Researchers from Oxford University say that the development of new drugs has become unsustainably expensive due to misguided research practices.
Dr Jack Scannell and consultant Jim Bosley from Oxford and UCL’s Centre for the Advancement of Sustainable Medical Innovation presented their findings in a paper for scientific journal PLOS ONE, entitled ‘When Quality Beats Quantity: Decision Theory, Drug Discovery, and the Reproducibility Crisis’. They point out that despite huge advances in technology in recent decades, industrial research and development costs increased a hundredfold between 1950 and 2010, and have only gotten more expensive since. They also point out that drugs have a higher chance of failing in clinical development now than they did in the 1970s. Rather than making drug development cheaper, technological advances have coincided with a decline in efficiency.
They put this down to poor research methods. Scannell and Bosley argue that ‘validity’ – the extent to which experiments accurately predict results in sick people – should be the measure of drug-testing methods. Their research shows that small changes in the validity of experimental methods leads to a higher chance of discovering an effective drug than running ten or even a hundred times more experiments. But drug research methods have instead focused on processes which are easy to industrialise or fashionable among academics.
They argue that productivity has declined because the methods with the most validity have already led to the discovery of good drugs, such as those for the treatment of stomach ulcers, and so research in those areas has decreased or stopped altogether. This has left scientists working on previously untreated diseases such as Alzheimer’s, which has necessarily meant using less valid experimental methods, because there is less prior data on which to base predictions. As a result, the overall predictability, and therefore validity, of methods has decreased, and the cost of discovering new drugs has gone up.
Dr Jack Scannell said: ‘There is a nasty puzzle at the heart of modern biomedical research. On one hand, the technologies that people think are important have become hundreds, thousands, or even billions of times cheaper. On the other hand, it costs nearly 100 times more to bring a drug to market today than it did in 1950. New drugs can be very expensive, yet the industry is closing labs and firing scientists. Our work goes some way towards explaining the puzzle. Governments, companies, and charities should focus on identifying and funding predictive methods, even if they don’t match current scientific fashion.’
Credit: Tom Varco (CC BY SA 3.0)