David Healy misrepresents All Trials and Ben Goldacre

This blog post by David Healy is absurd – Dr Ben Goldacre response to Dr David Healy

After I posted “Fu*£ed or WTF is going on? @DrDavidHealy Thoughts about #AllTrials @BenGoldacre #GSK @Truthman30” yesterday, Dr Ben Goldacre visited DES Daughter Network’s blog leaving a comment which has now appeared on Dr David Healy’s website. I only added few related links (in the original text response) with the purpose to bring more clarity and/or references to the readers.

image of ben goldacre
Ben Goldacre is doctor, nerd cheerleader, Bad Science person, stats geek, procrastinator.

” Hi there,

I’ve posted this on David Healy’s blog, it’s currently “In Moderation” so I’m posting it here too in case it’s of interest.

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 ChalmersBen 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. “

Fu*£ed or WTF is going on?

Dr. David Healy: “We told you here 18 months ago not to trust GSK – but BMJ and All Trials went ahead”…

image of David Healy
David Healy is professor of psychiatry and co-founder of data based medicine, operating through RxISK.org , working towards making medicines safer.

Last year, after GlaxoSmithKline (GSK) was fined $3 billions, then signed the All Trials campaign, we were wondering if other pharmaceutical companies would follow GSK plans to share detailed clinical trial data online for researchers. What if “their selective transparency is a smokescreen for a wider, more nefarious agenda, which is further control” warns @Truthman30…

In his recent post, Dr. David Healy explains the following:

Read Fucked – Apologies for the Language
by Dr David Healy, CEO of RxISK, May 21, 2014.

Testing Treatments Interactive free Book, Better Research for Better HealthCare

This book should be in every school, and every medical waiting room says Ben Goldacre

image of Testing Treatments Interactive Book
Click for free download.

The 2nd edition of Testing Treatments was published in 2011. It urges everyone to get involved in improving current research and future treatment, and outlines practical steps that patients and health professionals can take together to do this.

How do we know whether a particular treatment really works? How reliable is the evidence? And how do we ensure that research into medical treatments best meets the needs of patients? These are just a few of the questions addressed in a lively and informative way in the free book written by Imogen Evans, Hazel Thornton, Sir Iain Chalmers and Paul Glasziou.

The full text of the 2nd edition is available for free download, and the paperback and ebook editions can be purchased from the publisher or from online booksellers. The text is already available in some other languages, and translations into additional languages are being prepared.


UK Medicines Regulator MHRA destroys Prozac Research and Clinical Trial Data after 15 Years on File

UK meds regulator destroys detailed information on the benefits and harms of drugs it has approved after it has held it for 15 years on file

image of the MHRA logo
The MHRA UK medicines regulator destroys detailed information on the benefits and harms of drugs it has approved after it has held it for 15 years on file.

BRITAIN’S medicines regulator has destroyed the original scientific data supporting the licensing of Prozac, the antidepressant drug that is provoking growing controversy over evidence that it is linked to suicide.

It means that scientists who have tried to re-examine the evidence justifying its release may now never be able to find out how good the science was. Patients making compensation claims will face the same problem.

The UK medicines regulator destroys detailed information on the benefits and harms of medicines it has approved after it has held it for 15 years. This means that for medicines which have been on the market for longer than 15 years, which is the majority of them, the Medicines and Healthcare Products Regulatory Agency (MHRA) no longer holds the data it based its licensing decision on.

This came to light after Professor Peter Gotzsche, co-founder of the Cochrane Collaboration, asked the European Medicines Agency for the data used to support the licensing of the antidepressant Prozac (fluoxetine). Gotzsche was referred to the MHRA as the UK is designated as the Reference Member State for Prozac meaning the MHRA is the nominated body within the EU that holds the information on the drug. Never the less, the MHRA had shredded clinical evidence about the benefits and harms of the product. It told Professor Gotzsche “Under MHRA record management policy, all application files and data for licences are held for 15 years. After this period, files are destroyed unless there is a legal, regulatory, or business need to keep them, or unless they are considered to be of lasting historic interest.”

