8/07/2010

Potti - Nevins Scandal: New clouds over Duke's investigation

Fact Checker here.

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Because of a tip from a Loyal Reader, Fact Checker can state this morning that a very serious potential conflict of interest should have stopped the Brodhead Administration from appointing Michael Cuffe MD '91 to review the credentials of Dr. Anil Potti.

Cuffe was the point man in the opening stages of the current investigation, right after The Cancer Letter revealed Potti had faked a Rhodes Scholarship, invented a fellowship at an Australian university that does not exist, claimed a mentor who did not know him, and offered different dates for his medical degree.

In 2008 Cuffe was made Vice Dean of the Medical School. He was put into office by Medical School Dean Nancy Andrews shortly after her arrival from Harvard and now reports to her.

Here's the problem: Dean Andrews' husband is Bernard Mathey-Prevot, Ph.D., a noted cancer researcher who left the renowned Dana-Farber Cancer Institute to accompany his wife and now works at Duke.

Mathey-Prevot is a co-author with Potti and his mentor Dr. Joseph Nevins, of at least one recent medical journal article.

In other words, the husband's career is riding with Potti's, and his wife should not be supervisor of the point man in the investigation.

See Proc Natl Acad Sci U S A. 2010 Apr 13;107(15):6994-9. Epub 2010 Mar 24.

The rules are absolute: avoid conflict of interest. Avoid any possible appearance of conflict of interest.

Earlier, before publication of the Potti / Nevins / Mathey-Prevot article, but while their work (and presumably their grants) was known, Fact Checker pointed out that Cuffe and Dr Sally Kornbluth, vice dean for research who also reports to Andrews, signed off on last winter's investigation of three questioned cancer studies, a review that is now being blasted for clearing Potti-Nevins to continue their work. The Who's Who in the world-wide genome community -- discussed at length in earlier Fact Checker postings -- who demanded the federal government stop Duke's studies took direct aim at this review.

These situations reflect a rather lax control -- to say the least -- of a grave situation that is tarnishing Duke world-wide. They shine new light on President Brodhead, who has shown no visible leadership, now revealed to be at great expense.

Duke University must have a clean, no-holds-barred, sanitized and squeaky clean investigation. Stakeholders cannot wake up six weeks into the crisis and discover potential conflicts of interest among those named to resolve it.

Once again, our administration is responding to a crisis, by creating a second one.

✔These other developments in the Potti - Nevins mess:


Several top level members of the Medical School faculty reached out to Potti early this week and tried to nudge him to resign. It is not known if they acted individually or at the behest of the administration.

When they failed, they put it more bluntly on Thursday, telling him point-blank he is unrealistic in expecting the internal review now led by Provost Lange into his faked credentials (including a Rhodes Scholarship) to result in a censure letter being put into his file. Potti was advised his career at Duke is over and he had to depart.

But Potti and his lawyer, whose name is not known, are said to have responded by digging in, setting the stage for a confrontation not only in the Lange investigation but in the coming external investigation -- potentially far more important and far more damaging -- into the "science" of Potti and his mentor, Dr. Joseph Nevins.

Nevins is the Barbara Levine Professor of Breast Cancer Genomics and Director of the Center for Applied Genomics and Technology. Potti also holds two appointments: associate professor in the Medical School and researcher in the genome center.

Fact Checker stresses that the above information is from good source, but cannot be confirmed.

There is no word at all on why the review into the credentials is taking so long. When Vice Dean Cuffe was in charge, he said it would be wrapped up soon, a timetable that translated into July 30 at the latest.


Loyal Readers will recall I spotted two words in Chancellor Dzau's e-mail to the medical faculty that I wondered about: he said the coming external investigation would be "broader" than the review conducted last winter. Note that word, "broader" rather than "unconditional" or "total."

And Dzau said the external review -- which has not yet been arranged although there are reports he is in active negotiation with a division of the National Academy of Sciences -- would address the Potti-Nevins "science," seemingly leaving out very substantial questions of administrative and institutional failure.

Dzau, through his spokesman, provided a detailed, point by point response immediately that satisfied Fact Checker on all counts -- and my Fellow Dukies know that's not easy to do! Excerpts:

"Duke will have NO involvement with this investigation, other than providing any/all data, etc. that the investigation is interested in receiving; it is our belief and expectation that such an investigation will have the freedom to thoroughly investigate the situation in whatever way they see fit."

"It is our hope that this review will not only achieve resolution regarding the science in the Potti/Nevins labs, but that it will also provide some much-needed direction in terms of the necessary data controls, processes, stage-gates and oversight that might be needed across this relatively new field of translational research.

"With the situation involving the science of Drs. Potti and Nevins having brought this need to light, it is our expectation that the review will likely point to process gaps that may have existed and ways that this could be improved. As this process unfolds, it is becoming apparent that the presence of process gaps in this area of research may represent a national concern."


