Monday, August 14, 2006

Procter research shenanigans 4: Befriending the red herring

Pharmaceutical companies are accused of overturning the safeguards of science. The accountability of authors is the most fundamental of these safeguards. Readers expect that authors are the authors, that they vouch for the work and would be able to defend their findings if challenged. They expect that authors would be able to provide underlying raw data.

One of the many "red herring" excuses provided by Procter & Gamble to justify refusal to supply data codes underlying ghostwritten material (statistical reports, abstracts, two draft publications) to me as first author and to the Sheffield authors of a previous publication based on a subset of the same data (Eastell et al., 2003 JBMR 18:1051-6) is discussed here. The backstory is here and here.

This particular excuse (see correspondence here) was that they :
"use the approach described in PhRMA guidelines and that in these guidelines there is not access to the data (other than those from your center) for investigators".
So, what's wrong with this excuse:
  1. PhRMA (the Pharmaceutical Researchers and Manufacturers of America) is the lobbying organization for the industry. It is recipient of recent awards: The Fox Guarding the Hen House Award (for pushing toothless voluntary guidelines) and The Truth is Stranger Than Fiction Award (for a scandal involving the bribing of authors to produce a thriller as a stealth marketing tool to frighten the public (see Karasik Conspiracy). PhRMA has no authority to override ethical guidance.
  2. Even PhRMA does not suggest research findings should be closed to scrutiny by authors, or that authors should lie to journals. The cited PhRMA suggestion is that some paid recruiters of patients in multiple-center studies might not get to share in complete data access. This has nothing to do with the rights and obligations of a principal investigator or first author.

  3. Inability of a scientist to supply raw data constitutes prime facie evidence of research misconduct. Ability to provide data is an explicit condition of submission to any respectable Journal.

  4. Innumerable guidelines make the obligations of authors perfectly clear. For example:
    • The European charter for researchers: "details of the data should be open to internal and external scrutiny"

    • The Association of American Medical Colleges affirms right of "investigator to receive, analyze, and interpret all data generated in the research, and to publish results, independent of outcome" and affirms "an investigator’s accountability for the integrity of any publication that bears his or her name", and "Institutions should not enter, nor permit a covered individual to enter, research agreements that permit a sponsor interfere with an investigator’s access to the data or ability to analyze the data independently".

    • The International Committee of Medical Journal Editors (ICMJE) requirements: "researchers should not enter into agreements that interfere with their access to the data and their ability to analyze it independently" Editors may request that authors of a study funded by an agency with a proprietary interest in the outcome sign a statement, “I had full access to all of the data in this study and I take complete responsibility for the integrity of the data and the accuracy of the data analysis.

    • The World Association of Medical Editors (WAME) state : "Authors should be asked to affirm in writing that they have not entered into an agreement with the funding organization that limited their ability to complete the research as planned and to publish the results". "Authors should state in writing that they have had full control of all primary data. Authors' should agree in writing to allow the journal to review their data if requested."

    • CIOMS state: "investigators should not enter into agreements that interfere unduly with their access to the data or their ability to analyze the data independently, to prepare manuscripts, or to publish them."

  5. Concealment of raw data is contrary to the rules of any respectable University. Guidance at the University of Sheffield states:
    "research evidence should be made available to other researchers on request, prior to or following the publication of results".
    "Publication of research results does not negate the need to retain original records of research evidence"
    "evidence for research based on clinical samples or relating to public health be retained for twenty years."
    "Errors detected following the publication of results could be mistaken for research misconduct if a researcher could not subsequently provide valid corroborative research evidence.

Scientists may disagree about the presentation of data. There can be no legitimate debate when that data is not available for scrutiny even to authors.

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1 comment:

Anonymous said...

You may be fighting a reasonable fight, based on logic and good science. Procter and Gamble doesn't care about science, the truth or anything else. Science is irrelevant as far as they are concerned.

The decks are stacked in favor of the cheats.