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Law profs attack guest authorship of medical studies

TORONTO - Two professors are using a strong five-letter word - fraud -to describe what can happen when academics or scientists assume guestauthorship of medical studies without actually having a hand in thework.

TORONTO - Two professors are using a strong five-letter word - fraud - to describe what can happen when academics or scientists assume guest authorship of medical studies without actually having a hand in the work.

The practice is condemned in an article appearing in the journal PLoS Medicine on Tuesday, penned by Simon Stern and Trudo Lemmens of the faculty of law at the University of Toronto.

Stern said the public gets a slice of what's going on when it comes to light during lawsuits, for instance when large pharmaceutical companies are sued in negligence class actions by patients who have suffered bad side-effects from drugs.

“One of the things that becomes clear in some of these cases is that what seemed to be objective, disinterested studies published in medical journal articles were actually sponsored and conducted by the pharmaceutical itself,” he explained.

“The academic doctors whose names appeared as authors on the articles were added very late in the day and had very little involvement in the study except for perhaps reviewing the final draft and thinking that it looked legitimate and being willing to sign their name to it on that basis.”

He and Lemmens describe this as a disturbing violation of academic integrity standards.

Leading medical journals have made a good effort to crack down on this by requiring someone who wishes to be designated as a lead author to sign a form satisfying authorship requirements, under guidelines from the International Committee of Medical Journal Editors, or ICMJE, Stern said.

“It's been suggested that universities ought to be more vigilant in policing their faculty members. It's been suggested that medical journal editors might take more aggressive steps, or that medical licensing organizations might sanction members of their organization for doing this sort of thing,” Stern said.

“We've proposed a theory of legal liability because it's become clear that these other actors, for whatever reason, haven't stepped up to the plate.

“And so the hope is that if there's a powerful theory of liability that would bring home to these academic doctors the point that they are engaging in fraud, that it's a form of legally actionable fraud, and that they could be on the hook for the damages that result, that that might be an effective way of deterring them from lending their names to these articles and being complicit in this practice.”

Amir Attaran, a professor of law and medicine at the University of Ottawa, said he thinks Stern and Lemmens have come up with something that is “theoretically interesting but practically impossible.”

“I don't see the remotest chance of a prosecution taking place on the basis of what the authors have described,” he said in an interview.

“But it is useful to think about - certainly good food for thought.”

Dr. Paul Hebert, editor of the Canadian Medical Association Journal, said he takes issue with the U of T authors' suggestion that medical journals haven't taken the problem seriously.

“Well, that's not true. This is a big deal for us and many other major journals. ... Frankly, ghost authorship is a big deal. We find out about this, this is scientific misconduct,” he said.

And he said that “99.9 per cent of authors are honest and uphold the standards we promote.”

At CMAJ, study authors are asked to provide contributorship statements that spell out what they actually did, Hebert said.

There are opportunities for problems to come to light because peer reviewers or editors suspect something, or if there's a whistleblower, he added.

Udo Schuklenk, a professor of philosophy at Queen's University, said he believes Stern and Lemmens may have a point because it appears that self-policing has “completely failed.”

He's not a lawyer, so Schuklenk is careful about judging the question of whether or not in a legal sense this is fraud.

“Where I think there is no doubt in my mind as an ethics person that this is fraud is if a pharmaceutical company is massaging data, creating fake studies, and then you have senior academics for payment adding their name to studies that they have not undertaken,” he said.

Editors of medical journals don't have the resources to investigate every single paper they get, so to some extent they must rely on trust, he said from Kingston, Ont., where he is joint editor-in-chief of the journals Bioethics and Developing World Bioethics.

He noted that authors of studies in medical journals normally have to declare conflicts of interest.

“Most journals put all of this in the public domain and you can actually look @ what the situation is. If you discover that the senior author got paid like a million dollars from a pharmaceutical company, I would be really concerned.”

Still, he said doctors are busy and have no time to read full articles and check for possible conflicts of interest as they're prescribing drugs to their patients.

Stern said that any case for legal fraud - “a person makes a knowingly false representation in order to acquire something of value, and harm occurs as a result” - would go back to ICMJE certification.

“The journal wouldn't have published the article had the person not misstated their own role in bringing the article into being. And that misstatement, that falsity, is passed along to readers who are typically doctors who are well aware of the publication requirements of leading medical journals,” Stern said.

Readers could be misled into thinking a study was conducted in a disinterested objective way by an academic researcher, when in fact it was worked up by a pharmaceutical and a medical writing company, with the aim of finding a favourable result for the drug, or at least with all the subtle biases that creep in when you're conducting a study in which you have a stake in the outcome, Stern said.

Schuklenk said very few people have tackled this issue.

“It's David and Goliath really, and Goliath at the moment is winning hands down.”

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