Tag: clinical trials
Would you pay $1 million to enroll in a phase 1 clinical trial of an “anti-aging” gene therapy?
Libella Gene Therapeutics, LLC made the news last week for announcing a "pay-to-play" trial of its telomerase-based anti-aging gene therapy. What was shocking about the announcement was not that it was a "pay-to-play" trial, given that such trials have become all too common, but rather the price of enrollment: $1 million. Worse, the trial is being conducted in Colombia; the therapy doesn't...
Federal “right-to-try” over a year later: Still a failure and still about the money (and weakening the FDA)
Federal "right-to-try" legislation was passed and signed into law by President Trump over a year ago. Advocates promised that lots of terminally ill people who were dying then would be saved by having the right to "try" experimental therapies outside of the context of clinical trials. That has not happened. This should come as no surprise, because right-to-try was never about getting...
For-profit stem cell clinics, universities, and “pay-to-play” clinical trials for autism
Stem cell therapies show great promise, but as yet the vast majority of that promise has not been validated in rigorous clinical trials. Unfortunately, for-profit stem cell clinics are running clinical trials that require patients to pay to be part of it. These trials are not rigorous. Even more unfortunately, it appears that some universities are also running "pay-to-play" clinical trials that...
The FDA’s accelerated drug approval program is failing to protect cancer patients
Drug approval is a process that should be and, for the most part, is rooted in rigorous science. However, there is always a countervailing pressure to approve new drugs rapidly, particularly in cancer. That's why the FDA created the accelerated approval program in the early 1990s. Unfortunately, increasingly this approval process appears to be failing us in oncology. Reform is needed.
Naturopaths try (and fail yet again) to argue that they are science-based
That booster of all things "integrative," John Weeks has devoted the entire most recent issue of The Journal of Alternative and Complementary Medicine, which he edits, to trying to demonstrate that naturopathy is science-based. It does not go well. Same as it ever was.
Are antivaxers “holding science hostage”?
Melinda Wenner Moyer published an article in The New York Times arguing that fear of how antivaxers will react to scientific findings is leading scientists to self-censor. I'm not convinced that this is the case.
The very worst version of the sham known as “right-to-try” is poised to become law
"Right-to-try" laws are a cruel sham that purport to allow terminally ill patients access to promising experimental drugs. In reality, they strip away many protections and leave vulnerable patients on their own. After four years and a number of toothless state laws, a federal version of "right-to-try" is poised to become law. A version passed by the Senate could be voted on...
Essential Oils in the Ambulance
Aromatherapy with essential oils is pseudoscience, backed only with low quality studies guaranteed to show a placebo effect. Their growing popularity warns that better science education is needed.
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...
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.