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Fraud and Misconduct in Biomedical Publishing

Candlish J. The jurispruential nature of fraud in biomedical publishing. Medical Law 27, 285-305 (2008)

Bird’s Eye View
What do we identify as fraud? Guidelines from editors A sample case Professional versus legal sanctions Detecting and preventing fraud What to do if accused of publishing fraud

In rough order of perceived heinousness (wickedness), is it fraud to…..
- Slice a piece of work into overlapping segments to produce multiple papers? (“salami slicing”) - Persuade a distinguished person otherwise unconnected to put his/her name on a paper otherwise difficult to publish? - Put your boss’s name on every paper so that he will support your promotion? (Indeed some bosses insist on this - promotion or not.) Also, spousal reciprococity ensures spousal support. - Overlook the “massaging” of results by a coworker in the interests of getting the paper out?

- Allow your name to be put on a paper because you (merely) read the draft and correct some syntactical errors?
- Put the name of a young colleague on the paper because he will not be awarded a new contract in default of a publication? (The general public might find this rather laudable, perhaps!)

- If you are the chief, overlook publishing fraud in a subordinate because disclosure thereof will ruin his career (and tarnish the reputation of the unit/university/nation? - Refrain from pointing out, in some way, the activities of a colleague with a bee in his bonnet (hyperenthusiastic for his theory), who is exaggerating his results to the media.

-Ghost author a paper for a drug company in the knowledge that this will enhance the value of its product, whether or not you believe this to be the case? - Invent patients/subjects in a clinical trial when they become scarce, in order to finish the project and receive the fee/promotion/travel benefits attached? - In numerous scenarios, suppress unwelcome results, perhaps for a drug company, perhaps to protect your theory and therefore your fame?

(Plagiarism is another issue not dealt with here.)
……so are these breaches of ethics, or corruption, or sharp practice, or criminal behaviour, or practices actionable in civil courts?

Criteria for authorship from the International Committee of Medical Journal Editors
Authorship should be based only on a substantial contribution to:

A Conception and design or analysis and interpretation of data and B Drafting the article and revising it critically for important intellectual content and C Final approval of the version to be published. Note: the criteria are conjunctive. But do the editors check? And what happens when the perpetrators are found out? (The result in any case is “polyauthoritis giftosa “ See Kapoor, VK Lancet 1994;346:1039.)

Some famous cases - 1
Alleged perpetrator(s) Issues

L Pasteur 1880s
G Mendel 1890s Gallo 1980s Baltimore 1980s Sir Cyril Burt 1930s Dr W McBride 1970s Dr J Darsee

Now known to have fudged some results
His assistant supplied the results that he thought Mendel wanted Dispute as to priority for HIV virus Alleged fraud in Baltimore’s lab, successfully denied Invented data and published them in own journal to defend hereditarian views. Fraudulently tried to show that any drug given to pregnant woman is harmful 53 fraudulent papers from Harvard

Famous cases - 2
Perpetrator(s)
Dr S Shorvon 2000

Issues
Manipulating numbers of patients

Dr M H Williams 1998 Untraceable telephone interviews Dr Goran Jamal 2003
Dr Aws Salim 1995 Dr N Shankat 2003 Prof M Baum 1995 Profs H Baum and T Peters 200

Falsifying results of a drug trial to boost sales
Over 60 spurious papers Altered mortality data showing Indians suffer more from coronaries than Europeans Concealing knowledge of spurious paper Concealment of fraud in papers from King’s College

Some recent cases
Wakefield - MMR vaccine and autism Stapel – fake social psychology papers. Hwang Woo-suck

Retractions are Rising Steadily

A Case in Point (Gift cum Ghost authorship)
In 1995 Dr Malcolm Pearce published a paper claiming that a patient had given birth to a healthy baby after he had successfully relocated a five week old ectopic embryo via the cervix.

His HOD Prof “Bodger” Chamberlain accepted coauthorship and published it in the Brit J Obstet and Gyn, or which he was chief editor. The paper received international acclaim. Suspicion was aroused by the large number of women cited in the paper and also because nobody in St George’s was aware of the ongoing work. Perce was struck off.

Prof Chamberlain resigned as editor and also as President of the Royal College of Obstetricians and Gynaecologists.
Dr Pearce was found guilty of serious professional conduct by the GMC. Were these condign “punishments”……………………..?

The tendency seems to be to apply professional sanctions only.
The criminal law has had no place in this context, so far, except in USA…………………..

