Secret no more: the report that Duke would not let you read!

Important update. Names, quotes from secret report. As Mr. Brodhead might say, the facts keep changing!

Fact Checker here.

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A secret report that Duke contends it cannot release because of federal law enmeshes a third cancer researcher in the Potti scandal.

Secret no more. Fact Checker has just finished reading the report which lists targets for investigation:

First, Associate Professor Potti himself.

Then his mentor, whom we have known about: Dr. Joseph Nevins, Barbara Levine University Professor of Breast Cancer Genomics and Director of Duke's Institute for Genome Sciences and Policy.

And the new name: William T. Barry, who received his Ph.D. at Carolina in 2007 and is an assistant professor of bio-statistics and bio-informatics, working in the cancer center.

As Fact Checker has warned, the metathesis of this scandal will catch far far more people, including people who have published with Potti and worked in his lab. What did they know? When did they know it? And if they did not know, is that professional negligence?

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Fact Checker will now give you the name of the faculty member who led Duke's ill fated internal investigation last winter -- and cleared the way for new patients to be recruited for experiments.

Duke has refused to release the faculty member's name, again citing federal law. Duke has not responded to repeated Fact Checker requests (correct that, they were demands) to specify precisely what law they were hiding under.

Secret no more. The chair was Dr. John Harrelson, professor of orthopedic surgery and associate professor of pathology. A Deputy Fact Checker reports he is a double Dukie, Trinity '61 and MD '64, who also stayed on at Duke to train on the House Staff. He is now retired.

The Deputy believes he is the John Harrelson who is active in the life of Duke Chapel but could not immediately confirm this. A Harrelson with the same first name received a Ph.D. at Duke in chemistry in 1986, but we believe he lives in Florida.

F-C will return in a moment to focus on the vice chair and 15 peer faculty who worked with Harrelson, and to provide more information about the structure of their work under the Duke Institutional Review Board, widely known in scientific circles as IRB.

Loyal Readers, the following is written with substantial detail to accommodate new stakeholders (Welcome Class of 2014) and those returning after a summer away. Please read, for there's a lot of new stuff below. Including lots of quotes from the secret report.

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The IRB review came after three years of persistent questions about Potti's claim to have made a stunning advance in "personalized medicine." Hidden in the DNA and RNA of each human, and in each cancer, is information that would enable doctors to identify precisely what chemotherapy to use, and what dose to prescribe, on each individual patient for best results.

Right now it is hit or miss, with doctors subjecting patients to different types of chemicals at different dosages.

The advance would be huge. Huge. This is the Holy Grail: taking pure science and tailoring it to individuals, a process called translational medicine. As a Deputy has put it, think Lasker Award, think Nobel Prize.

The Institutional Review Board, whose mission is "to ensure the protection of human research subjects by conducting scientific and ethical review of research studies..." endorsed the science involved, which is to say the board cleared Potti, Nevins and Barry and ended a suspension of enrolling new patients who had given their "informed consent" to participate. During this period, Potti was not personally suspended.

By joining the Potti trials, these patients gave up the opportunity to receive other cancer treatments -- a tragic choice if it had turned out the report found bum science.

Immediately, the Harrelson / IRB report was attacked from top to bottom, front to back.

Keith Baggerly and Kevin Coombes, bio-statisticians at MD Anderson Cancer Center, University of Texas, intrepid in their pursuit of truth even in the face of official Duke animosity, had been largely responsible for Duke's inquiry to start with, and now they simply would not shut up. I mean they were worse than Fact Checker!!!!

Then three outside consultants (three is correct, previously we reported two) who the IRB hired to handle very technical matters stated flatly that Duke was distorting their work, over-emphasizing supporting material and neglecting to properly factor in challenges. To boot, Duke had limited their inquiry to two questions while others loomed.

Then 15 co-authors of a Potti medical journal article renounced their own work.

And worse, a world wide Who's Who from the genome community organized an unprecedented and embarrassing letter to Duke -- cc to the entire cancer establishment -- demanding an end to Potti-Nevins experiments because they endangered patients.

