REBUTTAL TO FINDINGS OF SCIENTIFIC MISCONDUCT NIH GUIDE, Volume 24, Number 42, December 8, 1995 Updated April 27, 2018 P.T. 34 Keywords: Ethics/Values in Science & Technol Grants Administration/Policy+ Department of Health and Human Services
In anticipation of any future inquiries, I have provided my description as an affidavit of an event that occurred in my career 24 years ago. I have also attached a link to a letter from a colleague who was aware of the actual circumstances surrounding this incident. Please feel free to contact him or me directly if you have any further questions or concerns.
I Daniel Bednarik, affirm that I was part of an ORI investigation while working for the CDC in 1990. The issue was due to an error in one manuscript identified by a journal referee who questioned whether this data was not properly represented. There was no fabrication in the submitted manuscripts — My Division Chief at that time confiscated key laboratory notebooks that contained original raw data demonstrating the work was accurately completed; I and others in this Branch testified that certain pivotal notes and data were withheld and/or not provided to ORI investigators that would have cleared me. Multiple staff from this laboratory testified to a “alternative agenda”, but ORI was unrelenting and maintained that I could not prove the work was actually done without the additional information. I have never been able to prove or provide the original and highly probative data that was missing. Being a young and very inexperienced PI, I exhausted all financial options available to me at that time and I decided to voluntarily exclude myself from applying for Federal grant funding for a period of two years. Such “voluntary exclusions” are commonplace but are often misconstrued as an implication of guilt – it clearly was not to be construed as an admission of guilt as was defined by the ORI ruling. This ruling only means that either side could not prove its case resulting in a settlement. I regret settling with the ORI as the accusation was false and did not rise to the level of misconduct. The exclusion period has long since expired but remains indexed by Google.
A good read that captures what to do when falsely accused of misconduct can be found here — https://www.smartsciencecareer.com/falsely-accused/ . My situation is described under Point #3:
“These persons have a political motivation to ruin the reputation of a scientists for example in the context of elections for important positions such as dean, rector etc. Also in this case it is difficult to evaluate whether the accusations are true or just a political game. Sometimes small justified allegations which would be considered as ‘sloppiness’ or ‘honest error‘ may be exaggerated and followed up by an institution or a commission in a ‘vendetta style’ with destructive effects on the reputation of a scientist. These persons intentionally abuse the whistleblower status.”
Since that incident, I have been productive in obtaining external funds, with my coauthorship of a 2006 DARPA contract proposal as one example, and funding from the Canadian Institutes of Health Research (CIHR) as another. I have also extensively published in peer reviewed journals. My successful employment history at Human Genome Sciences, Gene Logic, Artesian Therapeutics, Cardiome Pharma, Diaxonhit Therapeutics and Intrexon Corp. is validation of my integrity and reflects these companies’ full support of me. I have also succeeded in obtaining venture funding via Oxford Bioscience Partners, the Maryland Dept. of Business & Economic Development, and Brown Advisory, Baltimore that also attests to my professional track record, integrity, and the comfort of the individual investors with my record. The ORI ruling was independently reviewed by the DARPA Project Manager and Defense Dept. General Counsel who further confirmed this not considered to be an issue or concern.
If it is of any help to people who read this rebuttal and if you are a junior investigator early in your career, ALWAYS make sure to make copies of everything; raw data, notebooks, etc. to keep in your possession to protect against those supervisors who are sociopaths and create artificially pressurized environments to advance their own publication goals and heighten their self perceptios.
If you wish to inquire further, please contact Dr. Paul W. Doetsch at Emory University, who was witness to the evolution of this incident, I would encourage you to read the letter below.
Dr. Doetsch’s contact information can be found at his Institutional website – Contact Information for Dr. Paul Doetsch
Daniel Bednarik, Ph.D.
Daniel Bednarik is scientist who works and studies within the field of biopharmaceutical and medical research. Daniel’s experience working in his field includes leading the cultivation and implementation of inventive, adaptive technologies that apply to the conducting of research within the clinical field of study. He has extensive knowledge within practice of heading the creative process of product development along with the business extension within newly-formed companies, as well as long-established businesses. He holds a deep understanding of genomics database design and application, and is competent in the process behind the development of bioinformatics equipment.
Daniel Bednarik is a trained professional in the niche of infectious diseases and has contributed to the enhancement of the use of animal model studies by working on animal model development in the realm of biopharmaceutical field. He also has contributed his knowledge and experience to the endeavor of the stratification of clinical trials that utilize human biomarkers. Daniel Bednarik has served as an active member of the FDA Advisory Committee, and has taken part in the discourse and administration behind their regulatory dealings. Daniel has authored and submitted numerous IND, IDE, BLA and CMC regulatory documents for review and publication. While he seen a great deal of success within his field, one of his noteworthy career moments in which he feels a great deal of pride is his co-founding role in the creation and launch of Artesian Therapeutics, Inc. For this business, Daniel is responsible for raising $5M worth of private equity funding for the startup business. Along with these impressive accomplishments, Daniel has done a great deal of consulting within his field of biopharmaceutics and is frequently sought out for his wisdom and advice.
