Ben Goldacre: Start A Dialogue… Not A Diatribe…


I have written a few posts about Ben Goldace, Alltrials and David Healy on this blog, the most recent one- just yesterday- received yet another defensive response from Ben. Ben has responded to a few of my posts but to be honest I mostly find his responses do not address anything I raise in the posts themselves and they also quickly descend into a diatribe against David Healy. This is childish and serves no purpose considering the seriousness of what is happening. These kind of responses from Ben are not just inadequate, but often they are generic and have nothing to do with addressing the content or core of the points I am trying to get across. I did find this initially frustrating until I noticed that he doesn’t just ‘interact’ with me like that – he does it to most people- particularly those who differ with, or oppose, his views.

Take for example my post recently urging Ben to listen to David Healy’s warning about the possibility that GSK are misleading Alltrials, and thus also misleading Ben. David made some well researched, and very salient points, which also made a lot of sense. David is an extremely credible voice in this arena, he is a professor of psychiatry, a distinguished author and an expert in psycho-pharmacology- he also has extensive experience with how GSK operate- yet on my blog, on David Healy’s blog, and on another blog where David’s opinions were also being discussed, Ben posted the exact same generic response, literally copied and pasted, in the comments section of all 3 separate blogs. This is not a dialogue with Ben, this is glib diatribe. This is churlish defensiveness. If I didn’t know better, I could be mistaken for thinking that Ben is stonewalling me?

Anyhow,

This is the comment he posted, repeatedly :

Ben Goldacre on May 27, 2014 at 11:11 pm said: Edit

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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

 


I am not going to go into the content of Ben’s comment because it has already been responded to on David Healy’s blog- by David Healy- and I have no idea why Ben posted it on my blog because it is a response to David Healy’s post, not mine- my posts have been questioning different aspects of this and they have had a different tone. It concerns me that Ben doesn’t seem to see that there are many informed, educated and wise opinions from many different people in this debate, his opinion is not the sole authority on data transparency, the ills of the industry or the direction we should all be headed to. Ben needs to listen to others and stop dictating generic responses which do not address the concerns and opinions of others but merely inflate his own sense of ego and self-importance. It would be nice to think that we can engage with Ben and those who have differing views on the same subjects without the fear of childish retorts. I won’t hold my breath for some proper adult engagement but I will always be open to it. We desperately need dialogue here…

I will finish this post with what i think was one of the most insightful- yet also humble and intelligent- comments in this debate that I have seen so far ( copied from David Healy’s blog):

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments


Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect. I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all. The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not. If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.” In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned. This is closer to a war than a negotiation. The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.

– See more at: http://davidhealy.org/fucked/#comments

http://davidhealy.org/fucked/#comments

 1boringoldman says:

May 29, 2014 at 12:14 am

Over recent years, there has been a growing awareness that the data in pharmaceutical clinical trials has been routinely manipulated, and that we often can’t trust what we read in our journals about either efficacy or adverse effects. There’s a building consensus that there’s a space between the actual raw results and the public presentation that has been a devil’s playground and that the only solution is make it totally transparent. Goldacre’s AllTrials Movement, Godlee’s BMJ, the Cochrane Collaboration with Chalmers and Goetche, Healy’s efforts and RxISK, Doshi and Jefferson’s RIAT project, and many others have come at the problem from different angles trying to set things right. And the decision of the European Medicines Agency to implement a broad data transparency policy was an exciting step in the right direction.

Throughout this process, the pharmaceutical industry has erected roadblocks to data transparency at every turn. The suit by AbbVie against the EMA, the current attack mounted against Dr. Godlee, the article posted right now on the PhRMA site on intellectual property rights [http://www.phrma.org/innovation/intellectual-property], are just a few examples of industry’s attempts to undermine full data transparency. Even the concessions they’ve made are suspect.

I’m on a RIAT team currently using the “remote desktop” interface provided by GSK for our project. The data is there, but the interface is so constricted that it severely limits anyone trying to do a thorough analysis of the information. I can’t see how it protects confidentiality or trade secrets. It just makes checking the data much harder than it needs to be. So I’ve come to see it as just another obstruction, nothing more. The recent turnaround in the EMA policy with a movement to view-on-screen-only access is a major setback – making the task of vetting clinical trials un-necessarily difficult.

I can see no reason for industry to have a seat at the table in the negotiations about data transparency at all.

The misuse of their current ownership of the data, the record of the level of corruption in reporting, the number of negative studies with-held, the soft-pedaling of adverse effects, all point to what happens when they are allowed to control the data. The only pertinent issues are the true efficacy of the drugs and an accurate reporting of the adverse effects. The economic health of the current pharmaceutical industry is, in my mind, an immaterial point, as is whether they join AllTrials or not.

If the standards required to guarantee the integrity of our pharmacopeia are prohibitive to our current system, then our system needs to change – not our standards. So as to the argument in the comments in this post above, I have nothing but respect for all parties represented and all of their efforts. But when it comes to the involvement of industry in deciding where we’re headed on this issue, I agree with BMJ editor Dr. Fiona Godlee who said that they have an “irreducible conflict.

In my mind, their track record is ample proof that they aren’t responsible players and should be viewed with the highest index of suspicion they’ve earned.

This is closer to a war than a negotiation.

The task of evaluating the efficacy and safety of medications is an essential obligation of the medical scientific community to our patients – a bottom line. It’s irrational to move that line because of the economic needs of any commercial sector. If that impedes research into new treatments, that simply means we have to rethink how we do medical research.
– See more at: http://davidhealy.org/fucked/#comments

ben-goldacre-1

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4 comments

  1. Ben Goldacre

    I am fully up for serious conversations about strategy. But as I pointed out in my post, Healy is simply saying things that have no foundation in reality.

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

    David Healy says:
    “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 says:
    “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 has given no justification or response on these two blatant examples, and I’m really sad to see that you won’t address that, and degenerate into heckling.

    Differences are one thing, they’re great, I’m always keen to discuss them. But they have to be anchored in reality. With the best will in the world, as above, David Healy is simply saying things that aren’t true, and it’s very hard to see how it’s possible to have a serious conversation with someone who does that. Perhaps you might have better luck in asking him to justify or re-think the two obviously untrue things (chosen from a long list) that he said above. I fear all you will get is distraction and changes of topic.

  2. truthman30

    Hi Ben,

    Thanks for commenting.

    First of all – did you read my post at all? The one which you just responded to? I don’t think you did because if you had read it you wouldn’t be whittling on about David Healy because my post was actually about how you ignore my posts and proceed to write about Healy. I wrote the post- can you not have a dialogue with me? This has happened with other posts too. I don’t think you have read any of them properly. For example, the main point of my post above was highlighting a comment from 1boringoldman’s blog- because I feel his points, and his posts in general, about GSK, data transparency, and the entire debate which surrounds it- are some of the most poignant and profound that can be found anywhere…. unfortunately though- again- you don’t seem to be listening…

    If you have issues to discuss with Dr. Healy, be a grown up- and find an avenue which suits both of you to act like adults and discuss those issues… It surely can’t be that difficult?

    There are several things I would like to discuss with you, without drama or diatribe (from either of us), but I can’t do that if you don’t engage properly or read my blog posts….

    Cheers…

  3. Deadmansvitamin

    What do you get when (supposedly) intelligent people go to school for 8(?) years to study a science which has no scientific base. Psychiatrists. Round and round and round you go.

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