Trust of medical volunteers 'betrayed'

pills Research suggests half of all clinical trials have never been published

If you signed up to a medical trial you might assume that the results of the research would eventually be published. But that is far from certain. Pharmaceutical companies are under no legal obligation to publish all the available data about drugs.

A group of 53 clinical trial participants has written an open letter to the European Medicines Agency - the body which licenses drugs. Some of the individuals are healthy volunteers and other have conditions like cancer.

Start Quote

This is medicine's dirty secret, so it's great to see patients speaking out”

End Quote Ben Goldacre Doctor and columnist

They say that many participants in trials have been misled because thousands of clinical trials have not been published. They point out that important data from trials may not be available to doctors, researchers or regulators who work on particular diseases.

The letter is part of a growing campaign to force the industry to be more open and has support from the British Medical Journal and Sense About Science.

Ben Goldacre, doctor and Bad Science columnist in the Guardian been a driving force behind this issue. Author of 'Bad Pharma' he said: "This is medicine's dirty secret, so it's great to see patients speaking out, and so many eminent organisations joining up, to finally fix this problem.

A petition calling for all results to be registered has so far attracted 8,000 signatures. Among those who have signed are the Cochrane Collaboration - which analyses clinical data, and the Medical Research Council, which now makes publication a condition of all studies it funds.

Just what proportion of trials are kept under wraps is unclear - one of Donald Rumsfeld's known unknowns - but a 2010 study from the National Institute of Health Research suggests that half are never published, and those with positive results twice as likely to get into print.

Earlier this week the Commons Health Select Committee said drug companies should be legally obliged to share data so that they cannot deliberately withhold adverse results.


Carl Heneghan, Director, Centre of Evidence-Based Medicine, University of Oxford is part of a Cochrane team reviewing the effectiveness of the anti-viral drugs Tamiflu and Relenza. The government spent £500 m stockpiling Tamiflu for use in the H1N1 influenza pandemic.

The review is clearly important if policymakers and governments are to decide whether the money spent on anti-virals was worth it and whether they should do so again in the event of another pandemic.

He told me that he was 'getting nowhere' with Roche, makers of Tamiflu who had refused to hand over much of its clinical trial data. For its part Roche cites issues of patient confidentiality and says it disputes the methods being used by Cochrane.

Dr Heneghan has also spent 'four to five months' negotiating access to data from GSK, makers of Relenza but has yet to receive the clinical study reports. GSK told me it was committed to release the material provided - again the issue of patient confidentiality was raised. Last year GSK said it was committed to provide researchers with the detailed data that underpin its trial results.

I have taken part in a number of trials including one of an avian flu vaccine at Oxford University. I did receive a detailed summary of trial results.

Prof Andrew Pollard, Director of the Oxford Vaccine Group said it was a condition of all contracts with industry that the results would be released and editorial control rested with the researchers.

From January 2014 the European Medicines Agency will publish all clinical study reports - the data behind medical trials, which often run into hundreds of pages. This is already done in the US by the Food and Drug Administration.

But that still leaves all the trial data which is never submitted to the regulators.

This issue makes the pharma industry an easy target for critics and it seems surprising that bona fide researchers are still encountering resistance.

The Association of the British Pharmaceutical Industry (ABPI) says increasing amounts of data are being published but there must be recognition that 'release of commercially confidential information could undermine investment in research and development of future medicines'.

Doctors and patients will not want to damage the millions that are spent by drug companies developing new medicines. Equally, drugs firms that demonstrate they have nothing to hide by giving full access to data could receive a massive boost in support from patients, medical staff and those all-important trial volunteers.

Fergus Walsh Article written by Fergus Walsh Fergus Walsh Medical correspondent

Defeating cancer, the 'evil genius'

Can we win the war against cancer? Over the past 18 months, Panorama has followed a group of patients on drug trials. Some who'd been given months to live, are keeping cancer at bay for years.

Read full article

More on This Story

Related Stories

The BBC is not responsible for the content of external Internet sites


This entry is now closed for comments

Jump to comments pagination
  • rate this

    Comment number 69.

    The people talking about 'setting a bar' earlier... Surely you can't set a single bar for all drugs according to serious side effects per thousand people or whatever. The side effects should be assessed against the benefits of the drug. For e.g., a drug that may cause hair loss and vomiting may be acceptable as a successful anti-cancer drug but would be unacceptable if it were for sore throats...

  • rate this

    Comment number 68.

    #67 You're happy for the taxpayer to fund 50 drugs that fail at one stage or another in return for 1 that works at a reasonable price?

    Me too. That makes my job a lot more secure.

    I suspect you haven't had a lot at many GSK, Merck etc share prices recently. Not a lot of profiteering going on. Its why Astrazeneca has sut 2 out of 3 plants in the UK, Pziser pulled out of Sandwich etc

  • rate this

    Comment number 67.


    Where did I say the drug companies should pick up the bill? Oh, I didn't - it shows how utterly devoid of weight your arguement is that you have to claim I said things I did not.

    I said contract the drug compnies - contracts usually involve money. And yes, tax payers should fund the research as it is for our ebenfit and we'd save the profiteering in the long rund.....

  • rate this

    Comment number 66.

    #65 and who covers the cost of developing the drugs that don't work?

    What you want is the NHS to pay little more than cost for the stuff that does work but the drug companies to cover the cost of the stuff that doesn't.

    They'll go bust in months. Virtually nothing that works in the test tube makes it through to NICE approval. I've heard only 1% of potential drugs.

  • rate this

    Comment number 65.

    Drug companies should be contracted by national health agencies to dveleop new drugs, to more stringant standards than they apply to themselves, then be licensed to produce those that prove successful.

    There should be no room for excess profiteering in the health field.....


Comments 5 of 69


Features & Analysis

BBC Future

(Getty Images)

What it’s really like to die

The seven experiences you face at the end


  • Former al-Qaeda double agent Aimen DeanHARDtalk Watch

    Islamic State is about revenge says former al-Qaeda member turned spy Aimen Dean

Copyright © 2015 BBC. The BBC is not responsible for the content of external sites. Read more.

This page is best viewed in an up-to-date web browser with style sheets (CSS) enabled. While you will be able to view the content of this page in your current browser, you will not be able to get the full visual experience. Please consider upgrading your browser software or enabling style sheets (CSS) if you are able to do so.