In this week’s issue of Nature, there are three articles relevant to the above theme:
1. Sandra Titus of HHS’s Office of Research Integrity and two colleagues surveyed 2,212 researchers throughout the United States. Titus’s team found that almost 9% of the respondents in their survey, mainly biomedical scientists, had witnessed some form of scientific misconduct in the past three years, and that 37% of those incidents went unreported. Titus et al. outline a number of measures to address this situation, including better protection for whistleblowers, and promotion of a “zero tolerance” culture in which scientists have just as much responsibility to report others’ misconduct as they have for their own behavior.
2. There’s a news brief about a researcher suspended for falsifying data. Two of the scientist’s papers have been retracted, and the Office of Research Integrity barred her from receiving any US government grants for five years.
3. There’s an editorial, entitled “Solutions, Not Scapegoats,”, in which the editors of Nature argue that “the solution [to scientific misconduct] needs to be wide-ranging yet nuanced”
Believe it or not, anti-vaccinationists have already begun to grab onto these stories. If you fail to see the connection, here’s a direct quote from a post referring to the above three articles: “For some people, to vaccinate or not is an issue of trust. When government/pharma sponsored research is so obviously self-serving and unreliable, it is no wonder people have been shunning vaccinations.” I still think this is a non sequitor, but some members of the ant-vaccination crowd love to collect stories of research fraud (even if completely unrelated to vaccine research).
One of their favorites is the case of Anne Butkovitz, “ex-clinical study coordinator,…who [in 2005] pled guilty to falsifying case report forms, and has been debarred permanently by the FDA. The study was a multi-site pediatric study of a rotavirus vaccine and was sponsored by a… pharmaceutical company. ([Note that]…the drug company apparently did nothing wrong.). According to the study protocol, the clinical study coordinator at each site was supposed to contact subjects parents at specified intervals to determine whether any serious adverse events had occurred. At one of the sites, however, Butkovitz failed to contact parents but stated on case report forms that she had contacted them and that no serious adverse events had occurred. The pharmaceutical company sponsor reportedly disregarded data from her site.” (This quote is from the now defunct blog Regulatory Affairs of the Heart, which tried to report objectively on “drug regulatory affairs and FDA compliance” and was certainly not an anti-vaccination blog.)
Are these cases evidence that Modern Science is failing us, “research is unreliable,” and people shouldn’t put their trust in scientific research? I would argue just the opposite. If you’ll allow me a paragraph of intellectual digression (so I can enter this post in the Carnival of the Elitist Bastards), outside of Communist countries where Lysenkoism was practiced, Modern Science has been an “open society.” What do I mean when I say that Modern Science has been an “open society”? I think the concept was best summed up by Robert Merton, the “father of the sociology of science,” in what he described as the CUDOS set of scientific norms: Communalism, Universalism, Disinterestedness, and Organized Skepticism. Communalism is the common ownership of scientific discoveries, according to which scientists give up intellectual property rights in exchange for recognition and esteem. According to universalism , claims to truth are evaluated in terms of universal or impersonal criteria, and not on the basis of race, class, gender, religion, or nationality. According to disinterestedness, scientists are rewarded for acting in ways that outwardly appear to be selfless. By organized skepticism, Merton meant that all ideas must be tested and are subject to rigorous, structured community scrutiny. (Merton wrote in 1942. For a 2005 constructive critique of CUDOS, see The Public Value of Science, Or how to ensure that science really matters.)
But let’s get back to a few “evidence-based” arguments for why I think the Nature articles and the Anne Butkovitz case provide facts in favor of keeping our trust in Modern Science. Let me count the ways:
1. The study by Sandra Titus and colleagues was published in Nature, one of the two major general science journals. The results weren’t hushed up, nor were they uncovered as part of a world-wide conspiracy by a Freedom of Information Act request. The same is true of the news brief about the researcher who falsified data.
2, In the United States there is an Office of Research Integrity (ORI), which promotes integrity in biomedical and behavioral research. ORI “monitors institutional investigations of research misconduct and facilitates the responsible conduct of research through educational, preventive, and regulatory activities.”
3. In the case of Anne Butkovitz, she was permanently debarred by the FDA, and the pharmaceutical company sponsor disregarded data from her site.
4. Most scientists, especially those in supervisory positions, do try hard to create an environment where fraud and misconduct will occur very rarely, hopefully not at all. A fascinating example of this is the consulting firm, P. Below Consulting, which provides clinical research services for the pharmaceutical and medical device Industries. One of the activities they specialize in is helping investigators to avoid fraud and misconduct. I highly recommend taking a look at their web page on this subject. It includes Powerpoint presentations and links to several worthwhile references.
In sum: Researchers aren’t perfect. However, to lose all trust in science is going way too far. The Office of Scientific Integrity, the FDA, and others are clamping down on questionable research practices. Nature and other scientific journals are urging scientists to go even further in their vigilance.