The Cochrane Collaboration, founded in 1993, purportedly exists to “produce high-quality, relevant, up-to-date systematic reviews and other synthesized research to inform health decision making.” Over the past 25 years, Cochrane has produced 7,500 such reviews and influenced the standards and practices by which systematic reviews are done by the academic community at large.
In “The Crisis in Cochrane: Evidence Debased Medicine,” psychiatrist Dr. David Healy reviews the circumstances leading to the removal of one of Cochrane’s co-founders, Peter Gøtzsche, from Cochrane’s board in late 2018.
How can the Cochrane organization justify tolerating 15 years’ worth of reviews based on ghost-written articles and no scrutiny of trial data due to lack of access? Surely, this has been as deep a betrayal of the core Cochrane mission as it is possible to imagine.
—Dr. David Healy, "The Crisis in Cochrane: Evidence Debased Medicine." The Indian Journal of Medical Ethics. First published online on November 5, 2018.
In 2004, an FDA review found that many published trials of pediatric antidepressant drugs were “either ghost or company written, in all cases the data were inaccessible, and in the case of published studies, the publications were at odds with the data regulators revealed.” These problems fundamentally undermine the idea of systematic review, which implicitly assumes the data presented in published trials reflects experimental reality (Gøtzsche would later write “Deadly Psychiatry and Organised Denial” on the lack of evidence supporting pediatric antidepressants).
In 2007, Gøtzsche asked the European Medicines Agency to release clinical study reports on two slimming pills. EMA refused, arguing that such data was commercially confidential. Gøtzsche complained to the European Ombudsman, resulting in a release of the relevant data in 2010. This was a breakthrough for healthcare research and patient safety. Throughout this period, Gøtzsche further alienated Cochrane leadership with “his forthright manner.” In July 2018, Gøtzsche and two other authors published a critical review of Cochrane’s HPV vaccine review (published in May 2018), in which he criticized a variety of biases and oversights in its construction. Soon after, Gøtzsche was expelled from Cochrane, and nearly half the board resigned in solidarity (Gøtzsche wrote his own editorial on the expulsion for the BMJ). On Nov. 6, 2018, Denmark’s Rigshospitalet, host of the Nordic Cochrane Center, announced that Gøtzsche was suspended from the medical center.
Healy argues that Gøtzsche’s expulsion and the fundamental issues leading to the division represent a critical point for Cochrane and all regulatory bodies purporting to oversee evidence-based medicine. For their review to be seriously considered, they must contend with the problem at hand: A significant share of the evidence supporting pharmaceutical interventions is ghost-written and based on inaccessible data that cannot be scrutinized. Healy further argues that these trends have led to pervasive overmedication without sufficient evidence, and that this overmedication may in fact be shortening life expectancies.