Select Committee on Health Written Evidence


Letter from Malcolm Boyce to the Clerk of the Committee (PI 107A)

  Here is my company's publication policy that I first wrote several years ago and recently revised to mention the EU Directive on Good Clinical Practice. It covers in more detail some of the things, including examples of publications, that I mentioned during my evidence on 2 December 2004. I am still battling with several pharmaceutical companies (all from outside the UK) to get their approval to publish trials that my company carried out for them over the past year or two, so I cannot give you more information at the moment. Anyway, I don't think that specific examples will help the Committee.

  Also, here is a list of new molecules that my company tested for pharmaceutical companies, UK and non-UK, during 2003 and 2004. Altogether, we tested 47 new molecules in a total of 77 trials. So, 61% of the trials involved new molecules. We had to give trial subjects some information about the new molecules they received, in a written information leaflet, so what's in my list is already in the public domain and I am not breaking confidentiality.

  We work for most of the big pharma companies and what we do reflects development of new medicines worldwide. Thus, this evidence does not support the view, expressed by one member of the Committee, that new products are mostly line extensions and me-too products. Incidentally, my list shows that we tested several different new molecules for some classes. That's because several companies are competing to be the first to the market in the same research area. If all the new molecules in the class come good, which is extremely unlikely as the attrition rate is normally high, the second, third, fourth etc to the market might end up being referred to unfairly as me-too products!

New molecules studied by HMR 2003-04


  Publications include the following: abstracts or papers about specific trials or general aspects of drug development at external meetings or in a scientific, medical or other journal; theses (eg MD, PhD); dissertations (eg BSc, MSc); course work (eg CIPD, TVU) for academic or professional qualifications. HMR encourages its staff to produce publications.

  This policy describes our philosophy about publications and how we review them before releasing them into the public domain. The purpose of the review process is to:

    —  prevent release of confidential information about trial subjects;

    —  prevent release of the sponsor's confidential information;

    —  prevent release of confidential information about HMR or its staff;

    —  improve the quality of the publication; and

    —  recognise, either by authorship or acknowledgement, the contribution of staff of HMR or the sponsor or others to the publication.


  Writers and co-writers of any of the above documents must follow this policy. The Staff Training Manager (or delegate) reviews course work of ward staff. Line managers review course work of other staff. The Medical or Managing Director reviews manuscripts, theses or dissertations, negotiates with sponsors who restrict unreasonably publication of trial-related data, and deals with requests for information from the media. The Medical and Managing Directors decide on authorship of papers. The Managing Director has overall responsibility.


3.1  Our philosophy about publishing trial-related data

  The ICH Guideline for Good Clinical Practice (GCP), section 6.15, requires the trial protocol to include a statement on publication policy, if not covered in a separate agreement. Article 4 of the EU GCP Directive also requires the trial protocol to include a statement on publication policy.

  Our policy is that if the data merit, either the trial sponsor or we may prepare a draft manuscript, for review and editing by both parties, before a final version is submitted for publication. Authorship should recognise those responsible for designing the trial, analysing or interpreting the data, and writing the paper, in accordance with established principles (Davidoff et al 2001). Unfortunately, not everyone involved with generating trial-related data can be a named author, but whenever possible the contribution of individuals should be acknowledged in the publication.

  The templates for our protocols and agreements contain statements about our publication policy. Most sponsors have a similar policy. However, some sponsors insist that the trial data are exclusively theirs, and forbid publication. That policy is contrary to ours. But more importantly it is contrary to the Declaration of Helsinki (Edinburgh, 2000) and to the policy of the editors of 13 of the world's most influential medical journals (Davidoff et al 2001). They have agreed that they "will not review or publish articles based on trials that are conducted under conditions that allow the sponsor to have sole control of the data or to withhold publication". We should follow the spirit of our quality policy (CP002) and not agree to a sponsor's protocol or contract that forbids publication, except for patent-sensitive reasons. Once patents are in place, publication should be permitted.

3.2  Manuscripts, theses or dissertations based on trial-related data and written by HMR staff

  Manuscripts prepared by HMR that contain trial-related data for publication in a scientific, medical or other journal must be well researched, accurate, and well written, and the interpretation of the data must be balanced. The writer and reviewer(s) prepare as many drafts as are necessary to give a final, polished version. The sponsor should be given reasonable time to comment on the draft manuscript(s). Both parties must agree to the final version. Theses or dissertations that are prepared by HMR staff for higher degrees and contain trial-related data must meet the same criteria, but the role of the supervisor or reviewer is advisory only. Individual trial subjects must not be identifiable in any publication, unless their specific consent has been obtained. Also, information provided by the sponsor that we have agreed to keep confidential must not be included.

3.3  Manuscripts based on trial-related data and written by the sponsor or co-investigator

  Sponsors (eg Sardina et al 1995) or co-investigators (eg Watts et al 1997; Bryan et al 2000) with whom we share trials may write the manuscript for publication in a journal. Most sponsors or co-investigators allow us adequate time to comment, and include HMR staff among the authors. But not all sponsors or co-investigators are as well behaved. Some give us very little time to review and comment on their manuscript (eg Harada et al 2002). Some submit manuscripts for publication without giving us any opportunity to comment (Curtin et al 2000; Moore et al 2001). Sponsors sometimes publish papers, based on trials that we have done for them, without respecting our contribution and without ever informing us; we may discover their existence while searching the literature (eg Thompson et al 1999; Shangold et al 2000). Occasionally, investigators publish articles based on our trials, using data from the investigator's brochure (eg Hornung et al 2002).

