Last summer British researchers provoked concern when they published a paper raising the possibility that by following an established guideline UK doctors may have caused as many as 10,000 deaths each year. Now they have gone a step further and published an estimate that the same guideline may have led to the deaths of as many as 800,00 people in Europe over the last five years. The finding, they write, “is so large that the only context in the last 50 years comes from the largest scale professional failures in the political sphere.” The 800,000 deaths are comparable in size to the worst cases of genocide and mass murder in recent history.
In their new article published in the European Heart Journal, Graham Cole and Darrel Francis continue to explore the extent and implications of the damage caused by the Don Poldermans research misconduct case. The earlier paper demonstrated the potentially large and lethal consequences of the current European Society of Cardiology guideline recommending the liberal use of beta-blockers to protect the heart during surgery for people undergoing non cardiac surgery. The guideline was flawed because it was partly based on unreliable research performed by the disgraced Poldermans (who also served as the chairman of the guideline committee). This may seem like a highly technical question but it effects many millions of people and may, as Francis and his colleagues have demonstrated, led to many thousands of unnecessary deaths.
The new article, the first of two parts, makes no new scientific claims, but instead begins to consider the broader implications of the story. Cole and Francis briefly consider the dilemma of clinicians who may “feel unable to act in contravention of guideline recommendations recognized as ‘state-of-the-art’ by the European Society of Cardiology” and who may even be penalized for failing to follow guidelines.
They note that more than half of the lives lost– potentially more than 400,000– may “have occurred after the research was discredited,” though some of the damage may have been mitigated if doctors changed their practice after reading about the controversy. (There was a 2 year delay after the start of the Poldermans affair until the ESC withdrew the beta-blockade recommendation.)
The aviation profession has led the way in systems to prevent, recognize, study, and learn from professional failures. Clinical medicine is now following the same path. We must develop similar systems for research.
In the second part of their article, to be published in two weeks, Cole and Francis will raise the possibility that the responsibility for misconduct lays not just with misguided researchers like Poldermans but also the institutions and the institutional leaders that provide uncritical support to research factories. Further, they will discuss the role of journal editors and, even, journal readers.
Comment: It would be easy to dismiss the views of Cole and Francis as outrageous and overly provocative. After all, with the exceptions of Josef Mengele or Hannibal Lecter, doctors aren’t usually murderers, at least not intentionally. My best guess is that the Don Poldermans of this world strongly believe they are doing good, though that may lead to cutting corners and, then, covering up the corner cutting.
But there are good reasons to think that this sort of provocation is necessary. There is, it has now become clear, a general lack of concern and response to evidence of scientific fraud and misconduct. Journal editors, deans, department chairs, and others seem more concerned with protecting the reputation of their respective institutions than aggressively upholding the integrity of science and research. Of course, defending science and maintaining the reputation of an institution should not be opposing choices. But since they are, perhaps a little provocation is in order.