An editorial by William Bains, a biotechnologist and entrepreneur, questions the usual drug development process:
Translational Medicine [about going from research to practice] conferences are full of discussions of PET fMRI, gene arrays and proteomics, far beyond the means of the GPs that see 95% of patients, and divorced from the simple clinical observations that resulted in the discovery of drugs as diverse as aspirin and viagra.
Because this is the way that biomedical research (especially drug research) is done, it is assumed that the features of this process are features that have to be part of the biomedical research process. These include:
(i) that only professionals operating in established organizations can have the knowledge to identify new areas of medicines research;
(ii) that biomedical research can only be done using cutting edge technology, which is enormously expensive;
(iii) that only tests on huge numbers of people can validate a new approach.
None of these is true.
There is precedent for other ways of doing things:
The majority of clinical advances in the last 20 years of dermatology have been made by individuals working outside the mainstream of academic research, but possessing a keen observational eye, strong, skeptical analytical skills and constant contact with patients