Potti Mess: federal researcher testifies that Duke sits on explosive internal report with "very troubling accusations made... so sensitive."

Search words Anil Potti Duke University

✔✔✔ Good day, Fellow Dukies. FC here. Probative, Provocative.

There have been several developments in the Anil Potti scandal. We want to look today at Duke's involvement as an institution, and also review some questions about Potti himself that Loyal Readers have raised with FC.

In case you just landed on earth, Potti was the highly regarded, highly promoted Duke cancer physician who, it turned out, invented a Rhodes Scholarship for himself and then faked very important cancer drug trials -- experiments on human beings with medications for breast, lung and ovarian cancer. Duke has now conceded these trials should never have been allowed.

Potti was suspended with pay, and as a formal faculty misconduct review was beginning -- secret by federal law -- Potti quit.

The Institute of Medicine -- sought out by Duke for an outside review of the entire Mess -- continues to conduct hearings, with an eye toward Duke's involvement but also a great concern for what the genome community might learn as procedures and protocols emerge for this cutting edge science.

In one recent hearing, Lisa McShane, a National Cancer Institute biostatician testified -- and said Duke is holding on to explosive information about data manipulation in at least one of Potti's three clinical trials.

The witness said Duke had prepared an internal report on this: "There's quite frankly a bit of -- not a bit -- a lot of detail in (the report). Names Named. Very troubling accusations made."

Despite being pressed by the IOM committee, McShane said “I would prefer not to release (the report) because it's so sensitive, but if you have no success getting it from Duke, I can certainly take it to the National Cancer Institute leadership (the people who dispense federal research dollars) and we can decide what we think we could release."

The Cancer Letter -- in a piece freelanced by the Chronicle's Taylor Doherty -- could not get Duke to comment.

If Duke does not make this report available in full, it would be a fundamental breach of its commitment to the Institute of Medicine and to every stakeholder in the university for an "unfettered" investigation. The institute is a top notch private organization of 2,000 people, including approximately 80 at Duke, described this way by Wikipedia: "The Institute provides unbiased, evidence-based, and authoritative information and advice concerning health and science policy to policy-makers, professionals, leaders in every sector of society, and the public at large."

✔✔ Another recent witness before the IOM was Dr. Joseph Nevins, Potti's mentor and his co-author for many (we've heard but have not confirmed the number 14) medical journal articles, four of which Nevins and other co-authors have now renounced and asked to be withdrawn. Interestingly, the Cancer Letter is now referring to the Mess as the Potti-Nevins Affair.

An important source tells FC that the Nevins testimony was a disaster.

"Joe clearly doesn't 'get it.' He's digging his heels in and just doesn't see that there's a need for a mea culpa.

"The design of the overall project appeared to be fine (in my opinion) and had some good statistical advice from collaborators; but clearly Nevins (as the overall project leader) did not look closely enough at the data and certainly didn't respond to or take seriously the emails from (scientists at the great M D Anderson Comprehensive Cancer Center at the University of Texas) once problems were found.

"That was a mistake, plain and simple -- understandable as a human foible, but not defendable after the fact. Nevins screwed up -- inadequate mentoring of Potti, poor oversight of the data on 'his' project, and poor responsiveness to colleagues. But he hasn't yet reached the point of agreeing to the previous sentence."

And our source added, "Part hubris, part self-delusion perhaps. None of us ever wants to admit failure. And Nevins certainly wasn't prepared to do so at the time of his IOM presentation."

✔✔Several Loyal Readers have written FC about Potti's being licensed by the state of South Carolina -- to practice cancer medicine in the hamlet of Loris, near the North Carolina border and the Atlantic Ocean. This is part of a large group cancer practice headquartered in Myrtle Beach.

According to the website for Coastal Cancer Care, Potti's little office not only sees patients, not only does research, but has clinical trials too. Ummmm... here we go again?

