Belief Listing Project: Drug Efficacy Evaluation
|August 16th, 2011|
As things stand, however, doctors are already permitted to prescribe drugs that the fda accepts as safe but not effective for the prescribed use. This is via off-label use. Once a drug has been approved by the fda as safe and effective for some use, it can legally be prescribed for any use. In fact, in cases where off-label use of a drug is a standard treatment, a doctor would be negligent if they refused to consider it just because of it's 'off-label' status. We should remove the requirement that new drugs be proven effective before the fda can accept them.
 This was in response to the discovery that thalidomide, given for morning sickness during pregnancy, produced severe birth defects. Which doesn't make sense, because the problem with thalidomide was safety, not efficacy.
 "At this rate the benefits of FDA regulation relative to that in foreign countries could reasonably be put at some 5,000 casualties per decade, or 10,000 for worst-case scenarios. In comparison, it has been argued above that the cost of FDA delay can be estimated at anywhere from 21,000 to 120,000 lives per decade." (Dale Gieringer 1985 p196)
 The FDA rejected the computer vision system melafind, designed to identify skin cancers, because it was not better than an experienced dermatologist at the task. (Michael Mandel 2011) They did this even though some people are currently not getting checked out for skin cancers due to cost concerns, and a cheaper option than a dermatologist visit could save many lives.
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