Efficacy and safety of new medicines: a human focus
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ORIGINAL PAPER
Efficacy and safety of new medicines: a human focus Robert A. Coleman
Received: 5 May 2010 / Accepted: 16 July 2010 / Published online: 28 July 2010 Ó Springer Science+Business Media B.V. 2010
Abstract The introduction of safe and effective new medicines is proving ever more difficult, a problem arguably due at least in part to over-reliance on experimental animal-based test systems. In light of the increasing awareness of the lack of predictiveness of such non-human approaches, the necessity to focus on human-based test methods is clear. There has been considerable progress in human in vivo (microdosing) and in silico approaches, primarily to identify ADMET issues, however, in vitro functional studies using human tissues are receiving inadequate attention. The potential scope of human tissue-based research is considerable, but much methodological development is required, which necessitates an increased willingness on the part of the Pharma industry to support it. This approach also requires considerably improved access to the cells and tissues themselves. While current acquisition is almost exclusively from surgery and post mortem, the range of tissue types, the quantity, quality and frequency of supply will remain inadequate to support human tissue as a key component of pre-clinical efficacy and safety testing. Additional routine access to non-transplantable tissues from organ donors for research purposes would be of inestimable value, but in order to realise this, true
R. A. Coleman (&) Safer Medicines Trust, PO Box 62720, London SW2 9FQ, UK e-mail: [email protected]
collaboration will be required between NHS, the Pharma and biotech industries, and the general public. Keywords TGN1412
Heart-beating donors Drug safety
It is generally agreed that the pharma industry has a problem in bringing safe and effective new drugs to market. This may well be due, at least in part, to the over-reliance of the industry on using animals as human surrogates. Indeed, the most widely used animal species, rodents, dogs and non-human primates, have all been shown to be highly unreliable in their ability to predict drug behaviour in man. A comparison of the bioavailability of a range of drugs in man with that in these three species by Grass and Sinko (2002) demonstrated a very poor level of correlation. Furthermore, a retrospective study by Olson et al. (2000), showed that for some systems, the predictive value of animal studies to identify potential toxicity in human subjects performed little better than the spin of a coin. In the light of such low predictive power, it seems surprising that such store is set by animal safety data. To look at the situation from another angle, if evidence of animal tolerability was required before foodstuffs were deemed safe for human consumption, we would for example not have coffee, Brussels sprouts, avocados, orange juice, chocolate or onions, as all these and many others prove toxic when consumed by rats and/or dogs. And of course the
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