In his opinion paper on cardiovascular research in the pharmaceutical industry, J. Conway [1] underlined the huge burden of long development times and the associated high costs of new drugs as a major obstacle in devising innovative therapies for major cardiovascular indications. Having worked for 25 years in a large pharmaceutical company with a few successful contributions to CNS drug research and development (and, of course, many more futile and frustrating endeavours), I cannot but agree with his opinion. I wish to extend his conclusions to my field and to suggest two additional strategies to improve the situation.
As a consequence of increasingly long development times, many drugs do not appear so very innovative when they finally reach the patient, and some have even been pronounced to be 'dead on arrival' by members of the medical community (Klawans HL, personal communication). It has also been more a rule than an exception that, during prolonged development times, new regulations and guidelines have come into effect and have been applied retrospectively, e.g. to clinical studies that had been planned and initiated long before. Over such a long time most managers are not likely to carry the responsibility for innovative drug projects that necessarily involve a greater risk than 'me-too' projects. Due to the high development costs of new drugs (at least US$ 200 million), in the CNS field, too, only a few diseases remain accepted targets for drug companies; they include Alzheimer's disease, stroke, major depression and general anxiety disorders, and, possibly, sleep disorders, epilepsy, schizophrenia, Parkinson's disease, and migraine. However, if in the last five diseases only subgroups of patients are eligible for a new treat-R.