Friday evening Fact Checker made formal inquiry to Chancellor Dzau about the 107 or 109 people still getting treatment for lung and breast cancers in three clinical trials where new enrollments are suspended. Their treatments were set up by Potti following his "science." Some doctors say these people are in dire need of help, but Dzau has an opposite view.

There is also the matter of a huge number of people who may have undergone procedures to retrieve tissue samples, and their fate. It is premature to report on any of this now.


Fact Checker has learned that Dzau's July 29 medical faculty e-mail was, curiously, intended only to be shared with other employees in the medical and health fields. Instead, it was posted as part of the July 30th university-wide employee newsletter, Duke Today.

This is disturbing to say the least, for it means there is still a view -- held not necessarily by Dzau but within the Brodhead administration -- that the scandal is an isolated medical problem rather than one that is rocking the entire university. It means there is a denial about the need to keep the entire community informed.

As Fact Checker has noted, aside from a cursory e-mail in response to a Chronicle question before the full dimensions of this mess were known, President Brodhead has made no statement.

Brodhead did surface once this week, at a summer-time pre-kindergarten class at a Durham public school, a Duke Vice President and university photographer in tow. Earlier this summer he was in Aspen on a panel related to this, talking about what students need to learn in school. Yes the panel wandered.


So far as is known -- and these things are kept highly secret -- the Trustees Executive Committee last met June 18, before the scandal broke.

The full board, which met at Commencement in May, will meet October 1-2. The Executive Committee probably will have a telephone meeting in advance to confirm the agenda.

Fact Checker is considering organizing a petition to demand the Trustees provide a full transcript of that portion of their meeting related to Potti-Nevins.

Nor is it known if Brodhead has turned to the personal Trustee emeritus advisers he has leaned on in the past. Principally Roy Bostock '62, life-long advertising and PR executive.

Fact Checker asked Duke PR VP Michael Schoenfeld if it has engaged a crisis consultant, as was done when a hoax by a prostitute and prosecutor enmeshed the lacrosse team. There has been no answer.


Fact Checker also learned that Potti is being paid in full while on administrative leave, and that Duke distinguishes his case from Nevins who retains full status because Nevins is not involved in credentials fraud but only questions about his science. Only.

Schoenfeld also failed to respond to an inquiry made after unconfirmed reports that Potti was seen in his lab and office in the Fitzpatrick Building last Sunday. The inquiry was made because we know of at least one student put on administrative leave -- the same status as Potti -- who was escorted from a hearing to his dorm room by Duke Police, watched while he packed, escorted off campus, and told he'd be trespassing if he returned. Fact Checker wanted to know if similar rules are in effect for faculty.

Duke also failed to respond when asked if Potti was on administrative leave from both his appointments as an associate professor in the medical school and as a genome researcher. Fact Checker reported whispers a week ago that the internal review of Potti's credentials might lead to a split verdict: he could retain one job with a censure, while being fired from the other. That possibility is increasingly remote.


Fact Checker got the silent treatment in one case and a brush off in another when asking about two revelations made on the Chronicle's discussion board relating to the years-old probe into the science of the James B. Duke Professor of Biochemistry Homme Hellinga. An academic star, winner of the $2.5 million Director's Pioneer award from the National Institutes of Health, there have been serious doubts since 2007 about his design of an enzyme.

Quote from the post: "Even more galling are (Duke Medicine's) strenuous efforts to silence dissent over this cover-up. Last November, Dean Nancy Andrews threw a Biochemistry graduate student out of a public meeting (topic: "issues facing the Duke Biochemistry Department") because he dared to question her apparent indifference to the spreading Hellinga scandal. Fact Checker asked for confirmation.

"This spring, in response to a Chronicle article about the Hellinga debacle, Wesley Byerly sent an e-mail to the Biochemistry faculty forbidding them to speak publicly about the case, even if they were not involved in it." Fact Checker requested the e-mail.

The official response: “We trust that you and your readers will understand that it would be inappropriate for Duke to comment on any specific proceedings due to confidentiality and other restrictions.”

This is what is known as boiler plate in newspaper terms: the same crap sent to the Chronicle when it made inquiry last spring.

Loyal Readers, mark my words: a similar dally in the Potti case would be disastrous.


Undoubtedly, Duke officials are reeling from headlines that suggest a Potti-Nevins cover up, like this in the influential Cancer Letter, which broke the scandal:

"By Defending Potti, Duke Officials Become Target of Charges of Institutional Failure."

The extreme sensitivity is illustrated by a source who told the Cancer Letter that Duke has even prohibited employees from even running a Google search.


A couple of miscellaneous biographical notes on Potti.

His initial interest seemed to be AIDS. He prepared at least two papers on epidemiology of the disease in urban populations.

His application to the University of North Dakota Medical Center to be a resident said he was most interested in cardiology.

His admission to medical school was conditioned on his practicing medicine in under-served areas of India for four years. He left India immediately after graduation and a year's internship.

