Duke is Capable of Acting Quickly on Misconduct …

Update: The Economist covers the entire story (through Sept 2011).

Update: The NYT ran a front-page story on the Potti case … but neglected to comment on Potti’s hucksterish Website.

Update: Another Potti publication, J Clin Oncol 2007;25:4350-7, has been retracted. Details can be found on RetractionWatch.

Update: The IOM now plans to investigate the Potti case and the issue of -omics-based clinical trials more broadly (i.e., whether these biomarkers/predictors are sufficiently robust to support scientifically and ethically sound clinical trials).

Update: On Sunday, Duke and other participating sites (again) halted the 3 clinical trials based on Potti’s earlier results. This morning, Rob commented on the lack of local media coverage of the Hellinga case but the quick reporting of Duke’s rapid action taken against Anil Potti:

Durham’s media has been absolutely silent on the Hellinga debacle. The did, however, take note of another pompous liar in the medical center ranks:

http://www.newsobserver.com/2010/07/17/585434/duke-scientist-placed-on-leave.html

Our friends at GenomeWeb have also alerted the scientific community to detective work by The Cancer Letter (also noted on their blog):

… one of Potti’s biographical sketches says he was a “Rhodes Scholar (Australia)” in 1995 and another says he held a “Research Fellowship at Queensland Research Institute, Australia (Mentor: Gordon McLaren)” at that time. “We don’t have any record that Anil Potti was a Rhodes scholar,” a Rhodes Trust spokesperson told The Cancer Letter. In addition, Rhodes says that its scholarships may only be used to study at the University of Oxford.

Furthermore, McLaren was “‘shocked,’ ‘saddened,’ and ‘flabbergasted'” to learn he was listed as Potti’s mentor in Australia, according to the newsletter. The Cancer Letter goes on to describe other inconsistencies on Potti’s résumé, including the year he graduated from medical school and an assertion that he was a National Merit Scholar.

According to The Cancer Letter, Potti claims to have worked under McLaren at the “Queensland Research Institute” (which does not exist). The Queensland Institute of Medical Research, which does exist, does not have any records of Potti having ever studied or existed there.

GenomeWeb also includes links to Potti’s 2006 Nature Medicine article, Genomic signatures to guide the use of chemotherapeutics, plus 2 corrigenda to correct errors in 2007 and 2008 (MD Anderson biostatisticians found the errors, as reported by Nature Medicine, which also noted Duke’s reluctance be entirely forthright about their outside review of 3 suspended clinical trials that were resumed this January).

According to the Durham News Observer:

“Duke is aware of the allegations raised in the article regarding Dr. Potti and has instituted a formal internal investigation,” Duke spokesman Douglas Stokke said Friday afternoon. “Dr. Potti has been placed on administrative leave pending the outcome of the investigation.”

… On Friday, the American Cancer Society suspended payments to Potti’s grant pending its own investigation.

“We are profoundly concerned to learn that a Duke University researcher made claims about his credentials in applications to the American Cancer Society and others that may not be true,” said Otis W. Brawley, the American Cancer Society’s chief medical officer.

It isn’t clear whether a false biographical claim would put a federal research grant in jeopardy. NIH spokesman Don Ralbovsky would say only that “it is NIH policy to neither confirm nor deny that a review has been initiated or is under way.” [Potti is PI on 5R01CA131049-02 and 1R01CA136530-01A1]

… If he did falsify his biography, Potti may have committed a crime. The federal False Claims Act prohibits, among other things, falsifying applications in order to receive grant funding.

“It is most certainly unethical,” said Peg Vigiolto, UNC-Chapel Hill’s associate vice chancellor for research, speaking generally and not about Potti specifically. “And it would most certainly initiate all sorts of scientific integrity questions.”

Indeed.

As a side note, this issue of The Cancer Letter also covers Harold Varmus’ return to NCI, and his distinct lack of enthusiasm for megascience, giving preference to work done by individual scientists.

43 Comments »

  1. noblesse d'epee said

    Astounding. Duke has no problem going after Professor Potti’s allegedly fabricated CV claim of a Rhodes Scholarship, but can’t bring itself to take action on Hellinga’s scientific fraud. Duke’s ethics are indeed shitty, Potti nonwithstanding.