The Sunday Times reported yesterday that “the MHRA said it had shredded the detailed information and held only some documents that summarised the findings. Eli Lilly, the manufacturer, retains the data and the MHRA said it can order it to be submitted.”

Professor Gotzsche wrote in a letter in the BMJ in June 2011 “As citizens in the EU, we should not accept this state of affairs. … The UK government should introduce legislation that will prevent the MHRA in future from destroying the evidence in its possession.”

Dr Ben Goldacre, co-founder of AllTrials said: “The MHRA needs to recognise that the world has changed, it is no longer acceptable for decisions about medicines to be based on secret meetings, about secret information that is then shredded. Doctors, researchers and patients need access to all the evidence, to make fully informed decisions about which treatment is best, and help spot problems with treatments as quickly as possible. Science progresses, and medicine improves, when we have many eyes on the data.”

  • MHRA shreds clinical trial info after 15 years, AllTrials.net, News release, 24th March 2014
More information, letters, opinions and articles:
  • Drug regulator destroys Prozac research, TheSundayTimes, 23 March 2014
  • and take names… , 1boringoldman, 23 March 2014
  • MHRA destroys trial data after 15 years on file, PharmaTimes, 23 March 2014
  • Restoring invisible and abandoned trials: a call for people to publish the findings, BMJ 346:f2865, 13 June 2013
  • UK drug regulator destroys all evidence after 15 years, BMJ 343:d4203, 5 July 2011
  • Opening up data at the European Medicines Agency, BMJ rapid-response, 20 June 2011
  • Opening up data at the European Medicines Agency, BMJ 342:d2686, 10 May 2011
  • UK Drug Regulator Destroys All Trial Data After 15 Years, Medscape 746109, July 11, 2011

Agreement reached at the European Commission on EU Rules on Clinical Trials of Medicines

Clinical trials: clearer rules, better protection for patients

Clinical trials: clearer rules, better protection for patients
Glenis Willmott led the MPs who proposed the text of the Clinical Trials Regulation. Pharmaceutical companies and academic researchers will be obliged to upload the results of all their European clinical trials to a publicly accessible database, under a provisional agreement reached between Parliament and Council of ministers on EU rules on clinical trials of medicines.

Exciting news from Brussels this morning – law that would mean researchers running a clinical trial in Europe have to register the trial before it begins and to publish summary results within a year of its end is a step closer. The committee of representatives from every EU member state government has agreed with the text of the Clinical Trials Regulation proposed by MEPs led by Glenis Willmott. This agreement now has to be formally ratified by the European Parliament and the Council of Ministers (probably in early 2014) but today’s provisional agreement is a fantastic result at a very important stage of negotiation and is down to the hard work of the MEPs and thanks to your input. The legislation will need final approval from the European Parliament.

The proposals agreed today include:

  • A publicly accessible EU database, set up and run by European Medicines Agency, containing:
    • A register of all trials carried out in the EU
    • A summary of results for all trials, uploaded 1 year after the end of the trial at the latest
    • As well as a summary understandable for a layperson
  • Clinical Study Reports for all trials used in a marketing authorisation request, whether it is approved, rejected or withdrawn
  • A statement that Clinical Study Reports should, in general, not be considered commercially confidential
  • Fines to be imposed by Member States for non-compliance with the transparency requirements
  • A requirement for all trials to be registered or published in order to be used to back up a new clinical trial authorisation (will encourage the retrospective registering/publishing of old trials)
  • The Clinical Trial Master File retained for at least 25 years.

Glenis Willmott MEP said: “For too long, unflattering studies on new medicines have gone undisclosed. Around half of all trials are never published, usually those with negative or disappointing results. It is vital we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge they are ineffective, or even dangerous.

We are determined to finalise this before the European elections in May. This legislation will set the global gold standard for transparency in clinical trials, and I call on all EU governments to support the agreement”.

Síle Lane, Director of Campaigns, Sense About Science said: “We are very pleased to hear that EU governments have agreed the draft Clinical Trials Regulation which contains proposals that would mean all clinical trials done in Europe will have to be registered and results reported. Well done to Glenis Willmott MEP who has worked very hard to get this agreement. We know Glenis was helped enormously by the hundreds of individuals and organisations who got involved and told MEPs and Ministers their reasons why transparency is vital. Now is the time for companies and academics to listen to all these voices and commit to registering and reporting results from trials done in the past too. There’s no excuse for not publishing results but a huge public health benefit to having a complete picture of what was found in trials conducted on treatments currently available to patients.”

