Strategic MedComms Forum 2011 part 1: marketing and data sharing

Last week, I spent a fascinating day at the Strategic MedComms Forum 2011. This event, subtitled “Trust and Transparency - Myth and Reality” and expertly organised by Peter Llewellyn of Network Pharma brought together a range of people working in medical communications for the pharma industry, as well as others with an interest in the field, to discuss the issues of trust and transparency in the way that the pharma industry communicates with the wider world.

The day was split into 4 sessions, each with an expert panel and a session leader. Thankfully, use of PowerPoint was kept to a bare minimum, and most of the day was spent in discussion, rather than listening to someone’s presentation. The day was also widely discussed on Twitter, and Peter had the fantastic idea of preserving the day’s tweets for posterity, which are well worth a read.

The first session—“Innovation, Transparency and Excellence from Early Phase Onwards. Partners or foes?”—covered a range of issues including motivations for drug development and the role of pharma company marketing departments. One important theme that came out is that the old models of pharmaceutical development, characterised by a top-down, command and control approach, are looking increasingly outdated and doomed to failure. The future is more networked.

One revelation for me from this session is that I became convinced that pharmaceutical marketing is being done dramatically wrong. Marketing departments are currently very much involved in products that are already licensed, but have far less involvement with drug discovery. That’s completely the wrong way round. In an ideal world, drug companies, through their marketing departments, would be engaging in meaningful dialogue with patients right at the start of the process. They should be listening to patients far more before they ever go near a lab, to find out what the needs of patients really are. Then they can go off to their labs to try to meet those needs. No doubt some companies are already working this way, but it seemed to most people in the room that that is the exception rather than the rule.

Our chairman for the day, Dr Phil Hammond, made a fascinating point that sounded totally valid to me. He pointed out that the HIV patient community have traditionally been highly engaged with those who treat them, and that progress in HIV drugs since HIV first emerged in the 1980s has been phenomenal. Perhaps that’s not a coincidence.

I had the privilege of leading the second session, entitled “Sharing data. Opening the Pandora's Box?”. We asked what data should be shared and what data actually are shared, which of course are two very different things. Most people in the room agreed that sharing data, in the form of making raw data from clinical trials publicly available, was a good thing. It facilitates evidence-based-medicine by making life far easier for any meta-analysts who may be interested in the data, and it also discourages dishonest analyses. Anyone who knows that their data could be independently re-analysed has a powerful disincentive to do anything suspect when analysing the data.

However, despite this widespread agreement on the benefits of data sharing, few were actually doing it in practice. We discussed some of the barriers, and I was heartened that the argument of protecting intellectual property did not come up. I’ve never really believed that one: if you are publishing a study anyway, then it’s hard to see why there could be any intellectual property concerns about making the data available.

Nonetheless, there are indeed many reasons why people don’t make their data available: some good, some not so good. For me, the most serious one is the ethical issue of consent and patient confidentiality. Clearly, no-one would release raw data that included patient names. However, I don’t think it’s safe to assume that simply omitting names removes all problems of confidentiality. It would often not be impossible to identify an individual patient if you knew their age, sex, diagnosis, and which hospital was treating them: all data that are likely to be easily available if raw data are released. To release such raw data without patients’ explicit consent would therefore be ethically questionable.

This is, in principle, an easy problem to solve: when writing consent documents for clinical trials, a paragraph could be added to explain the intention to share the data from the trial, and patients’ explicit consent could be requested. I imagine most patients would readily agree. That consent, however, should not be assumed. Sadly, no-one in the room was aware of it being standard practice in their companies to ask for such consent. I sit on a research ethics committee and read a lot of patient consent documents, and I don’t remember ever seeing this mentioned. Therefore, one action point from the meeting for me is to recommend that this be mentioned in any consent document in trials in which I am involved from now on.

This will make it easier to share raw data in the future, but it is still not clear to me how easy it is going to be to share the mountains of data from existing trials.

This was not the only reason why data are not being shared, of course. It seemed that the other main one was simply one of inertia: most companies do not have procedures in place for doing so, and in the absence of suitable incentives, few companies seem keen to invest the (potentially significant) resources needed for putting such procedures in place. One suitable incentive might be if some journals required raw data to be shared as a condition of acceptance. We learned at the meeting that this is already routine in some other scientific fields, such as genomics, although I’m not aware of any journals doing this in clinical medicine. Are any willing to take this on?

I seem to have written quite a long article so far just on the first 2 sessions, so I shall spare you having to read about sessions 3 and 4 for now. I’ll write about them soon, so do come back to find out, among other things, what Ben Goldacre thought of those of us working for the pharmaceutical industry.

As always, I would love to read your comments via the form below.