It’s likely that most readers of this blog, let alone most members of the public, have little idea of what the Ingelfinger Rule is and less about why it is so important.
First promulgated in-house by the New England Journal of Medicine in 1969, the rule stipulated that the editors would not accept findings that had been published or broadcast in whole or in part in other media. Soon adopted by other journals, it was widely seen as an attempt not only to protect the scientific embargo system, but also the integrity of the scientific process itself. As the NEJM editorialized some 12 years later:
“Even the most honest investigators cannot be expected to judge their own work dispassionately…. The process of interpreting data is seldom clear-cut, and it is easy to be unaware that the data are inadequate to support the conclusions. Without the discipline of organizing and presenting their evidence, and without the criticism and revisions stimulated by the peer-review process, investigators may unconsciously misrepresent their work or exaggerate its importance.”
In recent years, we have taken note of a disturbing phenomenon: scientists who appear to want to circumvent the rigorous and protracted process involved in bringing new findings to the public by announcing them before scientific results are available for review – usually in highly dramatic terms – in the media.
The Most Recent Example of Scientists Jumping the Gun
The recent media appearances by a Canadian researcher once again highlights this problem. According to an article posted on the Radio Canada website, one of the authors of a study slated to be published in Environmental Health Perspectives (EHP), Élyse Caron-Beaudoin, is “raising a red flag” about what she claims are findings of the endocrine disrupting effects of neonicotinoid pesticides in humans. In addition to her Radio Canada interview, Dr. Caron-Beaudoin discussed her results on camera in a video posted by CTVnews. In this interview, Dr. Caron-Beaudoin stated that despite the fact she doesn’t work in the regulatory arena, she would recommend that studies like hers need to be included in the approval process.
Not surprisingly, such claims are guaranteed to draw media attention, given the on-going debate about pesticide effects in the environment, and the fact that they are profoundly at odds with the considered regulatory reviews of both the US EPA and the Canadian regulatory authorities, who have found neonicotinoid pesticides safe for widespread use in agricultural production as well as in homes, including for flea and tick treatment of pets, on which they are applied directly to the skin.
The problem is that the scientific study being discussed by the media for the last 10 days is impossible to assess because it has not yet been published. We don’t know anything about the methodology employed, the neonic concentrations assessed, or the specific results of the experiments.
No Scientific Detail Provided
In the Radio Canada blog post, the journalist stated that the investigator used “a tool in the laboratory that mimics the cellular relationship between the fetus and the placenta.” In the CTVnews interview, Dr. Caron-Beaudoin states that she and her colleagues used “a co-culture, which is two different cells that are put together and that mimic the interactions between the fetus and the placenta.” As far as the findings were concerned, she merely stated that they found “an alteration of estrogen production.”
These vague descriptions are emblematic of the problems inherent in describing the results of complex scientific research in media interviews. Without the benefit of a formal research report (the type of report that will be forthcoming in EHP), it is impossible to assess the validity or reliability of the research findings. The assessment of scientific research is predicated on having a detailed description of the methods used and the results obtained. Only then can scientists understand whether the methods were appropriate and the associated results of worthy of a public health concern.
Why Embargoes Matter
Dr. Caron-Beaudoin’s public comments in advance of publication should be of particular concern to the editors of the EHP. Whether or not EHP adheres strictly to the Ingelfinger rule, all studies accepted for publication in EHP are embargoed, which practically speaking amounts to the same thing, and researchers are prohibited from discussing the findings from these studies until after publication. According to the EHP embargo policy, “[a]ll pre-press materials will be clearly identified as embargoed and will include the embargo date and time established by EHP in conjunction with the authors.” The policy clearly states that the authors and the media “are responsible for ensuring that all third parties with whom they share pre-press materials honor the embargo.”
There are very good reasons for such policies, as they provide a level playing field on which the results of a study can be appropriately vetted by the scientific community in response to media reports. Vivian Siegel, writing for The Conversation, an independent academic blog devoted to knowledge-based journalism and academic rigor, highlighted the importance of embargo policies and the problems associated with breaking them: “Scientists who jump the gun and allow their research to become news before publication in an academic journal are making unvetted claims that can turn out to be less important once the peer-reviewed article eventually appears.”
Given the importance of embargo policies, we tried to get more information from EHP, asking when the article was scheduled for publication and if it is indeed currently under embargo. EHP journal editor-in-chief Sally Perreault Darney told us in an email reply that there was “active discussion about this situation” and that we’d receive a reply to our inquiry as soon as possible.
Lack of Rigor and Transparency with Assessment of Pesticides
The appropriate interpretation of studies on pesticides is particularly important due to a long history of misinterpretation of data, failure to adhere to reliable media practices, and apparent lack of transparency. This is not the first time we have encountered an author of a pesticide study breaking the embargo policy and reporting on study results before a scientific study has been published. Indeed, when we were finally able to review the actual published study report, the findings appeared to be questionable and, as far as we are aware, have not been replicated or repeated.
Neonics (the type of pesticide at issue in these current news reports) are a class of chemicals used as insecticides for their neurotoxic action on the nicotinic acetylcholine receptor. For the past decade, researchers have been concerned that neonics have an adverse impact on the health of bees, specifically causing what was widely reported as a catastrophic decline in honeybee populations. After years of un-vetted claims of a “bee-pocalypse” in the media, however, it turned out that bee populations had been stable or rising the entire time neonics have been used in agriculture.
The story with the assessment of other pesticides is even worse. Take the petition from PANNA and NRDC asking the EPA to revoke the tolerances for the pesticide chlorpyrifos based on a Columbia epidemiological study allegedly linking this pesticide to adverse human health effects. Yet, despite multiple requests, an EPA visit to Columbia, and a public commitment to “share all data gathered,” CCCEH has not provided EPA with the data used.
At the end of the day, rigorous and reliable assessment of scientific data related to the potential health effects of pesticides is important for maintaining the public health. However, it is critical that these assessments adhere to the appropriate standards and that they are conducted in a transparent and objective manner.