Fraud in medical research

1. Fraud in medical research Richard Smith Editor, BMJ September 2001

2. What I want to talk about • Why fraud matters • Britain’s most dramatic case of fraud • What is fraud? • How common is it? • Why does it happen? • What does a country need to respond? • A comment on COPE (Committee on Publication Ethics)

3. Why fraud matters • It’s like child abuse: we didn’t recognise it, now we see alot • It undermines public trust in medical research and doctors • It corrupts the scientific record and leads to false conclusions • Most countries do not have good systems of either treatment or prevention

4. Britain’s most dramatic case of fraud

5. August 1996: a major breakthrough • Worldwide media coverage of doctors in London reimplanting an ectopic pregnancy and a baby being born • Doctors had been trying to do this for a century. It was a huge achievement

6. August 1996: a major breakthrough • Achieved by Malcolm Pearce, a senior lecturer in at St George’s Hospital Medical School in London • A world famous expert on ultrasonography in obstetrics • A story from a paper in the British Journal of Obstetrics and Gyneacology. Pearce was an assistant editor.

7. August 1996: a major breakthrough • A second author on the case report was Geoffrey Chamberlain, editor of the journal, president of the Royal College of Obstetricians and Gynaecologists, and professor and head of department at St George’s. • The same issue contained a randomised controlled trial also by Malcolm Pearce -- and others.

8. Autumn 1996: both papers are fraudulent • A front page story in the Daily Mail exposed the two papers as fraudulent. • It had a full length picture of Geoffrey Chamberlain saying that he hadn’t known that the work was fraudulent despite his name being on the paper. • Chamberlain said it was common within medicine for people to have their name on papers when they hadn’t done much.

9. What had happened? • A young doctor at St George=s Hospital Medical School had raised questions about the two papers. • An investigation was promptly started and showed: • The patient did not exist. • The patients supposedly in the randomised trial could not be found • Among studies investigated back to 1989 - three others fraudulent, two of them in the BMJ.

10. What had happened? • All the papers were retracted. Questions about ones before that. • Pearce was fired and subsequently struck off by the General Medical Council • Chamberlain retired or resigned from all his positions, a terrible end to a distinguished career. • His crime was gift authorship, which was normal at the beginning of his career, scandalous by the end.

11. What is fraud? • The Americans have argued for years over a definition • The Europeans have tended to take a broad view and not attempt a specific, operational definition

12. What is fraud? • Fabrification: Invention of data or cases • Falsification: Wilful distortion of data • Ignoring outliers? • Not admitting that some data are missing. • Post hoc analyses that are not admitted? • Not including data on side effects in a clinical trial

13. What is fraud? • Plagiarism: Copying of data or papers • But by how much? • Stealing ideas? • Redundant publication • Gift authorship. • Not attributing other authors. • Not publishing research • Not disclosing a conflict of interest

14. What is fraud? • We need a full taxonomy • Better we need codes of good research practice--and we now have several

15. How common is fraud? • Obviously depends on how fraud is defined? • How does serious fraud relate to minor fraud? • Are they quite separate? • Does minor progress to serious?

16. How common is fraud? • How many of you know of a case? • In how many of those cases was there a proper investigation, punishment if necessary, and a correction of the scientific record?

17. Study by Stephen Lock • Asked 80 researchers who were friends, mostly British. Not a random sample. • 100% response rate. • Over half knew of cases: • Over half the dubious results had been published - only 6 “retractions” - all vague and not using that term

18. How common is fraud? • US congressional inquiry heard of over 700 cases • The British General Medical Council has dealt with over 30 cases • Committee on Publication Ethics has discussed over a 100 cases

19. How common is fraud? • Redundant publication occurs in around a fifth of published papers • About a fifth of authors of studies in medical journals have done little or nothing • Most authors of studies in medical journals have conflicts of interest, yet they are declared in less than 1% of cases

20. Why does scientific fraud happen? • Why wouldn’t it happen? It happens in all other human activities. • Pressure to publish. • Inadequate training. Not taught good practice. Indeed, sometimes taught the opposite. • Does sloppy behaviour spill over to fraud? • You can get away with it. The system works on trust.

21. What does a country need to respond to research fraud? • A recognition of the problem by the medical community and its leaders • An independent body to lead with investigations, prevention, teaching and research • An agreement on what fraud is • Protection for whistleblowers • A body to investigate allegations • A fair system for reaching judgements • A code of good practice • Systems for teaching good practice

22. Committee on Publication Ethics (COPE) • Founded in 1997 as a response to growing anxiety about the integrity of authors submitting studies to medical journals. • Founded by British medical editors--including those of the BMJ, Gut, and Lancet

23. COPE’s five aims • Advise on cases brought by editors • Publish an annual report describing those cases. Three published (www.publicationethics.org.uk) • Produce guidance on good practice • Encourage research • Offer teaching and training • (Shame the British establishment into mounting a proper response)

24. COPE’s first 103 cases • In 80 cases there was evidence of misconduct. • Several cases have been referred to employers and to regulatory bodies • Problems were • undeclared redundant publication or submission (29), • disputes over authorship (18) • falsification (15) • failure to obtain informed consent (11) • performing unethical research (11) • failure to gain approval from an ethics committee (10)

25. Conclusion • Research misconduct is problem • Most countries have not developed a coherent response to the problem • They need to in order to avoid a collapse in public trust in medical research