Bad Pharma, silent archivists

I finished Ben Goldacre’s Bad Pharma on Friday, and it’s got me thinking again about professional ethics and public engagement in the archives and records management community. After an exchange of tweets with @melindahaunton and @stefarchivist the other night, I foolishly committed to trying to put my thoughts in order in a blogpost.

As background, Bad Pharma (subtitled in Britain ‘How Medicine is Broken, and How We Can Fix It’) is doctor and science writer Ben Goldacre’s account of what’s wrong with the global pharmaceutical industry and its interactions with the medical profession. If you want a general overview, here’s the New Statesman’s review and here’s the Economist’s, but the thrust of his argument is that the evidence base for the drugs vital for modern medicine has been tainted by decades of bad practice: benefits have been exaggerated, and evidence of side-effects played down or hidden; new drugs are only tested for effectiveness against placebo, whereas the far more useful comparison would be the best existing treatment; doctors’ ongoing professional education about the latest drugs has been funded by industry, with predictable bias resulting; supposedly independent articles and trial reports have in fact been ghost-written by industry authors; and regulators, medical journals and professional associations have all failed to tackle these issues, while in fact making matters worse by giving the impression that any problems are in the past and have now been solved.

All in all, Goldacre argues that the flow of information about drugs to clinical practitioners has been so distorted that nobody has a clear and accurate idea of which treatments are the best, the most cost-effective and the safest.

A large section of the book is devoted to missing clinical trials. The Randomised Clinical Trial, as reported in medical journals like the Lancet, the British Medical Journal and so on, is our best tool for understanding the safety and effectiveness of a given drug. Trials are how a drug gets approved and how bodies like NICE decide whether they will fund its use in the NHS. The problem here is that there is no obligation on pharmaceutical companies to publish all the trials they carry out, and it appears that they don’t do so. Trials that suggest that a new drug is safe, effective and better than what’s already on the market are, it seems, far more likely to be submitted for publication than those that don’t. And worse still, the existence of the unpublished trials is not even disclosed. This is the basis of the AllTrials campaign of which Goldacre is part. It is calling for action by governments, regulators and the industry itself such that ‘all trials past and present should be registered, and the full methods and the results reported.’

The reference to past trials is an important one. As Goldacre points out, if all trials from now on were registered and published, this would not solve the problem that we don’t have a true picture of the effectiveness of all the drugs currently on the market – these were trialled back in the eighties, nineties or noughties, and many of these trials are missing.

And so we get to archives and records management.

Clinical trials produce records, in great numbers and great length: designs and protocols; reports of symptoms; clinicians’ notes; results of blood tests; collated spreadsheets and databases of outcomes; summary reports of findings and more detailed Clinical Study Reports. These are all held by the pharmaceutical companies that carry out the trials and some also by regulators. But they are kept secret and also, Goldacre says, that those records that are published are done so selectively, and with misleading accounts of their authorship and the circumstances of their creation. Goldacre’s argument is that this is hobbling evidence-based medicine.

He describes in detail the evidence that results of a significant proportion of clinical trials have gone unpublished:

If you want to prove that trials have been left unpublished, you have an interesting problem: you need to prove the existence of studies you don’t have access to. To work around this, people have developed a simple approach: you identify a group of trials you know have been conducted and completed, then check to see if they have been published…In 2008 a group of researchers decided to check for publication of every trial that had ever been reported to the US Food and Drug Administration for all the antidepressants that came onto the market between 1987 and 2004…The researchers found seventy-four studies in total, representing 12,500 patients’ worth of data. Thirty-eight of these trials had positive results and found that the new drug worked; thirty-six were negative…Then the researchers set about looking for these trials in the published academic literature, the material available to doctors and patients. This provided a very different picture. Thirty-seven of the positive trials – all but one – were published in full, often with much fanfare. But the trials with negative results had a very different fate: only three were published. Twenty-two were simply lost to history, never appearing anywhere other than in those dusty, disorganised, thin FDA files. The remaining eleven which had negative results in the FDA summaries did appear in the academic literature, but were written up as if the drug was a success.

Other investigations had similar findings.

Goldacre also details a culture of secrecy among regulators, who often decline to provide access to the trials records that they hold. He explores at length a prolonged fight by researchers from the Nordic Cochrane Centre to gain access to trial protocols and study reports for two diet drugs, orlistat and rimonabant, held by the European Medicines Agency (EMA), the EU’s pharmaceuticals regulator. The EMA refused to provide these, first on grounds of commercial interests and intellectual property of the drug companies and later on grounds of patient confidentiality. The researchers went to the European Ombudsman who gave the EMA’s position extremely short shrift, eventually reviewing the documents himself, determining that they held no commercial or patient confidentiality concerns, and ordering that they should absolutely be made available to the researchers on clear public interest grounds.

