Ben Goldacre: Wake The Fuck Up!



“That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been” (David Healy).

“Clinical trials are the gold standard way to hide adverse events” (David Healy).

“it would be better for mankind if all clinical trial data were sunk to the bottom of the sea rather than being made visible to academics stuck in a submarine and only able to view things through a periscope, which is what the GSMA-ESK system offers”. (David Healy).


bggHEALU
1362503627273.cachedI was supposed to be taking a break from blogging but reading David Healy’s latest blog post (titled ‘fucked‘ ) this morning made me very annoyed. I won’t go into detail about the post here, but I will post it in its entirety, because personally I think that David Healy is one of the few commentators out there worth listening to; particularly in matters regarding GSK and their so called ‘Transparency’ era. I seriously hope Ben Goldacre begins to wake up and smell the coffee, because if what David (and others) have observed comes to fruition and patients and consumers of pharmaceutical drugs are put at even greater risk, than they are already- because of this sham ‘transparency’ smokescreen– then Goldacre and his cohorts will be partly responsible. The sub- title of Ben’s book is ‘how drug companies mislead doctors and harm patients’. Isn’t this ironic considering GSK are misleading Dr. Ben Goldacre, and in the process- this is inevitably going to harm more patients?

If Goldacre really wants to help patients and hold pharmaceutical companies to account (as he claims) then he needs to begin to listen to people like David Healy, or at the very least begin a dialogue. So far, all I have seen and heard from his direction is arrogance and hubris. As I have said before on this blog: Would The Real Ben Goldacre Please Stand Up?

And if you can’t get real and stand up Ben, please- for the sake of those who are trying to get through to you- just maybe do yourself a favor and wake the fuck up!…


http://davidhealy.org/fucked/#comment-105798

Fucked

Editorial Note: Apologies for the Language

A year and a half ago this blog ran a series of posts about access to clinical trial data – reporting on how industry were going to engineer the appearances of transparency.  See Won’t get Fooled AgainAccess to Clinical Trial Data, and  The Data Access Wars.

Do Academics have Wild Dreams?

Several months later, soon after being fined $3 Billion, GSK trumpeted their endorsement of transparency by signing up to the AllTrials campaign and declaring their intention to put in place a method to allow researchers access to clinical trial data that would go beyond the wildest dreams of researchers.  See April Fool in Harlow, and GSK’s Journey.

Its all to easy to imagine a marketing department figuring that academics don’t have very wild dreams.

When GSK signed up to AllTrials Ben Goldacre rolled over and purred.  The BMJ featured Andrew Witty on their front cover as the candidate of hope.

Rain on the Parade

In contrast, on this blog, 1boringoldman and on RxISK a small group have warned consistently that this was not good news.  That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been.

No one wanted to rain on the AllTrials parade – it never seems like a good idea to fracture a coalition. RxISK put the AllTrials logo on its front page.

Not content with a few academic ghost authors, GSK’s maneuver has put industry well on the way to making Academia a ghost, a glove puppet manipulated by company marketing departments.

Meanwhile Iain Chalmers co-wrote an editorial with GSK endorsing the GSK approach (The Attitude of Chicks to Trojans and Horses) and the British Government produced a document on clinical trial data access that could have been written in GSK central.

The GSMA-ESK Model

The great hope for those dismayed at all this lay with EMA who following Peter Gotzsche’s initiative and a European Ombudsman’s ruling looked like a beacon of hope.  But this week EMA has come out and said it is going to put in place the GSK model of data access.

Everyone is in a spin.  AllTrials are asking for more donations to continue their successful campaign.

As someone who has been working the GSK system, I can say with confidence that this is a disaster.

The key thing that companies are trying to hide are the data on adverse events.  To get to grips with the adverse events in a clinical trial is a bit like playing the children’s game Memory – where you have a bunch of cards with faces turned face down and you get to pick up two and then have to remember where in the mixture those two were when you later turn up a possible match.

