Thursday, July 22, 2010

Duke Scientist Bringing Millions from NIH and Pharma Suspended Over Rhodes Scholar Claims

The New York Times reports that a medical researcher faked claims to being a Rhodes Scholar, and that a major scandal that has erupted.

The scenario is very familiar to readers of Healthcare Renewal, with universities collecting millions from public sources and the pharmaceutical industry, turning a blind eye to credentials discrepancies of faculty "taxpayers", and the public possibly put at risk through faulty research and suspect "reviews":

Duke Scientist Suspended Over Rhodes Scholar Claims
New York Times
July 20, 2010

Duke University School of Medicine has suspended a researcher and stopped patient enrollment in three cancer studies upon learning of reports that the researcher had overstated his academic credentials.

One of the lead investigators on the cancer studies, Dr. Anil Potti, was placed on administrative leave, said Douglas J. Stokke, a spokesman for Duke, while the university investigates allegations that Dr. Potti had falsely claimed that he was a Rhodes scholar.

The controversy erupted late last week after an article published in The Cancer Letter (PDF), a weekly publication for cancer specialists, reported that Dr. Potti, an assistant professor of medicine, had on occasion exaggerated his credentials. (A spokeswoman at Rhodes House at Oxford confirmed on Tuesday that Dr. Potti had not received the scholarship.)

The scientist, Anil Potti, was engaged in cancer clinical trials using questionable and possbily erroneous analytical methods (prediction models).

In addition, several dozen biostatisticians and cancer researchers at Harvard, Princeton, Johns Hopkins and other academic institutions are now questioning the methodology behind the three clinical trials, urging a halt to the Duke studies — two on lung cancer and one on breast cancer — in a letter sent to the director of the National Cancer Institute.

He'd used the fake credentials to get American Cancer Society money:

When questions about Dr. Potti’s credentials became public, the American Cancer Society suspended payments of a five-year, $729,000 grant awarded to Dr. Potti to study the genetics of lung cancer. The society awarded the grant based in part on a résumé from the doctor that included the Rhodes honor, said Dr. Otis W. Brawley, the chief medical officer of the cancer society.

According to The Cancer Letter's exposé linked above:

A high-profile cancer genomics researcher at Duke University claimed in multiple grant applications that he had been a Rhodes scholar, when, in fact, the Rhodes Trust states flatly that he was not.

Documents obtained by The Cancer Letter show that in biographies submitted to NIH, Duke oncologist and genomics researcher Anil Potti claimed variously to have won the prestigious scholarship in 1995 or 1996, depending on the version of the biography.

Potti also made the Rhodes claim in an application that resulted in a $729,000 grant from the American Cancer Society. “We don’t have any record that Anil Potti was a Rhodes scholar,” spokesman for the Rhodes Trust said to The Cancer Letter.

Assuming the fabrications are proven, a number of questions arise:

  • How can a Duke scientist have gotten away with exaggerated credentials on a CV used in a grant applicationa to NIH, the American Cancer Society, and perhaps other organizations, claiming to be a Rhodes Scholar?
  • Did he make similar exaggerations in his application to Duke itself?
  • Do the exaggerations made in NIH and/or other federal grant applications constitute a crime, e.g., under Title 18 of U.S. Code, Section 1001 which makes it a federal crime to make a false statement to the government, according to one contributor to The Cancer Letter article?
  • Will Duke act on fabrications as criminal matters?
  • What were the Duke grants office and/or credentials-checking staff doing during their working hours?
  • Why did this exaggeration come out in The Cancer Letter?

Patients may be at risk:

[MD Anderson Cancer Center biostatisticians] Keith Baggerly and Kevin Coombes said they devoted about 1,500 hours to checking Potti’s and Nevins’s work. These efforts—dubbed “forensic bioinformatics”—resulted in a paper in the November 2009, issue of the Annals of Applied Statistics.

“Unfortunately, poor documentation can shift from an inconvenience to an active danger when it obscures not just methods but errors,” the paper stated. “Patients in clinical trials are currently being allocated to treatment arms on the basis of these results.”