Goldacre also mentions, incidentally, that when records are made available by regulators often it is in a far from useful form. Describing the publication of historical trials records on the US Food and Drug Administration’s Drugs@FDA website, he first explains how poor search functionality makes it hard to find the documents you need even when you know exactly what you are looking for. Then he moves on to other problems which will ring a bell for many of us:

If you’re a nerd you might think: these files are electronic; they’re PDFs, a type of file specifically designed to make sharing electronic documents convenient. Any nerd will know that if you want to find something in an electronic document, it’s easy: you just use the ‘find’ command: type in, say, ‘peripheral neuropathy’, and your computer will find the phrase straight off. But no, unlike almost any other serious government document in the world, the PDFs from the FDA are a series of photographs of pages of text, rather than the text itself. This means you cannot search for a phrase. Instead, you have to go through it, searching for that phrase, laboriously, by eye…There is simply no reason for this obfuscation and chaos. These problems aren’t caused by technical issues specific to trials, and they would hardly cost any money at all to fix. This is plainly, simply, unhelpful, and the best we can hope is that it’s driven by thoughtlessness.

Another thing worth mentioning is that in at least one case, a drug company has declined to make trial results available to independent researchers specifically because it had objections to their perceived line of inquiry. This was Roche, in regard to Tamiflu, which has of course been in the news again recently. Back in 2010, Roche was declining to provide Tamiflu trial records to researchers from the Cochrane Collaboration:

Firstly, it insisted on seeing the Cochrane reviewers’ full analysis plan. Fine, they said, and posted the whole protocol online. Doing so is completely standard practice for Cochrane, as it should be for any transparent organisation, and allows people to suggest important changes before you begin. There were few surprises, since all Cochrane reports follow a pretty strict manual anyway. Roche continued to withhold its study reports…and began to raise odd personal concerns. It claimed that some Cochrane researchers had made untrue statements about the drug, and about the company, but refused to say who, or what, or where. ‘Certain members of Cochrane Group involved with the review of the neuraminidase inhibitors,’ it announced, ‘are unlikely to approach the review with the independence that is both necessary and justified.’ This is an astonishing state of affairs, where a company feels it should be allowed to prevent individual researchers access to data that should be available to all…

Another long saga of researchers from Cochrane attempting to get hold of trial documentation on anti-depressants from the EMA is worth another extended quotation:

The researchers put in their request to the EMA, but were told that the drugs had been approved back in the era when marketing authorisations were given out by individual countries, rather than the EMA centrally. These local authorisations were then ‘copied’ to all other nations. The MHRA, the UK drugs regulator, held the information the researchers wanted, so they would have to approach it for a copy. The researchers dutifully wrote to the MHRA, asked for the reports on a drug called fluoxetine, and then waited patiently. Finally the answer came back: the MHRA explained that it would be happy to hand over this information, but there was a problem.

The documents had all been shredded.

This was in keeping, it was explained, with the agency’s retention policy, which was that such documents were only kept if they were of particular scientific, historical or political interest and the files didn’t meet those criteria. Let’s just take a moment to think through what the criteria might be…[Another anti-depressant of the same type, paroxetine] was involved in an unprecedented, four-year-long investigation into whether criminal charges could be brought against GSK. That investigation into paroxetine was the largest investigation the MHRA has ever conducted, of any kind, ever. Quite apart from that, these original study reports contain vitally important data on safety and efficacy. But the MHRA shredded them all the same, feeling that they were not of sufficient scientific, historical or political interest.


Does any of this sound worrying from an archivist’s or a records manager’s perspective? I may only be recently qualified but these sound to me mightily like the issues of provenance, context, reliability, accuracy, completeness, open and impartial access and reuse that are such an important part of our professional values.

I would suggest that there are a whole suite of issues here around professional ethics and archival principles.

First, there are the questions for the archivists and records managers working for pharmaceutical companies and regulators around the world. I want to be clear that I am making absolutely no glib judgements or accusations about any records, information or knowledge professionals working in this sector. I’m a career-changer, new to the profession, and I certainly do not wish to cast aspersions on anyone.

As we know, an individual archivist or records manager’s power to improve matters is likely to be limited. Recordkeepers, especially in large corporate bodies, are very often not the ultimate decision-makers on what is retained and what is destroyed, what is disclosed and what is kept private. Very often, their ability to influence these matters may be limited to ensuring that their bosses have been informed of principles that may be in play and what best practice is. Moreover, Goldacre notes that the practices he is criticising in the industry have been standard for decades and not recognised as anything wrong or problematic. They are the norm, and he is at pains to point out that many thousands of good, ethical people have been misled by their ubiquity.

