Control groups
As a general rule things which are not true are also not very interesting. This is why Giampaolo Giuliani’s claim to have predicted the L’Aquila earthquake failed to generate much coverage in its own right: with no scientific basis, his warnings amounted to little more than Speakers’ Corner-style scaremongering. Of far more interest was his treatment by the Italian authorities, which highlighted an important issue for researchers: that of what is allowed to enter the public domain.
With last month’s encouraging news from Glaxo it looked like researchers’ repeated calls for more openness were finally being answered. Openness is helpful: it can give researchers access to findings they can build on, opportunities to pick up on what others may have missed, and the means to perform useful things like meta-analyses.
Openness can also make it harder to bury unflattering data and “negative” findings, or as Ken Ostlie puts it: “If a company can control the research that appears in the public domain, they can reduce the potential negatives that can come out of any research”. Ostlie clearly knows exactly where he stands. As an entomologist at the University of Minnesota, Ostlie studies the interactions between pests and the crops they feed on. Along with 25 of his peers who also signed a statement addressed to the Environmental Protection Agency, he would like to learn more about genetically modified crops, but companies including DuPont, Monsanto and Syngenta have hit upon an ingenious way of holding them back. Claiming their modified seed products as their intellectual property, they have drawn up buyers’ contracts which effectively prohibit research. These fair use policies are unusually restrictive: in Syngenta’s case the term “research” even extends to farmers comparing Syngenta seeds to their competitors’ products.
Their message is clear: buy our product, but don’t open the box and have a look inside. As a scientist’s work essentially consists of looking in the box, this is a handy way of restricting sales to those uncomplaining farmers who just want higher yields… but what if some of those scientists also just want higher yields? Biotech firms have good reasons to be paranoid, but not everyone is out to shut them down.
Fancy contracts and slick legal advisers do a good job of keeping scientists at arm’s length, but for those who like to play dirty there’s the good old-fashioned claim of libel. Anders Eriksson and Francisco Lacerda found themselves on the receiving end of a claim when the wonderfully-named Nemesysco had a paper pulled from the wonderfully specialist International Journal of Speech, Language and the Law. “Charlatanry in forensic speech science: a problem to be taken seriously” was withdrawn from the journal’s website over allegations that it contained personal attacks (though thanks to Scribd it is still available to view here). While the language does seem emotionally-charged, the idea that research findings can be called libellous is still bizarre. Findings are not a matter of opinion- at least not if the study in question has been designed properly, and anyone can learn to be the judge of that. Where a good scientist would appreciate the value of “negative” findings, a charlatan would take them as a personal insult and refuse to be forced back to their drawing board. They can’t fight good data with more good data of their own, so they simply attempt to shout it down, as Simon Singh is now all too aware.
When calls for openness get louder firms react by finding new ways to cover their backs. “Breach of copyright” is a handy label for an uncomfortable truth, and unlike Glaxo’s noble initiative, it serves no-one but shareholders. With drug development slowing and no signs that GM food is about to put an end to famine, corporates must now realise that a focus on profit will not make for a viable long-term strategy.
From a purely PR point of view, heavy-handed legal threats do the plaintiffs no favours when they’re issued against relatively powerless individuals. Those who cry libel fail to realise that more civilised debate is possible outside the courtroom, and one could argue that it is even necessary in a world where documents leak online and censorship doesn’t work the way it used to.
Independent researchers also need to gain the trust of those who feel so threatened by them. A good working relationship could benefit both parties- and for that matter, society at large.
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I know that Ben Goldacre is strong on the issue of releasing negative results and has made the point that a lot of effort gets repeated by different companies tramping over the same ground. However, drugs companies are, of course, commercial endeavours and that information has been gained at a cost. Another company that doesn’t have to repeat the same research is going to be at a commercial advantage. If there was to be free access to research trial information like this then many companies won’t be prepared to finance it if they think they can gain similar information from another. Now there is no obvious way round this whilst no financial value is associated with such negative research. In other words, some mechanism would have to be found such that there is a value to the companies in publishing this information by those who would use it for commercial gain.
Now Ben often characterised large pharma as “evil” – maybe he is being somewhat ironic in using that term. Of course the aren’t “evil” as such – ammoral may be a better way of putting it. They are commercial concerns and work within a regulatory environment. I also don’t think it’s sensible to do down the interests of shareholders – for the most part these are major instruments by which our savings and pensions get invested, not to mention tax revenues for the Government. As the current financial crisis shows, once commercial concerns fail to generate profits and wealth, then it has a huge impact on public finances and the ability to spend money on services.
Now I realise that independent researchers would like access to this data as well as commercial organisations, but it is important to realise that health research does not live in some bubble isolated from the world of commerce. The two are heavily interlinked, and a disinsentive to invest to the private sector could have huge impacts, both in research and in both public and private finance. I know this goes against the grain of academic freedoms and free sharing of data, but people’s welfare also depend on the effective working of an economy, not just the drugs and treatments. We had better be aware of the consequences of what some propose in this area to at least try and take into account the potential behavioural differences.