be go after the other big dog in Integrative Medicine

The CME certification powers-that-be go after the other big dog in Integrative Medicine

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The original version of this Post incorrectly stated that IFM’s CME status was revoked by the ACCME. THAT WAS INCORRECT! Sorry about that. However, the highly respected Institute for Functional Medicine (IFM) has had some issues with its CME course accreditation, via the Family Practice physicians’ group. It’s complicated, so see my post at: http://wp.me/p7pwQD-d3 Previously, the ACCME had initiated revocation proceedings against other organizations. See:http://wp.me/p7pwQD-9q The ACCME has taken on the other big dog in the IM (Integrative Medicine)…

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A Bad Decision on IFM’s CME battle

A Bad Decision on IFM’s CME battle

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I’ve previously discussed the ongoing efforts by the AACME (the main CME accrediting agency) to revoke the CME granting status of various unnamed integrative medical groups. See post at: http://wp.me/p7pwQD-9q But the ACCME isn’t the only organization which grants CAM groups CME course accreditation. The AAFP (American Association of Family Practitioners) does also. The AAFP used to give the Institute for Functional Medicine (IFM) CME status for all its courses. But that changed in 2014 when its CME status was…

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First 2018 Stem Cell Update

First 2018 Stem Cell Update

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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!

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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

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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

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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

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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

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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

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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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