About the Principal Investigator

 

Robert P. Bauchwitz C.F.E., Ph.D., M.D.,

 

Educational and Research Background

 

Robert Bauchwitz is a biomedical research scientist and certified fraud examiner who was the relator (plaintiff acting on behalf of the government) in a federal False Claims Act qui tam case, United States ex rel Bauchwitz v. Holloman et. al., No. 04-2892 (E.D. Pa.).

 

Dr. Bauchwitz received an A.B. degree in Biochemistry from Harvard University in 1982. Thereafter, he completed a joint M.D./Ph.D. program at Cornell University Medical College ("Cornell"; subsequently, "Weill Cornell") and the Sloan-Kettering Institute. He received his Ph.D. degree in Molecular Biology from Cornell in 1990, and his M.D. degree from Cornell in 1991.  

 

From approximately 1987 through 1990, while pursuing his Ph.D. degree, he worked as a graduate student in the laboratory of William K. Holloman, Ph.D. at Cornell. From 1991 through 1996, he was a postdoctoral fellow in the Columbia University Department of Genetics and Development. While in the Columbia Department of Genetics and Development, he obtained his own lab and grant funding.

 

From 2001 to October 2007, Dr. Bauchwitz was employed by the St. Luke's-Roosevelt Institute for Health Sciences at Columbia University as Director of the Cognitive Neuroscience Laboratory, at which time he was a tenure-track Assistant Professor in the Department of Neurology. He was also for several years during this period an adjunct professor in the Department of Natural Sciences at Fordham University. Some of the highlights of his research efforts to develop assays and neuropharmaceuticals relevant to a form of mental retardation that also shows significant autistic and epileptic symptoms can be found here. His current efforts are moving away from solely relying upon the use of mice for higher cognitive testing, towards performing clinical "testing" on human subjects, by which is actually meant "training" in the context of compounds and other treatments which can enhance neuroplasticity.

 

Qui Tam Case Involvement

 

From 2000 through 2002, Dr. Bauchwitz assisted science journalist Gary Taubes with an article on various phases of concern in the scientific community over the work of William K. Holloman, Ph.D. and his former graduate student, Eric B. Kmiec, Ph.D.

 

Taubes then recommended to the federal Office of Research Integrity (ORI) that they contact Bauchwitz regarding additional potential research misconduct associated with Holloman and Kmiec. ORI told Bauchwitz that they had already been investigating Kmiec's "chimeraplasty" claims, which had received international scrutiny from other scientists.

 

ORI subsequently agreed to proceed with an attempt to recover government funds through a qui tam suit against the defendants in which Dr. Bauchwitz was to act as relator for the government. The case United States ex rel Bauchwitz v. Holloman et. al., No. 04-2892 (E.D. Pa.) was filed under seal on June 30, 2004 in federal district court in the Eastern District of Pennsylvania (the location recommended by the ORI). The ORI was to produce a report for the Department of Justice on the science involved. In its summary ORI stated:

"Dr. Bauchwitz' complaint identifies three false claims, as identified above. ORI notes that these false claims deal with only a very small portion of the much  larger scope of possible misconduct issues that have been linked to Drs. Kmiec and Holloman (see footnote 8). The reason for this is that Dr. Bauchwitz has limited his claims to issues that he has direct knowledge of. He has made a solid case that the 'story' on Ustilago maydis recombination genes, their associated proteins and their enzymatic properties has shifted dramatically over the past 20 years. Many scientists working in this area appear to have believed that erroneous  claims have been consistently published by Drs. Holloman and Kmiec." [Emphasis added.]

The case ultimately settled without going to trial in significant part because the judge reduced the time for discovery to less than the parties had agreed and then rejected a motion to extend it. (The volume, complexity, and poor readability of evidence of one of the three claims against the defendants would later take as long to assess as the total, reduced, time which had been provided for discovery and expert reports.) There were no rulings on any of the evidence obtained during the limited discovery which was performed. There were no protective orders or any confidentiality agreements made during settlement.

 

Among the most clear-cut pieces of evidence were obtained by subpoena from Harvard University's Microchemistry Laboratory regarding amino acid sequencing work that the defendants had claimed was performed by that laboratory and which was foundational to the claims that the defendants had made in scientific publications and grants:

These sequences are not consistent with the data we provided.

 

“... none of the sequence data we obtained agrees with the data they claimed was from our lab.

 

I am confident that there is no other data”.

Although the judge did not permit what was believed to be sufficient time to complete discovery and production of expert reports, nevertheless, after the case, two experts, who had earlier presented comments to the court, reviewed the evidence for two of the three claims, including the one involving the statements by Harvard's Microchemistry Laboratory. They concluded:

a. Based on the evidence and the standards of intent provided in this document, do the allegations in your judgment have merit? In other words, does the preponderance of the evidence suggest that the defendants have fabricated or falsified scientific claims?


