hen the editors of the New England Journal of Medicine warned in January that some scientists thought that sharing data would lead to “research parasites” — a subspecies of researchers who gained unearned glory off the backs of their hard-working colleagues — they earned heaps of scorn from the scientific community.
Critics blasted Dan Longo and Jeffrey Drazen, deputy editor and editor-in-chief, respectively, as petty and shortsighted, more concerned with personal gain than the expansion of knowledge. As one reader responded: “When data can be withheld, researchers can have their cake, by hoarding their data, and eat it, too, by claiming public credit.”
The esteemed journal is at it again, however. A new editorial, from a group of more than 280 researchers in more than 30 countries, argued that science is moving too hastily in the direction of open data, a headlong and thoughtless dash that, they predict portentously, will retard progress and jeopardize human health.
The essay takes aim at a recent proposal by the International Committee of Medical Journal Editors (ICMJE, of which Drazen is a member) to require that data from any randomized controlled trial — the gold standard of clinical studies — be made fully available within six months of publication.
The new editorial said that proposal, in short, stinks: Although researchers who conduct trials would still get initial credit or their work, they might lose the chance to publish secondary papers and other analyses that they — and not others — deserve.
“A key motivation for investigators to conduct RCTs is the ability to publish not only the primary trial report, but also major secondary articles based on the trial data,” the researchers wrote. “The original investigators almost always intend to undertake additional analyses of the data and explore new hypotheses. … Once the investigators who have conducted the trial no longer have exclusive access to the data, they will effectively be competing with people who have not contributed to the substantial efforts and often years of work required to conduct the trial.”
And they warn of large risks and trivial rewards from mandatory sharing. “The current ICMJE proposal therefore risks reducing the incentive for coinvestigators and site investigators to participate in trials. A reduction in the number of investigators willing to recruit patients into a trial or supervise its conduct in a country will compromise the likelihood of successful completion of large trials that address important questions.”
In other words: Data sharing will cripple scientific progress and harm patients. Full stop.
Implicit in this bleak outlook is a rather stunning arrogance. Are we really supposed to believe that only the researchers who generate data are competent to analyze them? That claim becomes harder to swallow when one considers the poor track record of so many studies. Scientists should want scrutiny.
And while the opportunity cost argument is easier to accept, it’s a straw man hung on a specious scaffold. Of course sharing data will carry costs and divert resources from “the actual conduct of trials.” But again, is that necessarily a bad thing? Not when the state of clinical trials is so shaky to begin with — and so many remain unpublished anyway because they don’t have sexy results. Maybe fewer but more rigorous trials are exactly what the doctor ordered.
The consortium’s solution is to mandate a sharing-free period of two years from initial publication of the data, with up to three more years of exclusivity depending on how long it took to conduct the trial. What’s more, they call for end users to bear at least part of the cost of the sharing — which has a bit of a “We’re going to build a wall, and we’re going to make them pay for it” flavor.
The tone of the essay — which is thrown into relief by accompanying essays by Senator Elizabeth Warren (D-Mass.) and two data sharing proponents — resembles a Cato Institute plea for small government. And in fact, two of the coauthors of the editorial, P.J. Devereaux and Salim Yusuf, of McMaster University in Hamilton, Ontario, have played this song before. The pair were among the coauthors of a 2013 commentary in the NEJM which called for tearing down “unnecessary obstacles” to randomized clinical trials.
Among these perceived barriers: a lengthy and expensive approval process for studies; a “one-size-fits-all” approach for trials of low- and high-risk interventions; and overly burdensome guidelines for the safety and rights of trial volunteers. “Unless radical improvements are made to the regulatory environment,” they wrote, “the potential of clinical trials to assess the safety and efficacy of new and existing treatments, and, thereby, to produce substantial improvements in health care will not be fulfilled.”
Here’s a thought: Putting a hold on data is an unnecessary obstacle, too. Apparently, however, for the authors of the new editorial, obstacles that maximize value for the people who got somewhere first — even by relying on study volunteers — are just fine.
And ultimately, those are the people that trials are meant to help.
“Some scientists seem to believe that as the people with a god-like ability to save lives — like mine — they are the focus of the whole enterprise,” said patient activist Dave deBronkart, who blogs as “e-Patient Dave.” deBronkart credits his survival of a bout of metastatic kidney cancer to being able to get into a trial of an experimental therapy. “And I profoundly disagree. I think that attitude, while it’s understandable from our shared past, is moribund.”
We’re all for fairness in science, but this new proposal is only concerned with fairness for one group: researchers. What’s missing is the second, and, arguably, most important group: the public, including the people who’ve taken part in trials. They deserve a system in which the fruits of studies come as quickly as possible.