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Fact Checker corrects all errors: a Loyal Reader in Vancouver (yes, that far away) and others inform me that many news reports contained a mangled leak to an article in a Duke publication where Potti is clearly identified as a Rhodes Scholar.

Fact Checker wrote that Duke had taken down the article, part of an attempt to rewrite history. This was wrong. If you check on page 7, Potti's lie is there in full shameful glory. Duke should post a correction next to it.

http://www.genome.duke.edu/ press/genomelife/archives/ issue25/GL_JanFeb07.pdf

The Wall Street Journal does report an attempt to rewrite history, its reporter stating: When I attempted to access The Cancer Letter link to one of the announcements at Duke’s YouTube page, the URL returned with the message: “This video is private.”

Many publications and Fact Checker as well reported that Potti is on his second suspension. This is incorrect. While it conducted a review of the Potti-Nevins status last winter, and suspended enrollment in their trials, Potti was not personally suspended.

Introducing...

THE FACT CHECKER HONOR ROLE

-- Keith Baggerly and Kevin Coombes, biostatisticians at MD Anderson Cancer Center, University of Texas, for their intrepid pursuit of truth, even in the face of Duke's clearing Potti-Nevins during the first investigation.

-- Paul Goldberg '81, meticulous editor of the Cancer Letter who broke the story of Potti's fake Rhodes Scholarship and many angles on the science investigation. Sample quote: "When questions about Potti’s science emerged in scientific literature and in alarms sounded by internal critics, the Duke administration formed a protective barrier around the man they considered their star, forming committees that operated in secret, and then incorrectly portraying the findings of one of these committees as validation of Potti’s science."

-- Three Potti co-authors of a key December, 2007 paper in Lancet Oncology who took the lead in setting the record straight and denouncing their own work: Mauro Delorenzi, head of Bioinformatics Core Facility at the Swiss Institute of Bioinformatics. Richard Iggo and Hervé Bonnefoi affiliation unknown.

- David Collingridge, editor of the highly respected British journal Lancet Oncology for his July 23rd, no nonsense retraction of a Potti-written article.

- American Cancer Society Chief Medical Officer Otis Brawley, who minced no words in immediately demanding a full accounting and transparency from Duke officials.

NO EVIDENCE OF INVOLVEMENT

Duke Comprehensive Cancer Center Director H. Kim Lyerly HS '90

SIGNED OFF ON FIRST REPORT

Dr. Michael Cuffe, vice dean

Dr Sally Kornbluth, vice dean for research

NAME HAS NOT YET APPEARED; possible connections unknown.

Tina Tyson, chief compliance officer, Duke School of Medicine.

Institutional Review Board. Jodie Power, executive director.

Dr. Michael Kelley, identified by Potti as mentor on a grant application to Department of Defense.

THESE PEOPLE WORKED WITH POTTI - NEVINS

Did any of the people who worked with Potti know of this mess? What did they know? When did they know it? If they did not know, can they be held to a professional standard that would have required them to know had not been negligent?

FORMER STAFF, called "my alumni" by Potti

Carey Anders, MD. assistant professor, UNC

Ariel Anguiano, MD

Katie Garman, MD, assistant professor, Duke

Cindy Moylan, MD, assistant professor, Duke

Kelly Salter, medical student, UNC

CURRENT STAFF MEMBERS OF THE LAB, many of whom joined relatively recently and may have no information.

Chaitanya Acharya, research associate, bioinformatics since 2006.

Aidan Burke '09, research associate, since August 2009.

Yanis Bellil, MD since June 2009

Isaac Chan, BSE 2005, MD, Ph.d. Student, since September 2009

Kristin Higgins, MD since July 2009

Wisut Lamlertthon, MD, visiting scholar from Thailand since July 2009.

Tripp Mostertz, research associate since July 2008

Stephanie Norfolk, MD since November 2009

Sridhar Reddy Nagelli, research analyst, since September 2009

Arati Rao, MD since August 2008

John Strickler, MD since August 2009

Marvaretta Stevenson, MD since July 2008

Sascha Tuchman, MD since August 2007

Ashleigh Pappadake, research associate, since February 2009

Kelli Walters, lab manager. October 2006.

Burt Hillary, physicians assistant

WROTE MEDICAL JOURNAL ARTICLE WITH POTTI NEVINS

Bernard Mathey-Prevot, Ph.D, husband of Duke Medical School Dean Nancy Andrews.

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My fellow Dukies, I know all of us have heavy hearts as we watch this crisis unfold, threatening careers and overwhelming the wonderful research, teaching and patient care that make Duke Health so remarkable. Having said that, Fact Checker believes all of us who care about and love Duke have a deep obligation to be fully informed and involved in this situation.

Thank you for reading Fact Checker on good days and bad.

Email Duke.Fact.Checker@gmail.com
Blog http://dukefactchecker.blogspot.com/

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