Familiar themes in a new instance of scientific misconduct: the Kuklo case.

The New York Times has an article about a physician-scientist caught in scientific misconduct. The particular physician-scientist, Dr. Timothy R. Kuklo, was an Army surgeon working at Walter Reed Army Medical Center. He is now (for the time being anyway) a professor of medicine at Washington University in St. Louis. Since the wrongdoing of which Kuklo was accused happened while he was at Walter Reed, the Army investigated.

That investigation "substantiated all the accusations against the physician."

The Kuklo case has lots of ethical issues we've seen before. The New York Times article goes through them for the Nth time. That we've seen these same issues in misconduct and "misbehavior" cases on many, many, occasions might make one wonder how scientists, journal editors, and corporate sponsors of research failed to internalize any of the lessons they might have learned from the (N-1) times that came before this one.

After all, they're supposed to be good at spotting trends in the data.

Among the familiar themes in this case, I notice:

The use of made-up or "guest" authors, presumably to bolster the credibility of the paper on which their names appear.

From the New York Times article:

Dr. Romney C. Andersen, a Walter Reed Army Medical Center surgeon, was surprised last summer when his neighbor, a fellow doctor, congratulated him on a new medical journal study bearing his name.

"What study?" Dr. Andersen asked.

Soon, he was not the only person asking questions. Army officials, alerted by Dr. Andersen, began an investigation. They uncovered an apparent case of falsified research by a doctor who had befriended Dr. Andersen when they both worked at Walter Reed, treating American soldiers severely injured in Iraq. ...

The disputed journal article was written by a former Army orthopedic surgeon, Dr. Timothy R. Kuklo, who is now a medical professor at Washington University in St. Louis. Dr. Kuklo, the investigation found, forged the signatures of Dr. Andersen and other Army doctors on his study and never showed it to them before it was published.

The British journal that published Dr. Kuklo's study [The Journal of Bone and Joint Surgery] retracted it in March and has banned him from its pages. His future at Washington University will very likely be determined by an inquiry the medical school is said to be conducting. University officials declined to comment for this article.

Discovering you are an author of a paper you didn't even know existed is not generally a happy surprise, especially if you take seriously the idea that the named authors stand behind the published findings, putting their credibility on the line with the results the paper communicates. Cutting your coauthors out of the loop of preparing the manuscript, sending it out to journals, responding to referee reports on the manuscript, revising, and resubmitting is undermining the constructive engagement between scientists working together that is supposed to result in more objective knowledge.

Indeed, if your coauthors don't even know there's a manuscript, it raises questions about how seriously involved they are in the research, and about how much communication there is in your collaboration. It might even raise questions about whether the research you're reporting actually happened the way you say it did.

The bottom line here is that authors who are unaware of their status as authors cannot exercise their authorial responsibilities to make sure the paper, and the scientific research it reports, meet proper scientific standards. This is not a little thing. It is a big thing.

Sadly, it may be encouraged by the next theme that jumps out of the Kuklo case:

Journals whose procedures seem designed to thwart efforts at due diligence on the part of journal editors and of manuscript coauthors.

Again, from the New York Times article:

The Walter Reed episode also shows how medical journals may fail to conduct adequate due diligence on the studies they publish -- information that other doctors rely on for guidance. As happened in the Kuklo case, for example, they often deal only with a study's principal author, rather than all the credited contributors. In his study, Dr. Kuklo, who has not responded to repeated interview requests, reported that a bone-growth product sold by Medtronic, called Infuse, performed "strikingly" better than the traditional bone-grafting technique used to heal soldiers' shattered shin bones. Other Walter Reed doctors told an Army investigator that claim was overblown.

Dr. Andersen was never contacted by the British Journal of Bone and Joint Surgery that published the paper on which he was listed as a coauthor -- he didn't know about the paper (and his supposed role in it) until it had already been published. How hard would it have been for the journal editors to email all the named authors -- to let them know the manuscript had been received, to transmit copies of the referee reports, to acknowledge receipt of the revised manuscript, etc.?

