Editorial Note: This is the first of four posts about the link between Sense about Science and AllTrials triggered by the post Fucked and comments afterward by Ben Goldacre, Tracey Brown and others which raised these links.
My first contact with Sense about Science was linked to the Simon Singh affair. Singh had made some relatively innocuous statements about chiropractic and been sued for libel as a result. The case became a cause celebre – there was widespread support for his position among the scientific community and widespread concern about an inappropriate deployment of British Libel Law.
I supported him. I ended up on the mailing list for Libel Reform. As both of us had been on the receiving end of efforts to shut us up on academic issues, I met him when we were both invited to a workshop on academic freedom in 2011 in Cambridge.
It made sense that Singh’s efforts to change the libel laws was linked to an organization called Sense about Science, and by association Sense about Science seemed a good thing. It didn’t seem unreasonable to me either to have Sense about Science linked to AllTrials when AllTrials took shape.
The Cowardice of a Pampered Society
Long, long before I had ever heard of Sense about Science I’d read Living Marxism and thought it a breath of fresh air. Marxism like this felt like it might even stand a chance in the marketplace.
Looking at the Sense about Science website now, I realise I know some of its trustees and even have stayed in one of their houses. The people I know are reasonable people. Others must think they are reasonable too as these trustees have ended up as Presidents of Royal Colleges for instance – very much part of the establishment as Dick Taverne the founder of Sense about Science is. I’d imagine Tracey Brown is engaging and interesting also.
Being a consultant to a pharmaceutical or tobacco company or the military is no bar to being engaging. I have several friends who have been consultants for all three and the greatest help in terms of adverse events has come from people employed within Pharma.
I’m sure Andrew Witty (AW 1) is also engaging and interesting. Guido Rasi of the European Medicines’ Agency is handsome, charming, engaging, sophisticated, dresses in great suits and had me believing him after a meeting at EMA eighteen months ago on data access that he wanted me to keep in touch.
And many of the views that Sense about Science espouse are ones that should be heard. They think the precautionary principle is over-precautionary – “Over-precautionary Tales: The precautionary principle represents the cowardice of a pampered society”. That people who smoke should be responsible for their own behaviour. That we need GM foods. That climate change has been overplayed.
The problem arises with views that aim to capture or pre-empt debate and rather than being views for debate are part of an agenda that is being implemented. Not that being part of an agenda to be implemented is wrong either, but a political program deserves more scrutiny and anyone engaging with such views deserves to know that the person opposite them is not holding incidental views. It’s good to know when you’re dealing with a believer.
The common focus in Sense about Science views is on risk – the risk to corporations and other interested parties such as governments of things being perceived by the public as risky rather than the risk to you and me from treatments or climate change.
Within the pharmaceutical domain, the luckiest break for the Sensible Scientists was Andrew Wakefield (AW 2). Wakefield’s paper on the risks of the MMR vaccine gave the British and other governments a wonderful example of how a scientific paper can cause a huge scare that threatens lives and corporate profits. Managing the fall-off in vaccination uptake was a significant national event.
While many people fought shy of the MMR vaccine, perhaps even Tony Blair himself, this was an event that the public – me included – could readily understand and we were quite prepared to turn on Wakefield as the perpetrator, the bogeyman, the visible manifestation of why we needed sense about science.
In the UK, the most potent weapon on the lips of the academic puppets sitting on corporate hands ever since has been that Godlee or Jefferson is another Wakefield. In the fuss about the BMJ’s article about the hazards of statins a few weeks ago, Rory Collins, one of the industry associated statin supporters, accused Fiona Godlee, the editor of BMJ, of potentially being far worse than Andrew Wakefield.
Elsewhere in the world, where AW is not a household name, the accusation is one of being an anti-vaccinationist or being someone who pays heed to the TV actress Jenny McCarthy.
Many of the people I know who seem to have been approached to be a Trustee of Sense about Science would have readily signed up to an organization offering to bring sense to bear on scientific issues like this. I might have signed up myself if approached and unaware of its background.