Ben Goldacre, co-founder of AllTrials said: ”This is great news, and patients around the world should be grateful for the fantastic work that has been done on this by politicians in Europe. However we must remember that it only covers new trials, starting from 2014. The vast majority of medicines prescribed today came on the market 5, 10, or 20 years ago. This new law will do nothing to improve the evidence base for those treatments. We still cannot get all the results of all the trials on even the simplest everyday treatments, the antidepressants, the statins, the blood pressure treatments, and more. Those are the drugs that doctors are using right now, and will continue to use for at least a generation. Notably, the law would also do nothing to ensure that researchers and doctors can access all the results of trials on controversial drugs such as Tamiflu.

The campaign for access to trial results began over 20 years ago. Throughout the 1990s and 2000s, industry promised that everything had changed, and that everything had become more transparent. We now know that this wasn’t true. It is unacceptable that results from the 1990s and 2000s should continue to be withheld from doctors, researchers and patients. It is unacceptable to say that these trial results were allowed to somehow continue “disappearing”, even while some of the industry was publicly promising greater transparency. With their reckless belief that they could stonewall forever, too much of the industry have stored up a big problem for themselves, and for patients. We need the results of all trials, of all uses, of all the treatments we prescribe today. Without that, we cannot practice medicine safely and effectively.”

Mark Wilson, CEO, Cochrane Collaboration said: “Cochrane is delighted with today’s agreement on clinical trials transparency; a victory for patients, practitioners and policy-makers across Europe, and a clear and compelling message to decision-makers worldwide. The ratification of the agreement in 2014 will be a key milestone on the AllTrials journey to ‘all results reported’ becoming a reality.”


European Parliament Press Release: Clinical trials: clearer rules, better protection for patients, 20-12-2013 – 12:09.

Related: Agreement reached in Europe on Clinical Trials Regulation, All Trials Registered | All Results Reported, 20 Dec 2013.

Our posts tagged AllTrials – Ben Goldacre – Clinical Trials – European Commission – European Union.

Doctors should be responsible for declaring All their Pharma Benefits received

Doctors like to think they’re above being influenced by the pharmaceutical industry, but the evidence suggests otherwise

Let's see a register of GPs' interests
“Doctors should be responsible for declaring all their own benefits received and conflicts of interest on a simple register” says Ben Goldacre

This week GlaxoSmithKline, one of the biggest drug companies in the world, said it would stop paying doctors to give lectures promoting their drugs. Some patients might be surprised to hear that their NHS doctor ever participated in such a practice, and that is one of the great merits of this announcement: it will help shine a light on a hidden corner of medicine. ”

Continue reading Let’s see a register of GPs’ interests
by Ben Goldacre, The Guardian, 18 Dec. 2013.

All our posts tagged Ben Goldacre – Big PharmaDoctorsDrug MoneyMedical Representatives – Pharmaceutical Industry

Medicine’s Missing Half

How withholding clinical trials degrades the evidence base

Science & the City interviews Dr Ben Goldacre – author of Bad Pharma: How Drug Companies Mislead Doctors and Harm Patients – who discusses the pervasive bias in reporting clinical trials of medications.

Dr Ben Goldacre calls for all trials to be registered and for all trial results to be reported. Otherwise, he says, doctors, researchers, and patients are prevented from making discerning decisions about treatments and the field of evidence-based medicine is pointlessly hobbled.

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Alok Jha, Science correspondent at the Guardian and BBC TV presenter, speaks with Campaigner, Writer, Dr Ben Goldacre about his investigation into the pharmaceutical industry and his book Bad Pharma.

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Dr Ben Goldacre calls for GP Support on Trial Transparency

Campaigner Dr Ben Goldacre – RCGP conference 2013

The lack of transparency over clinical trial data harms patient care as much as medical incompetence, Dr Ben Goldacre has warned.

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