Expert 1: Yes.
Expert 2: Clearly the data presented includes a demonstration of data fabrication and falsification of scientific claims. I would suggest that there is a dangerous mix going on here: Out and out fraud together with ignorance of the truth and selective use of facts for the expressed purpose of substantiating a story(ies) that allowed the perpetrators to secure tangible assets (e.g., grant funding) as well intangible assets (e.g., standing in the scientific community).


b. If you were a member of an NIH scientific review committee (study section) and you were made aware of any of the information presented here as a grant reviewer, would it have had a significant negative impact on your scoring of the grants at issue from the applicants/defendants, H and K?


Expert 1: Yes.
Expert 2: YES. This level of evidence would sway me not to even score such a grant in the current funding climate. That is, the level of apparent malfeasance and/or open questions regarding the data and prospective conclusion would immediate disqualify this grant for further review.

A third expert reviewer then concluded with respect to all of the evidence obtained:

“In every instance the evidence is strong and in many instances it is air tight. The fact that there has been no serious investigation to date shows major problems in the system.”

Subsequent to conclusion of the case, which ended without any real judgment on the merits, attempts were made to obtain corrections of the scientific literature based on evidence obtained during discovery from Harvard University. However, the responsible journal, Molecular and Cellular Biology, and its parent organization, the American Society for Microbiology, refused to take any action to have the responsible institution investigate or do so themselves, as would have been appropriate under the COPE publishing guidelines they claimed to follow.

 

The responsible former defendant institution, Weill Cornell Medical College, continued its longstanding resistance to initiating a formal inquiry, the first step of record towards an investigation, and if appropriate, retraction of the affected publications. Indeed, Cornell has stated that it had never initiated a faculty inquiry or investigation on any allegation related to the senior investigator involved in the case. The importance of that remarkably common claim as it relates to the handling of allegation of biomedical research misconduct in the United States has been addressed in a paper by Dr. Bauchwitz.

 

Furthermore, the responsible oversight and funding agencies in the U.S. (ORI and NIH), also took no known, meaningful action based on the information discovered despite there being no basis in law which would have prevented their doing so. More detail on the issues of evidence use and failure to act can be found here. An affidavit regarding the evidence can be found here. (1)

 

The all-too-frequent gulf between what the institutions and journals have been claiming about an interest in scientific integrity and their actual behavior does not appear to be specific to this case, or even to science in the U.S.. The severity and widespread nature of an unwillingness to deal effectively with scientific misconduct has been presented repeatedly by other scientists. Among the most recent of these is a report that alleged:

"A secret dossier that warns that fraud in biomedical research is even more prolific than feared is being considered by Jo Johnson, the [UK] universities and sciences minister, documents passed to Times Higher Education ... concludes that some research institutes, university administrators, funders, journals and science leaders have been covering up malpractice."

 

Current Research

 

Dr. Bauchwitz's research interests are now in notable part related to the handling of research misconduct. He had previously obtained significant training in fraud investigation from the Association of Certified Fraud Examiners (ACFE; associate member since 2004) and the John Jay College of Criminal Justice. Subsequent to the qui tam case, Dr. Bauchwitz obtained legal training at the Widener University Legal Eduation Institute (2). He also obtained computer network security training (CompTIA Security+ certification) because of the significant importance of secure and confidential digital communications to potential whistleblowers, plaintiff's attorneys, and fraud investigators, among others. A network security expert who works for the firm, along with Dr. Bauchwitz, discusses in a blog a variety of issues that they have encountered in working with others interested in the investigation of scientific research misconduct and fraud.

 

Dr. Bauchwitz's work in the area of research misconduct and whistleblower support is performed through the firm he founded, Amerandus Research. Dr. Bauchwitz is a certified fraud examiner (CFE) and a member of the Institute of Internal Auditors (IIA), from which he has obtained training in operational audit. (Fraud examiners are also known as forensic or investigational auditors.) In addition to consulting and investigative activities, and ancillary IT audit functions, the firm also has some interest and expertise in perfomance audit of government functions. (Performance audit is the government and non-profit version of corporate operational audit.)

 

Amerandus Research website.

 

 

 

(1) Note that the evidence affidavit does not include more recent analysis of almost three thousand pages of evidence regarding the Bennett and Holloman, 2001 publication; the latter findings will be presented shortly.

 

(2) Eight courses at Widener University Law School in 2010; Dr. Bauchwitz obtained certification from the Widener Legal Education Institute.