In Alamaba in 2007 Dr Anne Kirkman Campbell was involved in a clinical trial antibiotic Ketex. She was paid for each patient recruited. This included her entire family and her nurses, making over 400. No drop-out was recorded. She was convicted of using the US mails to defraud, and sentenced to 57 months in prison. In 2010 Massachusetts anaethesiologist Prof Scott Reuben was given six months for fabricating results favourable to such gdugs as Celebrex.

It has been pointed out that patients might be harmed , or even killed, by the application of conclusions in fraudulent papers, based on clinical trials or otherwise. Since medical ethics/medical law is expanding as rapidly as medicine itself, in future, a manslaughter charge is not inconceivable, based on legal concepts of knowledge and recklessness. If the fraudster is financially rewarded as a result of the spurious paper, he could conceivably be charged with obtaining financial advantage by deception under the appropriate Theft Act or Penal Code. In Malaysia S 415 (“Cheating”) might be appropriate (5 years with or without a fine).

On this latter point, to quote the medical whistleblower Dr Peter Wilmshurst (Brit Med J 2003; 327: 113):

“…..journals and academic institutions fail to recognise the venality of some researchers for whom getting research published is worth a great deal of money. The gains from dishonest research are great…” ……and he offers the following solution which is to put in place robust random checks on raw data, rather in the manner of drugs tests at sporting events.” Is this workable or not?

Many of these cases involved feckless collaborators. How can you detect fraud/ sharp practice for self-protection if you are asked to insert your name on a paper, or if you are an - editor (or a grant assessor):

Look at the statistics. Are the standard deviations impossibly small? or has the perpetrator changed the mean but forgotten to change the s.d.? Or is there a preference for certain numbers? In this connection Benford’s law may be useful

- Are there cited, in the draft paper, large numbers of patients with unusual conditions?

Or alternatively, in any case, are there preternaturally large numbers of patients or even normal subjects?

-

- Do you suspect -

excessive elimination of outliers?

If a tight correlation is claimed, insist on seeing the scatterplot.

-Were colleagues aware that the research was ongoing? Did the culprit author mention his work to colleagues? -Talk to the technical staff who did the benchwork/ interviews/examinations. They have much less of a financial and/or prestige stake in publication than the principals. (A novel suggestion?) - Is a colleague becoming obsessive or fanatical about a theory or technique? - Does the work in question produce perfect or near perfect results, while identical or similar projects produce scatter or negativity? The golden rule is never allow your name to be appended to any document you have not closely scrutinised

What happens if you are wrongly accused of fraud ? You can sue the accuser in libel (or slander if the accusation is spoken) and obtain damages because your reputation has been sullied in the eyes of rightthinking citizens. Make sure you can stand costs if it goes against you. Recently (1997) a Dr Peter Nixon had to drop his libel case against a T V company which (correctly) accused him of attributing a whole range of diseases to hyperventilation, and he had enormous costs. You must insist on a full hearing according to the principles of natural justice. (Ridge v Baldwin, 1963) If dismissed, you can bring an action for wrongful dismissal.

Who is going to accuse you of fraud?

Not the editors of the journals, according to S Lock, ex-editor of BMJ, they are too much afraid of libel actions.
Others ( journalists, TV producers, colleagues, superiors) may not be so hesitant. What are the possible charges?

Unprofessional conduct (by professional bodies and/or employer) and …………

Possible legal action (confined here to civil law)

Tort of deceit Tort of passing off Tort of conspiracy Misfeasance in a public office

In general the plaintiff in a tort action has to

prove loss of some sort (even if only loss of reputation, possibly) so the categories of persons with standing to sue are limited.

Denying Knowledge of the Fraud
Can the scientist accused of a publishing fraud deny all knowledge of it? Knowledge comes in degrees, as evinced by the English Court of Appeal in the Baden Delvaux (1992) case (which involved breach of trust)
1 Actual knowledge of the relevant facts (blindingly obvious

fraud) 2 Wilful shutting one’s eyes to the obvious (the Nelsonian touch)

3

Willful and reckless failure to make enquiries that an honest and reasonable person would make (can’t be bothered) Knowledge of facts that would indicate the obvious to an honest and reasonable person ( too obtuse to smell a rat) Knowledge of circumstances that would put an honest and reasonable person on enquiry (let sleeping dogs lie)

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Conclusions
Fraud in biomedical publishing is a rich broth of ethics, law, economics and psychology. Fraud in biomedical publishing can take many forms. It can happen anywhere (or maybe not?) One can become involved unwittingly ( or due to politeness). The result will often be loss of employment, professional standing, or promotion, with legal sanctions in the background. There are ways to avoid being involved.

There are remedies if wrongly accused.