Orthopedics This Week | February 14, 2017 - Page 21


Plagiarism or Standing on the Shoulders of Giants ?

In June 2014 , Rehabilitation Research and Practice retracted a review article from 2012 titled “ Therapeutic Management of the Hallux Rigidus ” authored by researchers in India . The reason ? “ Substantial flaws in scientific methodology ”— and that was it . Little information was given on what constituted the alleged flaws of the article on stiff big toes . There has been no response from the journal or the researchers involved .

Originally published on May 21 , 2014 , the article was written by A . Aggarwal , S . Kumar and R . Kumar . The redaction was covered by the Retraction Watch website , which noted , “ Frankly , we ’ re not sure what ‘ scientific methodology ’ the authors might have be-flawed . Did they in fact mistype the search terms , contrary to what they declared ?”
In the abstract for the piece , the authors claim their goals was “ to systematically review the literature available for therapeutic management of the hallux rigidus by identifying and evaluating the randomized controlled trials ( RCTs ) and non-RCTs Methods .” One commenter on Retraction Watch who goes by the handle @ Neuro Skeptic and who blogs for Discover and the PLOS Neuroscience Community says , “ I suspect it is a euphemism for plagiarism .” This “ skeptic ” selected a sentence from random from the original article and found it had been plagiarized from a 2003 article by Dr . Michael Coughlin ( University of California , San Francisco ) and Dr . P . J . Shurnas in Foot Ankle International , “ Soft-tissue arthroplasty for hallux rigidus .”
Plagiarism has long plagued the academic and research community . Dr . Izet Masic published the article “ Plagiarism in Scientific Research and Publications and How to Prevent It ” in the Materia Socio Medica journal , citing ten common types of plagiarism in scientific journals — and outlining why plagiarism isn ’ t always black and white .
Science reveals truth by building on the discoveries of others ( Latin : nanos gigantum humeris insidentes ). Reproducing earlier work is an essential aspect of moving science forward . When does repeating earlier work cross into plagiarism and when is it , as Sir Isaac Newton wrote in 1676 : “ If I have seen further , it is by standing on the shoulders of giants .”?
According to Dr . Tracy Bretag (“ Challenges in Addressing Plagiarism in Education ,” published by PLOS Medicine ), 33 % of 3,600 mid-career and 4,160 early-career U . S . scientists report that they ’ ve taken part in sketchy research practices ranging from questionable data to unethical peer reviews to cut corners — and those are just respondents who admit to questionable tactics . That ’ s quite a generous slice of the research pie .
More to come on this important subject , for sure . — JM
Source : Wikimedia Commons and Nina Paley
Device Makers and FDA in Limbo Over Trump Executive Orders

Are you a medical device manufacturer getting ready to start a clinical trial or submit notification or approval requests to the FDA ? Hang on to your hat .

President Trump is a man of his word when it comes to his campaign promises to cut government regulations . On January 30 , 2017 , he signed an executive order ( EO ) which is creating great uncertainty with the FDA and device industry .
Photo creation by RRY Publications , LLC
“ One In , Two Out ” Regulation Order
The EO , dubbed , “ one in , two out ,” requires all government agencies , except the military or national security branches , to eliminate two regulations for every new regulation instituted . The EO also gives the White House Office of Management and Budget ( OMB ), authority to exempt other agencies .
The FDA would most certainly seek exemptions from the OMB . It ’ s also likely to make regulatory affairs directors at device companies pull out their hair .
Zachary Brennan wrote on the RAPS ( Regulatory Affairs Professional Society ) blog on January 30 that no one knows how such a plan would work for a public health mission like the FDA , “ par-
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