In an effort to shore up their reputations, pharma and professional publishers have come together to craft an accountability plan.
The concept, outlined in the May 2012 edition of Mayo Clinic Proceedings
, is based on a roundtable discussion facilitated by the Medical Publishing Insights and Practices Initiative, which is made up of members of both the pharmaceutical and publishing industries. MPIP was founded in 2008, in the aftermath of fiascoes like Merck's Vioxx incident
and the subsequent castigation of the New England Journal of Medicine over hidden results
. The authors say the guidelines are a way to overcome mistrust of industry-sponsored studies and the articles that describe them.
For skeptics, the easy culprit in industry-sponsored clinical trial accounts is pharma, since the money for the studies and the write-ups come from that sector. With this in mind, the guidelines for the pharmaceutical industry include the following:
• Explain why the research is happening
, how the protocol was developed and who was on the advisory board. “Credibility is compromised when clinical research is intended for marketing purposes rather than advancing scientific and medical knowledge,” the guidelines read.
Maja Zecevic, the Lancet
's North American editor and one of the authors of the article told MM&M
that stating the scientific reason for a trial is particularly important for pharma because “in some ways pharma is accused of using human suffering for profit.”
• Make all results public
, good and bad. See: Vioxx
• Make protocols public.
The guidelines say privacy agreements often keep authors from being able to share the information that backs their findings, but urge the end of nondisclosure agreements that keep authors away from the studies behind the research and blind journals to the underpinnings of what they hope to publish.
Yet Zecevic isn't putting all the responsibility for transparency on pharma. She said journals have a right and a responsibility to be more assertive about the information they require before a piece is published, and to do so as an industry, not just on a journal-by-journal basis.
To that end, recommendations for publishers included:
• Tell pharma and academics what journals want
“Most of the authors of the clinical trials, be it for NIH or pharmacy, they are all academic-based individuals and they actually don't have a proper training course in their education or in their practice for proper reporting” Zecevic said.
• Require authors disclose all conflicts of interest up front
Zecevic told MM&M
that this includes clear conflicts of interest as well as the ones that an author may be willing to brush off as unimportant. She said no potential conflict should be ignored because an omission can haunt an author and tarnish their image if it's revealed after publication. “They should let the editor decide what is important or not” she said.
Zecevic said guidelines from the International Committee of Medical Journal Editors served as an inspiration for her team's current recommendations, which also call out a need to identify authors and potential conflicts of interest, among other things. She said her group went a bit further, because ICMJE's guidelines, while helpful, need a bit of updating and haven't yet sifted out the “still persistent” problems that plague the industry.
• End ghostwriting
and bar “guest authors,” which the guidelines describe at people who “do not qualify because they do not meet ICMJE or journal criteria for authorship.”
• Standardize adverse event coverage.
The guidelines seek to do away with broad statements such as “generally safe and well tolerated” if it could be misleading. As a contrast, the guidelines suggest using clear, study-centric language such as “additional severe adverse events were not detected in this short, small trial.” Zecevic said there should also be a standard for how journals handle how adverse events are accounted for in publications.
Zecevic said uniform demands, such as conflict of interest disclosure, adverse events and the end of ghostwriting would make it easier for all parties. She said a standard would make it easier for pharma to navigate publishing requirements, which could expedite publication. And just as important – the end of inconsistent criteria would also make it harder to publish foggy data and reports that aren't open about who's behind the study (and, by implication, who could possibly gain). “There is still a lot of standardization that needs to be done among the journals,” she said.
Zecevic said these voluntary guidelines are just the beginning – industry members will descend on Chicago next year, which will be another opportunity to get things in line. On her list: transparency of the safety monitoring boards who oversee studies. She said members aren't revealed in papers but these boards are “an essential component of a trial,” and should be disclosed.