“Johns Hopkins is deeply committed to exploring innovative treatments for our patients. Our scientists have shown that psychedelics have real potential as medicine, and this new center will help us explore that potential.” Paul B. Rothman, M.D., Dean of the Johns Hopkins University School of Medicine and CEO of Johns Hopkins Medicine. Scientists today are […]
Author: mikepsinn
FDA Sentinel Initiative
Sentinel is the FDA’s national electronic system which has transformed the way researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices. Sentinel has developed the largest multisite distributed database in the world dedicated to medical product safety. In September 2019, FDA announced Sentinel would expand to three distinct coordinating […]
Observational Study Results Aren’t Much Different Than Randomized Controlled Trials
For many years it has been claimed that observational studies find stronger treatment effects than randomized, controlled trials. A meta analysis compared the results of observational studies with those of randomized, controlled trials. That analysis found little evidence that estimates of treatment effects in observational studies reported after 1984 are either consistently larger than or […]
All of Us Research Program
What is the All of Us Research Program? All of Us is a research program from the National Institutes of Health (NIH). The goal is to help researchers understand more about why people get sick or stay healthy. People who join will share information about their health, habits, and what it’s like where they live. By looking for […]
Geographic Differences in Lifespan
Neuro-Inflammation Case Study
These analyses suggest that this individual’s depression may be a manifestation of cytokine-induced interference with the conversion of tryptophan to melatonin and serotonin in conjunction with increased glutamate receptor activation. Background Recent studies have focused on the role of immune dysfunction in depression. and analogies to “cytokine-induced sickness behavior”. Sickness Behavior – Behaviors that develop […]
With Health Insurance, Medical Privacy is a Myth
Your insurance company most likely knows more about your health conditions than you do.
Clinical Trial Cohort Sizes
Millions of people are prescribed medications based on efficacy trials with as few as 20 participants.
Efficacy Trials Before 1962
There are hundreds of conditions that a given drug may be effective at treating. However, it’s impossible to know which conditions a drug may improve until it is tried by real-world patients. Prior to the 1962 regulations, it cost a drug manufacturer an average of $74 million dollars (2020 inflation-adjusted) to develop and test a […]
Human Costs of the High Cost of Clinical Research
Since 1962, the cost of bringing a new treatment to market has gone from $74 million to over $1 billion US dollars (2020 inflation-adjusted). Treatments for Rare Diseases Make No Financial Sense The costs of FDA regulations do not vary with the number of potential users of the drug, so the decline in drug development […]