Mouse models are often used as preclinical models of human disease, but the number of drugs that succeed in mice but go on to be approved as a drug for humans is only about one in ten. A new study comparing gene expression in the cells of human brains with those of mouse brains provides new insight into why.
A new study shows vitamin D supplements don't prevent diabetes. But there are still unanswered questions.
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...
New drug to treat hypoactive sexual desire in women, Vyleesi, is not very effective and has several drawbacks. It is NOT Viagra for women.
Medicare coverage of acupuncture is under consideration. A new proposal would provide coverage to Medicare patients participating in studies of acupuncture for back pain. This research would be used in making a final decision.
A new drug promises to cure postpartum depression, but it is restricted and patients must be hospitalized for a 60-hour IV infusion.
There's no reliable evidence that an infusion of blood plasma from a young donor will benefit an older person, and there are risks, but Ambrosia Health is selling "young blood" infusions for thousands of dollars anyway. The FDA has taken notice.
Over twenty years ago, cancer quack Stanislaw Burzynski pioneered the abuse of the clinical trial process as a marketing tool to sell his antineoplastons. Now, for-profit stem cell clinics are using ClinicalTrials.gov as a marketing tool for their unproven therapies by listing dubious and scientifically worthless trials in this government database. What can be done?
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.