non-negotiable…

Posted on Wednesday 11 June 2014

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by Ben Goldacre
June 11, 2014

Tough regulations, like a ban on researchers copying trial data or looking at it ANYWHERE but on screen, make it likely results won’t be analysed properly. Over to Ben…

There’s a big problem in medicine. We use clinical trials to find out which treatment is best. But the results of those trials are routinely withheld from doctors, researchers and patients. This means we can’t make truly informed decisions about the risks and benefits of treatments. Roche withheld unflattering information about Tamiflu for five years, for example, even though we spent half a billion pounds on it in the UK alone. We can’t really tell what the side effects of statins are, because important documents aren’t made available. None of these companies or researchers are breaking the law. Withholding this information is perfectly legal. This affects the whole of medicine, and it’s been going on for decades. Now we have a chance to push things forward. This story needs some boring detail: then we’ll see some photographs of civil servants behaving strangely, and large numbers of patients suffering and dying unnecessarily.

So. Last year the European Medicines Agency promised – under a barrage of criticism for their previous secrecy – that they would make Clinical Study Reports available to researchers. These are hugely important documents, thousands of pages long, which give very detailed information about the methods and results of clinical trials. Often, a trial will have design flaws that stop it being a fair test of the treatment. These can be glossed over in the brief report of a trial in an academic journal, and that’s why we need access to these long CSRs. That’s what the EMA promised. That’s what a new EU law promises [but only for new trials, not the previous trials, on the medicines we actually use today].

But now, at the last minute, the EMA have suddenly changed their mind. They’ve announced that they will make these detailed CSRs available, but only redacted, and only through some weird “on-screen only” viewing facility. You won’t be allowed to print anything out, add notes, save anything, or even use copy and paste. That’s a doctor from IQWiG: they’re the German equivalent of NICE, only much more muscular. They use these documents on a daily basis. And they are so annoyed by the EMA’s perverse new decision that they are actively mocking the European Medicines Agency through the official IQWiG twitter account. That’s because the new EMA policy is, basically, insane.

CSRs are highly complex technical documents, thousands of pages along, and any use of them requires extensive cross-referencing: you need to compare details in one part of the document with numbers in another; codes from one part against descriptions from another; definitions from one trial against the same definitions in another trial; and so on. But that’s not the end of it. This guy has a big sword hanging over his head. That’s because when you look at these documents, you’re now required to sign up to the EMA’s Terms Of Use on CSRs. These require academics and researchers to sign away various rights, and accept that they are liable to all kinds of things. What, exactly? This is very poorly specified, and because of that, it exposes researchers to what lawyers call “interesting cases”: long, and with potentially limitless legal costs. Big companies are used to using lawyers: that’s the fabric of their work. Individuals and academics are not: think about how much you pay a conveyancing solicitor, or a divorce lawyer. This is a serious imbalance of arms, and it will stifle research. That’s why IQWiG, and lots of us, think that the EMA’s new promises are pretend transparency…

We now have the support of almost all the professional bodies in the UK, over 100 patient groups, 75,000 members of the public, and massive organisations like Wellcome, NICE, GSK, MRC, and so on. We’ve written to the head of the EMA, the European Medicines Agency, who’ve created this mess. They wrote back, and we think their reply was shoddy, so we’ve written to them again. They are meeting tomorrow to finalise their absurd plans. Our letter is tabled for discussion at their board meeting…
Since the contentiousness several weeks ago in blog posts and comments involving David Healy and Ben Goldacre and the questions about where Sense About Science and AllTrials allegiances lie, Goldacre, AllTrials, and SaS have become much more active with public posts and twitters galore about the EMA U Turn. I was personally glad to see that, along with their letters to the EMA. For myself, I agree with Dr. Healy that sidling up to GSK is counter-productive and in denial about what a war this really is. But so long as AllTrials et al are doing the right thing, I’m glad to see them in the fray [again].

But there’s something about this piece that I think requires a comment. Ben Goldacre keeps saying "CSRs." That can mean the right thing if, and only if, the CSR is of the variety that has the pre-blind-broken, raw data tables [IPDs] as appendices [see achilles’ heel…]. If it’s the long-narrative-with-only-summary-tables variety, nothing doing. The loose use of terms here can undermine this whole effort, so I monotonously reiterate:
[a priori protocol] + [pre-blind-broken IPDs] + [CRFs re Adverse Events] = [Transparency]
A non-negotiable requirement…
  1.  
    June 11, 2014 | 10:01 PM
     

    Good to see Ben Goldacre taking up the cudgel again.

  2.  
    June 12, 2014 | 8:54 AM
     

    My question is, and always will be, why would he [Ben] want AllTrials associated with GlaxoSmithKline?