However, it is worth referring to the ARA Code of Conduct which states, inter alia that:

The primary duty of members is to maintain the integrity of the records in their care and custody. In the accomplishment of this duty they must have regard to the legitimate, but sometimes conflicting, rights and interests of employers, owners, data subjects and users, past, present and future. The objectivity and impartiality of members is the measure of their professionalism. They should resist pressure from any source to manipulate evidence so as to conceal or distort facts.


Members should select documents to be kept or to be destroyed primarily to save essential testimony of the activity of the person or the institution which produced and accumulated the documents but also bearing in mind changing research needs.


Members should discourage unreasonable restrictions on access and use…[they] should respect both access and privacy, and act within the boundaries of relevant legislation.

Members should take care that corporate and personal privacy as well as national security are protected without destroying information, especially in the case of electronic records where updating and erasure are common practice

But perhaps most relevant is this:

Members should not allow people outside the profession to interfere in their practice and obligations.

It is worth mentioning in passing that Goldacre makes a somewhat provocative request for someone with inside knowledge to to take matters into their own hands.

…many of you reading this have access to large quantities of data or documents that would change the lives of patients, and help to prevent ongoing suffering and harm. I would appreciate a data dump, on the scale of the US Iraq and Afghanistan war records, and if I’m honest, I’m surprised and disappointed this hasn’t happened yet. If you need any help, just ask: I will do everything I can to assist you.

Aside from the questions for individuals, however, are the broader ones for the profession. This issue of undisclosed clinical trials is a major one, of undoubted importance to society at large. When the book was launched in 2012, it got significant media coverage and questions were asked in the House of Commons and in Select Committees; and with the subsequent launch of the AllTrials campaign, it has remained, periodically, in the public eye. It is unequivocally about records, both current and historical, and it certainly relates to core archival principles.

Why, then have I not seen any archivists commenting about it?

Why have archivists not been prominent in the ensuing debate?

And most of all why have archivists’ professional bodies, in the UK and elsewhere, been silent on the issue?

I apologise profusely if there have been public comments and interventions, but I have not seen them.

Isn’t this precisely the kind of thing that we should be shouting about, throwing in to the debate our own professional expertise and understanding of the ethical issues around the protection of the integrity of records, and their disclosure to those who they affect? We have a unique role and perspective in a question like this and if we’re not weighing in now, when are we going to do so?

It’s striking to me that Goldacre lists the groups he think have a stake, and can make a difference: doctors, politicians, regulators, journal editors, patients and the public at large.

He doesn’t mention archivists.

He doesn’t mention records managers.

He’s wrong, but unsurprisingly so because we, as a profession have been nowhere on this issue, and on others like it.

Recently, Jenny Bunn announced the results of ‘The Hilarys’, awards for things that have encouraged us as archivists ‘to look up and outwards, to actively seek new ways of thinking and to try to see through the eyes of others.’

The winner of the Best Newcomer award was a post by Canadian archivist and librarian Myron Groover entitled ‘The Last Days of Aaron Swartz’. I’m proud to say that it was my nomination. It is worth repeating a key section of Groover’s post. Referring to the suicide of internet and open information activist Aaron Swartz, he says:

It is our firm hope that this tragic event will galvanize the resolve of the people who work in fields which deal with the generation, stewardship, preservation, and transmission of information. Where we have fallen short, let us strive to improve. Where we have succeeded, let us build on that legacy. Above all, let us be less willing to shy from the challenging aspects of our work at the level of policy and advocacy – our voices are desperately needed. We no longer have the luxury of silence, and whispering position statements is simply not enough.

Amen to that.

I feel like I should end on a slightly more cheerful note and, indeed, it’s not all bad news. Goldacre mentions the Drug Industry Document Archive at the Centre for Knowledge Management at University of California, San Francisco. This brings together in one place documents from companies like Merck, Parke-Davis and Pfizer that have come into the public domain as part of court cases. It seems an excellent project to ensure that this kind of information, once disclosed, stays remembered and accessible.

With examples like that in mind, can we start shouting louder, please?




  1. As promised…

    I nearly commented before but failed to, on account of feeling that I’d got too much condensed – questions of what we can realistically expect of professional bodies, questions of collective and individual ethics, retention and access, the difference between public and private practice, the issue of prominence and engagement with a topic. But they’re all in your blog, so here’s an attempt at least.

    In terms of practical support, I’d hope there is scope collectively to recommend and standardise good retention practice, so that individuals can point to a collective voice and not have to act alone – as in the example of destroying trial records because they aren’t seen as needed for the long term. A retention practice for drugs on the market of patent life plus 10-20 years could perhaps be established as a norm without sending anyone into spasm? (I did tweet Ben G over this some time ago and got a mildly interested response.) Although I’m sure these are voluminous series, it’s hard to sustain the idea that there’s no ongoing need for trial records of drugs which are in active use, given how long it can take for issues to emerge.