  We should not allow sponsors or co-investigators to influence adversely our philosophy about publication. We should always involve them in publication of trial-related data. Furthermore, if we are given the opportunity to review and comment on manuscripts written by sponsors or co-investigators, we should try as best we can to apply the same standards of quality that we apply to manuscripts that we write ourselves.

3.4  Course work written by HMR staff

  Course work is unlikely to be read by people outside of HMR other than the candidate's tutor. Nevertheless, course work may contain trial-related data or information that is the property of HMR or confidential information about HMR staff. Therefore, course work should be vetted in a similar way to a thesis or dissertation. Some course work, eg for TVU, should be vetted to check that it is the candidate's own work.

3.5  Signing off publications

  The author(s) of a publication, and the relevant person(s) identified in section 2, must complete and sign FM840 before releasing the document. Authors of manuscripts for publication in a journal may have to sign a statement that the work is theirs and that they concede ownership to the publisher of the journal.

3.6  Dealing with the media

  Requests for information about HMR, from journalists who work for newspapers, magazines, radio or TV, must be passed to the Medical or Managing Director. Sometimes journalists participate in our trials, to gather information for publication. Their requests for information should also be referred to the Medical or Managing Director.


  Approval of a publication  FM840

  External meeting or course  FM812


  Note that HMR authors are in bold font.

  Bryan S, O'Connor B J, Matti S, Leckie M J, Kananbar V, Khan J, Warrington SJ, Renzetti L, Rames A, Bock J A, Boyce M J, Hansel T, Holgate S T, Barnes P J. Effects of recombinant human interleukin-12 on eosinophils, airway hyper-responsiveness, and the late asthmatic response. Lancet 2000; 356: 2149-2153.

  Curtin S P, Eardley I, Boyce M, Larson P, Haesen K, Gottesdiener K, Gertz B J. Single dose methodology to assess the influence of alpha-1 adrenoceptor antagonism on uroflowmetric parameters in patients with benign prostatic hyperplasia. Br J Clin Pharmacol 2000; 49; 269-273.

  Davidoff F, DeAngelis C D, Drazen J M, Hoey J, Hjgaard L, Horton R, Kotzin S, Nicholls M G, Nylenna M, Overbeke A J, Sox H C, Van der Weyden M B, Wilkes M S. Sponsorship, authorship, and accountability. NEJM 2001; 345: 825-26 and Lancet 2001; 358: 854-56.

  Harada M, Suzuki N, Cho Nobuo, Urushibara T, Takekawa S, Horinouchi A, Clark E, Furuya S, Onda H, Boyce M, Fujino M. TAK-013: a novel, potent, and orally active, nonpeptide antagonist for the human gonadotropin-releasing hormone receptor. Submitted to Endocrinology 2002.

  Hornung D, Dallwiener D, Davies J, Hibberd M. TAK-013: a new oral GnRH antagonist. Proceedings of the congress of gynaecological endoscopy and innovative surgery; Berlin, Germany. 25-28 April 2002.

  Moore K H P, Cass L M, Dallow N, Hardman T C, Jones A, Boyce M, Prince W T. Pharmacokinetics and safety of escalating single and repeat oral doses of GW420867X, a novel non-nucleoside reverse transcriptase inhibitor. Eur J Clin Pharmacol 2001; 56: 805-811.

  Sardina M, Warrington S J, Boyce M J, Johnston A, Bianchini C. Hemodynamic and humoral effects at rest and after head-up tilt tests during 24 hour infusion of a new nitrate ester, ITF-296, compared with ISDN and placebo in healthy volunteers: A double-blind, randomised, within subject trial. J Cardio Pharmacol, 1995, 26 (supp 4) S80-S90.

  Shangold G, Fisher A C, Rubin A, on behalf of the multicentre EVRA 002 trial group. Pharmacodynamics of the contraceptive patch. Obstet Gynecol 2000; 95 (4 suppl 1): S36.

  Thompson H S, Davies M L, Holding F P, Fallon R E, Mann A E, O'Neill T, Roberts J S. Phase I safety and antigenicity of TA-GW: a recombinant HPV6 L2E7 vaccine for the treatment of genital warts. Vaccine 1999; 17: 40-49.

  Watts M J, Addison I, Long S, Hartley S, Warrington S, Boyce M, Linch D. Crossover trial of the haematological effects and the pharmacokinetics of glycosylated and non-glycosylated G-CSF in healthy volunteers. Br J Haematology 1997; 98: 474-479.

  ICH Guideline for Good Clinical Practice, section 6.1

  EU Commission Directive of laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products. Draft, June 2004

  Data Protection Act, 1998

  Declaration of Helsinki, Edinburgh, 2000

  Quality policy  CP002

  Data protection policy for HMR staff  CP014

  Trial protocol  HMRserver1

  Trial information and consent form  HMRserver1

  Trial agreement  HMRserver1

  Thames Valley University (TVU)

Certificate in Practical Pharmacology  Modules 1 and 2, and Course Handbook

  MSc in Drug Development,

Queen Mary College & Barts Medical College  Course Handbook


    —  Staff intending to write a document for release into the public domain should first seek agreement of the appropriate supervisor (see section 2).

    —  If the publication is not trial-related, the writer should add a statement that his/her views are not necessarily those of HMR, and mark the document "confidential".

    —  Writers must comply with the Data Protection Act (1998) and the Data Protection Policy for HMR staff (CP014).

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