Experts argue that drug development crisis is linked to poor technology choices
Jack Scannell from Oxford University's Centre for the Advancement of Sustainable Medical Innovation (UK) and consultant Jim Bosley have used mathematical tools to address the hypothesis that poor choices of study method are the root of unsustainably expensive drug discovery.
The cost of developing novel therapeutics is becoming unsustainably expensive, despite technological advances, and a new report argues that this is because researchers are using the wrong methods. The authors, Jack Scannell and Jim Bosley, propose that drug discovery should be based on ‘validity’, or how well the experiment’s results predict results in patients, rather than on methods that are simple to industrialize or are academically fashionable.
The authors used tools commonly employed by economists to study decision making to show that the chance of discovering an effective drug is highly sensitive to the validity of the methods used during the experiment. Minor changes in validity, they demonstrated, can have a greater effect that running 10 or a 100 times more experiments.
Scannell and Bosley put forth that productivity has declined because more predictive methods lead to the discovery of good therapies, allowing research in those areas to cease (for example, stomach ulcers). Researchers are then left to address harder-to-treat diseases with less predictive discovery methods. The authors also propose that changes in fashion, within industry and academia, have contributed to the problem.
The authors’ conclusion was that methods have become progressively less predictive over time, leading to poorer decisions and a rise in the cost of drug discovery. Despite this, drug approvals have increased since 2012. The researchers claims that this is probably due to the rising implementation of genetic data, which raises the validity of rare disease drug discovery, but less so for common diseases.
“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,” explained Scannell.
Scannell concluded: “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.”
Source:Scannell JW, Bosley J. When Quality Beats Quantity: Decision Theory, Drug Discovery, and the Reproducibility Crisis. PLOS ONE. DOI: 10.1371/journal.pone.0147215 (2016) (Epub ahead of print); http://www.eurekalert.org/pub_releases/2016-02/uoo-ddc021216.php