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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.

One of 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 are “unavoidably unsafe,” and use the Supreme Court finding to support their argument that people should not be forced into vaccination because even the Supreme Court acknowledged how unsafe vaccines are. I’m here to tell you that it never happened. The Supreme Court has never held or decided or…

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Is cord blood/umbilical cord stem cell treatment legal?

Is cord blood/umbilical cord stem cell treatment legal?

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

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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What Should Happen if a Stem Cell Clinic Harms Many Patients? (Revised)

What Should Happen if a Stem Cell Clinic Harms Many Patients? (Revised)

Here’s my core position: I support a patient’s access to his/her own stem cells (autologous use) for any use agreed to by the patient after proper informed consent which is not tainted by false or misleading advertising claims by the stem cell clinic. This post is about autologous use, not allogeneic, i.e., another person’s stem cells. My philosophical/public policy/constitutional thinking is that people do/should have a right to determine what happens to their own bodies, so long as that right…

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What Should Happen if a Stem Cell Clinic Harms Many Patients?

What Should Happen if a Stem Cell Clinic Harms Many Patients?

Here’s my core position: I support a patient’s access to his/her own stem cells for any use agreed to by the patient after proper informed consent which is not tainted by false or misleading advertising claims by the stem cell clinic. My philosophical/public policy/constitutional thinking is that people do/should have a right to determine what happens to their own bodies, so long as that right doesn’t endanger public health or safety, or impinge on another’s protected rights. I don’t see…

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Is CAM under stealth attack by the Monopoly Internet Megacompanies ?

Is CAM under stealth attack by the Monopoly Internet Megacompanies ?

CAM (Complementary and alternative medicine, now more commonly known as integrative medine) has always been polarizing in the medical community, and has consistently come under attack by conventional medicine advocates. In the time since I became active, it was the quackbusters, then the sceptics who evolved into the bloggers who attack all things CAM. Heretofore, they have have had a relatively small impact on the CAM community. However, there might be a new threat developing which could have a much…

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Five Things the FTC won’t like about Private Stem Cell Clinic Advertising and What it Can do About it

Five Things the FTC won’t like about Private Stem Cell Clinic Advertising and What it Can do About it

Why the FTC won’t like the private stem cell clinics advertising

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Brief Memo on Advertising to Private Stem Cell Clinics (Especially the “Affiliates” of the two Defendant Organizations)

Now would be a good time for private stem cell clinics to change their web site advertising

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

Some Perspective on the California Medical Board’s “task force” on Stem Cell Clinics

A few days ago, the big dog blogged that a San Diego TV station was reporting that the Medical Board of California (MBC) has announced its intention to form a task force to “investigate” private stem cell clinics, presumably following the Federation of State Medical Board’s (Federation) report on the subject. Here is the post: https://ipscell.com/2018/11/medical-board-of-california-task-force-to-investigate-stem-cell-clinics/ The intended or unintended implication is that all these clinics are about to be shut down by the MBC. But let’s take a breath….

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Private stem cell clinics should start worrying about some new regulatory players

Private stem cell clinics should start worrying about some new regulatory players

Up until very recently, the FDA has basically been the sole regulatory threat to the private/for-profit stem cell clinics, via published guidance documents, site inspections, warning letters and the recent federal civil injunction cases against the two biggest stem cell operations. See my posts about the status of these cases at: http://rickjaffeesq.com/2018/09/26/update-on-fda-injunction-cases/ As an aside It’s no coincidence that the defendants in both of these injunction cases have many dozens of so-called “affiliate” stem cell clinics throughout the country. Both…

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