  2. whimple said

    Well, it’s much more clearcut in the Potti case with documented evidence of outright fabrication. Potti doesn’t have a sloppy-science shield to hide behind.

  3. scotus said

    Fabrication of credentials on a PHS grant application is grounds for a finding of scientific misconduct as these golden oldies from the research misconduct archives attest.

    http://grants.nih.gov/grants/guide/notice-files/not94-244.html

    It sounds as though Potti’s goose is cooked but if he’s facing termination and has some money to spend on legal representation it might be interesting to see him claim that he’s being scapegoated for misbehavior thats not directly research related while credible allegations of bona fide research misconduct against other faculty go unanswered. Its not like there aren’t plenty of research savvy lawyers in the RTP area that might be willing to take this on.

    Of course, it also sounds as though Dr Potti has been responsible for some at best sloppy research so maybe the allegedly bogus Rhodes Scholarship will be the least of his problems.

  4. scotus said

    The Suprennant case was of interest to me at the time because we were working on the same class of receptors and I regarded her research as being pretty sound.

    A quick google search revealed that she’s been up to mischief again:

    http://www.timesonline.co.uk/tol/news/uk/education/article6824795.ece

  5. If this douchebag is brazen and stupid enough to lie about something like a Rhodes Scholarship on his biosketch, dollars to donuts he’s been faking data.

  6. Holy fucknoly! This Suprenant douchebag lied about having a motherfucking MD, and she managed to become a motherfucking professor at University of Manchester!?!?!? I thought Manchester is a legitimate university?

  7. scotus said

    Suprenant’s husband is currently a Dean level administrator at the University of Manchester which as you note is a reputable institution.

    http://www.mhs.manchester.ac.uk/aboutus/keypeople/alannorth

    I think he’s reasonably well regarded (or at least not a pathological liar and general scumbag like his wife) which is probably why they have been able to move around every time she self destructs.

    Strange how these scientist couple arrangements seem to provide some level of functional immunity from the consequences of research misconduct…

    • noblesse d'epee said

      When Hellinga was flying high with his NIH Pioneer Award, (most) faculty and administrators looked the other way when his wife, Duke Biochemistry Prof. Lorena Beese, behaved unethically toward graduate students and colleagues. With Hellinga’s stock in free-fall, I cannot help but wonder if Duke fears upsetting Beese (now a member of the NAS, perhaps not strictly due to scientific merit) by disciplining Homme. I’ve been told by faculty that they have been hesitant to publicly assail Hellinga’s fraudulent science, for fear of Beese’s reaction. Situations like these demonstrate why married faculty should *never* be hired to work in the same department unless they run a joint laboratory.

  8. scotus said

    Not all husband-wife faculty are evil. As I recall, you have another example of a decent pair of husband wife faculty (who I realise share a lab) in the Biochemistry Department at Duke. Unfortunately in academica research funding and status confer power and this is multiplied (not added) when you are dealing with a couple.

    The Potti biosketches posted on the “cancer letter” blog site are a shocking example of rampant deliberate embelishment and obfuscation. Along with the “Rhodes Scholarship” some undergraduate support he received in India is referred to as a “National Merit Scholarship” presumably in the hope that someone would think he had received the US equivalent. I suspect this goes on a lot, particularly in cases where hard to document foreign credentials are extrapolated to US qualifications. A particular peeve of mine is that several US based German trained researchers in my field who did what would translate literally as an “MD Thesis” (a short relatively modest research project) during Medical school (which they enter from high school) refer to themselves as having an MD Ph.D. degree, even in grant applications. Maybe one effect of the Potti case becoming more widely known is that people will be more conservative when “translating” foreign credentials for inclusion in their biosketches?

