CardioExchange Archive

John Henry Noble, Jr., offers his perspective on the issues raised by Richard Smith’s December 2013 blog post “Should Scientific Fraud Be a Criminal Offence?”, which appeared in the BMJ.

At a conference in Britain in 2000, Alexander McCall Smith asserted that research fraud should become a criminal offense. Since then, former BMJ editor Richard Smith has come to the reluctant conclusion that science is indeed failing in its public duty, calling research misconduct “terrifyingly common” and stating that “…hundreds of studies (and probably many more) that are fraudulent remain in the scientific literature without any signal that they are inventions.” Smith urges that research fraud be criminalized to put an end to it.

Bill Skaggs and Jeanne Lenzer, in their comments on Smith’s BMJ blog post, argue that criminalization is likely to be ineffective. Lenzer argues, “If people are reluctant to report their colleagues now, might they be even more reticent if they knew their (possibly incorrect) suspicions would mean their colleague would be dragged through public proceedings and possibly put in jail?” She advises against directly targeting individuals but instead says that the research enterprise should change how it incentivizes individuals’ behavior. She urges “putting researchers on salary and ending grant awards on an individual basis, and stop rewarding bad behavior by acknowledging that publishing 200 articles per year cannot represent careful work.”

Responding directly to Lenzer on the BMJ site, I quoted Machiavelli’s famous passage in The Prince:

We must bear in mind, then, that there is nothing more difficult and dangerous, or more doubtful of success, than an attempt to introduce a new order of things in any state. For the innovator has for enemies all those who derived advantages from the old order of things, whilst those who expect to be benefited by the new institutions will be but lukewarm defenders.

Nonetheless, I believe that we should do whatever we can to reform the system that incentivizes the wrong and harmful behavior of individual researchers. Criminalization of individual research fraud is necessary because that fraud debases and undermines the entire scientific enterprise on which human action and progress depend. Furthermore, the false claims of the perpetrators rise to the status of crime against society, insofar as they endanger public health by sullying and misdirecting the physician’s “standard of care.”

Consider the impotency of the U.S. Department of Justice’s practice of occasionally exacting large fines from corporations for the egregious harms they commit. The companies simply write off the fines as part of the cost of doing business, and the corporate leadership walks off scot-free to concoct another scam. Exacting a fine is but the first step toward eradicating the problem. The leaders who are responsible then need to be criminally indicted and subjected to trial by jury.

Similarly, researchers should be held criminally liable when scientific fraud and misrepresentation are proven. Their actions reflect the thinking and intent of knaves, not fools. These people know what they are doing. The due process of law is likely to uncover and judge the evidence of guilt or innocence more reliably and fairly than will the institutions of science and the professions that historically have resisted taking decisive action against the perpetrators.

Let’s step back to reflect on the biomedical research establishment’s current state of affairs, using three perspectives:

1. In a frequently cited 2005 Plos Medicine article, John Ioannidis concludes, “…for most study designs and settings, it is more likely for a research claim to be false than true. Moreover, for many current scientific fields, claimed research findings may often be simply accurate measures of the prevailing bias.”

2. In a 2009 Lancet article, Ian Chalmers and Paul Glaziou describe the “avoidable waste in the production and reporting of research evidence.” For the >85% loss of the more than US$100 billion annual investment in biomedical research worldwide, they identify these four causes: (a) choosing the wrong questions for research; (b) doing studies that are unnecessary, or poorly designed; (c) failure to publish relevant research promptly, or at all; and (d) biased or unusable reports of research.

3. In a 2014 New York Times Sunday Review article, Michael Suk-Young Chwe suggests that the way to cope with the deserved lack of credibility of today’s science is to “look for help to the humanities, and to literary criticism in particular.” He argues that science cannot heal itself because of the “pride and prejudice” in its self-limited view of the world. He cites the need to question “the validity — of the fore-meanings dwelling within (oneself)” when interpreting text, as advocated by the German philosopher Hans-Georg Gadamer in “Truth and Method.” Suk-Young Chwe concludes, “To deal with the problem of selective use of data, the scientific community must become self-aware and realize that it has a problem.”

As much as I wish that the biomedical research establishment could become so self-aware, I do not believe that will happen without much stronger incentives than have been delivered in the past 40 or so years since I have been tracking premeditated bias in its many forms (see my 2007 article — Monash Bioethics Review 2007; 26(1-2):24). The research establishment has demonstrated tenacity in hunkering down and going passive-aggressive when confronted by efforts to get it to clean up its act. I have noted that pointing out the systemic incentives to cheat merely serves first as an explanation, then as an excuse, and finally as justification.

As Meredith Wadman reports in her 2006 article “A Few Good Scientists,” the ethicist Arthur Caplan suggests a more measured approach than rejection of the entire body of commercially tainted biomedical research, lest “the search for the untainted investigator … become like Diogenes’ quest to find an honest man.” In my view, Caplan reflects the pervasive view among members of the research establishment that corrupt practices are inevitable and unavoidable — when push comes to shove, they will shield their colleagues.

For myself, I see no viable alternative to ferreting out and reporting premeditated bias — the extreme of which is outright falsification of data — committed by researchers who often have concomitant conflicts of interest that affect the reliability and validity of biomedical science. Should we give up and hope to escape becoming another iatrogenic morbidity or mortality statistic? No!

For this reason, I side with Richard Smith’s assessment: Scientific fraud should be made a criminal offense. The shock of jail time may signal to the scientific community that it has a problem that can’t be explained away or rationalized.

Do you agree with John Noble? Share your comments here.