Blog

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…

Read More Read More

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It’s been almost a month since the FDA’s two day hearing on the draft guidance documents on autologous stem cells.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…

Read More Read More

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…

Read More Read More

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…

Read More Read More

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…

Read More Read More

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…

Read More Read More

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…

Read More Read More

The most important question at the FDA Stem Workshop was the one not asked

The most important question at the FDA Stem Workshop was the one not asked

I didn’t hear the first couple of presentations in the FDA’s Stem Cell workshop. However, I did listen from mid-morning to Dr. Irv Weisman’s closing.  Yesterday’s post was my take on the highlights.  http://rickjaffeesq.com/2016/09/08/really-tough-day-stem-cell-advocates/ Upon reflection, what is disturbing to me is what I didn’t hear, namely a discussion or even a mention of what I think should have been the most important question in the autologous stem cell public policy debate: whether autologous stem cell transplants should be treated…

Read More Read More

And So it Begins: First Accusation filed against a Vaccine Exemption Writing Doc

And So it Begins: First Accusation filed against a Vaccine Exemption Writing Doc

  As I’ve told the mostly unwilling-to-listen Vaccine Concerned Community, the real battle, and the one which will have the most direct positive or negative impact on this community is the future actions by the California Medical and Osteopathic Boards against the docs who write unlimited medical exemptions for the kids of the vaccine concerned. Well the future is now. A few days ago, the Medical Board filed an accusation accusing a well known and highly regarded CAM doctor of…

Read More Read More

A Really Tough Day for Stem Cell Advocates

A Really Tough Day for Stem Cell Advocates

The FDA’s Stem Cell “Workshop” just ended, and if you’re a person who wants continued access to stem cell therapies outside of clinical trials (or a transplanter of “unproven stem cell therapy”), it was a very depressing day. It was way worse than I had feared in my post yesterday.  http://rickjaffeesq.com/2016/09/07/fda-stem-cell-meetings-close-hand-stakeholders-sides-worried-one-side-really-worried/ Sure the two ethicists said that it was wrong and unethical to provide unproven stem cell therapy except in FDA sanctioned clinical trials. But the real punch came from…

Read More Read More