Or, perhaps I should rephrase the question: Would routine email notification of all the named authors on a submission (using the "cc" feature found in most of your better email clients) be more trouble than retracting papers where one or more of the coauthors indicate that they were not properly involved?

As well, journals to which Kuklo submitted the manuscript and which rejected it were pretty unhelpful to Dr. Andersen -- a coauthor of record -- when he tried to get information about the manuscript he has supposedly been involved in submitting and about the reception it had gotten from the peer reviewers. One of these was a U.S. journal called The Journal of Bone and Joint Surgery (no relation to the British journal of the same name that published, then retracted, the Kuklo paper):

Dr. Andersen contacted the American journal's editor, Dr. James D. Heckman, who confirmed in an e-mail message that Dr. Kuklo had submitted the report in mid-2007. The journal rejected it two months later, sending Dr. Kuklo the comments of an editor and two outside doctors who had reviewed it, Dr. Heckman wrote.

Dr. Andersen, curious about what Dr. Kuklo had actually submitted, asked Dr. Heckman for copies of those reviews. But the editor turned him down, even though Dr. Andersen was supposedly one of the study's authors. In a recent interview, Dr. Heckman said that his journal, like many others, considered such reviews confidential and shared them only with a study's lead author.

"It is all confidential information," Dr. Heckman said, when asked by a reporter for the reviews. "It is protected by the peer-review process."

So, what's the rationale for making the lead author privy to information the journal keeps confidential from the coauthors? Wouldn't the journal editors want all of the named authors to be able to do pre-publication quality control work on the study?

In light of policies of this sort that actually block communication with coauthors, I have to wonder whether journal editors have a very different view of what authorship involves than do many working scientists. Do journal editors mean to give their readership the wrong impression of who is willing (and able) to stand behind the papers they publish?

Undisclosed conflicts of interest and the effects of corporate sponsorship on the integrity of research and researchers.

Not that we've ever had reason to doubt that the motives of those corporate sponsors are strictly honorable ... except for the (N-1) times that came before this one.

From the New York Times article:

Medtronic financed some of Dr. Kuklo's research and travel while he was at Walter Reed and hired him as a consultant in August 2006 when he took his current academic post. But Dr. Kuklo did not disclose his Medtronic relationship in the journal article, which was published in August 2008.

Medtronic has declined to provide the financial details of its relationship with Dr. Kuklo, although the company said Friday that it planned to provide some of that information next week to Senator Charles E. Grassley, Republican of Iowa, who is investigating the matter.

Medtronic has said that it had no involvement in the disputed Infuse study, despite its business ties to Dr. Kuklo. The report was published in Britain last August in The Journal of Bone and Joint Surgery. ...

Infuse, the subject of Dr. Kuklo's study, is a bioengineered bone-growth protein that the Food and Drug Administration approved in 2002. Walter Reed surgeons used it both in certain spinal surgeries and to treat severe leg injuries.

Dr. Kuklo, a spine specialist, also had other research interests that dovetailed with Medtronic's; while at the military hospital, he led five studies financed by the company, Army officials say. ...

Dr. Kuklo, who moved into a $2.1 million home near St. Louis, was not the first departing Walter Reed doctor to get a consulting deal from Medtronic. For instance, it had struck an arrangement with Dr. Kuklo's former boss, Dr. David W. Polly Jr., when he left the military hospital in 2003.

Dr. Polly is now one of Dr. Kuklo's staunchest public defenders. Recently, Dr. Polly blocked a reporter's request that the University of Minnesota, where he now works, release his financial disclosure statement showing how much he made from Medtronic.

At this point, even if Dr. Kuklo had done nothing else wrong, the failure to disclose a financial relationship with Medtronic (the maker of Infuse) to the journals when submitting the manuscript would be a big problem. Not only is it a problem for Kuklo, but it is a problem for Medtronic.

