With the current level of risk associated with drug development and the level of regulatory red-tape it seems unlikely. Even Big Pharma themselves are having second thoughts about the current paradigm and trying new things. Many companies have closed down their neuroscience research centres in Europe and are partnering with academic institutions to reduce the costs of preclinical drug development. Ten of the world’s biggest drug makers have launched Transcelerate Biopharma to reduce costs associated with the complexity of drug development. Transcelerate Biopharma is focusing on areas where clinical drug development is wasteful and duplicates procedures like training clinicians, running websites or data portals, or creating procedures to document the benefits and side effects of new medicines. Interestingly, Transcelerate Biopharma will be a non-profit. The ten companies that are supporting it are:
- Bristol-Myers Squibb
- Eli Lilly and Company
- Johnson & Johnson
The aims of Transcelerate Biopharma are admirable, but they still underpin BigPharmas’ main aim of launching novel drugs that are big earners. The problem we are having in academia is the repurposing of drugs, or developing drugs that BigPharma have discarded. Take Simvastatin for example; how is Dr Chataway and his colleagues, who have a positive phase 2 neuroprotective study, going to take this forward when Simvastatin is off patent? Merck-Serono stopped the development of oral cladribine for MS, despite it already being licensed in Russia and Australia. Can we, the MS community resuscitate cladribine? The cladribine results are very good and in my opinion would make a big difference to the treatment of RRMS and potentially progressive MS. How do we get cladribine back on the table?
We need an alternative system to one BigPharma uses. Regulators and politicians need to acknowledge this; in particular in this age of austerity when drug budgets are soaring. The current pharma model is broken and the costs associated with it are too high to be sustainable in the long-term. I have been asking you the readers of this blog, in particular those who are always bashing BigPharma, for alternatives for over 2 years. Some of you have suggested a new Tax or levy on BigPharma drugs to pay for non-profit drug development. This is unlikely to work if the regulatory red-tape remains so complex and expensive. In addition, the skill set resides in industry. Taxation as a way of paying for new initiatives seldom works; it is inefficient. Personally, I would prefer a market-driven system.
As a start we need to get regulators and politicians to lower the bar for non-profit or academic drug development. They should create incentives in a similar way they have done for orphan drug development. For example, allow the design of adaptive phase 3 efficacy programmes to be done at the same time the drug is given a provisional license. This will allow the necessary data to be collected at the same time the drug is being marketed under controlled conditions. For example, the EMA and FDA have concerns about the long-term safety of oral cladribine. Why not give the drug a provisional license and allow the drug to be sold on condition that every MSer who goes on the drug is registered in a well-controlled pharmacovigilance study to assess the risk of the drug. This study would need a control group to compare the relative risks; the control group could be subjects going onto interferon-beta or glatiramer acetate. Instead the EMA and FDA have thrown the baby out with the bathwater and MSers are being denied a potentially very effective drug. We need to change this!
I therefore propose starting a new organisation to lobby our politicians to change the paradigm and create an alternative to BigPharma to develop drugs for MS. The working model will be a non-profit, or social entrepreneurship, with the aim of getting legislation enacted similar to that for orphan-diseases; the primary objective to aid academic and non-profit drug development. The aim is to get drugs – which are off-patent or don’t have the necessary IP life-span for BigPharma to recoup development costs and make a profit – to market at an earlier stage under a provisional license, whilst the data is being collected for a definitive or full license.
This organisation needs a name, seed money and help from politicians or stakeholders. If you want to be part of this initiative please register your interest below and any suggestions you may have to help. The organisation will need a leader, administrators, secretaries, etc. Volunteers are most welcome.