Over-Hyped Scientific Literature and FDA-Regulated Industry
[Posted on: Thursday, March 9, 2017]
Often you see a scientific article being touted in the news for its sensational findings. Journals make news releases, authors give interviews to news outlets, newspapers headline the findings, and pundits discuss what it means for everyone. However, an independent analysis of such articles found that less than half of the publications promoted on newspapers are confirmed in subsequent studies. The number drops to one-third, if the original story was based on a single study. However, only about 20% of the times news reporters publish the later findings. So, the initial hyped-up news about the said article may stick around long after the original findings were refuted. Not that the original article was false, just that the results could not be replicated independently and hence fail the criteria for scientific validation. Scientific literature is full of contradictory reports; reports that get more publicity end up influencing public opinion more than the ones that don’t. While scientists and journal publishers may argue that this is the normal course of science, the regulatory consequences of such reports are complex. Peer reviewed scientific articles play an important role in establishing the rationale for developing a given product. Articles are used to support the expected safety and effectiveness of products, with emphasis on safety. While the safety concerns regarding a product reported in the original publication may have been proven to be incorrect in subsequent studies, those articles may still haunt any companies developing related products. FDA frequently cites peer-reviewed scientific articles to support concerns about the safety of regulated products. Companies may need to defend their products to the regulators with unreasonable expense, resources and time. Hence, in recent years, companies have taken an approach to challenge offending articles legally.
Increasingly companies take the authors and even the publishers of such articles to court. In a recent editorial in Nature Medicine, it was argued that suing the scientists for unfavorable publications sets up a bad precedence and would discourage publication of controversial results. The editorial cites several cases where the authors had to spend significant resources and risk financial consequences when sued by a company who challenged their findings in courts. The journal would prefer that the offended party take a scientific approach of publishing counter arguments rather than using the legal recourse. However, that approach is not practical for companies that got negatively affected. First, the journal’s editorial board reserves the right to publish what they feel is an appropriate response, and the negative response may never be published. Most journals do not follow peer-review for rebuttal letters; the editors make the decision based on their interpretations and preferences. Second, even if published, the rebuttals will not garner publicity close to the original article thereby limiting the impact of the rebuttal. Third, even with the rebuttal, the journal and the authors have no obligation to revise or retract the original article, thereby keeping the hurting information alive. The legal course, on the other hand, provides better, defined incentives to the company suing the authors. However, as the editorial pointed out, it does create an intimidating situation for the authors. So, what is fair? Ideally scientific arguments should never have to be won in courts. At the same time, scientific information must be published with appropriate disclaimers and caution must be placed to not over-hype the information. Journals and authors are frequently responsible for over-hyping publications to increase the “eyeballs”. This should serve as a warning to publishers and authors; publicity comes with its risks. So make sure that reports about your publications are not misleading or you may have to defend them in a legal setting.