To the Ministry of Truth, at the MHRA, copied to Brown, Johnson and Vara:
Dear Sir or Madam,
It is my undertstanding, given previous correspondence with the MHRA, that there are three statutory criteria involved in the assessment of a drug for a marketing authorization. Those three criteria are efficacy, safety and quality.
A drug must, then, do the thing that is claimed, and that thing must be a benefit to the patient (efficacy). This benefit is then assessed against the safety of the drug. During this process, the nature of the condition is taken into consideration, and the less serious the condition is, the less tolerant the regulator will be of serious side effects. As such, a drug designed to treat a condition that is not life-threatening is unlikely to be licensed, if the side effects are life-threatening. This comparison between benefit and safety, I understand, is known as a risk:benefit analysis and the benefits must outweigh the risks, in order for the drug to be licensed. Finally, it has to be demonstrated that the drug can be produced to a consistently high standard (quality).
I would like to conduct my own risk:benefit analysis on fluoxetine, and I would like to use the MHRA's methodology, if it has one. Could you explain to me what the benefit of the drug is, please?