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Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

Cali. Medical Board makes it official: Docs who write non- standard-of-care medical exemptions will be prosecuted, (but maybe not)

vaccineimage The elimination of the PBE (personal belief exemption) via SB 277 has put a lot of pressure on vaccine concerned California pediatricians to write medical exemptions for the children of vaccine concerned parents. The recently dismissed San Diego federal anti-SB 277 lawsuit showed that at least one school board is collecting information about the docs who write these medical exemptions and will forward the information to the medical board for prosecution. Based on some non-binding legislative history, and some…

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Dear Donald: Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA

Dear Donald: Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA

Dear Donald: Good move on Dr. Tom Price at HHS and Jim O’Neill at the FDA. Both seem to be disruptor/game changers, which is exactly what HHS and FDA need. As a guy who has been battling the FDA for a few years and per your request, here are a couple things which they should do from the get-go, without alot of bureaucratic red tape. Let’s start with getting the FDA bureaucrats off the backs of patients and consumers. Stem…

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A short, mostly first-hand history on insurance reimbursement for CAM

A short, mostly first-hand history on insurance reimbursement for CAM

In litigating criminal and civil CAM (Complementary and Alternative Medicine) cases for three plus decades, I’ve seen a lot, and I have the medals and battle scars to prove it (meaning good and bad court opinions, jury verdicts and prosecutorial decisions). The decades have also given me a perspective on how things have changed, and haven’t. For CAM insurance reimbursement (including chiropractic), I see one constant dynamic: Insurance carriers don’t like to pay for CAM services, so (some in) the…

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Unwanted advice for the anti-vaxxer Cali. SB 277 lawsuit reboot

Unwanted advice for the anti-vaxxer Cali. SB 277 lawsuit reboot

Here’s what I’m getting from the Bolen Report’s prediction/foreshadowing of the new SB277 challenge, and so here is some more probably unwanted advice: 500 Plaintiffs: Really? HELLO: you’re fighting an asymmetrical battle. The government has a lot more financial and personnel power than you guys. Moreover, if what you say is true, namely that big pharma is behind the worldwide vaccine conspiracy, pharma has unlimited resources. You’re going to try to manage 500, or even dozens of plaintiffs? That doesn’t…

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Game Changing the Stem Cell Debate

Game Changing the Stem Cell Debate

It’s been almost a month since the FDA’s two day hearing on the draft guidance documents on autologous stem cells. Here is the short version of what happened: The stem cell research industry, meaning the basic scientists and academic physicians employed at big institutions, and their acronym organizations like the draft guidances. They agree with the FDA that non-homologous, (roughly meaning therapeutic as opposed to replacement) autologous (i.e. my) stem cells (or any kind of autologous tissue or “HCT/P’s”) should…

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WHAT’S WRONG WITH THE U.S. HEALTHCARE SYSTEM AND WHAT IT WOULD TAKE TO FIX IT

WHAT’S WRONG WITH THE U.S. HEALTHCARE SYSTEM AND WHAT IT WOULD TAKE TO FIX IT

I spend most of my professional time in the weeds of health care cases, so I thought it might be a nice change of pace to put down some of my observations and general critiques of the system based on my 30 years in the health care arena and as a consumer of health care services. (I originally posted this back in April, but so much has changed since then, I decided to update the problems, (including the FDA’s recent…

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THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

THE SCARIEST ATTACK ON PERSONAL FREEDOM YOU’VE NEVER HEARD OF/ THE BIG TAKEWAY: If the FDA gets its way, the most popular post mastectomy breast reconstruction procedure will become illegal, and so will many other life enhancing procedures

Using your own stem cells, tissue and body parts without FDA interference should be a no brainer and a slam dunk, but it isn’t. I mean it’s your own body. How can the federal government interfere with your privacy and autonomy right to use parts of your own body as a treatment? The short answer is they can and if the FDA gets its way, future patients are not going to be able to use their own cells and tissue…

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Press Release re Dr. Bob Sears case with Ca. Medical Board

Press Release re Dr. Bob Sears case with Ca. Medical Board

“I represent Dr. Bob Sears in the California Medical Board’s case against him for writing a medical exemption from vaccination. We take the board’s accusation seriously. But this case is very clear: this child had two unusual and severe vaccine reactions and his situation warranted a medical exemption. To continue vaccination could have put the child at risk of further harm. All physicians have an ethical duty to do no harm to a patient. This is no less true when…

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FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy

FDA Draft Stem Cell Guidance Documents Exposed as Improper Rulemaking, Bad Science and Heartless Public Policy

Today was a good day for people who want continued access stem cells outside of clinic trials, and also for people who want the FDA to allow faster access to this promising technology. There was a wide spectrum of opinions. Some stem cell companies involved in clinical trials wanted the non-clinical trials clinics shut down. But at least there were representatives from some of these “unproven” clinics and interest groups who made some important points about the rights of patients…

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More on The FDA’s Stem Cell Public “Workshop”: Stem Cell Clinical Trials aren’t the Answer for Everyone

More on The FDA’s Stem Cell Public “Workshop”: Stem Cell Clinical Trials aren’t the Answer for Everyone

Not unexpectedly, the organizing theme of the FDA’s Stem Cell workshop  was that patients should only be able to receive their own stem cells for non-homologous use in FDA approved clinical trials until FDA marketing approval (i.e., until a New Drug Application is granted for some non-homologous use). I’ve been involved in legal/policy issues relating to clinical trials for a long time. I understand that clinical trials is the standard of care for patients when FDA approved treatments (on or…

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