    Where I’m less sure there’s a role is in professional associations campaigning for access to private business records – particularly those which are semi-current, where routine external access to records would be unusual in any business context. I think Goldacre makes an excellent case for why these private records have public implications, but legally they are private. The balance of private and public interests is a horribly tense one. Despite the code of ethics, ARA and IRMS do not campaign to open up private archives wholesale – we can argue elsewhere about whether they should/could, I suppose – so campaigning on this one area seems like a major departure. They are small societies, picking their battles. It doesn’t surprise me that this is one.

    One reason why it doesn’t surprise me, and where I do agree with you completely, is that there’s a lack of engagement from archivists and records managers (the societies’ members and driving force, after all) in wider issues that aren’t firmly flagged as ARCHIVES AND RECORDS. It’s been hard to get people involved in pretty solid records issues like revisions to Data Protection and PSI. As the voting in the Hilarys showed, asked to think outside the box, we tend to think ourselves back in pdq. Of course it’s partly about being busy, stretched people with limited time – and *of course* that’s true – but we tend to be better at responding conscientiously to challenges which are in front of us (what the hell is the copyright situation with this?) than acting to change (why the *hell* is copyright so mad, and how can we change it?). Which filters through to our (again, small, stretched) professional associations, who support us admirably in our practice, but don’t always aim to lead change, especially in areas which aren’t A&R flagged. (Have to say, recent statements on changes to the EU DP Regs are an important exception here – yes, it’s archives, but it’s also pretty starkly campaigning. I’m glad to see it.)

    Views, fairly obviously, my own and not my employer’s. Because you don’t ask why TNA didn’t talk about AllTrials – and you probably know we couldn’t, even if we had wanted to.

  2. All excellent points, thanks.

    I agree that the issue of retention is perhaps the ‘easiest’ one here. What is described as having happened at MHRA appears to be an error plain and simple, and one whose repetition in future would be prevented by clear best practice guidance. Incidentally, I assume that as a Central Government public authority (their website says they are an Executive Agency of the Department of Health), MHRA is bound by the Public Records Act, and as such deposits at TNA?

    As to TNA’s broader responsibilities, yes I realise that there is no specific mandate. TNA has though acquired a more formal sector leadership role since the wind-up of MLA (as of course you know well given your day job looking after archive accreditation). As I understand it, that role does include providing information and advice to Ministers on archives issues. It’s an interesting point as to whether senior officials at TNA should be proactively doing this (rather than simply responding to Ministerial requests).

    Would it be appropriate, for example, for the Chief Executive to write to the Secretary of State for Health (or to whichever junior minister it is that has responsibility for the MHRA and drugs approval) to say “Hey, there’s a problem here”?

    I thought about that in regards to a different issue last year: you’ll recall the issue around Michael Gove and his Special Advisors using gmail rather than departmental email in an effort to avoid oversight by civil servants and because they thought (incorrectly) that personal gmail accounts would be out of scope of the Freedom of Information Act. I wrote a post about it on this site.

    That story was reported as an FoI issue and the Information Commissioner was rightly vocal in his criticism of Michael Gove, his SpAds and the Department of Education in general about the lack of adherence to the FoI Act.

    But it occurred to me that it was also a breach of the Public Records Act: the actions of the Minister and his Special Advisors meant that the historical record for their policymaking will be missing important records, because the emails that were sent to and from gmail accounts (and were subsequently deleted with no review and no reference to the Department’s Records Management Policy) won’t ever have a chance of finding their way to TNA. And yet there was, so far as I’m aware, no public statement by the Chief Executive, notwithstanding that he is, as I understand it, guardian of the PRA in the same way that the Information Commissioner is the guardian of FoIA.

    Of course this may have all happened behind the scenes.

    Somewhat similar: so far as I know there has been no public TNA statement about the goings on with the FCO’s archive at Hanslope Park. Again, if I understand the coverage of that correctly, there appear to have been breaches of the PRA.

    On the question of whether archivists and records managers, either as individuals, or collectively through our professional bodies, should be being more vocal about retention and disclosure of private corporate records – it’s a good question isn’t it!

    You’re absolutely right that the ARA cannot be criticised for not doing so because we, as members, have not given them either the mandate or the resources to doing so. I wouldn’t have thought this is on Marie Owens’ radar, because we haven’t asked for it to be.

    My tentative view though is that we should as individuals be making an almighty fuss about this. We are the profession that supposedly cares about the importance of records, and where you have an issue like this, where private records have a clear public utility, I think we need to thrash out what we think about that, and then make our voices heard.

    Again, you’re right that we are apparently unwilling to do that. I guess the answer, really, is that archives is a sufficiently small profession that perhaps individuals can make a difference. So if I feel sufficiently strongly about it, I should keep writing things like this and encouraging others to do the same.

    And on that note, thanks very much for commenting – I feel validated!

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