    We really need an edit function around here. I just noticed that I misspelt “liar” in my above post. [edit function kicks in upon request – see above – writedit]

  9. Joe D. said

    At least the student journalists have kept an eye on it.

    http://dukechronicle.com/article/questions-linger-about-hellinga-case

  10. scotus said

    Apparently the University of Iowa can also act with urgency. However, at this point its unclear what crimes and or misconduct Dr Hunninghake has allegedly committed. Whatever happened necessitated search warrants, computer confiscation and precipitated a bizarre fake mugging report that is now the subject of a separate court case. The university considers the matter serious enough for him to be put on leave and replaced as PI of Iowa’s ~$6M/year CTSA grant.

    http://www.press-citizen.com/apps/pbcs.dll/article?AID=20107220317

  11. Sabrosa said

    Geez, you guys are missing the big picture here! The big story isn’t about him pretending to be a Rhodes scholar, it’s about another Duke coverup as Cancer Letter found out; Duke lied about the results of the investigation! Truth thanks to Freedom of Information Act!

    ========================
    From http://cancerletter.com/tcl-blog/copy148_of_whats-going-on-with-nih/CL36-27.pdf

    The two raised questions about Duke’s randomized phase II single-institution trials that used the Nevins and Potti technology to assign patients to treatment (NCT00545948, NCT00509366, and NCT00636441). Baggerly and Coombes argued that these trials “may be putting patients at risk.”
    After publication of this paper, Duke suspended the three trials, one of which (NCT00636441) was co-sponsored by the Department of Defense (The Cancer Letter, Oct 2, Oct. 9, Oct. 23, 2009). It’s not publicly known whether Potti’s biography submitted to DOD listed the Rhodes credential. A FOIA request for the application is pending.
    The university’s internal investigation at the time included a review of the scientific underpinnings of the trials. Duke’s Institutional Review Board turned to three directors of cancer centers and a separate, independent panel of biostatisticians. Sources said three biostatisticians were involved.
    Citing recommendations of these panels, Duke officials restarted the trials. This was announced in a statement signed by two Duke deans, who declared that “an examination of the underlying scientific methodology that had been published by the Duke investigators, and used in these trials, was confirmed by reviewers’ own independent analysis using the respective datasets and prescribed methods of analysis,” which led the reviewers to conclude that “the approaches used by the Duke clinical predictors are viable and likely to succeed.”
    The statement was signed by Michael Cuffe, vice dean, medical affairs, at Duke University School of Medicine, and Sally Kornbluth, vice dean for research (The Cancer Letter, Jan. 29).
    However, some very important information remained shielded from public view at the time Duke made its announcement. First, the text of the report prepared by outside scientists was not released. “While the reviewers approved of our sharing the report with the NCI, we consider it a confidential document,” Cuffe said to The Cancer Letter at the time.
    Also, Duke never identified any of the outside experts who were consulted.
    Duke officials apparently didn’t realize that sharing the report with NCI was inconsistent with their intent to keep it confidential.
    Once the report made its way into the institute’s hard drives and file cabinets, it became subject to provisions of the Freedom of Information Act, and was obtained by The Cancer Letter.
    The report and a related document are posted at http://cancerletter.com/special-reports.
    The documents were redacted to eliminate the names of individuals involved in Duke’s investigation and to protect trade secrets and patentable data.
    Experts asked by The Cancer Letter to review these documents noted that Duke deans Cuffe and Kornbluth were inaccurate in their description of the document’s substance and conclusions when they announced completion of the investigation and resumption of the clinical trials earlier this year.
    “Having read the committee’s report, we must disagree with Duke’s representation of the committee’s findings,” Baggerly and Coombes said in an email after reviewing the documents released under FOIA. The committee stated that “In our review of the methods … we were unable to identify a place where the statistical methods were described in sufficient detail to independently replicate the findings of the papers,” and further noted that the Duke investigators “really need” to work on “clearly explaining the specific statistical steps used in developing the predictors and the prospective sample assignments.
    “Duke’s statement implies other members of the scientific community should be able to replicate the reported results with the data available,” Baggerly and Coombes said. “Having tried, we can confidently state that this is not yet true.”

    • noblesse d'epee said

      Ack! This case is much worse than I initially realized.

      I wonder if my favorite Duke functionary, “Dr.” Wesely Byery, was involved with Duke’s internal investigation. I’d hazard a guess that the entire investigative effort (by the university) was undercut by several different conflicts of interest.

