Stephen Breuning – fake research on drug therapy in mentally retarded children led to the first US criminal conviction for research fraud.

Overview

Stephen Breuning was a psychologist and one-time clinical director of the Polk Center in Polk, Pennsylvania. In the late 1970s and early 1980s, he published data which purported to show that stimulant drugs like Ritalin were more effective and had less side effects than tranquilizers when treating mentally retarded children with hyperactivity. These findings had a significant impact in this small research field and undoubtedly affected the choice of treatment for such children. A 1988 report of an investigation by the National Institute of Mental Health (NIMH) in the USA who had funded his research found that he had “engaged in serious scientific misconduct”. Also in 1988 he was convicted in a US Federal court of fabricating research and misappropriating government research funds. He was sentenced to 60 days in a work release programme, 250 hours of community service, 5 years’ probation and ordered to repay part of his salary. He was the first person in the USA to face a criminal prosecution for research-related fraud. After his serving his criminal sentence, Breuning opened an electronics shop in Rochester, Michigan and since 2010 seems to have been running a counselling and hypnotherapy service in this area.  (Bibliography and links at the end).

Career timeline

In 1977, Breuning was awarded a PhD in psychology by the Illinois Institute of Technology and was employed for a year in Illinois at the Oakdale Regional Center for Developmental Disabilities. He then moved to the Coldwater Regional Center in Michigan where he collaborated in an NIMH-funded study with Professor Robert Sprague of the University of Illinois who was later to act as whistle-blower on Breuning’s fraudulent research activities. In January 1981, Breuning was appointed director of the John Merck program at Pittsburgh’s Psychiatric Institute and Clinic. In April 1984 he became director of clinical services at the Polk Center in Pennsylvania’s Department of Public Welfare.

Breuning’s research was largely focused upon the treatment of mentally retarded children who had behavioural problems like aggressiveness, self-harm and hyperactivity, similar problems to those of Attention Deficit Hyperactivity Disorder (ADHD) in non-retarded children. Many of these children were treated with neuroleptics commonly called the major tranquilizers. Long term use of the tranquilizers is associated with side effects including tardive dyskinesia which is a Parkinson’s-like condition involving sudden uncontrolled movements of the lips, tongue and cheeks e.g. lip smacking, chewing movements, cheek puffing and sudden protrusion or movements of the tongue. Stimulants like Ritalin have been widely used in the treatment of ADHD in non-retarded children. Breuning’s work seemed to show that these stimulant drugs were more effective than tranquilizers in treatment of hyperactivity in retarded children and had fewer side-effects.

Breuning’s work was particularly influential because there was relatively little research in this area of drug management of hyperactivity in mentally retarded children. According to Dr Alan Poling between 1979 and 1983 Breuning was a contributor to a third of all published research on the psychopharmacology of mentally retarded people. His findings suggested that less reliance on tranquilizers and wider use of stimulant drugs was warranted in hyperactive retarded children both to improve management and to reduce side-effects. His views were incorporated into a widely used and influential handbook Drugs and the Mentally Retarded which he edited with Alan Poling. Breuning’s work had a significant impact on the way that many physicians chose drugs for the management of mentally retarded children. Some US states (notably Connecticut) changed their public policy on the treatment of the mentally retarded because of Breuning’s research and writings.

Suspicions and their investigation

Robert Sprague of the University of Illinois was a collaborator and friend of Stephen Breuning. He used part of one of his NIMH grants to fund a study managed by Breuning at the Coldwater Center in Michigan. This study looked at the occurrence of side-effects like tardive dyskinesia in retarded patients during drug therapy and after withdrawal of drugs. Sprague published a long article in 1993 in the journal Ethics and Behavior in which he explains:

  • How his suspicions about Breuning were first aroused
  • How he tried over several years to persuade academic and grant awarding bodies to take effective action to investigate his suspicions and make their findings public
  • How he believes that his research career was adversely affected by his whistleblowing and attempts that were made to silence him.

Sprague was initially delighted with the large volume of high quality data that Breuning seemed to be generating. The sheer volume of studies that Breuning was generating then made him uneasy because he did not believe that they could have been completed in the number of available study days especially given the limited supply of suitable patients for these studies. This concern was greatly increased when Breuning and his team claimed to have achieved impossibly high (100%) agreement between nurses making independent and relatively subjective assessments of the extent of tardive dyskinesia in patients. In November 1983, Breuning sent Sprague an abstract for a presentation at a conference being organised by Sprague. This abstract purported to be a 2 year follow-up assessments at 6 monthly intervals of 45 out of 57 subjects (i.e. 180 assessments) who had taken part in the already published study on the effect of withdrawal of neuroleptic medication. Sprague did not believe that this follow-up data had actually been collected because this study was conducted at the Coldwater Center which Breuning had left at the start of 1981. He asked Breuning to supply the 180 assessments before he would accept the abstract for a presentation at the conference. When he checked with staff at Coldwater, it was clear to Sprague that Breuning had not collected this follow-up data and in response to his request for the 180 evaluations Breuning produced just 25 evaluations made 4 months after the initial study had finished and even the authenticity of these seemed dubious. Sprague formally reported his suspicions with a detailed rationale for these suspicions to the NIMH on December 20th 1983.

