Professionalism/Yoshitaka Fujii and Medical Research Fraud

Yoshitaka Fujii is a Japanese researcher in anesthesiology and ophthalmology who holds the record for most papers retracted at 183 papers. He alone accounts for 7% of all retracted papers from 1980 to 2011. It was founded that he completely made up data for at least 171 of his published papers. Fujii acts as a non-example in professionalism as his decision to fabricate data in his papers served only to better his own career and added no value if not detracted value from his profession, the field of anesthesiology, as well as medical research as a whole.

Yoshitaka Fujii
Yoshitaka Fujii was born on April 19th, 1960 in Hatogaya City, Japan. In 1987, he graduated from Tokai University School of Medicine with an M.D. degree in Isehara City, Japan. In 1991, he received his Ph.D. in anesthesiology at Tokyo Medical and Dental University. Over his career, Fujii worked at multiple universities and hospitals. He worked as an anesthetist at Toride Kyoto General Hospital from 1991 to 1995. Other notable institutions include the Tokyo Medical and Dental University, University of Tsukubu and Toho University. In 1997, he assumed a faculty position as an assistant professor at the University of Tsukuba Institute of Clinical Medicine. In 2005, he joined the Toho University faculty of Medicine as an associate professor of anesthesiology. The main subject of his research was clinical trials of medications to treat nausea and vomiting that often occurs after surgery. Throughout his career from 1993 to 2011, Fujii published more than 200 papers in the field of anesthesiology and ophthalmology.

Initial Suspicions
In April of 2000, Peter Kranke, an anesthetist and professor of anesthesiology at the University of Würzburg, and two colleagues wrote a letter to the editor of Anesthesia & Analgesia, a journal where Fujii was known to have actively published in. This letter served to call out Fujii for the his "incredibly nice" data, a jest of sarcasm as the data appeared too good to be real data. According to Kranke, Fujii's data didn't show normal variation present in real-world data sets. However, despite the implications from the letter, the journal Anesthesia & Analgesia did not take any action against Fujii and actually continued to publish his work for several years.

Anaesthesia Journal and John Carlisle
In 2010, Anaesthesia published an editorial by Moore et. al that claimed that publishers lacked the means of consistently and accurately detecting fraudulent papers. Readers criticized this editorial as researchers believed it was the responsibility of the journals to detect fraudulent work. As the then editor in chief that commissioned Moore et. al’s publication, Steve Yentis was forced to respond to the criticism that demanded action.

The field of anesthesiology was experiencing multiple coinciding shocks of misconduct with the infamous cases of Scott Reuben and Joachim Boldt. Anaesthesia had published six of Boldt’s papers - in turn, Yentis was especially pressured to take action. Yentis responded by challenging one critic, John Carlisle, to create and perform a rigid analysis of Fujii’s work to demonstrate the possibility of reliably detecting fraud.

Kranke’s letter in 2000 had not prompted action from journal editors, but it had alerted and cautioned the community’s researchers. The United Kingdom anesthetist, John Carlisle, while not specialized in statistics, quantitatively analyzed 168 randomized controlled trials conducted by Fujii from 1991 to 2011. Randomized controlled trials are considered the golden standard for clinical research. Carlisle gathered statistical distributions of seemingly random components such as blood pressure, height, and weight to from various publications as a standard of comparison to Fujii’s work. Fujii’s distributions for these random components demonstrated large discrepancies from Carlisle’s expected standard. Carlisle concluded that a majority of Fujii’s trials, assumed to be randomized, had a probability of less than 1x10-33 of occurring by chance; therefore, Fujii’s work was for the first time quantitatively deemed fraudulent.

Fujii's Conclusion
Independent of Carlisle’s analysis, Toho University initiated an internal investigation of Fujii’s work after they were alerted of Fujii’s credibility in August 2011. The investigation discovered that 8 of 9 trials that Fujii had claimed to have conducted at Ushiku Aiwa General Hospital had never been approved by an ethics committee and were deemed fraudulent.

The internal investigation by Toho University and Carlisle’s work prompted a large scale investigation led by Koji Sumikawa, an anesthesiologist at Nagasaki University. 212 of 249 of Fujii’s publications were investigated and of the 172 deemed to be fraudulent and retracted, 126 were completely fabricated. Of the remaining 40, 3 were found to be valid and 37 were found to be inconclusive by Koji. As of 2013, Fujii had 183 publications retraction. Additionally, Fujii was terminated from Toho University in February 2012.

Retractions
Retracting an article is more difficult than publishing it. Loadsman reports that when an article is reported fraudulent, retraction takes more time than publishing. On top of that, PubMed, a search engine for articles takes up to three years to index the retractions. Retraction is slow. McHugh and Yentis report that sixty months after two major authors were reported as frauds, all their fraudulent papers were not retracted. Twenty percent of Fujii's papers were not retracted. Ten percent of Boldt's, another fraud, papers were not retracted. Loadsman states two reasons why this problem exists. Not many papers are retracted, so most publishers don’t have the resources or precedents to retract papers. It is also unclear who is responsible for doing the retractions. If no one is responsible for investigating, retraction can take a while. A couple of solutions have been proposed.

Retraction Index
The retraction index is an index that divides the number of retracted articles by all the published articles from a journal. . This doesn’t solve the issue, but it provides a measure to quantify journals. If a journal publishes more articles, then they are rated with a higher impact. The retraction index has shown that higher impact journals tend to have more retractions compared to the number of articles they publish. Higher impact journals set an example for other journals. High impact journals seem to have a greater responsibility. Most journals agree that responsibility for retractions still lies with the institutions gathering good data, so this metric doesn’t help too much.

Transparency Index
A transparency index and retraction index can help gain a readers trust. Retraction index helps readers know that journals have certain retraction policies in place. Transparency index helps readers know what exactly goes into this decision to retract an article. The transparency index would have a couple of metrics. These would help a reader know how trustworthy a journal is. Some of these metrics would include if the journal has contact information for people that will respond, or if the journal uses plagiarism detection or other things that show the trustworthiness of a journal. This is still a subjective measure and may not fully solve the problems presented.

COPE and CLUE
The Committee on Publication Ethics has taken an initiative to invite institutions to a pilot program to proactively investigate fraudulent claims. A similar initiative called Cooperation and Liaison between Universities and Editors has a similar goal. Both initiatives want to provide a common mechanism to prevent fraudulent papers that publishers, editors, institutions, and other entities can follow. If successful, clear guidelines can be developed in finding and removing research misconduct.

Conclusion
While further research is required to determine the long-term effectiveness of systemic fraud deterrents, this case demonstrates the ambiguous nature of professionalism. Fujii's case illustrates someone who can be by definition professionally good at their craft, cheating, but at the same time be unethical and unprofessional by other standards. This case also illustrates the difficulty that occurs in professional life. One may be faced with similar situations, but a true professional would not fake data in order to further their career. The organization that a professional works for may not help them further their career or make them do unethical actions. It takes a proactive approach, in the terms of "Corporate ethics cannot be reduced to compliance" in order to actively try to act in an ethical manner.