Retraction Watch

Tracking retractions as a window into the scientific process

It’s official: Anil Potti faked cancer research data, say Feds

with 16 comments

potti

Anil Potti, via Duke

Following five years of scrutiny, more than ten retractions, multiple settled lawsuits, and medical board reprimands, we may finally have some resolution on the case of Anil Potti, the once-rising cancer research star who resigned from Duke in 2010.

While there have been numerous allegations of misconduct in Potti’s work, and strong comments to that effect by Potti’s former mentor, Joseph Nevins, there has been no official finding. Today, that changes. Potti “engaged in research misconduct,” the Office of Research Integrity (ORI) concludes in a report to be published in the Federal Register on Monday.

Potti — referred to as “respondent” in the report — included “false research data” in reports of research from six different NIH grants, according to the ORI:

  1. Respondent stated in grant application 1 R01 CA136530-01A1 that 6 out of 33 patients responded positively to dasatinib when only 4 patients were enrolled and none responded and that the 4 CT scans presented in Figure 14 were from the lung cancer study when they were not.
  2. Respondent altered data sets to improve the accuracy of predictors for response to treatments in a submitted paper and in the research record by:
  • Reversing the responder status of 24 out of 133 subjects for the adriamycin predictor in a manuscript submitted to Clinical Cancer Research
  • switching the cancer recurrence phenotype for 46 out of 89 samples to validate the LMS predictor in a file provided to a colleague in 2008
  • changing IC-50 and R-code values for the cisplatin predictor in a data set provided to NCI in 2010

He also “reported predictors and/or their validation by disregarding accepted scientific methodology so that false data were reported” in nine now-retracted papers, the ORI writes.

Potti, who hasn’t engaged in NIH-funded research since 2010 and says he has no intention to apply for more, “neither admits nor denies ORI’s findings of research misconduct,” according to the report, which notes that

…the settlement is not an admission of liability on the part of the Respondent. The parties entered into the Agreement to conclude this matter without further expenditure of time, finances, or other resources.

If he does ever apply for or receive such funding again, Potti agrees to have his research supervised for five years, beginning September 23, 2015. He also can’t serve on peer review committees for that period of time.

Last we know, Potti was practicing oncology in Grand Forks, North Dakota. His work came under scientific scrutiny beginning in 2007, but it was the discovery by The Cancer Letter in 2010 that he had claimed to be a Rhodes Scholar on a grant application that focused intense attention on his research. Eventually, three trials based on his work were halted, and Duke reimbursed the American Cancer Society for the partial payment of a $729,000 grant that Potti had begun to receive.

Update, 1:45 p.m. Eastern, 11/8/15: In a statement, Doug Stokke, vice president of marketing and communications for Duke Medicine, tells us:

We are pleased with the finding of research misconduct by the federal Office of Research Integrity related to work done by Dr. Anil Potti.  We trust this will serve to fully absolve the clinicians and researchers who were unwittingly associated with his actions, and bring closure to others who were affected.

Note to readers: We preempted Weekend Reads, which normally appears on Saturday mornings, to report this news, which we learned about this morning. Weekend Reads will appear tomorrow (Sunday). 

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Written by Ivan Oransky

November 7th, 2015 at 10:08 am

Comments
  • Mayo November 7, 2015 at 11:01 am

    How can we take seriously the daily hand-wringing about fraud, non-replication, and biased statistics when in so blatant a case of data manipulation (where flawed predictors were the basis for surgery and chemotherapy regimens) we read: “Respondent neither admits nor denies ORI’s findings of research misconduct”?
    I’m afraid it renders the entire program of fraud-busting to be, largely, just another fraud. I will look out for any uproars, and I’ll bet I won’t find them.

    http://errorstatistics.com/2015/01/12/only-those-samples-which-fit-the-model-best-in-cross-validation-were-included-whistleblower-i-suspect-that-we-likely-disagree-with-what-constitutes-validation-potti-and-nevins/

    http://errorstatistics.com/2014/05/31/what-have-we-learned-from-the-anil-potti-training-and-test-data-fireworks-part-1/

  • Helene Z Hill, PhD November 7, 2015 at 11:23 am

    Ah, yes! The usual slap on the wrist by the ORI.

  • Aquiles Brinco November 7, 2015 at 12:49 pm

    That is the very reason why many researchers are committing misconduct and still can work in the field… no real consequences or pushiments. so sad….

  • Conrad Seitz MD November 7, 2015 at 2:18 pm

    As someone who practiced in North Dakota for 2-1/2 years under an NHSC scholarship, I think I can authoritatively say that the fact that he is now practicing there is somehow fitting, like being sent to Siberia. And I mean that in the nicest way possible.

    • Paul Thompson November 7, 2015 at 7:30 pm

      Potti did his medical training in ND.