Currently, Daniel Bednarik is a Senior Vice President who will be defining the molecular engineering and protein design for a novel approach to immunotherapy that will be paradigm-changing and completely proprietary. Prior to taking on this new venture, Danial Bednarik worked at Intrexon Corporation, in Germantown, Maryland, where he served as the Vice President of the Operations of the Molecular Engineering Unit within the company. In his role, Daniel offered support by way of his understanding of molecular engineering for the various branches of the company, as well as dealt with “External Channel Partner,” collaborations in terms of proprietary gene design technology imperative to the facilitation of drug and/or product cultivation across a wide range of corporate divisions and sectors. As VP of the MEU, he worked alongside the Chief Scientific Officer (MEU) in a number of situations, along with the company’s President, the Human Therapeutics Division (HTD), and the Cell Engineering Unit (CEU) in order to improve and grow the translation of technology to application in the clinic or other areas.
During his time at Intrexon, Daniel specialized in a number of niches, one of which was the leading of the molecular measures for the Corporations. The other areas he worked within included the management of 14 direct reports, developing, cultivating and running testing for orally activated gene therapy solutions. Daniel Bednarik has come up with novel methodologies for coming to solid conclusions regarding gene therapy issues and can claim responsibility for the development of new ideas for platforms for production of new important discoveries that are derived from cell-based research. He is knowledgable of and has experience in biopharmaceutical efforts and studies dealing with veterinary work, food science, health sectors and bioinformatics, to name a few.
Prior to his role at Intrexon, Daniel Bednarik filled the role of Director of the Scientific Advisory Board at Albitech in Baltimore, Maryland. Earlier than that, he was the co-founder and vice-president of Artesian Therapeutics, a company that was ultimately acquired by Cardiome Pharma in 2005. After this acquisition, Daniel joined the Cardio Pharma team. Daniel’s vast and deep experience along with his varied background in biopharmaceuticals enable him to be a highly successful, reputable figure in his area of expertise.
“Who steals my purse steals trash,” Shakespeare wrote, but one who “filches [another’s] good name” takes “the immediate jewel of their souls.” The play is Othello, but he could just as well have been writing about science, where reputation is, in the words of the University of Washington’s (UW’s) policy on research misconduct, “of paramount importance to a researcher’s career.” So when UW dismissed longtime staff researcher Mercedes Perez-Melgosa after her lab chief, genome sciences professor Deborah “Debbie” Nickerson, concluded that Perez-Melgosa had “changed data,” as Nickerson would testify in a May 2015 court trial, Perez-Melgosa was devastated. It felt as if “my scientific career, my professional career—a very big part of my life had disappeared in front of me,” Perez-Melgosa testified in the same Seattle courtroom as part of a lawsuit she brought against UW related to her termination.
Perez-Melgosa believes she has been unjustly accused of falsification, which is an element of career-killing scientific misconduct. She denies changing data and wanted a panel of competent and impartial scientific experts to examine the evidence, but the relevant UW unit, then known as the Office of Scholarly Integrity (OSI) and now called the Office of Research Misconduct Proceedings, did not investigate the case. As this never happened, the question of whether she changed or only interpreted data appears to remain unsettled. To read more, visit –> http://www.sciencemag.org/careers/2016/12/can-you-rescue-damaged-reputation
New CDC chief stepped down from four groups to comply with ethics rules
CDC Director Robert Redfield, a longtime AIDS researcher, took over as CDC chief on March 26, 2018. (CDC)
Centers for Disease Control and Prevention Director Robert Redfield has resigned his positions at four groups, including a gene therapy biotechnology company and a conservative AIDS organization, to comply with government ethics rules, according to his financial disclosures.
Redfield, a longtime HIV/AIDS researcher who started the job March 26, succeeded Brenda Fitzgerald, the former Georgia public health commissioner, who resigned Jan. 31 after serving only half a year because she was unable to divest from her financial holdings. She had also purchased tobacco stocks as CDC director.
“The job of CDC Director is very important to me,” Redfield said in a statement issued Tuesday. “Therefore, I have worked closely with the HHS Ethics Office to comply with all reporting requirements of the Ethics in Government Act.”
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His public financial disclosure report has been reviewed by the ethics office of the Health and Human Services Department, to which the CDC belongs.
Redfield, a professor of medicine at the University of Maryland, said he has also divested stock holdings in two private biotechnology companies and is recusing himself from participating in matters involving the university and seven organizations, according to his ethics agreement and a memorandum about his recusals provided to The Washington Post by an individual with knowledge of the plans.
Among the organizations from which Redfield has resigned his positions:
* American Gene Technologies International Inc., a Rockville, Md., gene therapy company where Redfield served since 2011 as an adviser and later chair of the clinical advisory board for its HIV cure program. Redfield earned consulting fees of $57,250 from the beginning of 2017 through March 2018.
* Children’s AIDS Fund International, a faith-based AIDS organization, where Redfield has served as a director since 2003.
* Guidepoint Global, LLC, where Redfield had been a consultant since 2014. He earned $1,508 from the beginning of 2017 through March 2018.
Redfield sold his stock in Profectus BioSciences, a Baltimore vaccine-development company, before he started the CDC job, and in American Gene Technologies, according to his ethics agreement.
Redfield also will no longer work as a consultant for four law firms or as a speaker for a medical education company. He said he plans to sign over his share of royalties from a forthcoming book about HIV infections to his co-author and future licensing fees or royalties on several patents to the University of Maryland.
His compensation from the university from the beginning of 2017 through March 2018 was $757,100 plus a $70,000 bonus, according to his public financial disclosure.