      • scotus said

        Is Michael Cuffe also involved in the Hellinga investigation?

        Cuffe’s comments in the N&O indicate that the Potti resume issues (which can only end one way) will be resolved shortly.

        However, he also attempts to invoke the Hellinga-esque defense that the ahem “inconsistencies” identified by the MD Anderson group and discussed in their various public statements are “scientific debate”. Pesumably Michael Cuffe would also argue that John Richard and Birte Hocker were also trying to have a “debate” about the validity of the Hellinga work rather than focusing attention on the inescapable conclusion that it is fraudulent.

        Is there anyone credible in a position of autority at Duke who has the balls to take a stand against this continued harm to the credibility of the institution. Maybe a faculty-led grass roots approach is needed?

      • noblesse d'epee said

        The Medical Center administration is lacks credibility with regard to creating and maintaining an ethical research environment. The faculty, as a group, have no “balls,” and therefore would not participate in a broad grass-roots uprising. The Board of Trustees could step in, but I’m not sure if/how its members interfere in managerial decisions, or whether it primarily rubber-stamps university legislation and focuses upon university finances.

  12. scotus said

    Baggerly and colleagues have also caught Potti and Nevins lying about their predictive model having survived testing using blinded data sets.

    “Data was made available to us, blinded,” Nevins
    said. “All we got was the gene expression data. We
    ran the predictions and sent it back to the EORTC
    investigators, including the statisticians in the EORTC
    group. They took the results, analyzed it in the context
    of the clinical responses in that study, and did further
    analyses with respect to evaluating developing combined
    probability measures.”

    On the basis of some well reasoned detective work and having obtained the data in question directly from the EORTC group (see http://www.uccc.info/docs/pdf/cl-102309.pdf for more details) Baggerly concludes:

    “In sum, (a) the Lancet Oncology paper states that
    authors were not blinded, (b) treatment and response
    information were supplied before final predictions were
    made, and (c) the Duke group’s co-authors in Europe
    cannot independently reproduce their predictions. We
    believe that blinded external confirmation has not yet
    been demonstrated”

  13. Rob said

    See an update at the N&O

    http://www.newsobserver.com/2010/07/24/595600/probe-expands-into-duke-researchers.html

    Also, the Lancet’s “expression of concern”:

    http://download.thelancet.com/flatcontentassets/pdfs/S0140673610701856.pdf

  14. Mo said

    If you think Duke can “act fast”, you are a fucking moron. Sure, they acted fast on the FAKE rape case by causing problems with the innocent white players with a racist response. Anyone who has any faith in the Duke system, the UNC system or any college in NC is a moron. You want the “facts” of the Duke Fraud? Go here:

    http://www.moronsinchapelhill.com

  15. pinus said

    I wonder if any of these things are contributing to the neuroscience flight over at duke…3 big labs gone (Ehlers, Feng, Augusting)…I wonder if that is the end of it?

    • Rob said

      Interesting that you bring that up. Rumor going round is that Augustine is going to Korea, and bringing Hellinga with him.

      Everyone in the know is keeping it quiet, but I hear that Hellinga visited Augustine’s nascent institute at the Korea Institute of Science and Technology to give a job talk. Beese did not accompany, so no word on whether the couple is planning a move.

      • pinus said

        Augustine is definitely going to Korea. Word on the street is that they gave him an incredible offer. That would be wild if hellinga were to leave duke as well. Rough time for Duke to be trying to fill up all those positions…with the whole endowment/economy tanking.

  16. scotus said

    http://dukefactchecker.blogspot.com/

    The author of this blog speculates that the Potti-Nevins fiasco may be the result of a power vacuum/lack of oversight created when the directors of the Duke Center for Human Genetics left the institution taking a slew of researchers and ~$34M of grants with them.

  17. writedit said

    Jennifer Couzin-Frankel gives this situation – particularly the work by Keith Baggerly and Kevin Coombes – some thoughtful coverage in Science this week.

    • scotus said

      “But Potti and Nevins continued to publish papers using the same method. This troubled Baggerly. He became obsessed with determining why the Duke team could make their prediction models work when he and Coombes could not”.