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.”

Duke initially suspended but then restarted the trials after an "investigation" by outside scientists. However:

Experts asked by The Cancer Letter to review these [investigation] documents [obtained under the FOIA] 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 has apparently now decided to stonewall:

... The Cancer Letter sent an email with questions to Potti, his collaborator Joseph Nevins, and Duke administration officials. The questions focused on the Rhodes claim, but also touched on other apparent discrepancies.

Responding to everyone on the email CC list, including this reporter, Potti wrote: “Sounds like I need to call him to clarify ...... and probably also talk with you all to clarify. I was a nominee..... and several of the others can also be explained. –Anil.”

After that email, Potti and Duke officials didn’t respond to questions seeking details that could substantiate this response. Multiple calls and emails from The Cancer Letter were not acknowledged.

One reason is that this escapade appears to have many twists and turns regarding credentials claimed by their researcher in the past. See the full article published in The Cancer Letter (PDF). The tale is stunning.

Another reason appears to be this:

Genomic research led by the two scientists [Potti and senior collaborator Joseph Nevins] has brought millions of public and private dollars to Duke. The duo’s connections with the industry are considerable. According to a recent disclosure, Potti is a member of the scientific advisory boards of Eli Lilly and Co., GlaxoSmith-Kline, and CancerGuideDx.

This also raises the questions:

  • Did Potti misrepresent his credentials to these pharmas?
  • Was Nevins aware of these exaggerations himself?

Of course this author is familiar with laxity in Duke's management and academics, and their not replying to pointed questions on their failures.

Perhaps at the time of this grant application, Duke personnel were busy checking the credentials of the Duke Lacrosse team, or of academics such as myself, maligned by Duke professors for having a strong sense of ethics (see link below). I then found myself "stonewalled" by Duke's President Richard H. Brodhead on the issues.

(See my Jan. 2008 post "A Truly Appalling Lawsuit Against Duke University" for more on that affair.)

-- SS


Anonymous said...

1. Duke – again.

2. Did Dr. Potti think people would not check his CV?

3. This whole scenario reminds me of Emory.

Steve Lucas

Roy M. Poses MD said...

Also see our previous post on the former Duke University board chair, whose fingerprints were on the global financial collapse/ great recession:

Grant P. Writer said...

"What were the Duke grants office and/or credentials-checking staff doing during their working hours?"

In fairness to the grants office staff at Duke, which I have interacted with on several occasions, it is not a typical practice of research administrators to verify credentials of scientists. The staff is simply too busy checking that all pieces of the application are completed correctly, often with very little time given by the PI. Generally, the university has done their own background check, etc., when a person is hired, and it is expected that they will be truthful on their CV and grant applications. Perhaps now that this incident has brought this possibility to light, institutions will look more closely at this type of information on proposals.

Greg Pawelski said...

What went wrong?

"The simple answer is that cancer isn’t simple," according to Dr. Robert Nagourney, one of the pioneers of functional profiling analysis.

Cancer dynamics are not linear. Cancer biology does not conform to the dictates of molecular biologists. Once again, we are forced to confront the realization that genotype does not equal phenotype.

In a nutshell, cancer cells utilize cross talk and redundancy to circumvent therapies. They back up, zig-zag and move in reverse, regardless of what the sign posts say. Using genomic signatures to predict response is like saying that Dr. Seuss and Shakespeare are truly the same because they use the same words. The building blocks of human biology are carefully construed into the complexities that we recognize as human beings. However appealing gene profiling may appear to those engaged in this field (such as Response Genetics, Caris, the group from Duke and many others) it will be years, perhaps decades, before these profiles can approximate the vagaries of human cancer.

Functional profiling analyses, which measure biological signals rather than DNA indicators, will continue to provide clinically validated information and play an important role in cancer drug selection. The data that support functional profiling analyses is demonstrably greater and more compelling than any data currently generated from DNA analyses. Functional profiling remains the most validated technique for selecting effective therapies for cancer patients.