She goes on to propose:
- 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.
Primum non nocere does not only hold true for physicians directly treating patients, but also holds true for all involved in medical research, biomedical publication, and medical education. When integrity in medical science or practice is impugned or threatened—such as by the influence of industry—patients, clinicians, and researchers are all at risk for harm, and public trust in research is jeopardized. Ensuring, maintaining, and strengthening the integrity of medical science must be a priority for everyone.
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Insider's view: Hear hear!
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