Duke stonewalled through all this. Consider, Loyal Readers, this excerpt from an interview that the Cancer Letter's editor Paul Goldberg '81 had with Vice Dean Michael Cuffe, Medical School Academic Affairs, double Dukie MD 91 and MBA '09:

Cancer Letter: I happen to know that Duke's administration had been alerted to some of the problems in the Potti lab. Is this something you can confirm?

Dean Cuffe: I don’t know what you mean.

✔By mid-July, when The Cancer Letter, a weekly publication, revealed Potti had faked his resume by claiming a Rhodes Scholarship in two different years, the news media world-wide had fodder it could easily understand. One Google News count showed an amazing 2,655 news outlets carried the story. A general search for internet hits turned up 122,000, almost all this year; a search for President Richard Brodhead only yielded 57,300 for all his years at Duke and Yale.

With this crescendo of criticism, Duke was forced to cave and institute a second review -- the subject of the Chronicle's update -- this time promising it would be "unfettered" and seeking an outside authority with impeccable reputation to handle it all.

Duke's failure two weeks after making announcement of the new review to formally enlist the authority -- believed to be a unit of the National Academy of Sciences -- is starting to stir questions. Not to mention Provost Lange's failure to wrap up a second, separate internal investigation into Potti's credentials -- said to be "almost completed" on July 29, once projected to be completed by July 30,

Here's what surprises Fact Checker: When Chancellor Dzau announced the new external review, his e-mail to the medical faculty referred obliquely to "the science conducted by Drs. Potti and Nevins."

There may be a reason why Barry was excluded. FC would like to hear it.

But at the moment it appears to be another inconsistency flowing from the Brodhead Administration, which has pledged a "transparent" investigation and has run into continuing bumps trying to deliver.

Forget Barry, never mentioned. Dzau's e-mail was so vague on whether Potti alone or Nevins too would be investigated, that the Cancer Letter asked the aforementioned Dean Cuffe point blank. His answer was anything but:

Cuffe: ...they are co-authors on much of this work. The outside scientists broadly have expressed concern, both publicly and privately, and, certainly, there is a broad base of science coming out of their labs that needs review by a credible outside party."

Dean, Dean. Fact Checker here . Do you know the word "yes?" Actually, while FC has mentioned Cuffe twice and been rough, he is extremely well regarded and we see him in high places in the future.

✔The Administration has not kept stakeholders informed. Its relations with the news media -- not to mention Fact Checker -- are poor. A flop.

Witness this comment in an Associated Press story sent around the world: "Duke officials did not reply to e-mails or phone calls requesting comment."

Try this in the Cancer Letter: "Multiple calls and emails from The Cancer Letter were not acknowledged."

Most of the faculty has had no official communication. None of the alumni, none of the students. This is no way to respond to a crisis. In fact this is a disastrous way. Particularly after you have pledged transparency.

Cancer Letter again: "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."

If Loyal Readers don't have enough, we shall conclude this litany with another Cancer Letter quote putting the entire Brodhead administration in the cross-hairs:

"Focusing on the three Duke trials may have been good enough last week, but not now..."

✔✔Back to Harrelson and the peer review

We believe Harrelson was picked from among 10 or 11 chairs and vice chairs who serve on the Institutional Review Board. We do not know the selection process. There is also a senior chair.

The board's workload seems to be quite heavy; during the latest academic year with complete statistics, the board began 1,275 new reviews and worked on 2,029 continuing reviews. In addition there were 4,035 "amendments," a term we could not immediately relate to.

During the period that the review was conducted, there were 10 or more boards in existence at Duke. FC believes Board 3 or Board 4 meeting in December 2009 heard the Potti Nevins Barry case. This was determined by a process of elimination, so we caution we have not confirmed it.

Board 3 had Edward Suarez Ph.D. as vice chair and Board 4 had Sharon Ellison Pharm D as Vice Chair. Each had 15 primary members.

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While much of the secret report is highly technical, including Power Point presentations which only MD's or Ph.Ds in the field are likely to understand, there are some unmistakable conclusions in plain English.

✔“the approaches (being used by Potti et al)... are viable and likely to succeed.”

