Medical Writing, Editing & Grantsmanship

Professor and Asst Professor, so perhaps mentor-mentee. Go check out the new format of the full notices, including lay-friendly research explanation and parenthetical comments and the disclaimer about accepting responsibility while not admitting intent or liability (e.g., “Dr. Thomas accepted responsibility for the reporting described above, but denied that she intentionally committed research misconduct. The settlement is not an admission of liability on the part of the Respondent” (though she did agree to a 10-year debarment).

In view of these changes to the notice language, perhaps The Scientist should have waited one more month to run their article (Life after Fraud) and editorial (Fairness for Fraudsters) criticizing ORI for its procedures and “serious miscarriage of justice against researchers” – this in regard to the fact that those cited for misconduct continue to have their misdeeds advertised (and hence are punished) beyond the agreed upon exclusionary period through Internet archives of the NIH Guide & Federal Register.

Perhaps The Scientist might also have discussed the policy article published in Science last August, Scientific Misconduct: Do Punishments Fit the Crime?, as discussed previously here and in Nature… not to mention the ORI survey data published in Nature about the underreporting of scientific misconduct (beyond the side bar comment by John Dahlberg).

Without further ado …

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on a finding of scientific misconduct made by UAB on January 24, 2008, a report of the UAB Investigation Committee, dated November 21, 2007, and additional analysis conducted by ORI during its oversight review, the US PHS found that Judith M. Thomas, PhD, former Professor of Surgery, UAB, engaged in scientific misconduct in research supported by grants R01 AI22293, R01 AI39793, U19 AI056542, U19 DK57958, and NIH/Novartis Cooperative Research and Development Agreement 96-MH-01/NIHITC-0697.

The objective of the research was to test the effectiveness of different agents, such as Immunotoxin FN18-CRM9 or 15-deoxyspergualin (15-DSG), administered around the time of renal transplantation in non-human primates, in preventing rejection of the transplanted kidney. …

PHS found that Respondent engaged in scientific misconduct by falsifying reports of research results in NIH-supported experiments with non-human primate renal allograft recipients in 15 publications and in progress reports in 2 NIH research grant applications.

Notice is hereby given that the ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on a finding of scientific misconduct made by UAB on January 24, 2008, a report of the UAB Investigation Committee, dated November 21, 2007, and analysis conducted by ORI during its oversight review, and further discussion between UAB and ORI to clarify UAB’s investigative findings and decision with respect to the requirements of 42 CFR Parts 50 and 93, the US PHS found that Juan Luis R. Contreras, MD, Assistant Professor, Department of Surgery–Transplantation, UAB, engaged in scientific misconduct in research supported by grants R01 AI22293, R01 AI39793, U19 AI056542, U19 DK57958, and NIH/Novartis Cooperative Research and Development Agreement 96-MH-01/ NIHITC-0697.

PHS found that Respondent engaged in scientific misconduct by falsifying in 7 publications reports of research results in NIH-supported experiments with non-human primate renal allograft recipients.

Oof. A fellowship director no less. Comment below provides “the rest of the story.”

Notice is hereby given that ORI and the Assistant Secretary for Health have taken final action in the following case:

Based on information that the Respondent volunteered to his former mentor on November 7, 2006, and detailed in a written admission on September 19, 2007, and ORI’s review of Joint Inquiry and Investigation reports by Harvard Medical School (HMS) and the Brigham and Women’s Hospital (BWH), the US PHS found that Dr. Robert B. Fogel, former Assistant Professor of Medicine and Associate Physician at HMS, and former Co-Director of the Fellowship in Sleep Medicine at BWH, engaged in scientific misconduct in research supported by awards P50HL60292, R01HL48531, K23HL04400, F32HL10246, and M01RR02635 [GCRC-writedit].