      Nice pic of Potti rocking another (possibly Carolina Blue) turtle neck accompanying the article.

      • noblesse d'epee said

        I hope that a cadre of deep-pocketed alumni cries foul if Duke spends one red cent for Potti’s/Nevins’ inevitable legal costs.

  18. AmusedtoDeath said

    Lots of interesting things going on at Duke.

    Mid-level administrative position listed on the HR website.

    Assistant Editor job description:

    “revise and rewrite manuscripts totally when necessary”

    Seems that would suggest authorship.

    “Review manuscripts for accuracy and completeness of scientific and technical information and data”

    This can be performed by someone with a year’s worth of editorial or production experience. It’s all very rational, if you think about it.

    http://www.hr.duke.edu/jobs/job_descriptions/campus/select.php?ID=2140

    I’ve been watching, and I am amused.

  19. scotus said

    http://dukefactchecker.blogspot.com/

    This guy is all over the potti business like whatever your favorite metaphor for being all over something is.

    Among the many bombshells revealed in his most recent post is that Duke COM dean Nancy Andrews cancer researcher husband has co authored papers with Potti and Nevins.

    • noblesse d'epee said

      Dean Andrews’ spouse is named Mathey-Prevot. He last published with Potti (and Nevins) in PNAS in April, 2010 (Gatza, ML et at.). Not too shabby. Michael Cuffe, who along with Sally Kornbluth signed off on the continuation of Duke’s Potti/Nevins clinical trials, appears to be Mathey-Prevot’s nominal superior. Corrupt? You bet. Surprising? Hardly.

  20. scotus said

    The PNAS paper was a direct submission. Although PNAS ended publication of papers communicated by academy members in July I had been harboring a brief hope that this one had been communicated by Lorena Beese.

  21. Federale said

    One of the vacuums left in the Center for Human Genetics was actually quite sobering and sad. A prominent faculty member, Marcy Speer, who was the Director of the Center for Human Genetics died in 2007…. I believe her unfortunate passing was the most major shock and setback for the center. She was incredibly well liked and on top of things.

    http://www.plosgenetics.org/article/info:doi/10.1371/journal.pgen.0030230

    The analysis provided above about the connections between the Deans and the researchers through familial and employment relationships is disturbing and could be called into question by groups such as ORI or other federal investigators, IGs, and auditors.

    • noblesse d'epee said

      But it won’t, because the NIH is afraid to take the DUMC administrators to task as it ought to. The Baltimore case still haunts that organization, at a great cost to honest science.

  22. scotus said

    I don’t understand why NIH would be “afraid” of DUMC administrators. I know that there are high level NIH administrators who like Nancy Andrews and want her to succeed (she is featured prominently in the NIH NCRR director’s presentation about how women scientists can become administrators for example) but once misconduct investigations are initiated they are ultimately overseen by the NIH ORI who would have no reason to show Duke preferential treatment.
    The Hellinga process has been abominably slow. The key difference with the Potti case is that he’s been put on administrative leave while the PI of two active R01s. He can’t be absent from the project site for more than 3 months without the grant being relinquished or reassigned to another PI. Duke has initiated a misconduct investigation relating to the fabrication/falsification of credentials in Potti’s grant applications which sounds like its running in parallel to the Provost’s investigation and could be resolved very quickly, presumably if needed by simply reconciling the biosketch information with records of the relevant awarding agencies depriving Potti of any opportunity to stall the process. Potti was put on administrative leave on July 16 so some decision will have to be made about his status as PI of the grants on or before October 16. In other words something will happen.

  23. Rob said

    The Duke Fact Checker guy is pretty good. Here is a tidbit from him that came out today (from http://www.dukechronicle.com/node/152510/talk ):

    “The first review was internal — though three outside consultants were hired because of very technical scientific issues. Here’s an update: those consultants — which the Chronicle’s sources say supported Potti — have now explained that Duke limited their inquiry to two questions while others were on the table. They said Duke took their findings and warped them in such a way as to emphasize what supported Potti, and to ignore what challenged him. ”

    This has some very direct implications for the Hellinga case as well. There is a rumor circulating that Duke is only allowing the investigatory committee to look at allegations of data fabrication. They do this because they know that Hellinga did not fabricate data; instead, he mis-appropriately assembled real data in a way that allowed him to reach his desired conclusions. The data was real, it was just stitched together from 30 independent experiments to derive a nice Km curve. The large variability that was inherent to his FRET-based assays allowed him to shape data to draw pre-determined ‘conclusions’. Every scientist knows that this is unacceptable.

