Tag: clinical trials
Sen. Ron Johnson: Holding the bill funding the FDA hostage unless the cruel sham that is right-to-try is added to it
Advocates claim that "right-to-try" laws help terminally patients by allowing them access to experimental drugs before approval, when, in fact, such laws strip legal and regulatory protections from patients using such drugs and their purpose is actually to undermine and weaken the FDA. Now advocates led by Sen. Ron Johnson (R-WI) are making a new push to pass right-to-try by embedding it...
The cruel sham that is right-to-try raises its ugly head at the federal level again
Ill-advised right-to-try bills are spreading like kudzu through state legislatures. Now federal legislators want to insert right-to-try language into the bill that funds FDA drug approval. Given the support of powerful Republicans like Vice President Mike Pence for right-to-try, is it too late to stop this juggernaut and protect patients?
Bills remove impediments to ill-advised state “right to try” laws, shield wrongdoers, and hide adverse events
Congressional bills will unleash state "right to try" laws, block terminally ill patients from redress for damages caused by negligent doctors and drug companies, and hide adverse drug events from the public.
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?
Chinese BioMedical Research: Sturgeon’s Law In Action
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.
Peanut Allergy Prevention Advice Does a 180
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?
R&D and the High Cost of Drugs
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...
The stem cell hard sell, Stemedica edition
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: Hype versus reality
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.
Responding to SBM Critics
A response to a critic of SBM, and setting the record straight on our actual positions regarding evidence and the practice of medicine.