Ben Goldacre began life taking on health fads and health scares like MMR (AW 2) for which he got a GSK sponsored prize (AW 1).
But something else has happened over the last decade since Sense about Science has been set up.
Doctors in general like a quiet life. Not unreasonably, they assume that what the regulators and their professional bodies say on issues are likely to be right. Doctors are also horribly vulnerable to complaints from patients or colleagues should they speak out about something. In addition for the last two decades, many of them are likely aware that they increasingly face a world where if they speak up about some treatment related problem – to do with Vioxx, Avandia, or SSRIs – they will be subject to vituperative rhetoric and be branded as being in league with the forces of darkness – in a way that would never have happened twenty years ago.
The rhetoric gets at doctors where it hurts. It’s been designed by people who understand doctors better than they understand themselves, and know just what to say to make them feel uncomfortable.
Some of the Sense about Science trustees that I know who have been subject to death threats from people unhappy with their scientific views could be forgiven for thinking its maybe no bad thing to fight fire with a little bit of fire.
Before coming to AllTrials, two housekeeping points. Another important and increasing criticism is that critics are anti-capitalist. We’ll tackle this in a third SaS post.
Yet another defence has been that raising questions linked to Sense about Science is just a smear tactic. This will be tackled in a fourth SaS post.
AllTrials is a coalition between the BMJ, PLoS, the Cochrane Collaboration, Sense about Science, the Centre for Evidence Based Medicine (Carl Heneghan), the Dartmouth Institute for Health Policy and Clinical Practice, the James Lind Library (Iain Chalmers) and Ben Goldacre.
It called for the registration of all trials and their results to be shared as open data. It probably took off so well because this ask was simple and vague. Even GSK could sign up.
In embryo this looked like a great thing. The idea that getting only the appearances of greater access might be harmful is too subtle a point for most people. And we don’t like to think that good intentions can be hazardous.
From outside it’s hard to know what might be going on in the AllTrials bedroom. The BMJ, and PLoS can be expected to go along with proposals that ask for the registration of trials and it’s hard to argue against greater access to the data from trials. Their editors, Fiona Godlee and Virginia Barbour, working within constraints have taken their journals to places no man would ever dare.
I know nothing about Dartmouth or the CEBM.
Cochrane is a mixed bag – Peter Gotzsche, Tom Jefferson and Peter Doshi have done more to drive this debate forward than anyone else.
The Sense about Science website is a masterpiece of non-direction but their track record suggests a clear focus even if all their trustees don’t realise it. GSK, one of the major signatories to AllTrials, have an even more focussed agenda.
Iain Chalmers and Ben Goldacre are the two who are hardest to read. It came as a huge surprise to many to see Iain co-author an editorial with Patrick Vaillance a sneior figure within GSK, accepting the view that patient level data was out of bounds.
Ben has eloquently told Pharma on many occasions that people will simply not accept the sequestration of data. But what is data?
For AllTrials and EMA it now looks like Clinical Study Reports (CSRs) are data. This is likely not what most people understand by data. It’s certainly not my understanding.
CSRs are a company’s first edited report on what the underlying data looks like – the point at which they begin to mislead themselves. If companies know these and only these are going to be made public they will very rapidly become tools designed to mislead the rest of us. These are the documents that even when the company didn’t think they might become public have already coded suicidal events as episodes of emotional lability. Without access to the data its impossible to know what is reliable and what isn’t.
The data are contained in what are called Clinical Record Forms (CRFs).
After a study is finished, a company will ghostwrite an article like the infamous Keller et al article in Study 329. For every page of this article there will be roughly 100 pages to the CSR from which it is drawn – or 500 pages if the company is being fully transparent. Behind this lie the CRFs. For every published page in a standard article there are between 5000 – 10,000 pages of CRFs. This is as close to the data – the patients – as we are ever likely to get. In some cases the real data never exist.
At the moment with the music stopped Iain and Ben look like they are in bed with Tracy, Guido and Andrew. Are they in bed just to stay in the game, still hoping to make the right call at the right time?
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