Loyal Readers, quite frankly, we do not think Potti should be licensed to do these specific things so soon after he fumbled so badly --- doing precisely these things.

There is nothing in the South Carolina record to indicate that Potti was asked for an explanation of his conduct at Duke, nor asked if he needs treatment for whatever caused his elevator to start skipping floors.

While there is a question as to whether the applicant sought help from mental health professionals, there is no inquiry as to whether he should have.

Potti seems to have slipped through other cracks in the rather extensive questioning he did face in his written application. Indeed, his comments in the application clearly indicate that he expected just a temporary license, not the full license he did obtain.

More troubling are some of his answers. "Are you currently under investigation or the subject of pending disciplinary action by any Medical Licensing Board, health care facility or other entity?" Originally Potti checked No. Then with a slight squiggle, he seemed to cross that out, perhaps hoping no one would notice. He did check the Yes box too.

Similarly, he said No to an inquiry about whether he ever discontinued the practice of medicine for more than a month. From his suspension at Duke to his emergence in a South Carolina application was a longer period.

✔✔ Equally disturbing, a review of Potti's license to practice medicine in North Carolina indicates there are no "Health Care Institution Suspensions or Revocations." We think Duke should have reported its suspension of Potti --- as a medical school professor, as a researcher and as a clinician treating patients. This might have flagged a problem South Carolina did not catch.

✔✔ In his South Carolina application, Potti benefited from an effusive recommendation from Duke's #1 cancer doc.

Dr.Jeffrey Crawford, chief, Division of Medical Oncology, wrote an effusive recommendation to South Carolina officials. Words of praise incorporating phrases like these:

"...Honesty, integirty and humility."

"...great admiration and respect.."

And the kicker, "Anil developed an impressive research program..."

This was written on official Duke University Medical Center stationery. We suppose the freedom from restraint accorded our faculty allows them to proclaim the earth is flat, and suffer no more than approbation from their colleagues. But we feel university officials should at least speak to Dr. Crawford about this travesty.

In all four Duke doctors wrote letters of recommendation. Another came from Dr. David Rizzieri, bone marrow and stem cell implant expert, who was more subdued. Loyal Readers will recall our 11/14/2010 post identifying Rizzieri as a North Carolina leader in getting money from drug companies -- a practice that has come under increasing fire. Rizzieri got a whopping $240,150 over two years from drug companies: $36,000 from GlaxoSmithKline for speaking engagements and a whopping $204,150 from Cephalon under the vague category of "honoraria."

This list may not be complete, as reporters at the Pro Publica organization are still getting raw data. Potti himself was in on this, receiving far less however.

✔✔ FC is quite concerned too that Duke is letting Potti get away with hiring an internet image consultant, who basically floods the internet with good news, pushing the bad deep into searches. The problem is, the posts convey an inaccurate accounting of Potti's years at Duke. The University should thus take steps to protect its own integrity.

There will be litigation because of the Potti Mess. One concern of attorneys is to identify how the potential plaintiffs were harmed. In cancer treatment, it's hit or miss trying different drugs. Potti's claims that he had unlocked the human genome to reveal which cancer drugs might best target specific cancers in specific individuals may have been bunk; but except for a small number of patients who got a cocktail of chemotherapy that Potti himself concocted, the treatment he gave patients is the same they might have gotten by chance. For sure, Potti deceived patients into participating in his trials by alleging a scientific basis for them, and that's a significant part of the plaintiffs' case.

✔✔✔ We conclude with this e-mail from a Loyal Reader:

"I knew Dr.Potti when he was a resident and prior to all that has happened at Duke. He was an intelligent physician who could have done well without staining his name.Like many others, he has chosen the wrong path to reach the top. He should not go any further unless he can face why he wronged so many who believed in him and if he is capable of correcting his dishonesty. Medical licensing boards have a duty not to neglect this and issue a license without such proof."

Thank you for reading FC and caring about DUKE.

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