Patterns of Deception

In the same way, picking up adverse events is about recognizing patterns – patterns of events, and patterns of deception.

To do this you have to be able to spread maybe a hundred documents out over a big area and dip back into them if something in one document reminds you of something in another.  The new GSMA-ESK remote access system simply won’t allow this.

Not only will it not allow this but it is about to make things far far worse than they are at present.

At the moment when it comes to studies like Study 329, GSK have been stuck by a Court order with putting the Company’s Study Reports up on the web where they can be downloaded and pored over – all 5,500 pages of them for Study 329.  They have refused to do the same for the 77,000 pages of raw data from Study 329, making it available to a small group of us through a remote desktop system.

For all other trials – future and past – investigators won’t even be able to get the Company Study Reports in usable form.  They too will only be accessed remotely.

For anyone who wants to look at the efficacy of a drug this might just about work for outcomes that involve rating scale scores or lipid levels.   The efficacy of drugs is pretty well all that most Cochrane groups, Iain Chalmers and Ben Goldacre are interested in.  The Cochrane exceptions have been Tom Jefferson, Peter Doshi and the Tamiflu group.

But this system is a bust when it comes to adverse events and it won’t work if the efficacy outcomes are in any way complex.

What can be done?

The first point to make is this.  Clinical trials are not all they are cracked up to be.  Even if well designed, not using surrogate outcomes, of sufficient duration, done on patients who actually exist, and not written up by ghostwriters, clinical trials systematically get the wrong answer, especially on adverse events.  Clinical trials are the gold standard way to hide adverse events.

One of the risks of the data access wars is that it will put an unwarranted premium on clinical trials and their data – and in this way play straight into pharma’s hands. This is what led “Crusoe” to warn Peter Gotzsche a year ago that his data access crusade might backfire – See Marilyn’s Curse.

Let’s make no mistake here – it’s morally indefensible that there is not full access to the data from scientific experiments.  In this sense Peter is right and his outrage is well-placed and close to magnificent.

But, ceteribus paribus, it would be better for mankind if all clinical trial data were sunk to the bottom of the sea rather than being made visible to academics stuck in a submarine and only able to view things through a periscope, which is what the GSMA-ESK system offers.

It might have been better if AbbVie had won their legal action.  Instead EMA’s accomodation with them has fucked us all.

Rape is a loaded word these days but in so far as what is happening is an abuse of consent and will primarily do harm to women and children it perhaps come close to being the best word.  Consent processes in clinical trials were about telling you you were on a new drug that might be dangerous or might be involved in a marketing trial.  Instead they have become a way for companies to justify hiding your data on the basis of a confidentiality clause they have slipped into the forms. See When Does Yes Mean No.   Iain Chalmers, Ben Goldacre and AllTrials appear to have signed up to this.

Whether raped or fucked, the Dan Markingson case is a stunning example of what has gone wrong – the Markingson petition is probably a much better petition to sign if you really want to save yourself and others you know and love than the AllTrials one.

Let’s Do the AbbVie Again

Second the data companies are really hiding is their adverse event data.  There are other ways to collect adverse event data.

We invited you 18 months ago to join an AbbVie – Let’s Do The AbbVie Again.  This Irish invention is the reverse of a boycott – another Irish invention.

A boycott of a company’s drug would mean you don’t get the benefit.  If you decide to AbbVie a company’s drug, you – we – can all make these drugs better by reporting on the effects they have.

Company efforts are geared more than anything else to ensuring that doctors and patients don’t report adverse events or ensuring that these events don’t register.  If you really want to get up their nose, if you really want to send the marketing departments into a spin, if you really want a company CEO to blow a fuse, this is what you need to do.

Companies want to transform adverse events into non-information.  You can stop this happening. If an event happens to you on a drug, you are in possession of the missing information.  It’s our tolerance of the patients who have Disappeared in clinical trials that is killing medicine as we have known it.

AbbVie with us and then sit back and take pleasure in a marketer who says “Thank you for helping us make our drugs better – without you we couldn’t do it“.

