The Association of the British Pharmaceutical Industry (ABPI) and BMJ Group held a joint conference at BMA House yesterday entitled ‘Innovation in research methods and dissemination – ensuring best practice’. The event brought in some big names, including our very own Dr. Fiona Godlee (Editor-in-chief, BMJ), Professor Sir Alasdair Breckenridge (Chairman, Medicines and Healthcare products Regulatory Agency/MRHA) and even Jimmy Wales (Co-founder of Wikipedia).
The conference was essentially a get-together of the ‘movers and shakers’ of the pharmaceutical and health regulatory industries, focussing on policy and future practice relating to drug development. With pharmaceutical outputs falling in recent times despite more funding, questions are being asked about the effectiveness of current methods.
Some of those present, including and especially Professor Breckenridge, were keen on imposing PM David Cameron’s wish for ‘every willing NHS patient to be a research patient’, with the entire consortium of NHS hospitals in the UK effectively serving as one single clinical trials unit. Indeed, others present at yesterday’s conference generally went along with this, with some issuing a word of caution about the obvious problem of patient participation.
A significant development that did stand out was the coming change in drug development schedule. The current model is an ‘all or nothing’ linear scheme, from screening to development, phase I-III clinical trials, etc. This is expensive, time-consuming, and generally inefficient. However, by 2020, there will be increased focus on molecule development and pathophysiology, leading to a shorter clinical development schedule and early approval. But that’s not where it ends. Increased focus on post-marketing safety and effectiveness will also be a key part of the plan.
Professor Breckenridge was also keen to shift attitudes about drugs from looking at ‘safety’ to considering the ‘risk-benefit balance’. ‘If you think about it, we don’t actually look at safety. We look at the risk-benefit balance. Anti-HIV drugs, for example, may not be safe, but their benefits far outweigh their risks, so we use them’, he said.
There was more focus on the sluggish pace of drug development in the UK. ‘We take nearly two months longer than some other countries, and the biggest obstacle still seems to be NHS R&D approval’, said Dr. Tony Whitehead, Medical Director at Sanofi. He also stressed that we should continue to press forward in the most successful areas of the industry, including oncology and translational research/personalised medicine. In order to ensure tighter restrictions on time frames, Dr. Whitehad also suggested a ‘more formal business relationship between pharmaceutical companies and NHS trusts’.
The general vibe at this meeting was a positive one, but this was undermined ever so slightly by startling data relating to a lack of reporting from clinical studies. Dr Trish Groves, Deputy Editor of the BMJ revealed that up to 50% of data may not be reported, with approximately 60% of studies having more than one primary outcome changed prior to publication. It was stressed that incomplete reporting is a serious misconduct, essentially half-way between making an incorrect observation and frank fabrication of data. This may come as as surprise to many, as the retention of data by labs is notoriously ubiquitous.
But what about quality control? ‘There is quite a lot of misinterpreted data out there’, said Dr. Carl Heneghan of the Centre for Evidence-Based Medicine (CEBM) in Oxford. He used the recent example of rosiglitazone and the well-known thalidomide controversy to illustrate his point. On the contrary, he also reported that pharmaceutical companies are now providing data to CEBM so that it can be checked.
Cue a coffee break, and then a sudden influx of young adults from BMA House into the conference room. Most had left their desks just for this bit. Jimmy Wales received a round of applause before he had even said anything – not surprising for a man who created a website that clocks around 10 billion page views per month (according to h-online.com).
Jimmy’s focus was on open access publishing and access to the results of research. ‘Taxpayers pay for research, so shouldn’t they be able to access it? It would be good if intelligent non-researchers can access all the research in the world’. One attendee asked the obvious question of quality control. ‘We obviously know a lot about this!’, said Jimmy, followed by an explosure of laughter from the attendees. ‘We need to focus on how reliable sources are and involve academic experts as much as possible.’ He also dismantled the notion that academics hate Wikipedia – ‘For people who hate it, they sure use it a lot’. Then followed a debate about the issues involved with open access publishing, namely privacy and confidentiality issues. The fact that labs will obviously want to publish their own data in a journal first was also an issue that was highlighted.
All in all, this was a hugely enjoyable conference with some very interesting developments noted. ‘Healthcare innovation’ is a term that is being thrown about a lot these days, but it was fruitful to see just what this means in the context of policy within the pharmaceutical industry.