JANUARY 2003 BROADSHEET - Drug Discovery to Human Trials
Our last meeting was in November and seems a very long time ago with Christmas and New Year parties in between; all of which I trust you enjoyed immensely. The meeting was very well attended and the speakers both knowledgeable and inspiring. Committee member John Batten, who chaired the meeting, first introduced Gordon Smith Baxter as CEO of Biowisdom, a company he founded to provide IT to the pharmaceutical industry. He outlined the tremendous growth and investment in the last five years in the Genebank arising from the human genome project. The massive increase in databases and the millions of data points arising have not, unfortunately, led to any greater reliability in obtaining higher success rates in drug approval. The possibility of personalised cures is also along way off as one man's cure can be another man's poison. Drug discovery is not at all easy and of the 433 distinct compounds, 50% were discovered before 1938 and there are many still looking for a use. Contact: gordon.baxter@biowisdom.com
Gordon was followed by Malcolm Thomas, a clinical pharmacologist who specialises in First Time in Man Studies. He explained how highly regulated clinical trials were and that animal tests, though good for measuring therapeutic effectiveness, were not entirely reliablefor assessing toxicity. It was therefore necessary to use human volunteers and furthermore, young healthy male volunteers. There were several reasons why patients suffering from the target disease could not be used, principally because of the need to use placebos in double blind experiments, but also because they would be more likely to succumb to any toxic effects. The only exemption was when someone suffering from a life threatening disease might obtain immediate benefit. The dosage was always low so as to keep any incipient toxicity within safe levels. Contact: thomas@saintagnes.demon.co.uk
During question time some of the anomalies were revealed. For example General Practioners have none of these stringent regulations imposed on them and can prescribe a drug for a patient if they think it will be beneficial. The fact that major disasters occasionally occur showed that the number of volunteers had to be very large to cope with, say, a 1 in 10,000 possibility. A Vet in the audience made interesting points on the use of placebos in animal testing (for animal drugs, of course). Although animals had difficulties in communicating, their owners were a very reliable source of information. Progress was to a certain extent hindered by impatience - here was this new gene technology to pinpoint cures and yet drug discovery was still a long uphill battle with serendipity as king! The extremely high cost was invariably due to the many failures on the way, though very occasionally the side effects turned out to be winners, famously Viagra and Epinutin which was designed for epilepsy and proved better for cardia eurythmia. The answer to a question on hometherapy just proved the truth of the placebo effect.
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