Donald Trump versus the FDA: Is the standard of evidence for drug approval actually too low rather than too high?
All of the candidates being considered by President Trump for FDA Commissioner believe that the FDA is too strict in its standards for approving new drugs. In a commentary in Nature last week, two bioethicists argued that, at least in terms of preclinical data, the standard of evidence is actually too low. Which is correct?
A Chinese government investigation has found that 80%, yes eighty percent, of Chinese biomedical research is fabricated. I bet that is an underestimate for Traditional Chinese Pseudo-Medicine.
New guidelines suggest that preventing peanut allergies may be as simple as giving peanut-containing food, beginning in infancy. How did old guidelines, which recommended avoidance, get it so wrong?
Until a year ago very few people had ever heard of Martin Shkreli. In 2015 the then-32-year-old CEO of Turing Pharmaceuticals LLC became the poster boy for Big Pharma eXXXcesses when Turing acquired rights to Daraprim, an antiparasitic drug used widely to treat toxoplasmosis. The acquisition itself wasn’t particularly controversial. Raising the price of Daraprim from $13.50 per pill to $750 per...
Stemedica Cell Technologies, a San Diego company that markets stem cell treatments for all manner of ailments, likes to represent itself as very much science-based. There are very good reasons to question that characterization, based on the histories of the people who run the company, as well as the company's behavior.
The Cancer Moonshot has been promoted as a strategy to break the logjam that seems to be holding up new, much more effective treatments for cancer. The key word is "seems," because in reality the Cancer Moonshot is more hype than promise.
As incredible as it seems, advocates of "integrative medicine" are on the verge of creating a new specialty, emergency acupuncture. I wish I were joking, but I'm not.
With the rise of precision medicine and genomics, the conventional randomized clinical trial appears more and more outdated. Fortunately, clinical trials are evolving, but will it be enough to incorporate the numerous advances in "-omic" medicine in a rigorous scientific manner to benefit patients?
One common theme that has been revisited time and time again on this blog since its very founding is the problem of how science and medicine are reported. For example, back when I first started blogging, years before I joined Science-Based Medicine in 2008, one thing that used to drive me absolutely nuts was the tendency of the press to include in...
“Complementary and alternative medicine” (CAM), now more frequently referred to as “integrative medicine” by its proponents, consists of a hodge-podge of largely unrelated treatments that range from seemingly reasonable (e.g., diet and exercise) to pure quackery (e.g., acupuncture, reiki and other “energy medicine”) that CAM proponents are trying furiously to “integrate” as coequals into science-based medicine. They do this because they have...