Ebola might change the way we think about pharmaceutical innovation
There is positive news on the Ebola outbreak with several different pharmaceutical companies working on creating a vaccine, this includes the potential cure that everybody has been talking about, which is ZMapp. While this all sounds very promising we are years away from ever having these vaccines widely available in the marketplace, this is also with recent efforts to fast track them into development.
Currently there isn’t a problem with creativity and innovation of the researchers of the pharmaceutical companies however the current problem lies with, the current drug development system. The current system is far too costly and unwieldy when trying to bring a new drug into the market. Research done by the NIH, the average time to market for a new drug is 14 years, with the average cost of developing any new drug being around $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.
With this in mind the current Ebola outbreak may change the way we think about pharmaceutical innovation. This is due to the fact we don’t have six years to test an Ebola vaccine, we have six months at a huge push if we are realistically looking stopping Ebola from transforming into a global health crisis rather than a regional health crisis in Africa. This has caused many people to rethink the new drug development process and look into why it takes so long. If you were to think of the drug development pipeline as a huge funnel, then we will need more ways to either widen the funnel or shorten it.
You can already see the very early signs of a change in thinking which has been brought on by this new urgency. The World Health Organisation officially came out on the 12th of August, with a decision to fast track new Ebola treatments, even if they haven’t been fully tested. This is why the much talked about ZMapp has been shipped to Africa even though it hasn’t been fully tested on humans.
Other speed bumps that can occur trying when trying to get a cure into the market have been promised by the FDA to be removed. This has hugely benefited Canadian company Tekmira Pharmaceuticals, with the FDA announcing that it was ready to move Tekmira’s Ebola treatment from “full clinical hold” to a “partial clinical hold.” This decision from the FDA allows the treatment to be used on patients already infected with Ebola, which removes a key roadblock in its eventual approval.
Obviously safety is and should always be a primary concern but from that perspective the current drug development system works, in the sense that it ultimately produces drugs which have been readily tested on humans and also have been shown to be safe with limited side effects. But you should expect that when you spend $2 billion and have 14 years of testing.
With the current drug development system there are also a lot of flaws, for example some pharmaceutical companies won’t produce certain drugs as it doesn’t make financial sense. The focus most companies have is to create drugs where there is a large target audience. You must think of this from the perspective of a CEO or a shareholder; the price of shares are surely going to go up if the market perceives you are on to something big.
The easiest way to understand this is to look at the current situation, nobody was prepared for such a large scale Ebola outbreak. Unfortunately Ebola is seen by many as a disease of poor people in poor countries. So the big CEO’s of the pharmaceutical companies don’t have a financial incentive in creating a pipeline that only a few thousand people are going to pay for. Surely though the 1000 plus people that have lost their lives are worth more than the the $2 billion that it would have cost to develop the drug in the first place especially if the epidemic spreads and becomes a global crisis that $2 billion dollars will start to sound very cheap in comparison to what is going on in the world.
There are ways of speeding up the drug development process without recklessly rushing new drugs into the market. The NIH for example has already proposed a number of new innovations that could reduce time. The new bio-chips for testing drug safety developed with the help of DARPA can help reduce the number of animal and human clinical trials required. In December 2011, the NIH also created the National Centre 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 speed bumps and what can slow a process down, 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 use that thinking and add it to the pharmaceutical industry. In the drug development process this 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.
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