Category: Clinical Trials
Marty Makary and Vinay Prasad embrace a “more fluid concept of evidence” at the FDA
Last Thursday during a roundtable on stem cell therapies, new FDA Commissioner Marty Makary referred to EBM levels of evidence as an artificial and dogmatic construct. Apparently Dr. David Katz's "more fluid concept of evidence" now reigns at the FDA—selectively.
The tragic termination of the Diabetes Prevention Program Outcomes Study
An invaluable resource is being starved to death with no scientific or ethical justification
The use of placebo controls in clinical trials
Why the value of placebo controls is not an affirmation of a powerful placebo effect
Indiscriminate, Cruel, and Wasteful: Abandoning USAID clinical trials
The chaos and cruelty of its abrupt deconstruction are self-evident and already demonstrable
EMDR Is Still Dubious
A recent meta-analysis of eye movement desensitization and reprocessing (EMDR) therapy concludes that the evidence “confirms” EMDR is effective in treating depression. It is a great example of the limitations of meta-analysis, and how easy it is to create essentially a false narrative using poor quality research. EMDR was “developed” by Dr. Francine Shapiro in 1987. It is the notion that bilateral...
Latest Acupuncture Pseudoscience
JAMA Internal Medicine just published an article titled: Acupuncture vs Sham Acupuncture for Chronic Sciatica From Herniated Disk, A Randomized Clinical Trial. In an accompanying editorial comment, Jerard Z. Kneifati-Hayek and Mitchell H. Katz write: “This was a methodologically rigorous study; there were multiple experienced acupuncturists, the comparison group used a well thought-out sham control, and patients were followed up for 1...
Donald Trump bragged that “right-to-try” has saved thousands of lives. It hasn’t.
Former President Donald Trump bragged in his acceptance speech at the Republican National Convention that "right-to-try" had saved "thousands of lives"? What's the real story? (Hint: Nowhere near that.)
FDA Advisory Committee Recommends approval of new Alzheimer’s drug Donanemab
If approved, donanemab would be the third FDA approved disease-modifying beta-amyloid treatment for Alzheimer’s disease.
Generic Drugs: Are they different?
Standards in place for generic drugs should give consumers confidence that these products are just as effective as their brand-name equivalent.
We finally learn from TACT2 what we should have known two decades ago: Chelation therapy doesn’t work for heart disease
At SBM, we've long argued that chelation therapy for heart disease is quackery. An abstract presented recently finally confirmed that. Why did it take so long?