    This is the very reason we haven’t gotten a conclusion on the Hellinga case. Rumor is that the committee has petitioned time and time again to have the charges expanded to cover inappropriate representation of his data. Every time, the Dean of Medicine has turned them down.

    • David said

      These rumors that the Dean has prevented the internal ethics committee from expanding the Hellinga inquiry suggests that the committee is done investigating everything it was originally empowered to investigate. Dean Andrews ought to be able to confirm or deny that the committee has finished its work and delivered their findings to her. If she does not have the report, she ought to explain what the delay is. If she has the report, she ought to make the decision to exonerate Hellinga or not in under a week.

      Is there any way to file a Freedom of Information request regarding the investigations of a federally-funded researcher by federally-funded researchers (as nearly all professors at Duke are)? I would also think that a member of the Faculty Senate could somehow challenge the faculty members on the committee to explain how an investigation could last longer than the explicitly required 9 months.

      • noblesse d'epee said

        It is unclear to me whether an FOI request would somehow trump Duke’s oft-repeated argument in favor of complete confidentially for reasons of employee privacy. Wasted tax dollars be damned! On the other hand, Duke released the contents’ of lacrosse players’ “private” e-mail accounts during the investigation of the Mangum case. I suppose that an FOI request regarding Hellinga would force university attorneys to explain their double standard. In any case, I’ve lost all faith that Duke will do the right thing here. Despite widespread public outcry and condemnation, Duke has circled its wagons about Anil Potti and Homme Hellinga. The woefully incapable and unethical Dean Nancy Andrews will remain, and Duke will keep its worthless patents. This, ladies and gentleman, is why no sane person should contemplate a career at a research university. Why would anyone want to be associated with this massive scam?

  24. scotus said

    As far as I can tell Duke has never reported a finding of research misconduct to the NIH. By way of comparison, UNC has reported several cases of this type to the NIH resulting in sanctioning of (former) UNC reseearchers.
    Perhaps Duke’s record of manipulating these kinds of investigations to the benefit of the accused goes beyond the Potti and Hellinga cases?

    • kikidenee said

      Yes, it does. Duke is an ethical cesspool.

  25. writedit said

    The IOM now plans to study the Potti case and the issue of genomics-based biomarker trials more broadly. A good idea … a tad late to start … but better than never.

  26. scotus said

    Potti’s “mentor” Nevins has apparently unilaterally determined that the 2007 JCO paper needs to be retracted for essentially the reasons identified by Drs Baggerly and Coombes that led to the suspension, review and eventual reinstatement of their cancer chemotherapy prediction trials earlier in the year. Needless to say quite a few people find this outrageous.

    As usual our friends at Duke Fact Checker have an in depth analysis.

    http://dukefactchecker.blogspot.com/

    • anon for sure said

      Back in the day we would semi-collaborate with the Nevins lab which wasn’t a very happy experience even 15+ years ago. We used to joke about how much mileage Joe would get from:
      High-Impact-Paper-1: “We just discovered ‘Fact A’! ”
      followed later by:
      High-Impact-Paper-2: “Even though ‘Fact A’ is the prevailing view of the field, surprisingly, we have discovered that ‘Fact B’ is actually correct!”
      We always attributed this at the time to a combination of sloppy science and ruthlessly efficient self-promotion from the Nevins lab, but now that I hear the Potti story I wonder if some fraction of Nevins output could be explained more simply by straight-up evil.

  27. writedit said

    Another Potti publication, J Clin Oncol 2007;25:4350-7, has been retracted. Details can be found on RetractionWatch.

  28. writedit said

    The NYT ran a front-page story on the Potti case … but neglected to comment on Potti’s hucksterish Website.

  29. writedit said

    The Economist has a nice piece summarizing the full history of this case.

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