When universities stonewall investigations of research misconduct

Last month a doctor who for years was considered a leading figure in the rarefied world of trachea transplants received a pink slip from Sweden’s prestigious Karolinska Institute.

Colleagues had raised doubts about Paolo Macchiarini’s work since 2014, questioning whether he had obtained informed consent from patients, and alleging that he made up results. An initial outside inquiry found that he had, indeed, committed misconduct. But the Karolinska initially rejected that finding, saying that he had only been, well, slightly sloppy.

Then, in January, a story broke in Vanity Fair in which a former girlfriend recounted how Macchiarini claimed to be the personal physician to Pope Francis and to have treated the Obamas, Bill Clinton, and other world leaders. Combined with a very thorough Swedish documentary that raised other questions, suddenly Macchiarini’s oeuvre didn’t look so hot. Within a month, the Karolinska announced that it wouldn’t renew Macchiarini’s contract, and six weeks after that, they fired him, effective immediately.

But the narrative does look familiar. And it wasn’t the first time in which universities — who by US law are the ones that must open an investigation into misconduct — stonewalled the effort.

The other case we’re thinking of is that of former Duke University cancer specialist Anil Potti. Back in 2006, Potti led a team that published a paper in Nature Medicine about a way to tailor patients’ cancer treatments using their individual genetic signatures. In a glowing press release, Duke declared that its scientists “have developed a panel of genomic tests that analyzes the unique molecular traits of a cancerous tumor and determines which chemotherapy will most aggressively attack that patient’s cancer.”

Not everyone was so impressed. In 2007, a pair of statistics experts in Texas raised questions about Potti’s work. Upon analysis, they believed, Potti’s findings weren’t reliable. Potti’s — and Duke’s — response? Thanks for that interesting esoterica, but the results stand just fine. Anyone want to be in a clinical trial? And so hundreds of people with cancer lined up to be in the supposedly groundbreaking study, their treatment determined by Potti et al’s algorithm.

That study was published in The Lancet Oncology. Then, in 2010, Potti resigned from Duke in a misconduct scandal that continues to ripple even today. Last year, the Federal Office of Research Integrity (ORI) announced that Potti had faked data.

So what toppled the Blue Devils’ former golden boy? Not an internal investigation into the veracity of his research, since Duke steadfastly denied there were any problems. What brought him down was a report in a cancer newsletter that the Duke scientist had fabricated his resume to include, among other things, a bogus Rhodes scholarship. That revelation led to an unraveling of lies that, in the end, proved too great an embarrassment for the institution to ignore.

Rewrite the Potti script with new dates and a new research area, and you have the Macchiarini story. And vice versa.

Mats Engelbrektson, the Karolinska Institute’s human resources manager, said of its fallen star:  “He has acted in a way that has had very tragic consequences for the people affected and their families. His conduct has seriously damaged confidence in KI and for research, in general.”

All true, and several senior Karolinska officials have resigned in the wake of the scandal. But what’s also true is that those wounds are largely self-inflicted, avoidable, and, had officials at the Karolinska been paying attention to the Potti case, not terribly surprising. Consider the fallout for Duke: The university reimbursed the American Cancer Society nearly $730,000 in grant money the group had given Potti. Malpractice insurers settled at least a dozen claims against Potti.

On the scientific side of the ledger, the consequences are equally grave. At least 12 papers the disgraced researcher helped write while at Duke have been either completely or partially retracted. And a whole field of cancer research has been tarnished. According to a report by the Institute of Medicine (now the National Academy of Medicine), “failure by many parties [at Duke] to detect or act on problems with key data and computational methods … led to the inappropriate enrollment of patients in clinical trials, premature launch of companies, and retraction of dozens of research papers.”

Even if it were only these two cases in which institutions dragged their feet and ignored clear evidence of misconduct while patients suffered, it would be two too many, but it’s not. We see these sorts of cases play out all the time, with most flying under the public’s radar because they are not so high-profile.

We often hear that institutions are best-equipped to investigate their own researchers because they can make turning over lab notebooks a condition of employment, perhaps first and foremost. And it is certainly true that hard-working research integrity officers at many universities aggressively fight to do the right thing. Universities also, however, stand to lose the most when they have to admit there was fraud in their midst. The reluctance of universities to act is striking and harmful. Perhaps government overseers should have the power to act on their own. That prospect scares many scientists, but if universities don’t clean up their act, it may be time to make a change.