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

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  • 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.....

  • rate this

    Comment number 64.

    #62 Your point is? Some chemical compounds in cannabis (purified and at high concentration) have an anti-tumour effect.

    Smoking cannabis CAUSES cancer (oral and lung). That paper doesn't say cannabis is good for you. Radiotherapy and chemo treat cancer too. I wouldn't recommend recreationally taking 5-FU or high dose gamma rays if you want to avoid cancer

  • rate this

    Comment number 63.

    #61 Tamiflu was as much a political decision as a medical one. The Fergus-on-flu blog was full of hysteria at the time that not enough tamiflu was available or that supplies were intentionally withheld

    My advice both then and now is don't waste your time taking it. The only anti-viral drug that works is acyclovir and even its applications are limited and has some side effects (vertigo with me)

  • rate this

    Comment number 62.

  • rate this

    Comment number 61.

    @59 The UK government spent millions on Tamiflu. If all the Phase III Trial data had been available then perhaps that decision might not have been made.

  • rate this

    Comment number 60.

    #58 Actually I read what you posted again. Initially I misread it. Unless there's an allegation of actual fraud the Phase III trial WAS published but data from 60% of the patients wasn't included.

    From personal experience this probably means that 60% of the data was unusable. Lab tests failed, drug wasn't taken correctly, patient stopped taking drug half way through course etc.

  • rate this

    Comment number 59.

    #58 So draw your own conclusion.... the oseltamivir trial showed it didn't work. Even the drug companies own claims for Tamiflu were little better than 'it took the edge of'.

    Tamiflu's own website reckon 10% of people taking it have side effects (mainly nausea and vomiting)

  • rate this

    Comment number 58.

    @55 Tom Jefferson, co-author of the Cochrane review of oseltamivir (Tamiflu) “We identified that a large number of studies, including data from 60% of the people who have been involved in randomized, placebo-controlled phase III treatment trials of oseltamivir, have never been published. This includes the biggest treatment trial ever undertaken on oseltamivir.”

  • rate this

    Comment number 57.

    #56 In theory that would be incredibly biased.

    In the real world the MHRA only allows 1 trial. You just can't repeat it again and again until you get the answer you like. Its highly illegal... and COSTS A FORTUNE. You can test the same drug against different diseases & you can test it in combination with other drugs but each of those is a completely different thing to what you suggest,

  • rate this

    Comment number 56.

    There is a lot of misinformation in these comments that negative data is not useful and it is ok not publish it. If a drugs company conducts 6 trials on a drug but only publishes the 3 that gives positive results this is massive bias. Every science & engineering discipline would benefit from more publishing of negative results: it can save time & money (and sometime lives) in future studies.

  • rate this

    Comment number 55.

    #52 HUGE hole in your argument. if a trial result isn't published its because the drug has failed. It won't be available to prescribe.

    In some respects there's an even bigger hole in both your argument & #53 BluesBerry's. GPs cannot be aware of all the side effects of all the drugs in the world. Most routinely prescribe a few dozen types and are often very ignorant of new development

  • rate this

    Comment number 54.

    More people die of pharmaceutical poisoning in the UK than die in road accidents. Practitioners are careless about side-effects and use the "confidentiality" excuse to cover their backs in our ever increasingly litigious society when things go wrong. If a drug fails in trials, your competitor may go bust trying the same compound unknowingly, why publish?

  • rate this

    Comment number 53.

    If all results were published, if all doctor's were aware, would we get headlines like these: Pharma co. Mobius has initiated recall of 2 lots of Mitosol Kit used in glaucoma; since August 24, FDA has issued 8 drug recalls, ranging from contaminated/mislabeled drugs to unapproved supplements. There's even a site: US Food & drug Administration recalls: (select FDA Recall).

  • rate this

    Comment number 52.

    @50 And those risks are known so doctors and patients can factor them into their decision making.

    Where results of trials are left unpublished, medical professionals are working with an incomplete picture of the potential benefits and harms of a drug and doctors and their patients are denied the chance to make a truly informed decision.

  • rate this

    Comment number 51.

    So may I ask about SMA baby milk and the appalling rates in breastfeeding in this country? New mums being given samples of formula milk and the government cutting funding to breastfeeding support groups? SMA are owned by Pfizer btw.

    What about NRT? The failure rate of these drugs on the NHS are mind numbing, yet the NHS give millions and millions to GSK and Pfizer for drugs that don't work.

  • rate this

    Comment number 50.

    #48 O.K. You set the bar. Penicillin can potentially KILL 1 in 1000 people taking it. 1 in 100 taking it will suffer fairly unpleasant side effects (diarrhea, hypersensitivity, nausea, rash, neurotoxicity, urticaria, and superinfection -wiki c&p BTW)

    Do we ban penicillin as being too dangerous? If your answer is 'of course not' then the bar is ~1 in 1000 chance of death. Pretty bad odds I feel.


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