Thursday, February 5, 2015

Third year med student brilliantly teaches Integrity 101 to professors at Duke . . . and to all of us

I wish my field had something like the Cancer Letter.

Not sure how much this story has been chronicled outside of coverage in the Cancer Letter. Maybe the story has been widely disseminated and I just missed it before.

It is a truly impressive example of integrity. In a nutshell:

1. Duke third year medical student opts to do required third year research project in the lab of a rising star at Duke, Anil Potti.  Potti was collaborating with and working under the wing of a another, very prominent Duke faculty member running a large genomics program, Joseph Nevins.

2. Clinical trials were being designed and run--enrolling terminally ill cancer patients--on the basis of Potti's work.

3. The medical student becomes concerned about the research--based on reviewers' comments on a submitted manuscript--and acquires a sophisticated knowledge of the complex topic (analyzing large datasets from genetic studies and identifying markers of tumor susceptibility to specific therapies). His knowledge of the research rapidly advances to the point where he feels comfortable challenging the way the research is being conducted.

4. The student has enough confidence--and courage--to take his concerns up first with Potti and then, up to the next level, with Nevins, and then with the medical school leadership at Duke.

5. Remember, this is a third year medical student doing a required one year research project. He is planning to apply for a competitive residency program and not to go into research.  Potti is pressuring the student to get the manuscript out; if not to the journal that is asking questions, then to another one.  He has nothing to gain here by making waves and the paper would greatly bolster his chances of landing his desired residency.

6. The student next kicks his concerns up to Duke's associate dean for medical education and its director of student affairs. The former suggests that he reiterate his concerns to Nevins. The student then (March, 2008) writes a nuanced, clear memo of his research concerns. The Cancer Letter states, "According to top-tier biostatisticians who were asked to review these documents, his understanding of biostatistics was extraordinary for a med student—or even for someone with specialized training."  Impressive, no?

7.  Nevins "implored" the student not to take his concerns any further, according to the Cancer Letter, "because he did not want Duke or any other entity looking closely at the data underlying the clinical trials [that were ongoing and based on Potti's results]."

8. The Cancer Letter says:
Dr. Nevins validated many of Brad Perez’s [the student's] concerns by referring to the serious issues raised regarding Dr. Potti’s lab as “being somewhere along the spectrum between sloppy research and a difference of opinion to research fraud,” and that Dr. Nevins confirmed that he would “go back through each and every dataset that we have posted in relation to various publications to ensure that there are no errors.”
9. The student, having taken his concerns to Potti's sponsor (Nevins) and high up the chain at Duke then moves on.

And get this,
  • 10. He declines to resubmit his first author paper despite co-authorship with and reassurances from prominent Duke faculty members that all was above board and any errors would be fixed
  • 11. The student asks to have his name taken off every other paper from the laboratory--there are a number--on which he is listed as a coauthor.
  • 12. The student returns a merit award he received based on the research in question and turns down an opportunity to present at a major meeting
  • 13. He decides to repeat his third year of medical school rather than present or publish any results based on the flawed work in the Potti lab 
  • (and all this despite an upcoming application to a competitive residency program)

Epilogue:   The student wrote his letter of concern in April, 2008. According to the Cancer Letter, Duke administrators--aware of the letter--met in October 2008 to discuss Potti. Meanwhile, outside experts began to raise concerns. Nevins continued to defend the work and the ongoing clinical trials. Duke allowed the trials to continue.

In 2010 there was a slew of retractions of Potti's work--Lancet Oncology, Nature Medicine, NEJM, etc.--Potti left Duke, and the clinical trials were, late that year, finally halted. In March, 2011, Nevins admits "nonrandom data corruption."  The Cancer Letter has discovered that Duke--where Nevins still works--misrepresented its knowledge of the medical student's concerns and put out a false timeline regarding when they became aware of potential problems. Duke is currently being sued by participants in the cancelled trials.