February 10th, 2014

Is Fraudulent Science Criminal?

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.

12 Responses to “Is Fraudulent Science Criminal?”

  1. Dr Bilagi, MBBB,MD,DM cardiology says:

    Very much true

  2. William DeMedio, MD says:

    There are already laws on the books in the United States dealing with fraud. Research fraud is an especially serious criminal activity. Whether it involves taking government money and fabricating data for pay, or publishing false information from the private sector for secondary gain, it is theft. Theft is a felony or misdemeanor depending on the amount and location.

    In the special case of medical research fraud, people’s lives can be put at risk. If someone dies as a result of fraudulent medical research, there could be a manslaughter or murder charge involved.

    Fortunately, if a fraudulent researcher is identified, they are effectively barred from further research, as the academic community is not forgiving at all regarding the sanctity of good data and the loss thereof. In addition, conviction of a felony or misdemeanor often results in loss of medical licensure.

    • John Henry Noble Jr, BA, MA, MSW, PhD says:

      Dr. DeMedio,
      I have researched case law involving allegations of criminal “research fraud” in the sense of “fabrication.” I could find only one case–the first ever to have been allowed to progress to trial under the 150 year old federal False Claims Act.The case is: U.S. ex rel. Jones v. Brigham and Women’s Hospital, et al, 1st U.S. Circuit Court of Appeals, No: 10-2301. See: http://www.reuters.com/article/2012/05/11/us-science-fraud-idUSBRE84A0O820120511.
      In 2013, the Office of Research Integrity (ORI) reported eleven cases cited for “administrative” rather than “criminal” action. In one case the settlement included a voluntary exclusion agreement for two years by the cited researcher (1) not to contract or subcontract with any federal government agency; (2) not to serve in any advisory capacity to the PHS; and (3) to seek retraction of specific published papers that were based on fabricated data. No mention here of “felony” or “misdemeanor”! See: https://ori.hhs.gov/case_summary.
      In “Fraud and Abuse in Clinical Research: Three Case Studies” by Julie M. Rusczek & Andrew P. Rusczek (ABA Health eSource June 2010 Volume 6 Number 10), none of the three cases involved “research fraud” in the sense of “fabrication” but instead other kinds of fraudulent behavior while conducting research, namely, accepting or giving kickbacks, marketing disguised as research, and double billing. See: https://www.americanbar.org/newsletter/publications/aba_health_esource_home/Rusczek.html.
      I conclude that the odds favor research fraudsters against detection and prosecution. The Monash Bioethics Review article (2007; 26(1-2): 24-45), which I cite in my blog, provides evidence of the fate of whistleblowers who allege research fraud in academic settings. The article quotes two ORI officials who strongly advise ever playing the whistleblower role because of its adverse career consequences. Ironically, ORI largely depends on whistleblowers in detecting and taking action against research fraudsters. Thus, my sense is that not only will academic colleagues shield research fraudsters but will in some cases retaliate . . . “killing the messenger bearing bad news.”
      All of this argues for Richard Smith’s conclusion that research fraud should be criminalized. I conclude on the basis of the extreme rarity with which research fraudsters are found out and prosecuted that there is need for a new or amended criminal statute that specifies what kinds of research fraud reach the threshold of a “crime” and their prescribed penalties. Given the shameful treatment accorded academic whistleblowers in cases of research fraud, drafters of the new or amended criminal statute may want to consider “retaliation” and “criminal conspiracy” as related crimes subject to fines and imprisonment.

      • William DeMedio, MD says:

        If this is the case, then there should be an especially serious type of fraud charge when it involves medical research dealing with human beings. It should be a felony offense. The analogy should be similar to the difference between simple libel and a hate crime.

        “White collar” criminals in the US get away with things that the average thug on the street is incarcerated 20 years for. This needs to change.

  3. Jose Gros-Aymerich, MD says:

    In a world where such a peculiar thing as accepting information coming from a ‘witchboard’=’ouija’ as evidence in a court, this happened in Brazil, or where killing unborn people is considered and proposed by some a woman’s right, some restrictions sound at least ‘hard to implement’.

    However, at least on an individual basis, claims can be put by people that lost time and thus, had their health impaired when taking a therapy described in a fraudulent paper as good, or for a company or private investor, putting money in a business based on asumptions made after reading a tricky article or ‘scientific’ report.

    Can or should government authorities, for example, public bodies, or public prosecutors, act on themselves to punish scientific fakers, and restrict this way the spread of false or noxious concepts?

    Besides the legal doubts about the adequacy of this, the size of this iceberg and the resources it would require for an efficacious action are also to consider.

