Belief Listing Project: Drug Efficacy Evaluation

August 16th, 2011
current_beliefs, drug_efficacy
In 1962, an amendment to the food and drug act added a requirement that drug manufacturers prove that their drugs are effective. Before that, the food and drug administration would approve new drugs that had been demonstrated to be safe, but they did not consider efficacy. [1] Unfortunately, slowing down the progress of drug creation by running additional trials to test effectiveness has costs, about 60,000 lives per decade. [2] Additionally, while a new treatment that is significantly cheaper than an old one but is somewhat less effective makes sense from a cost-benefit perspective, the fda would reject such a treatment for not being more effective than current treatments. [3]

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.

[1] 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.

[2] "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)

[3] 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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