  3.  
    Annie
    June 12, 2014 | 12:04 PM
     

    Because he, Ben, is on a roll of self-achievement and, he, Ben, has got Alltrials, and, he, Ben, thinks he has achieved something world shatteringly fantastic and, he, Ben, has dropped the biggest clanger in the history of a potential lawsuit re GSK and, he, Ben, is a jumped up, nincompoop, who may look like a young child but he has burst onto the ssri scene like a dog on heat and he, Ben, needs to look a bit further than his own self-centred self.

  4.  
    June 12, 2014 | 12:38 PM
     

    Fid,

    Well put. Dead on. But sometimes a loose cannon hits the target…

    Annie,

    Well put. Dead on. I wish he would do what we shrinks used to do – have a decade of personal therapy as part of the deal.

  5.  
    June 13, 2014 | 5:06 AM
     

    I am left wondering if Ben has ever bothered to read the DOJ settlement agreement, also the agreements with 44 other states?

    This is NOT GSK doing the right thing at all. It’s GSK doing what they are told to do by lawmakers.

    Did you see the spin by GSK’s Deidre Connolly?

    “Critics may say it took a settlement with the U.S. Department of Justice over past sales and marketing practices to reach that conclusion. But we dropped sales targets well before the settlement, recognizing that traditional sales incentives were out of line with society’s expectations for our industry, and we had to change. Ultimately, past practices affected customer trust and satisfaction and, as a result, damaged the reputation of our industry.”

    I wrote about her article on my blog.

    What Connolly failed to mention is the settlement took nigh on 10 years, during which time GSK would have been making changes. Fact – the whistle had been blown on GSK’s illegal promotional activities, they were being investigated. She claims that GSK dropped sales targets well before the settlement – of course they did – they were rumbled. She fails to mention that GSK dropped sales targets during the investigation.

    Question is two-fold.

    1. Why change something that was working so well for GSK if it wasn’t illegal?

    2. Why did it take GSK so long to make such changes?

    Maybe Ben could answer given that GSK refuse to debate with me these days? Then again, Ben is of the opinion that I am an “angry, smeary, conspiracy theorist”

    More on the AllTrials/Settlements here – http://fiddaman.blogspot.co.uk/2014/06/gsk-thou-shalt-not.html

  6.  
    June 13, 2014 | 9:41 AM
     

    AllTrials has never stopped campaigning actively and energetically in all ways against restrictions on transparency from EMA. David Healy’s bizarre smears involved repeated false and misleading assertions about what people have done and said. It’s very destructive behaviour.

  7.  
    June 13, 2014 | 10:44 AM
     

    A brief reminder of how David Healy has been saying things that are very simply untrue.

    http://davidhealy.org/sense-about-science-follow-the-rhetoric/#comment-106400

    http://davidhealy.org/fucked/#comment-105894

    I think you need to seriously revisit whether David Healy blogging bizarre untrue smears about people campaigning on the same side for greater transparency is genuinely a productive contribution.

    I am surprised you are not worried that David Healy is denigrating AllTrials with fabricated smears in the course of promoting his private company RxISK as a better alternative, especially given the business model of his company.

    “There is one concerning issue that I’m loathe to raise, but equally loathe to leave unaddressed. David Healy has asserted on the previous thread that RxISK is a better approach than AllTrials. I am very concerned, like Andy Lewis, to find that RxISK is a private profit making company owned by David Healy, with six figure accounts, set up to harvest individual patient reports of adverse events, and then hold that potentially important data behind a paywall, with David Healy demanding that regulators or public health bodies pay him cash to have access to this information. I don’t believe that this is a productive contribution to side effects monitoring, or trials transparency, or our understanding of the relative benefits of treatments. I don’t see how it’s better than AllTrials, or even similar. It’s fine to make money doing your job, but it is odd to set up a business aiming to harvest and then keep important pharmacovigilance data secret, and very weird to launch repeated and unreasonable attacks on other people while trying to promote your own private profit-making business as superior. I’m also concerned that Tracey Brown making an allusion to concerns about this business model on the previous discussion thread seems to have been followed by an announcement of four long posts from David Healy denouncing her and others campaigning for transparency.”
    - See more at: http://davidhealy.org/sense-about-science-follow-the-rhetoric/#comment-106400

  8.  
    June 13, 2014 | 2:28 PM
     

    I’m uncomfortable about the vilification of Ben Goldacre in this kerfuffle, when his major sin is being naive about how corporations manipulate regulatory agencies, governments, and, yes, even organizations like AllTrials.

    (But then, a lot of people think corporations have rights and should have a seat at the bargaining table. In the US, we have a major political party dedicated to this.)

    Since the success of Pharmageddon, David Healy has developed an incendiary style that is sometimes excessive when he’s passionate about something.

    The two should shake hands, join forces, and stop the mutual ad hominems.

    One would hope Dr. Goldacre has learned from this. But the veteran bureaucrats at the EMA should have known better.

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