This is exactly the kind of headline the drug industry does not need. Via FierceBiotech, here’s a story in The Guardian on the recent efforts to get companies to disclose more about the clinical trial results for investigational drugs. GSK is the company that seems to have done the most in this regard, but the European Medicines Agency (EMA) is proposing mandatory disclosure of trial results into a public database. That’s a lot further than most companies are willing to go – so what to do?
The strategy was drawn up by two large trade groups, the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA), and outlined in a memo to senior industry figures this month, according to an email seen by the Guardian.
The memo, from Richard Bergström, director general of EFPIA, went to directors and legal counsel at Roche, Merck, Pfizer, GSK, AstraZeneca, Eli Lilly, Novartis and many smaller companies. It was leaked by a drugs company employee.
The email describes a four-pronged campaign that starts with “mobilising patient groups to express concern about the risk to public health by non-scientific re-use of data”. Translated, that means patient groups go into bat for the industry by raising fears that if full results from drug trials are published, the information might be misinterpreted and cause a health scare.
That’s what. Other parts of the strategy include “discussions with scientific associations” about the risks of data sharing and getting other companies in other industries that might be affected by similar proposals to lobby against this as well. None of this is to be done, it seems, under the banner of “Here’s why the drug industry opposes this idea”. It’s all a spontaneous upwelling.
Now, I don’t want to seem too shocked: this sort of thing is done all the time in politics. Every time some big regulatory or legislative idea comes along that might cramp some large group’s style, you’ll see all kinds of organizations pop up with serious-sounding names: “Public Coalition For XYZ” “United Citizens For QRS” and so on. Use of these “instant grassroots” fronts has earned the term “astroturfing” (which also means that any time some actual group of people comes together for real, their political opponents will always accuse them of being an astroturfed gang of shills).
Some of the patient advocacy groups the Guardian talks about are probably in this category. But many of them are real organizations that have been around for some time. There’s an evolutionary dance going on, though: while the advocacy groups want to get enough influence with the drug companies to steer their decisions, the drug companies want to get enough influence with the advocacy groups to steer theirs, for just the reasons we’re seeing now. And in that second half of the process, the pharma industry has a powerful offer to make: we’ll fund you. At that point, every advocacy group (in any industry) has some big decisions to make about what they’re trying to do and how best to do it. Will taking the money compromise them? Or will that be outweighed by what they can do with the funding?
But just because this is a common practice doesn’t mean that it’s right. Or a good idea. Or, at the very least, the sort of thing that the industry should be seen to be doing. Secret memos detailing a behind-the-scenes campaign of influence to avoid disclosing data? The people at PhRMA and EFPIA should apply a simple test to ideas like this: if it sounds like a bad movie plot, if it sounds like something made up by people who hate you. . .maybe it’s not such a good plan.
Update: here’s more on an effort to pull out unpublished clinical trial data. “Publish or be published” is their motto. The editors of the British Medical Journal and PLoS Medicine have endorsed the idea.