Sooner or later, we all rely on the results of clinical trials.
If we’re middle aged, we might take blood pressure medicines, if we ever get seriously ill, we definitely need therapies that have been thoroughly tested. But until a few years ago, only the outcomes of about half of all clinical studies have been published – usually the positive outcomes that make a target substance look really good. As Peter C. Gøtzsche, director of The Nordic Chochrane Centre, put it during a panel discussion at the 2014 Lindau Meeting, “Doctors cannot practice evidence-based medicine today unless we get access to all the data from all the trials that have been conducted.”
From the start, the panel ‘Academia and Industry’ focused on drug research. The participants reflected this focus, ranging from medical researchers and industry managers to critical voices like Gøtzsche. The discussion soon centred on the controversial topic of data publication. Should all data, negative and positive, be published? Maybe this topic arose because everybody present could identify with the need for academic publications, or because everyone will be affected by this sooner or later in their health care decisions. But certainly because in recent years, there has been a veritable movement putting pressure on industry and regulators to publish all data – NGOs like the Cochrane Collaboration as well as numerous individual academics are the main campaigners. And they have made huge headway in the last years: more and more ‘big pharma’ companies have agreed to publish all their data, although “screaming and kicking”, as Kemal Malik from the Bayer AG admitted during the Lindau discussion.
The European Medicines Agency EMA has announced it would publish all future data that was submitted for drug approval. But the catch is in the details: Who will be allowed to receive the data? And who will decide this? Can some results be blackened out? If yes, by whom? And to what extent? This debate is still in full swing. EMA had planned to announce practicalities last July, but they postponed their decision to October 2014.
If collaborations between academics and the pharmaceutical industry seem to be so difficult and fraught with tension – this tension was even palpable between some panelists – why pursue them in the first place? The answer is very simple: Both sides need each other desperately.
Academics need external funding urgently, and many pharma companies don’t have research and development departments anymore, the only do “search and development”, as Malik points out: they search for possible drug targets at universities, institutes and small companies. So whenever these very different partners start a project – what should they be mindful of? Bruce Beutler, 2011 Nobel laureate, talked about ‘trust’ and personal chemistry. Michel Goldman, director of the Innovative Medicines Initiative IMI, and Malik pointed out that the priorities for both parties should be made clear from the start, including all contracts and questions like who gets the intellectual property, or IP – including publication rights.
Fortunately, a lot is changing in this field. Kemal Malik talked about open innovation platforms where academics receive industry funding but retain all IP, Goldman explained about pre-competitive research projects in industry: fierce competitors on the market collaborate in an early stage to tackle intractable diseases like Alzheimer’s. Yes, academia and industry are very different and often have different goals – academics want papers published, industry formerly withheld data. But not only scientific research is moving forward, novel collaborative models like the ones mentioned, and many more, develop as well.
You can view the entire panel discussion Academia and Industry here: