Here’s me and Fiona Godlee (BMJ) giving evidence to Public Accounts Committee on withheld Tamiflu trials

June 18th, 2013 by Ben Goldacre in alltrials campaign, publication bias, tamiflu | 5 Comments »

In December last year a group of MPs including Sarah Wollaston, David Davis, Julian Huppert and Adam Afriyie wrote to Margaret Hodge, chair of the Public Accounts Committee, asking for an inquiry into Tamiflu. Specifically, they asked about the way that vitally important information on clinical trials around Tamiflu have been withheld from doctors and researchers. That signatory list – I’m thinking of Afriyie, Huppert, and Wollaston in particular – is an important reminder that we benefit from having people in parliament with professional experience of medicine and science.

The Public Accounts Committee inquiry into Tamiflu is now happening. Here is a video of me and Fiona Godlee (BMJ) giving evidence, followed by civil servants (mostly discussing less interesting issues like pill storage!).

I’ve some major round-up pieces coming on the campaign to stop clinical trial results being withheld – which is now vast – our progress, and the remarkable resistance put up by some small shrinking huddles. Until then, please do sign the alltrials.net campaign, and read our extensive news page, which covers a lot of the relevant activity.

www.alltrials.net/news/


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5 Responses



  1. iliff said,

    June 18, 2013 at 10:05 pm

    Well played, both. And well played the (uncredited) chair too.

  2. Andy S said,

    June 24, 2013 at 3:19 pm

    Long time reader here, but Microsoft Silverlight? It’s not the most accessible way to upload videos… Microsoft controls Silverlight about as tightly as big pharma and trial data!

  3. Paul Webb said,

    June 30, 2013 at 5:54 pm

    Silverlight, development of which has now effectively stopped, is required by the www.parliament.uk website (or Windows Media Player as an ‘alternative’) and is a result of Microsoft’s lobbying so you can’t blame this site for making available the only option there is. There are workarounds but not without expending considerable effort.

    Perhaps reading this NYT article that quotes Ben will cheer you up! www.nytimes.com/2013/06/30/business/breaking-the-seal-on-drug-research.html?smid=tw-share

  4. JohanBenesch said,

    July 11, 2013 at 10:23 am

    EFSA will organise a meeting that could be of interest:

    www.efsa.europa.eu/en/events/event/131120.htm?goback=%2Egde_1026407_member_256385394

    EFSA Info Session on Applications – Technical meeting on the reporting of human studies submitted for the scientific substantiation of health claims

    Parma , 20 November 2013

    Background
    Based on experiences encountered with the evaluation of health claims applications submitted pursuant to Regulation (EC) No 1924/2006[1], the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA Panel) has noted that, regardless of the publication status (i.e. published articles, study reports of unpublished studies), the reporting of human studies (e.g. design, methodology, statistics, results) varies considerably, which can lead to delays in the review process (e.g. request of additional information to the originating source) or preclude a complete scientific evaluation (e.g. if the additional information requested is not available). Consistent reporting of human studies submitted for the scientific substantiation of health claims in a harmonised and standardised way would benefit both EFSA and its stakeholders.

    In this context, the Applications Desk Unit, in collaboration with the Nutrition Unit, is organising an EFSA Technical meeting with stakeholders (scientists) in order to promote an interactive exchange of expert views regarding the information required for a full scientific evaluation of human studies submitted for the scientific substantiation of health claims.

    Objectives of the meeting
    The objective of this meeting is to discuss with scientists the information required for a full scientific evaluation of human studies submitted for the scientific substantiation of health claims (i.e. the requirements for the compilation and reporting of human studies investigating the relationship between the consumption of the food/constituent for which the claim is requested and the claimed effect, which should be complete, unambiguous and well organised, in order to allow a full scientific evaluation by the NDA Panel).

    This meeting will NOT address the scientific requirements for the substantiation of health claims, either in general or in relation to selected areas.
    Potential topics covered include:
    •Guidance for reporting on randomised trials;
    •Guidance for reporting on observational studies;
    •Guidance for reporting on systematic reviews and meta-analyses;
    •EFSA’s perspective based on experience gained in reviewing human studies for the scientific substantiation of health claims;
    •EFSA’s initiative to harmonise reporting in relation to statistical methodology, analyses and results.

    A detailed Agenda will be posted on EFSA’s webpage at a later stage.

    Structure of the meeting
    The Technical meeting will be organised in a way that provides for an interactive exchange of expert views.
    Participants will have the opportunity to provide feedback on their past experience (and difficulties encountered) in:
    •Reporting on the design, methodology and results of human studies;
    •Evaluating human studies reported by others when preparing and submitting applications for authorisation of health claims;

    The meeting will conclude with a session on possible learning outcomes. EFSA will issue an event report summarising the discussions of the technical meeting.

    Who should attend?
    The Technical meeting is intended for scientists:
    •Experts in designing, conducting and reporting human studies to be used for the scientific substantiation of health claims;
    •Experts involved in the preparation of health claims applications;
    •Experts from regulatory bodies in the field of health claims.

    In order to allow for a constructive scientific debate, participation is limited to a maximum of 150 scientists, including speakers and other experts already identified by EFSA.
    Participants will be selected taking into consideration a balanced representation of the various fields of expertise, as well as geographical balance.

    When will be possible to register?

    Registration for participation is foreseen to be open after the summer break.

    ——————————————————————————–

    [1] Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. OJ L 404, 30.12.2006, p. 9–25.

  5. pteropus said,

    September 23, 2013 at 6:25 pm

    Andy and anyone else wishing to side-step Silverlight (and I have enormous empathy for those who do) can do so by pointing their media player at this stream: www.parliamentlive.tv/Embed/Director.ashx?13335

    In VLC (for example), go to Media > Open Network Stream…, put it in the box under the ‘Network’ tab, and hit play.

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