|by Sharon J. Glazer, MPH, Editor, Academics@Baystate newsletter | July 01, 2012
|Dr. Richard Engelman, Director, Cardiothoracic Research
The Real Casualty is Patient Care
"Falsification of research is more than big, it’s a universal problem. And the impetus for addressing it has to be that it affects patient care,” claims Richard Engelman MD, Director of Cardiothoracic Surgery Research at Baystate Medical Center. Engelman recently gave a presentation, “A Universally Prevalent Form of Ethical Abuse in Medical Research: Falsification of research data," to the University Medical School in Kaohsiung, Taiwan.
As an example, he recalls the case of Scott Reuben, nationally recognized anesthesiology investigator and former BMC faculty member, whose research validated the use of anti-inflammatory drugs in addition to pain killers for improved recovery following orthopedic surgery. Dr. Engelman, who was an IRB Vice-Chair and Administrator at the time, says that when the IRB evaluated Reuben's studies, it became evident that he had “falsified clinical data to justify his conclusions. At least 21 drug trials spanning 15 years were basically invalidated—much of the data was falsified as were, in large measure, the statistics.”
Without doubt, patients have been adversely affected by Reuben's falsified research findings, asserts Dr. Engelman, saying, “The concept of multimodal analgesia is clearly damaged by this direct act of misconduct. Ultimately the patient is placed at risk.”
Extent of Research Misconduct Hard to Determine
What is Scientific Misconduct?
The US Office of Research Integrity (ORI) defines it as "fabrication, falsification, or plagiarism in proposing, performing, or reviewing research or in reporting research results.”
A May 2012 Nature article claims that the Office of Research Integrity (ORI) had 13 research misconduct rulings in 2011. A reasonable approximation may be the number of journal retractions–which, according to RetractionWatch, was 386 in 2011. Two World Conferences on Research Integrity have also dealt with the issue. The second, held in 2010 in Singapore, attracted more than 350 researchers, policy makers, funding institutions representatives, and publishers from more than 50 countries.
Top research institutions have their share of research fraud as well. At Duke University, cancer researcher Dr. Anil Potti published studies claiming that chemotherapy drugs for breast cancer could be tailored based on a genetic signature. But the ORI found he had manipulated data. "Potti had three clinical trials, all now discontinued," reports Engelman. "And 11 malpractice claims have been settled against the researcher."
One of the most infamous cases, because of the harm it created, was that of Dr. Andrew Wakefield whose 1998 Lancet paper claimed that the measles, mumps and rubella vaccine (MMR) had a link to autism and bowel disease. This was a deliberate and elaborate fraud. He benefited handsomely from his deception through fees he received as a result of lawsuits against the vaccine company, but patients and the public suffered, particularly children who were then susceptible to the potentially preventable diseases.
“Because of the report, some parents worldwide refused to have their children immunized, resulting in a number of potentially preventable measles cases, some resulting in death,” says Engelman. “Autistic children had also been subjected to unnecessary medical procedures such as colonoscopy and lumbar puncture.”
Reasons for Research Misconduct are Complex
According to Engelman, there are the obvious financial rewards for research misconduct, such as winning federal research funding. But there are academic rewards as well. In Reuben’s case, that included his becoming one of the founders of the Society of Orthopedic Anesthesia.
“The motivation is to publish something that is unique and achieve notoriety, become prestigious, improve your status.”
Lack of Research Veracity Exceptionally Difficult to Address
In the US, IRBs and IACUCs have the ability to do spot checks of researchers’ files which can be effective in preventing misconduct, explains Engelman.
“But ultimately, the IRB has to rely upon the honesty of the investigator. So the key to preventing it or dealing with it, is having researchers who are basically ethical…If you cheat on test in high school, are you more likely to fudge your research? Why wouldn’t you? If you cheat and succeed once, why not try it again?"
The problem of research misconduct is everyone’s responsibility. "If someone suspects research fraud, they are required to report it,” says Engelman. According to Anita Sarro, Baystate’s Research Integrity Officer, policy BH-AA-2.04, Misconduct in Research and Scholarly Activities explains the actions available to you should you have suspicions about the veracity of an investigator's research.