Tag: Food and Drug Administration

Stem cell clinics and unapproved, for-profit human experimentation

Editor’s note: I met Dr. Paul Knoepfler online in the wake of my two posts on Gordie Howe and his stem cell treatment for stroke. I was impressed by his posts on the topic and what I saw at his own blog. Given that he’s a stem cell researcher, I wanted him to write a post on stem cell clinics like the...

/ January 19, 2015

New FDA regulatory role threatens bogus diagnostic tests

The FDA regulates in vitro diagnostic devices (IVDs) as medical devices. IVDs analyze human samples, such as blood, saliva, tissue and urine. However, in the past, the agency did not use its authority to regulate what are known as “laboratory-developed tests” (LDTs), tests developed and performed at a single laboratory, with all samples sent to that particular lab for testing. Instead, it...

/ January 15, 2015

Using the fear of Ebola to promote the placebo legislation that is “right to try”

Libertarians and free market fundamentalists generally detest the FDA and want to dramatically decrease its power in the belief that the free market can guarantee the safety of drugs better than a government agency that requires strong scientific evidence of efficacy and safety before approval. Not surprisingly, they're at it again, this time in the service of promoting "right-to-try" laws and using...

/ November 2, 2014

The Texas Medical Board vs. Stanislaw Burzynski, 2014 edition

Here we go again. I'll give the Texas Medical Board credit for one thing. It's persistent. It's going after Stanislaw Burzynski's medical license again. Will this finally be the time the TMB puts a stop to Burzynski's abuse of the clinical trial process and patients? Or will this be a replay of the 1990s, with Burzynski slithering away yet again?

/ July 14, 2014

The Center for Inquiry weighs in on the FDA’s mishandling of Stanislaw Burzynski’s clinical trials

The Center for Inquiry points out how what Stanislaw Burzynski is doing corrupts the clinical trial process and harms patients.

/ July 3, 2014

Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA really caves

Once more, the FDA fails to shut down Stanislaw Burzynski's clinic and antineoplaston manufacturing operation. Cancer patients will suffer as a result of the FDA's failure.

/ July 1, 2014

Stanislaw Burzynski’s propaganda victory on antineoplastons: The FDA caves

Sadly, it looks as though Stanislaw Burzynski is going to win his latest round with the FDA. Same as it ever was.

/ March 24, 2014

The illusions of “right to try” laws

[Ed. Note: For additional commentary on why “right-to-try” laws are such a bad idea, see “Right to try” laws and Dallas Buyers’ Club: Great movie, terrible for patients and terrible policy and The false hope of “right-to-try” metastasizes to Michigan.] There is nothing like a touching anecdote to spur a politician into action. And those who want to try investigational drugs outside...

/ March 6, 2014

The Skeptics for the Protection of Cancer Patients need your help

We at SBM don’t normally ask our readers for much, if anything, other than to read and for the subset of you who like to be active in the comments to have at it. However, given the story of Stanislaw Burzysnki, which I’ve been covering with frequent blog posts for over two years now, how could I not listen to the appeal...

/ December 4, 2013

The Burzynski Empire strikes back

You might have noticed that I was very pleased last Friday, very pleased indeed. Given the normal subject matter of this blog, in which we face a seemingly-unrelenting infiltration of pseudoscience and quackery into even the most hallowed halls of academic medicine, against which we seem to be fighting a mostly losing battle, having an opportunity to see such an excellent deconstruction...

/ November 18, 2013