This is not a problem with the creativity and innovation of pharmaceutical researchers — this is a problem with the current drug development system. It’s simply too costly and too unwieldy to bring a new drug to market – especially a new Ebola cure. According to the NIH, the average time to market for a new drug is 14 years and the average cost for the development of any new drug is close to $2 billion. The average drug spends six of those 14 years in clinical testing, that is, testing drugs out on humans to make sure they’re absolutely safe before bringing them to market.
And that’s where the Ebola virus might change the way we think about pharmaceutical innovation. We don’t have six years to test an Ebola cure. We may only have six months, if we don’t want to risk Ebola transforming from a regional health crisis in Africa into a global health crisis. That’s causing people to rethink what’s causing the long, costly and unwieldy process for bringing new drugs to market. If you think of the drug development pipeline as a huge funnel, then we need more ways to either widen or shorten this funnel.
You can already see the first early signs of a change in thinking brought on by this new urgency. On Aug. 12, the World Health Organization officially came out with a decision to fast track new Ebola treatments, even if they haven’t been fully tested. That’s why ZMapp was being shipped to Africa even though it hadn’t been fully tested on humans. The FDA has promised to remove other bottlenecks involved in getting cures to market. Canadian company Tekmira Pharmaceuticals was the big beneficiary when the FDA recently announced it was ready to move the company’s Ebola treatment from a “full clinical hold” to a “partial clinical hold.” The FDA’s decision means that the treatment could start to be used on patients already infected with Ebola, removing a key roadblock in its eventual approval.
Don’t misunderstand – safety should always be a primary concern. From that perspective, the current drug development system works, in the sense that it ultimately produces drugs that have been clinically tested on humans and have been shown to be safe with limited side-effects. That’s what you get when you spend $2 billion and 14 years testing something.
However, the current drug development system also produces a lot of market abnormalities, in the sense that pharmaceutical companies won’t produce certain drugs because it just doesn’t make financial sense. Instead, the focus is on creating drugs where there is a large target audience. (You can think of these as the types of drugs you see advertised on TV every night). Think about this from the perspective of a chief executive or shareholder – the share price is only going to go up if the market is convinced that you’re on to something really big.
The easiest way to understand these market abnormalities is the current situation now, where we simply weren’t prepared for a large-scale Ebola outbreak. Ebola, unfortunately, is seen by many as “a disease of poor people in poor countries.” If you’re the chief executive of a Western pharmaceutical company, what’s the incentive for creating a cure that only a few thousand people are ever going to use or pay for? Doing the mortality math is an icky and morally challenging process, but the 1,000 lives already lost to Ebola are surely worth more than the $2 billion that it would have cost to develop the drug in the first place.
However, there are ways of getting rid of the bottlenecks in the innovation process without recklessly rushing new drugs to market that haven’t been fully tested. The NIH, for example, has already proposed a number of innovations that could reduce the time to market – like new biochips for testing drug safety developed with the help of DARPA that reduce the number of animal and human clinical trials required. In December 2011, the NIH also created the National Center for Advancing Translational Sciences (NCATS) to transform the drug development process so that new treatments and cures for disease can be delivered to patients faster. The focus is on re-engineering the drug development pipeline.
Understanding the bottlenecks in any operation is a classic business school case study. Often, what’s causing the problem can be removed with a huge impact on future operational efficiency. Now extrapolate this thinking to the pharmaceutical industry – removing bottlenecks in the drug development process could lead to huge gains, mostly measured in lives saved in cases when mortality rates are high. There’s been some great work already performed by the world’s best pharmaceutical researchers in creating a treatment – and possibly, a cure — for Ebola. Let’s not squander their work by letting it languish for years before they get a chance to show what they can do.