Now there is of course a huge conflict of interest here.  RxISK.org was set up precisely for this purpose – to register adverse events. But we will hand all events on to FDA or MHRA or whoever you want us to.  What we will also do though, and we invite any doctors or others out there with backbone to help us do it, is to decide when a drug is causing an event – this is something no regulator will ever do for you or for anyone.

Boycott

The other option is a Boycott.  Doctors could refuse to prescribe drugs for which the information was not fully available.  The Panalba and Thalidomide cases have shown that this is the one thing industry is scared of – Report to the President.

If I made claims about a drug to my colleagues but refused to show them the data, they’d have no problem telling me to get lost. I’d be boycotted from here to kingdom come.  But when it comes to industry, 99% of doctors lack balls

Doctors have been given a license to degrade us by treating us like addicts – the origins of prescription-only status.  They have been given a license to print money – we can only get our drugs through them.  The very least they could do in return is show some backbone.

But this is a decadent situation and decadence rarely breeds courage.

Emily’s Balls

The boycott was likely invented by Irish women.  The Abbvie was too.  There is one bulwark still standing in the way of GSMA-ESK.  It’s the European Ombudsman, an Irish woman – Emily o’Reilly.

– See more at: http://davidhealy.org/fucked/#comment-105798

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2 comments

  1. Ben Goldacre

    Hi there,

    I posted this on David Healy’s blog but it’s In Moderation so I’m posting it here too, since you’ve reproduced the same arguments.

    This blog post by David Healy is absurd.

    The AllTrials campaign is really simple: it calls for all trials to be registered, with their full methods and results made publicly available. Where CSRs have been made, we call for those to be placed in the public domain.

    Healy says we’ve created a situation where people are withholding CSRs: that’s simply absurd, this is precisely what we campaign against.

    Healy says we’ve created a situation where CSRs are inappropriately redacted: that’s absurd, again, this is specifically what we campaign against.

    Healy says we have created a situation where drug companies get to choose who has access to CSRs: again, that is ridiculous, this is exactly what we campaign against.

    GSK have signed up to the AllTrials campaign: they join over a hundred patient groups, more than 75,000 members of the public, NICE, Wellcome, MRC, almost all academic and medical professional bodies in the UK, and a growing number around the world. When Bad Pharma came out, industry and others were able to pretend that information about clinical trials is no longer withheld. We’ve transformed that, triggered two select committees and put the policy issue on the map, created a coalition, unpicked a web of dangerous false reassurances by professional bodies, and made it impossible for industry to engage in glib denialism.

    I’m delighted that GSK have signed up to AllTrials, along with all the other organisations. There are lots of problems in medicine. There lots of people and organisations who’ve done – and continue to do – things I think are harmful to public health. But where people do the right thing, I will applaud them for it. I genuinely think that’s the right thing to do. It doesn’t mean you’re part of an elaborate and complex conspiracy with people. It doesn’t mean you approve of everything they do at work and at home.

    It’s easy, and attractive, to scream from the sidelines, and carry on screaming forever. It’s also possible to shout out clearly and succinctly about problems, try to set out and discuss clear solutions, floodlight the path forwards, and encourage people to go down it.

    Lastly, and specifically, the issue of individual personal data. The AllTrials campaign doesn’t call for all the rich individual patient data from all trials to be simply posted publicly in the public domain: that poses too much of a privacy risk, because patients are identifiable in this data. This privacy risk isn’t as big as is claimed by some of those who seek to block transparency, but we decided that the issues around graded access control to IPD are too complex for a simple headline campaign, and we didn’t want to risk industry using the issues around protecting participants’ privacy as an excuse to derail discussion on the very important separate issue of access to methods and summary results. We were absolutely right: industry have repeatedly tried to pretend that AllTrials calls for individual trial participants’ personal data to be posted online, even though AllTrials is specifically focused on registration, methods, results, and CSRs. But as David Healy knows, most of the people involved in the AllTrials campaign, myself, Iain Chalmers and the BMJ included, are closely involved in pushing for greater transparency on IPD too. It is simply absurd to claim otherwise.