✔"...scientifically valid and with a few additions can be fully responsive to the comments of Drs. Baggerly and Coombes." (the intrepid MD Anderson researchers in Houston)

✔And also in the report: "We can understand some of the (Baggerly-Coombes) misgivings about the application of the methods in actual clinical trials. We think that many of the issues are due to poor and strained communications among the groups..... "

Right, this whole thing is caused by poor communications.

✔And most importantly reassurance for patients -- 107 or 109 already receiving Potti-determined treatment and more about to be enrolled: Use of the Potti science "does not endanger patients."

FC has information that in all, 1,525 patients were evaluated for Potti's trials, many of them receiving dangerous and painful removal of tissue for study. Malpractice lawyers, your future is assured!!!!

A Loyal Reader made a good point in e-mail: with criminal charges possible too, Duke must not pay any of the defense fees for these individuals. Stakeholders need assurance on this, and while it has not figured prominently in recent posts, it is prominent in our thinking.

✔Harrelson himself wrote an E-mail on January 7, 2010, to the National Institutes of Health. Of course Fact Checker has seen it: "Based upon the review process, we believe that the trials are safe for patients, the scientific basis for these studies is valid and we have every reason to hope that important results will be obtained. In light of these reviews, we are initiating processes to re-open enrollment in the involved trials."

Compare please what the Who's Who in the genome world declared: the "potential of patients being assigned to improper treatment " requires immediate intercession of the National Cancer Institute, which has broad jurisdiction over all human medical experiments.

"We, the undersigned, who have followed this debate closely, have concluded that the inability of independent experts to substantiate the above researchers’ claims using the researchers’ own data means that it is absolutely premature to use these prediction models to influence the therapeutic options open to cancer patients."

✔✔There were reports ten days ago that Potti was in his office and lab, not confirmed. This prompted FC to inquire of the impact of Potti's "administrative leave" with full pay -- if he were seeing patients, if his suspension were not like the student version where any appearance on campus is trespassing. On this very important point, as FC has noted before, the aforementioned Schoenfeld, vice president for public relations and obfuscation, has not replied.

Shame on him. This is nothing confidential related to Potti. It is an explanation of university policy applicable to all.

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Potti's only comment since the credentials issue exploded has not gotten much attention. Before publication The Cancer Letter's editor wrote Potti and :cc everyone else in the heirarchy, to ask about the Rhodes Scholarship and Potti replied:

“Sounds like I need to call him to clarify ...... and probably also talk with you all to clarify. I was a (Rhodes) nominee..... and several of the others can also be explained. –Anil.”

Loyal Readers, several versions of Potti's resume -- there are at least eight -- state flatly he was a Rhodes Scholar. Not a candidate, no fudge words. He presented this credential to receive grants. He was given the edge over other applicants because of it.

His co-workers widely understood he was a Rhodes Scholar, though we do not know if the Rhodes was on his application for employment at Duke. Ironically we have seen Potti's application to the University of North Dakota but not Duke.

This comment from the Rhodes Trust, which runs the awards: “Although thousands of outstanding young women and men apply for a Rhodes scholarship each year, the Rhodes Trust self-evidently expects that an individual will only claim to be a Rhodes scholar after having been formally awarded the scholarship by the trustees."

As Loyal Readers know, the credentials issue goes well beyond the Rhodes.

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FC has uncovered information that other aspects of Potti's work -- so far not discussed openly at all -- are in deep trouble. All of the above deals specifically with research that identified sensitivity to chemotherapy -- what meds would work best and in what dose for each individual patient. There are now serious questions about related research, about something called LMS, a prognostic model being tested for its ability to identify non-small-cell lung cancer patients who may be at high risk of recurrence.

Meanwhile, in his only comment, Brodhead talks about the possibility of truth, lies and an "intermediate explanation" to this whole mess.

Coming up soon from Fact Checker: Comparing the Potti Probe and the investigation into Hellenga's Hell. The two-faced standard the Brodhead Administration is using for conflict of interests.

Thank you for reading and supporting FC.
GO DUKE!!

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