There's a reason this particular article is in the Business section.

When the scientists and physicians that receive funding of various sorts from your company are secretive about it, it looks like they have something to hide -- like getting money from Medtronic might somehow cast doubt on their credibility. As a matter of public relations, this impression is pretty bad for Medtronic.

I'd think the best response to a case like this would be for Medtronic and other corporate sponsors of research to adopt a policy of total transparency: Here's who gets money from us (with the reasons and the amounts), and here's what their research shows (whether it ends up being good or bad for the company's bottom line). This kind of approach might significantly reduce worries about the corrupting influence of corporate money on science.

Digging in one's heels to block the release of information, however, will pretty much accomplish the opposite.

Making up data.

I suppose one reason to keep coauthors out of the loop is that you're planning on reporting the results from studies you didn't actually perform, and you think your coauthors might put the kibosh on this plan.

In his 2005 abstract, Dr. Kuklo had reported only Infuse results. But his August 2008 journal article cited other Walter Reed data to compare Infuse with the traditional bone-graft treatment for fractured shins. He declared Infuse the winner by a wide margin.

Dr. Kuklo said he had reached that finding by reviewing the records of two groups of the soldiers with similarly severe leg injuries, who had been treated either with Infuse or a bone graft. But Dr. Andersen suspected that Dr. Kuklo had fabricated the comparison groups, because many soldiers had received both Infuse and a bone graft -- not one or the other.

"It was like he was comparing apples and oranges," Dr. Andersen said. "But there weren't any apples or oranges to compare."

It would be interesting to see what experimental protocols the Walter Reed IRB might have approved here, although there's no guarantee that the IRB exercised enough direct oversight that it would have flagged a departure from the protocol if it happened.

In any case, if Andersen was really involved in the research, the results were not what Kuklo reported them to be. If Andersen was not really involved in the research, then listing him as a coauthor was a lie.

Forging signatures in a pretty clear attempt to deceive.

In a recent interview, Dr. Polly, the former Walter Reed physician who is now a Medtronic consultant, said Dr. Kuklo was mistaken to sign his co-authors' names. But he added that was not uncommon in the military for one officer, when it was expedient, to sign for another.

Dr. Kuklo, however, did not indicate that he was signing his four co-authors' names on their behalf. He even used a distinctively different handwriting style for each of them, a form he submitted to the British journal shows.

Regardless of what kind of behavior might be common in the Army, if one is interacting with scientific and medical journals, one is supposed to play by their rules. As well, since at least one of the coauthors in the Kuklo case didn't even know about the paper in question, the "expedience" excuse is pretty weak.

The reaction of Kuklo's colleagues to the investigation.

The physicians and physician-scientists who worked with Kuklo at Walter Reed had both professional and personal relationships with him. They shared not only a working environment, but a professional community whose members count on each other to uphold the standards that make it possible for them to accomplish their shared goals (of responsibly treating patients and of building good scientific knowledge, among others).

So how did his colleagues react?

Colleagues and friends of Dr. Kuklo say they are shocked by the accusations against him and predict he will eventually be cleared of any wrongdoing.

"I think that Tim is a brilliant researcher and surgeon," said Lt. Col. Richard C. Rooney, a spine surgeon at William Beaumont Army Medical Center in El Paso, Tex., who knows Dr. Kuklo and his work. "I don't believe the accusations. I don't care if the head of Walter Reed made them."

It is true that our starting point is to take the credibility of other researchers on faith. But is this really something scientists and physicians ought to do in the face of contradictory data?

That doesn't seem entirely compatible with a scientific approach to the world.

To be fair, not all of Kuklo's former colleagues are circling the wagons:

Later this month, Dr. Andersen expects to return to Walter Reed from Baghdad, to take a new position as the hospital's chief orthopedic surgeon He says that it has been difficult to reconcile the Dr. Kuklo he knew with the false research he says he believes his former mentor published.

