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 […]
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 […]
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 […]
Your insurance company most likely knows more about your health conditions than you do.
Millions of people are prescribed medications based on efficacy trials with as few as 20 participants.
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 […]
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 […]
In the 1800s there was a big problem with snake oil salesmen making false claims about the concoctions they were selling. The original solution was the AMA Council on Pharmacy and Chemistry certification to ethical drug products that met their standards. 1906 – Ingredient Lists and No Lying on Labels The 1906 Pure Food and […]
For thousands of years, everything sucked and the average human life expectancy was 28. Then something happened around 1800 and life-expectancy exploded. Structural Changes Leading to the Health Explosion Let’s zoom in and see what happened in the last couple of centuries leading to this explosion. We see on the timeline are two primary groups […]