The FDA vs. Bone Cancer Patients
In the three years that it took to duplicate what was already known, upwards of 80,000 men lost their lives to prostate cancer. This is equal to the number of men killed in combat in the Korean, Vietnam and Iraq wars combined.
Full article on the irrational standards of the FDA.
This has been going on for as long as there has been an FDA. Sam Peltzman wrote a classic article about the tradeoff between two types of errors: mistakenly keeping a drug off the market or mistakenly letting a drug on the market. He concluded that all the political incentives are to make the first type of mistake.
The result: thousands of unnecessary and/or premature deaths.
Ditto. The public (except for those that are really sick) doesn’t understand that being “protected” from drugs actually means that you don’t have access to them when you need them most.
The FDA kills. Doesn’t everybody know that?
The FDA and the public both need to better appreciate that there are varying degrees of risk among patients; and degrees of risk aversion. An FDA official, afraid of being embarrassed by an unforeseen risk, should not preclude all patients from having access to a particular drug therapy. Patients should have some ability to determine their own level of risk they are willing to endure.
The drug Vioxx comes to mind. Many patients, who were never at risk for cardiac problems, found Vioxx to be exceedingly good at controlling pain. But everyone lost access to Vioxx because of a very small subgroup who (theoretically) might die from using the drug.