An initial investigation was conducted at the University of Pittsburgh and this found that there was no raw data to support the findings of the initial study conducted at the Coldwater Center and they reported that Breuning had admitted that the data submitted to Sprague in the abstract were false. They did not investigate any of Breuning’s work at the University of Pittsburgh but they noted that Breuning had withdrawn a grant renewal application to the NIMH soon after speaking to Sprague. The report’s authors urged the dean to formally investigate the research practices of Breuning.  The dean of the School of Medicine on receiving this report showing clear evidence of data fabrication at the Coldwater Center wrote to the NIMH advising that he had no grounds to take any actions relating to his activities whilst at Pittsburgh.

The NIMH eventually conducted its own investigation into the matter which issued its final report into the matter on April 20th 1987 i.e. more than 3 years and 4 months after Sprague’s initial letter of concern and more than 3 years after the Breuning seems to have admitted data fabrication to the initial investigators at the University of Pittsburgh. When it eventually arrived this report was unequivocal and the panel unanimous in its findings relating to Breuning including the following statement that Breuning had:

“Knowingly, wilfully and repeatedly engaged in misleading and deceptive practices in reporting results of research”

“He did not carry out the detailed research; and that only a few of the subjects described in publications and progress reports were ever studied

They also found that Breuning had coerced other people into acting as co-authors for his studies even though they did not meet the criteria for authorship and even added names to the author list without the permission of these co-authors.

Effect upon the whistle-blower

In his 1993 article in Ethics and Behavior Sprague discusses in detail some of the adverse consequences for him and his own career of being a whistleblower in the Breuning case, he sums up his experiences by using the title for this article “Whistleblowing: a very unpleasant avocation”! Sprague complains that one of the first actions of NIMH investigators was to investigate him. In the final report there is commendation of Sprague for reporting the matter to the NIMH but also criticism of him for uncritically accepting Breuning’s findings and for failing to adequately oversee the subcontract with Pittsburgh. They partly blame the limited brief of the original University of Pittsburgh investigation for the long delay in concluding their investigation. Sprague had not only made the initial report to the NIMH of his suspicions about Sprague but had also been active in trying to publicise the case and speed up the investigations into Breuning’s activities.

Sprague believes that his involvement in this case played a part in the ending of the funding of his own work by the NIMH. In late 1986, after 17 years of continuous funding by NIMH his request for further funding was turned down despite having received a favourable assessment from the scientific reviewers. The denial by the NIMH that rejection of the grant was not retaliation for Sprague’s activities in relation to Breuning clearly did not convince a Congressional committee looking into the matter. Breuning was threatened with legal action by a Vice President of the University of Pittsburgh for making slanderous and libellous comments in relation to the University of Pittsburgh’s role in the Breuning affair at a Congressional committee hearing. This was despite the fact that statements made at a congressional committee are protected and one cannot be sued for testimony given before Congress. A letter of complaint to the President of the University of Pittsburgh by the chairman of the Congressional committee resulted in a letter of apology to Sprague from the President of the University of Pittsburgh which said that the original threatening letter had been sent without authorisation by the University. Sprague retired from the University of Illinois in 2000 but remained active in the field of drug therapy for the mentally retarded and research ethics and still has a LinkedIn listing.

Bibliography

Holden, C. (1987) NIMH finds a case of “serious misconduct”. Science 235, 1566-7.

Witkowski, T. (2014) From the Archives of Scientific Fraud – Stephen Breuning. Forbidden Psychology.

Breuning, SE and Poling, AD Eds. (1982) Drugs and Mental Retardation Charles Thomas: Illinois.

Scott, Janny (1988) Researcher admits faking data to get $160,000 in funds. Los Angeles Times September 20th 1988.  A contemporary newspaper account of his criminal trial, a report about his sentencing in the same newspaper can be found here.

Sprague, R.L. (1993) Whistleblowing: a very unpleasant evocation. Ethics and Behavior 3, 103-33. Access to this important article requires payment but for non-academic readers an independent commentary/summary can be found here.

 


 

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