    The comments section on this blog is clearly the worst place to say this, but it really is a big waste of everyone’s time to have to deal with the kind of misrepresentation and abuse that David Healy keeps posting. From past experience, I don’t believe that David will engage constructively with my taking the time to correct these repeated misrepresentations, and I honestly think that’s a shame. We’re all – most of us at any rate – trying to get things improved. Everyone’s time is short, and people run things like AllTrials in their spare time. If Healy has a better way to make things better, that’s great, he should crack on with it and get others behind him. If it involves misrepresenting campaigns, smearing people, shouting abuse, and hectoring from the sidelines, then I won’t be in.

    As an addendum, three brief specifics, since time is short:

    David Healy, above:
“Consent processes in clinical trials were about telling you you were on a new drug that might be dangerous or might be involved in a marketing trial. Instead they have become a way for companies to justify hiding your data on the basis of a confidentiality clause they have slipped into the forms. Iain Chalmers, Ben Goldacre and AllTrials appear to have signed up to this.”
    – This is complete and utter fantasy. Neither I nor AllTrials have signed up to this. David Healy will be unable to provide any evidence to show that we have. Consent forms being used to justify withholding information is exactly what I’ve campaigned against.

    David Healy, above:
“That what would be put in place was a mechanism that gave the appearances of transparency but in fact would lock academics into agreeing with GSK and other companies as to what the outcomes of their trials have been.”
    – This is completely bizarre. AllTrials simply calls for all trials to be registered, with their full methods and results made freely publicly available, and CSRs where they’ve been created. It is impossible to argue that this “locks academics into agreeing with GSK and other companies as to what the outcomes of their trials have been”.

    David Healy, above:
“Rape is a loaded word these days”.
    It’s always been a loaded word, David.
http://dictionary.cambridge.org/dictionary/british/rape_1?q=rape

    • truthman30

      Fair enough Ben, but to be honest I would prefer if yourself and David Healy had a public debate about how you both perceive this situation. Perhaps a podcast? or a radio interview? It is very confusing for the public to know what eactly is going on here… a debate might bring some clarity.

      The Alltrials stuff aside- what concerns me is how you can praise GSK at all.. I simply do not understand how you can’t see that you are dealing with a sociopathic organization run by immoral, devious, unethical people who have absolutely no interest in anything but their own self-interest and the self interest (and profitability) of the company they work for- they are involved in Alltrials because it makes them look good- but I agree with Healy, their agenda is nefarious and will lead to a worse situation in regards to transparency… Sorry Ben, I just don’t buy it… I remain utterly unconvinced..

      You say:

      I’m delighted that GSK have signed up to AllTrials, along with all the other organisations. There are lots of problems in medicine. There lots of people and organisations who’ve done – and continue to do – things I think are harmful to public health. But where people do the right thing, I will applaud them for it. I genuinely think that’s the right thing to do. It doesn’t mean you’re part of an elaborate and complex conspiracy with people. It doesn’t mean you approve of everything they do at work and at home.

      I’m delighted that you’re delighted that GSK have signed up to Alltrials but if you look at the timeline of events preceeding that decision, you will see that they had no choice but to sign up to some kind of transparency deal. What Healy has described seems to me to be a system where, obfuscation of data which is only accessed remotely, is hardly progressive. You are not critical enough of GSK and yes I find that concerning- this company caused the deaths of kids for gods sake Ben- yet you consistently praise their CEO as if he was some kind of pharmaceutical messiah- despite the fact that his company has been (and continues to be) involved in multiple instances of nefarious activities, including bribery, fraud, corporate manslaughter and worse…

      It’s kind of like saying Charles Manson does nice things for his grandmother…

      Thanks for commenting…

      and by the way, Healy is hardly on the ‘sidelines’…

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