Anyone who has access to or is responsible for collecting, transcribing, reporting, or monitoring data and is motivated to cheat may commit fraud. The motivations to commit fraud are as varied as human personalities.
Since the 1960s, more than 300 allegations have been reported to federal officials, including 40 clinical investigations audited by the FDA that have been classified as false information. Unfortunately, there is limited public awareness of fraudulent scientific/medical research (unless the information appears as newspaper headlines) and hence there is a limited outcry by the general public.
In the mid-1960s Industrial Bio Test (IBT) Laboratories "dry labed" many toxicology experiments, which led to the establishment of Good Laboratory Practices (GLP) regulations by the EPA and FDA.
In 1989, a series of investigations involving falsification of results from bioavailability studies of generic versions of innovator drug products led to the criminal indictment, conviction, and sentencing of several key officials at the FDA and generic pharmaceutical firms. As a result of those investigations, and investigations conducted by the FDA, four FDA employees were found to have accepted illegal gratuities from generic drug companies, and to date, 11 generic drug companies have been found to have falsified data submitted in premarket applications to the FDA.
In the FDA's investigations, which began as inquiries into illegal gratuities and questionable data submissions, the agency discovered broad patterns and practices of fraud in the applicants' abbreviated new drug applications. The discovery of this extensive pattern of fraudulent data submissions prompted the FDA to promulgate the Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities policy1 to ensure validity of data submissions called into question by the agency's discovery of wrongful acts, such as fraud, untrue statements of material fact, bribery, and illegal gratuities2 and to withdraw approval of, or refuse to approve, applications containing fraudulent data.
Fraud in scientific research is not new, as articles elsewhere in this book show (See Chapters 4 and 5). At least five cases have involved court hearings. Barry Garfinkel, MD, a child psychiatrist at the University of Minnesota, was sentenced in 1994 to six months of home detention and ordered to pay $214 000 in fines and restitution, as well as 400 hours of community service for fraudulent studies in treating children and adolescents with obsessive-compulsive disorder.
John S Najarian, MD and Chairman of the Department of Surgery of the University of Minnesota, and Richard Condie, Research Director of the University, received a 55-count indictment in April 1995 for the illegal commercial sale and distribution of the investigational product, antilymphocyte globulin (ALG) and failure to report all deaths and serious adverse experiences to the FDA.
Bruce I Diamond PhD, a pharmacologist, assumed clinical research responsibilities and tasks for which he was unqualified and untrained. He received five years in jail; 10 years' probation; and was ordered to pay $1.2 million in restitution to the University System of Georgia.
Richard L Borison, MD, PhD, was sentenced to 15 years in jail; and 15 years' probation for the failure to personally conduct/supervise the investigation, failure to inform employees assisting in conduct of the studies of their obligations, and failure to maintain adequate and accurate records. He was fined $125 0000 and $4.25 million in restitution to the University System of Georgia.
Robert Fiddes, MD, President of the Southern California Research Institute, was sentenced in 1998 to 15 months in prison and ordered to pay $800 000 in restitution for the fabrication and falsification of over 200 studies sponsored by 47 drug companies.
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