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Author: Richard Jaffe

Breaking News in the US Stem Cell Injunction Case!

Breaking News in the US Stem Cell Injunction Case!

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But first a ho hum update Last week, both parties filed motions for summary judgment. What that means is that both sides are arguing that there is no need for a trial and that the judge can decide the case on the summary judgment papers. The government argues of course that the defendants are violating FDA law by using their more than minimally manipulated products for non homologous use, and that it doesn’t fit within the same day surgical procedure…

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Is there a First Amendment right to share negative information/concerns about vaccines on Facebook?

Is there a First Amendment right to share negative information/concerns about vaccines on Facebook?

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Can Facebook engaged in vaccine censorship

There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

There’s just time for a quick update on the FDA’s Injunction Lawsuit against US Stem Cell Clinic

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Recent fillings and orders which were expected: Longer papers for summary judgement. The parties jointly moved to allow each to file more pages than is allowed for summary judgment under the local rules. The parties wanted double the amount. The judge gave them less. Yesterday the parties filed a joint motion to cancel the local rule required mediation. Mediation is a waste of time in a case like this. There’s no money damages sought, and the Government already told US…

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Real Time Censorship of case report on HPV vaccine associated with ADEM

Real Time Censorship of case report on HPV vaccine associated with ADEM

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Most pediatricians receive in the mail Pediatrician News. The most recent issue contained an interesting case report discussed in “Pearce-ings” by columnist Francine Pearce, M.D. It discusses a teenage girl who presented to an orthopedist with back pain of unknown etiology, who then had a seizure of unknown origin, according to the neurologist. The patient had more seizures and developed tics. She was hospitalized. A spinal tap and MRI confirmed ADEM (acute disseminated enchaphalomyelitis). She had been healthy and athletic,…

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FDA Commish talks from a place other than his mouth, and I agree with Richard Pan

FDA Commish talks from a place other than his mouth, and I agree with Richard Pan

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FDA Commissioner Scott Gottlieb has just threatened states that unless they tighten up vaccine exemptions laws, the FDA may have to come in and federally force school students to be vaccinated Here’s specifically what he said: “Some states are engaging in such wide exemptions that they’re creating the opportunity for outbreaks on a scale that is going to have national implications,” FDA Commissioner Dr. Scott Gottlieb said Tuesday in an interview with CNN. If “certain states continue down the path…

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Can the California Authorities Revoke my Child’s Vaccine Medical Exemption?

Can the California Authorities Revoke my Child’s Vaccine Medical Exemption?

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I’ve been asked that a number of times recently. Here’s my qualified answer: There is no statutory, other legal basis, or procedural mechanism for a school or public health official to revoke, rescind or invalidate a facially valid vaccine medical exemption issued by a duly licensed California physician. That is my opinion and it is based on the fact that since the California vaccine exemption law is a statutory enactment, it would take a statute to amend the current statute…

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A Injured Stem Cell Patient’s Story

A Injured Stem Cell Patient’s Story

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I previously posted about a west coast stem clinic which had injured several dozen patients with its autologous based stem cell product. Here is a link to the prior post: http://rickjaffeesq.com/2019/01/13/what-should-happen-if-a-stem-cell-clinic-harms-many-patients-revised/ Here is the story on one of the patients, written in her own words, with some deletions and redactions to de-identify the clinic. The clinic told me I was an excellent candidate for their Lyme SVF stem cell treatment. They promised this treatment would boost my immune system to…

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To my vaccine-concerned friends: stop saying that the Supreme Court decided that vaccines are “unavoidably unsafe.” It didn’t.

To my vaccine-concerned friends: stop saying that the Supreme Court decided that vaccines are “unavoidably unsafe.” It didn’t.

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(2/14/2021 note: Because so many people have apparently misunderstood this in-the-weeds legal analysis of this Supreme Court decision, I have recently revisited the issue of the “vaccines are unavoidably unsafe” mantra in a recent post which might make it clearer for some. Here is the link. https://wp.me/p7pwQD-Su ) One of the things that drives me crazy is when nonlawyers misstate the law. I have been informed by some of my vaccine-concerned friends that the Supreme Court actually stated that vaccines…

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Is cord blood/umbilical cord stem cell treatment legal?

Is cord blood/umbilical cord stem cell treatment legal?

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Virtually all the attention I’ve given to stem cells in my prior posts has been on autologous stem cell transplants. But the private stem cell clinic industry actually started with cord blood back in the early part of this century. I have written about the start of this field and the FDA’s first two cord blood clinic criminal investigations in Galileo’s Lawyer. The short of it is that even back then, the FDA didn’t think a private clinic’s use of…

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THE BEGINNING OF THE END OF THE FDA’S REGULATION OF AUTOLOGOUS STEM CELL TREATMENTS FOR ORTHOPEDIC USE

THE BEGINNING OF THE END OF THE FDA’S REGULATION OF AUTOLOGOUS STEM CELL TREATMENTS FOR ORTHOPEDIC USE

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A little over a year ago, the FDA made public its final guidance documents in the stem cell field (HCT/P’s in FDA parlance). The documents were highly restrictive and all but eliminated the use of autologous stem cells outside of clinical trials. (I have written about this many, many times. Just scroll through some of my prior posts in the stem cell category on my home page). Apart from being wrong, my view has been that the FDA does not…

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