Source: The-Scientist.com

Two researchers conducting animal studies on immunosuppression lied about experimental methodologies and falsified data in 16 papers and several grants produced over the past 8 years, according to the Office of Research Integrity (ORI).

The scientists, Judith Thomas and Juan Contreras, formerly at the University of Alabama at Birmingham (UAB), falsely reported that they performed double kidney removals on several rhesus macaques in experiments designed to test the effectiveness of two immune suppressing drugs -- Immunotoxin FN18-CRM9 and 15-deoxyspergualin (15-DSG) -- in preventing rejection of the a single transplanted kidney.

The experimental protocol was to remove one intrinsic kidney, replacing it with a transplant and starting the monkeys on immunosuppresants, and then remove the other intrinsic kidney a month later, according to Richard Marchase, UAB's vice president of research. "What occurred in a good number of these animals was that [Contreras and Thomas] never performed the second surgery," Marchase told The Scientist. In a statement emailed to The Scientist Marchase called the misconduct "a very serious offense."

Thomas's and Contreras's research was funded with more than $23 million in grants from the National Institutes of Health. UAB officials learned that Contreras and Thomas had left one native kidney intact in at least 32 animals -- which allowed those animals to live and inflated the apparent effectiveness of the drugs -- on January 27, 2006, when Thomas reported that she found an experimental monkey with one of its native kidneys intact and blamed Contreras for the mistake.

Marchase said that Thomas initially alleged that Contreras, a surgeon and Thomas's former postdoc, perpetrated the misconduct on his own without her knowledge, but the UAB investigation eventually showed that Thomas was in on the deception as well.

"The lack of second nephrectomies could have been discovered years earlier from examination of animal care records and from questions and concerns raised by various UAB staff," wrote Peter Abbrecht from ORI in a statement emailed to The Scientist, "but the principal investigator [Thomas] did not undertake any such actions, and appeared to exert very little control over the integrity of the study." Thomas accepted responsibility for the misconduct, but both she and Contreras denied intentionally committing fraud, according to the ORI report.

The ORI investigation found that the misconduct -- which specifically consisted of "falsifications in publishing of research results in journals and grant applications" -- spanned more than 8 years, from a fraudulent 1998 publication by Contreras and Thomas in Transplantation to a falsified paper that was published by Thomas in a December 2005 issue of the Journal of Immunology. The ORI also determined that Thomas first presented falsified data to the NIH in a 1999 R01 grant progress report.

In total Thomas and/or Contreras fudged data in 16 publications and several NIH grant applications. Fourteen of the publications have been retracted and two are in the process of being retracted, according to UAB. "The extent of misconduct with the widespread dispersion of falsified results had the effect of increasing the credibility of the respondents and thereby increasing the acceptance of the falsified results by other researchers in the field," wrote Abbrecht in the ORI statement. "Such acceptance could lead to wasted research effort by other researchers and possibly placing patients at harm if they were enrolled in clinical trials designed on the basis of the falsified results."

Thomas, who was also formerly on the board of directors at the NIH's National Institute of Allergy and Infectious Diseases, resigned her full professorship on January 10, 2008, after she learned of UAB's findings. At the time of her resignation she maintained a lab with 6-10 grad students, technicians and postdocs, according to Marchase. Thomas agreed to a "Voluntary Exclusion Agreement," under which she will not be able to receive any funding from the US government or to serve in any advisory capacity to the US Public Health Service (PHS) for ten years. A call placed to a number listed under Judith Thomas in Birmingham was not answered, and UAB officials declined to provide Thomas's contact information.

Contreras resigned his UAB assistant professorship last week, on July 6, and also entered a voluntary agreement with the ORI in which he will be excluded from government funding and PHS advisory roles for three years. Marchase said UAB barred Contreras from being PI on projects, animal protocols, and internal review board protocols, but that, "under a very tight mentoring and oversight system, he [would] be allowed to continue to do research on other folks' grants." However, said Marchese, UAB's and ORI's combined sanctions left few options for him. "Because there was really no position left for him, he chose to resign." Contreras initially agreed to comment on the matter, but later failed to return phone calls and emails from The Scientist.

Though the motivation for the misconduct remains unclear, the case has increased the university's vigilance in monitoring research integrity, according to Marchese. "We really don't understand it," he said. "It's just not a situation that is in keeping with what it means to be a scientist."