  • Bryan November 7, 2015 at 2:24 pm

    Sloppy science is unfortunate — inaccurate conclusions can be made honestly — and being to “fast and loose” with data forgivable.
    However, cases like this seem to be blatant fraud. Due to the amount of money wasted, criminal charges should be sought. Have those that fabricate data, to steal tax payer money, spend their next sabbatical in the federal pen.

  • herr doktor bimler November 7, 2015 at 6:53 pm

    and strong comments to that effect by Potti’s former mentor, Joseph Nevins

    Nevins: I regret that some of the issues that were raised along the way I didn’t recognize earlier, and that this could have been brought to a halt at an earlier time.

    “Didn’t recognise” is a delicate way of phrasing it.

    • Mayo November 7, 2015 at 11:08 pm

      On 60 minutes Nevins claimed he had no idea, and pinned it all on Potti.That seemed believable until the revelations of the whistleblower (see the first link in my earlier comment) made it clear that he was well aware of blatant finagling. Nevins retired in 2013.

  • captainhurt November 9, 2015 at 10:33 am

    Cancer is correctly well known as: By far the biggest source of profit in the medical arts.

    Worse than that, like all the medical industry, the model is : more profit from more and longer disease. more profit from more and longer procedures.

    and while the medical industry model perpetuates this evil deadly sham on the public, the other hand is waving, “look over here at these evil insurance companies raising prices”.

  • Julio Arroyo, MD November 9, 2015 at 3:58 pm

    Clinical research requires many hands. Dr. Potti’s mentor and colleagues do bear responsibility and is imperative to clarify their roles, ignorance is not an excuse.

  • Steven McKinney November 9, 2015 at 5:05 pm

    ” Update, 1:45 p.m. Eastern, 11/8/15: In a statement, Doug Stokke, vice president of marketing and communications for Duke Medicine, tells us:

    We are pleased with the finding of research misconduct by the federal Office of Research Integrity related to work done by Dr. Anil Potti. We trust this will serve to fully absolve the clinicians and researchers who were unwittingly associated with his actions, and bring closure to others who were affected. ”

    The ORI report in itself does nothing to absolve anyone else. The ORI investigation focused on Potti’s work, a single researcher alone, as their investigations typically do. The ORI report mentions nothing about other researchers.

    This is nothing but more shameful marketing from Duke personnel, obfuscating the situation with hand waving and double speak as was done for years as Baggerly and Coombes tried to shed light on this situation.

    The clinical trials patients’ court cases have been adeptly settled out of court with non-disclosure agreements, and now with this narrowly focused ORI investigation report, Duke marketing personnel present the spin that this somehow absolves others who were not under scrutiny by the ORI.

    Do not trust the proclamations of such a spin-meister. Closure was brought about in the case of Joseph Nevins via a quiet retirement exit. Any groups at Duke still using the methodology involved in the Potti-Nevins et al. fiasco still require careful scrutiny. If the methodology was so good, why did Potti have to fiddle with so many bits of data (as outlined in the ORI report)?

  • Mayo November 9, 2015 at 6:57 pm

    I agree with Julia and there was a whistleblower: “The three-page document was penned by Bradford Perez, then a third-year medical student …
    Instead of rewarding the student’s brilliance with a plaque and a potted plant, Potti’s collaborator and protector, Joseph Nevins—aided by a phalanx of Duke deans—pressured the young man to refrain from making a final complaint and reporting the matter to HHMI”. http://www.cancerletter.com/articles/20150109_1

    I’m beginning to think there’s need for some kind of citizen’s watch group that channels public outrage when patients are lured into clinical trials for treating serious diseases based on models/methods that haven’t been properly vetted.
    I made this comment on my blog: http://errorstatistics.com/2015/11/09/findings-of-the-office-of-research-misconduct-on-the-duke-u-pottinevins-cancer-trial-fraud-no-one-is-punished-but-the-patients/

    • herr doktor bimler November 9, 2015 at 8:38 pm

      MIstakes were made, concerns were ignored or suppressed not recognised earlier, a committee was convened to whitewash over the whistle-blower’s complaints without access to the actual data, these things just happen out of anyone’s control.

      • Mayo November 10, 2015 at 7:46 pm

        But it doesn’t have to be that way, and it ought not to be that way.We can’t change laws, but I don’t think we should rule out the possibility that if people raised loud objections (or applause, if deserved) in reaction to how fraudulent or bad practices were handled, that there might be some progress. Otherwise, what’s really the point, for the citizen or practitioner, of fraud watch?

  • Theresa Defino November 10, 2015 at 11:34 am

    Not aware of any actions against Duke by OHRP/FDA. These were clinical trials.

  • Theresa Defino November 10, 2015 at 11:34 am

    Or Potti.

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