"When your impressions of someone are that they would never do something like this, it was difficult for me," Dr. Andersen said. "But the more I looked at the data, the more I said this just can't be close to being true."

It's one thing to decide that Kuklo is not a fundamentally evil person, that he's basically a good guy (who, if he did something wrong, must have done so under extraordinary circumstances). It's quite another to decide that, because he's your friend and colleague, he must be trustworthy in the scientific results he reports.

Scientists, like measuring devices, need to be calibrated. This is just one reason why replication of results is so important. Good scientists want a heads up when their results might be faulty. Thus, it's no kindness to try to insulate a fellow scientist from deserved criticism -- or even from questions trying to get to the bottom of behavior that flies in the face of the professional community's commitments.

Evidence suggestive of fabrication, falsification, and efforts to deceive fellow scientists may not require that you believe your pal is a bad person. However, such evidence does require you to explore the possibility that your pal is a bad scientist.

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In relation to your points about keeping other authors in the loop, journals require designation of a single corresponding author for pragmatic reasons. Editors are busy, and they want to only have to deal with a single author concerning each manuscript. They do not want to have to mediate disputes between authors, nor do they want to have to engage in correspondence with multiple authors.

CPP's point that editors normally need a single point of contact is reasonable, but only under ordinary circumstances. These were not ordinary circumstances. Rather, a listed co-author was telling the editor that the manuscript was submitted without his knowledge or consent.

The confidentiality argument is specious. If Dr. Anderson really was a co-author, then nothing in the manuscript should be unknown to him. If not, then it's ludicrous to argue that the peer review process should help maintain the confidentiality of an act of fraud.

Additionally, that manuscript was sent out, reviewed, and rejected, probably by colleagues who know Dr. Anderson, at least by reputation. What claims did the manuscript make in his name? Without a copy, he has no way to know.

I think the journal editor was ethically obligated to provide Dr. Anderson a copy. (Perhaps there are legal barriers, but the editor apparently didn't mention any.)

CPP's point that editors normally need a single point of contact is reasonable, but only under ordinary circumstances. These were not ordinary circumstances.

Agreed. I was responding to what I perceived to be Janet's suggestion that other authors than the corresponding author should be included in communications as a matter of course.

Some journals do send out email notices of submissions to all authors. I think JAMA does, for example.

With any luck, the next step would be to allow electronic submission of all the forms, so that fax machines could finally be banished to their proper retirement community with Betamax video players and pet rocks.

As a former military officer, I would point out that, while yes, officers will sign documents in the name of other officers when expedient, they sign their own name (perhaps adding 'under direction of' or 'for' the other's name, as appropriate). Signing another's name is a violoation of an officer's professional code of ethics.

Eric Riley

By Eric Riley (not verified) on 09 Jun 2009 #permalink

1) The post says there are six comments, but only five show up, even on refreshing.

2) I wonder if there's an "Academic Dishonesty" bingo card lurking in all the data (though I didn't read comments about an "international court of appeals"). Academic cheaters sound a lot like people who get caught using 'roids, or amphetamines, or female fertility drugs as masking agents for 'roids (the 'roids were always a component in a supplement, whose maker we will claim to sue for not telling us about the steroids they were putting in there, and we will pretend that the steroids had nothing to do with the "Build Muscle Fast!" claims on the box). After hearing the same lines fifteen times, the only optimistic thing that I can glean from the comments is that the accused might be too dumb to cheat, or they all get the same lawyers.

Employment outside of the military requires approval from superiors. Apparently he did not have this. Also, Kuklo did not leave the military until March 2007, yet was full time at Wash University in Aug 2006. it is impossible to accrue enough military leave to cover this time span. The maximun consecutive days of leave possible is 90 days, thus if he retired March 1 07, the earliesy he could have left Walter Reed would have been Dec 2006.

It appears he was AWOL and triple dipping (Army pay +Medtronic pay + Wash University pay) all at the same time. This all points to a very elaborate though out plan to make money - unethically. I wonder why this issue is not discussed