  4. Research fraud has the potential to cause great harm. Boldt and Poldermans may potentially have caused great harm to patients. I suspect the harm attributed to Poldermans in the recently retracted paper by the EHJ is grossly exaggerated however. In these sorts of situations, then a criminal charge is appropriate.

    Much research, however, is likely to be read only by the author, their colleagues and their mother. Then, perhaps, sanctions imposed by the relevant university is more appropriate.

    • John Henry Noble Jr, BA, MA, MSW, PhD says:

      Dr Dayer,
      I wish that that only “the author, their colleagues, and their mother” were reading and relying on the large output of “premeditated bias” that gets published. I would simply put on insect repellent and avoid the places (journals) where the pesky fraud-producing insects congregate! If you read my Monash Bioethics Review article, it starts with the account by Richard Smith about the extreme difficulty he had as BMJ editor in running to ground one fraudulent author. Another account shows what happens in the academy when research personnel come forward with evidence of fraudulent behavior by a senior faculty member. Even government officials charged with rooting out researcher fraud and who rely heavily on whistleblowers to do so, advise against playing the whistleblower role because of its adverse career effects. My sense is that “premeditated bias” is so prevalent that sensibility to its presence is dulled, making detection unlikely. Why speak out or act against something that may draw unwelcome attention to yourself? Yet the continuing presence of premeditated bias–of which outright fabrication of data is the extreme case–contaminates the body of published and unpublished biomedical research on which we rely to guide medical practice and public policy.

  5. Additionally, I feel there are two other issues:
    (1) The truth will out eventually – and maybe the incriminating party will not be exposed but rather it all gets chalked up to human data versus animal models, but in the end we will find out what works and what doesn’t work.

    (2) There is such limited funding, we should only be directing it to successful, honest research. That is not to say that if there is money to burn we can give it to dishonest people, but these research dollars are an investment like any other and we need to be responsible about it.

  6. “All we see or seem is but a dream within a dream.” When he wrote this famous quote in his poem of that title, Edgar Allen Poe was suggesting that it is very difficult to distinguish between reality and fantasy. We can address Poe’s frustration by pointing out that science is the only answer. Only through scientific research can we truly distinguish between reality and fantasy: Now we know that we will not fall off the end of the earth and that the sun does not revolve around the earth; these ancient fantasies were corrected through scientific research. My point is that valid science is the only known way to acquire accurate new knowledge, to confirm hypotheses, and, indeed, to progress as a world society. Therefore, fraudulent science is a crime against humanity, and a much more important and far-reaching crime than robbery or kidnapping. Scientific fraud should absolutely be prosecuted as a crime, both to punish the perpetrator and to discourage others who would defraud us. Otherwise, how will we learn and progress?

  7. Enrique Guadiana, Cardiology says:

    Is fraudulent science criminal? Yes. Since a few posts have used literature examples. This topic reminds me of the Story of the Good Little Boy by Mark Twain. This is the typical clash of idealism and cynicism. We like to think people who do bad things do not succeed and people who do good things succeed, but the system rewards the corruption. The problem is “money and power”, for many people this is the ultimate goal and wants to have it at any cost and fraudulent science is a path to achieve it. With money you obtain power and visceversa and most people identify this with success and our society admires success. Nobody wants to question success and many like to think if you have it you are a good person. In most of the cases they are wrong. It is time to question this and fix it, but experience is against us. Mark Twain wrote this book in 1870 and is still very current.

  8. Joyce Ann Wahr, M.D. says:

    I find it hard to EVER disagree with Alexander McCall Smith on any topic, even that of the blue shoes (obscure reference to one of his novels). So, I agree with his view that scientific fraud should be criminalized, for the reasons already stated. But I think that misses the mark. The editors and reviewers for journals need to step up their efforts to verify the data in papers. The first step has already been taken – for every study on human subjects, Anesthesia journals require the telephone number for the Ethics Board Chair, and they personally verify that IRB approval was in place.

    The next step is to require submission of the entire database from which the results were drawn. Bright mathematicians have already produced algorithms to verify Jackson Pollack’s paintings (no, the drips are not random) and I am sure that one can derive an algorithm that identifies data that does not follow expected variations and thus at risk for having been faked. The plagiarism software and searches have done much for that arena; we need software to uncover potentially fraudulent results.

    That, I believe, will have much more of an effect than putting criminal penalties in place.

    • Joyce– Just to clarify: the view that scientific fraud should be criminalized was first stated by Richard Smith, former BMJ editor and current blogger, and not the popular novelist Alexander McCall Smith. (Though I would be interested in learning his thoughts on this matter as well.)