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Thursday, April 17, 2008

6 Reasons Not To Trust Medical Publications

who are they, anonomous
Medicine in every aspect is influenced by the pharmaceutical companies and medical device industries. This influence also jeopardizes medical publications in, until recent respected journals.

These are the tricks used to influence the medical publications even in high ranking medical journals:

  • They use Guest authorship. This has been defined as the designation of an individual who does not meet authorship criteria as an author.First authorship is wrongly attributed to academically affiliated investigators who had little or nothing to do with the reported research.

  • They use Ghostwriting. This has been defined as the failure to designate an individual (as an author) who has made a substantial contribution to the research or writing of a manuscript. This means that articles are written by unacknowledged authors who are employees of the pharmaceutical industry.The research is mostly done by the drug company as well as the analysis and the writing

  • Financial support for the authors is not disclosed in the publications.

  • Some journal editors allow articles and supplements to be published without requiring complete disclosure of individual support from the drug companies

  • They use data analysis done by the drug companies instead of an academic statistician with no ties with the drug company.This could lead to data misrepresentation and data manipulation

  • Some peer reviewers in editorials boards of journals have relationship with industries. This could lead to a biased review of an article favoring the drug of the drug company. A peer reviewer sent a confidential manuscript that he was invited to review and that demonstrated an increased mortality risk associated with a drug to the manufacturer of this drug weeks ahead of the publication.

This is a summary from an article in the JAMA: Guest Authorship and Ghostwriting in Publications Related to Rofecoxib(free article)
Their conclusion
often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.

This was based on their meticulous research of a database. In the course of the combined trials of Cona vs Merck and Co, Inc and McDarby vs Merck and Co, Inc, millions of documents were made available to and archived in an integrated database maintained by the plaintiff's attorneys. The authors had complete access to all archived documents. One investigator (J.S.R.) searched the database to extract a subset of documents related to authorship. The search was performed using the database keyword search function.Documents used for this article are posted at this site

Not all medical publications use these tricks but it is hard to tell which don't especially with the lack of disclosure of financial support.

What should we do about it?

In a recent editorial in the JAMA these are the proposed 11 measures:

  • All clinical trials must be prospectively listed in registries accepted by the International Committee of Medical Journal Editors (ICMJE) prior to patient enrollment, and the name(s) of the principal investigator(s) should be included as a required data element in the trial registration record.

  • All individuals named as authors on articles must fulfill authorship criteria. Journals should require each author to report his or her specific contributions to the article, and should consider publishing these contributions. All individuals who were involved with the manuscript or study but who do not qualify for authorship (such as those who provided writing assistance) must be named in the acknowledgment section of the article, with reporting of their specific affiliations and contributions and whether they were compensated for those contributions.

  • All journals must disclose all pertinent relationships of all authors with any for-profit companies, and must publish all funding sources for each article.

  • Journal editors must seriously consider funding sources and authors' disclosed financial conflicts of interest and financial relationships when deciding whether to publish a study or review.

  • For-profit companies that sponsor biomedical research studies should not be solely or primarily involved in collecting and monitoring of data, in conducting the data analysis, and in preparing the manuscript reporting study results. These responsibilities should primarily or solely be performed by academic investigators who are not employed by the company sponsoring the research.

  • All journals must require a statistical analysis of clinical trial data conducted by a statistician who is not an employee of a for-profit company.

  • Any author who fails to disclose financial relationships or other conflicts of interest, or who allows his or her name to be used for work that he or she did not actually perform, must be reported to the appropriate authority (ie, medical school dean or department chair) or appropriate oversight body. If an article in which this occurs is published, the offending author must then submit a letter to the editor, in which he or she provides full disclosure and apologizes for the infraction to the readers of the journal. Depending on the nature and severity of the issue, the author may be banned from publishing articles in that journal.

  • Any peer reviewer who provides any confidential information, such as a manuscript under review, to any third parties, such as for-profit companies, or who engages in other similar unethical behavior, also should be reported to the appropriate authority (eg, medical school dean) or oversight body, and should be banned from reviewing and publishing articles in that journal.

  • Any editor who knowingly allows (or is party to allowing) for-profit companies to manipulate his or her journal must be relieved of the editorship.

  • To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs.

  • Individual physicians must be free of financial influences of pharmaceutical and medical device companies including serving on speaker's bureaus or accepting gifts.
Ross, J.S. (2008). Guest Authorship and Ghostwriting in Publications Related to Rofecoxib. JAMA, 299(15), 1800-1812.


AmiyaMax said...

Politicians, journalists and now medical publications! Whom should we trust then?
Right, the question of funding, bias, and of course, ghostwriting is eroding the trust.

Dr. Shock said...

Ah well some can be trusted.
regards Dr Shock