PHS found that Respondent engaged in scientific misconduct by falsifying and fabricating baseline data published in Fogel,RB et al. Anatomic and physiologic predictors of apnea severity in morbidly obese subjects. Sleep 2003;2:150-155 and in a preliminary abstract reporting on this work. Specifically, PHS found that for the data reported in the Sleep paper, the Respondent:

• Changed/falsified roughly half of the physiologic data
• Fabricated roughly 20% of the anatomic data that were supposedly obtained from CT images
• Changed/falsified 50-80% of the other anatomic data
• Changed/falsified roughly 40-50% of the sleep data so that those data would better conform to his hypothesis.
• Respondent also published some of the falsified and fabricated data in an abstract in Sleep 24, Abstract Supplement A7, 2001.

Whoa. Each new and more incredible case of scientific misconduct should no longer be able to shock, but still my jaw drops in disbelief.

According to Anesthesiology News,

Scott S. Reuben, MD, of Baystate Medical Center in Springfield, Mass., a pioneer in the area of multimodal analgesia, is said to have fabricated his results in at least 21, and perhaps many more, articles dating back to 1996. The confirmed articles were published in Anesthesiology, Anesthesia and Analgesia, the Journal of Clinical Anesthesia and other titles, which have retracted the papers or will soon do so …

In addition to allegedly falsifying data, Dr. Reuben seems to have committed publishing forgery. Evan Ekman, MD, an orthopedic surgeon in Columbia, S.C., said his name appeared as a co-author on at least two of the retracted papers, despite his having had no hand in the manuscripts.

“Interestingly, when you look at Scott’s output over the last 15 years, he never had a negative study,” said one colleague, who spoke on the condition of anonymity. “In fact, they were all very robust results—where others had failed to show much difference. I just don’t understand why anyone would do this or how anyone could pull this off for so long.”

A cornerstone of Dr. Reuben’s approach has been the use of the selective cyclooxygenase-2 inhibitor celecoxib (Celebrex) and the neuropathic pain agent pregabalin (Lyrica), both manufactured by Pfizer. Dr. Reuben has received research grants from the company and is a member of its speakers’ bureau. However, a source told Anesthesiology News that Pfizer recently alerted its speakers to remove any reference to Dr. Reuben’s data from their presentations. Pfizer was unable to comment by the time this article went to press. The company has not been accused of wrongdoing in the matter.

Jacques Chelly, MD, PhD, MBA, director of the Division of Regional Anesthesia and Acute Interventional Perioperative Pain at the University of Pittsburgh Medical Center, said that the Reuben episode has left multimodal analgesia “in shambles concerning many of the drugs we use”—particularly celecoxib and pregabalin. “The big chunk of what people have based their protocol on is gone.”

As he has no listings in CRISP dating back to 1990, ORI will have no need to investigate Reuben, but this raises the question about who does provide oversight regarding the responsible conduct of research for industry-funded studies such as these. JAMA and other journals have begun to do so by requiring the data be submitted for independent analysis, but specialty journals such as these likely could not manage such an undertaking for every industry trial.

So is this the FDA’s responsibility? They have 3 separate offices that investigate misconduct (drugs, biologics, medical devices), but no quick option on their home page to report suspected research fraud (versus other types of criminal activity and adverse reactions). Or is this another case/cause for Senator Grassley?

Whoa.

Based on the reports of separate investigations conducted by Brigham and Women’s Hospital (BWH), CalTech, and MIT and additional analysis conducted by ORI, the US PHS found that Luk Van Parijs, PhD, former Graduate Student, Department of Pathology, Harvard; former Research Fellow and Instructor of Pathology, BWH; former Postdoctoral Fellow, Department of Biology, CalTech; and former Associate Professor, Department of Biology, Center for Cancer Research, MIT, engaged in scientific misconduct in research supported by grants U19AI56900, R21AI49897, R01AI42100, P01AI35297, R37AI25022, R01AI32531, R01CA51462, P30ES02109, and R01GM57931.

PHS found that Respondent engaged in scientific misconduct by including false data in grant applications R01AI54519-01A1, R01AI54973-01, R01AI54973-01A1, 2P30CA14051-34, and R21DK69277-01.

Specifically, PHS found that Respondent engaged in scientific misconduct by including false data in 7 published papers, 3 submitted papers (with 2 earlier versions submitted for one of these), one submitted book chapter, and multiple presentations as follows: Read the rest of this entry »