Wednesday, February 2, 2011

Drama Exists as Duke University Medical Wall of Silence Persists

Congratulations to "Duke Fact Checker" for being the conscience at Duke University.  The work done on this site is commendable and a service to the scientific community and the public at large.

Silence may be golden.  But when the silence relates to innumerable cancer patients who trusted Duke Medical physicians and researchers with their lives, the silence is inexcusable.

A recent piece of excellent reporting:

Monday, January 31, 2011
While Brodhead read Milton poems, Duke got smothered by Potti Mess in January
Search terms: Duke University Anil Potti 
Note: In preparation of this report on the Potti Mess and a coming special report on the campus-wide leadership of President Brodhead, FC asked VP for PR Michael Schoenfeld for input, for information and suggestions. He has ignored our request.
✔✔ In January, the Potti Mess spun out of control, pushing Duke deeper and deeper into a quagmire. FC shall detail what happened in a moment. 
First, we want to address the leadership that President Brodhead has provided during this crisis, now eight months old. 
We find only two statements by Brodhead, both made during routine start-of-the-academic-year conversations with the editorial boards of the Herald-Sun and News and Observer. 
Neither comment was significant enough to be reported in the Chronicle. 
Immediately after The Cancer Letter revealed Potti's fake claim of a Rhodes Scholarship and the Rhodes Trust confirmed there was no award, with other credential issues looming, Brodhead cautioned editors and reporters not to reach rapid conclusions of truth or lie, for there could also be "intermediate explanation."
And in another editorial board meeting, Brodhead was asked how in hell Potti ever got a job on our faculty: 
Brodhead: "The university will in general continue to accept credentials on their face as presented by the people who present them... We're not going to start running background checks and police checks on everybody... You can't reasonably do that, nor is there a need to."
Dare we point out that the President was immediately contradicted by Schoenfeld:
“In terms of faculty, [hiring] is a very thorough and rigorous process and involves extensive checking of references, conversations with people who worked with faculty members and reviewing work they do.” 
✔ This is not leadership; the request to wait for an "intermediate explanation" is mush from an English professor, not the mighty declaration of principle we needed from the guy in charge, that anyone falsifying credentials would be thrown out on their ass. And the waffling on how Duke vets its employees is bewildering.
✔✔ Loyal Readers know of our repeated concern for Potti's patients. We believe there were far more than generally reported: the total of 107, 108 or 110 represents only those enrolled when Duke finally pulled the plug on his "clinical trials," which is to say experiments on human beings. We believe -- but have been unable to confirm -- that over time more than 300 people participated in these experiments, with perhaps as many as 1500 undergoing invasive tests to see if they qualified. 
Has Brodhead ever said a word to any of these people? People who came to Duke in desperation, who got a quack instead of help and care.
Wouldn't it be appropriate for our President to address these people, to express our remorse, to reassure them, to bring them together for group therapy to help them cope with their mental anguish, to pledge that Duke will help them now obtain the best cancer care possible?
These people got ignored. They got silence from our President. 
And needless to say, in a rosy Happy New Year sent belatedly to all alumni on January 21, Uncle Dick did not mention the Potti crisis at all.
Pathetic. Dick, just pathetic. 
✔✔ And now the horrible month of January, with the Potti Mess spinning out of control: 
✔ 1) As the Chronicle reports today, a third research paper that Potti published with his mentor Dr. Joseph Nevins has been retracted, which is a nice way to say withdrawn in disgrace. More to come. 
✔ 2) In January, Nevins, Barbara Levine University Professor of Breast Cancer Genomics, saw the research center he headed disappear from the face of this campus. That is, the Center for Applied Genomics and Technology where Potti worked. 
We have been cautioned against reading too much into this -- for two other centers that neither Potti nor Nevins were involved in were also terminated as part of a review of the entire genome enterprise prior to its 10th year. The Cancer Letter, which has broken most of the Potti stories, does not agree with that interpretation. 
✔ 3) As the Institutes of Medicine (IOM), which is supposed to conduct a well financed "unfettered" investigation of the Potti Mess arrived on campus to begin its work, The Cancer Letter gave us a peek at some of the documents the IOM has amassed. 
BOMBSHELL: The National Cancer Institute, which was using federal money to pay for some of Potti's research, became so concerned that on June 29, it summoned top Duke officials to its offices in Maryland for a showdown. For purposes of our analysis, the key person there was Sally Kornbluth, PhD, professor of pharmacology and cancer biology, and vice dean of the medical school. 
This would not have been the first time that a highly authoritative challenge to Potti's work landed in her lap: Loyal Readers will recall how the previous November, as Duke's first internal investigation into Potti was beginning, she and Dr. Michael Cuffe, another vice dean, received an extraordinary letter from the eminent MD Anderson Comprehensive Cancer Center in Houston, with Dr. Keith Baggerly outlining in new detail precisely what was phony about Potti's research. 
This letter was concealed from the investigation. Concealed. Repeat, not sent to the investigators, concealed. 
We are told by a reliable source that Kornbluth and Cuffe were only some of the people in this decision; one account says "leadership": of Duke signed off -- in writing -- on this course. FC is at work trying to pin this down. (Later, Cuffe told Nature that if a similar situation were to ever occur again, he would forward “every shred” of evidence to the review panel. Whew.)
And even after the internal Duke investigators gave rousing approval to Potti's work, the letter was not send along as part of a reconsideration.
Rather, Kornbluth and Cuffeh and Cuffe signed off on the investigation -- allowing clinical trials to continue. 
Thus, Kornbluth was in a unique position to know the full dimensions of the implosion. But she -- and others -- did nothing. Only in the past horrible month, these details fell together. 
✔4) It appeared more and more that the Institute of Medicine isn't delving into the nooks and crannies of Potti at all, but rather is more interested in a broad survey of standards in the emerging field of genome studies. This is undoubtedly important -- but not at the expense of a thorough investigation into Potti. 
✔ 5) BOMBSHELL We learned that the Food and Drug Administration is on Duke's tail too. Part of Potti's clinical trials fell under their jurisdiction, because the tests that he used to determine who might benefit from what cancer drug are considered a "device." 
No one can plead ignorance. On other similar trials, Duke doctors, including Nevins, secured FDA approval. Yet in documents just revealed, Duke’s Institutional Review Board put N/A for non-applicable next to checkboxes intended to indicate whether this form of FDA clearance had been obtained.
Investigators are on campus. 
✔6) BOMBSHELL During the month of January, we learned that some of the people in Potti's clinical trials for lung cancer, received a chemotherapy cocktail that he concocted -- that is -- a combination of very powerful drugs used in a way not approved by drug regulators.
This should be a criminal offense. 
✔ 7) Also in January, Duke surrendered the last of the Potti research funds, multi-year grants from the federal government involving cancer research, one with one year and $200,000 left, and the other with six months and $100,000. Potti's lab -- once vibrant with hope of a major scientific breakthru -- had shrunk to four employees, and they learned they are being laid off. 
✔ 8) As FC reported, Potti started to emerge from the seclusion of his Chapel Hill home... building his Facebook site, sending out tweets ( and worse, apparently trying to capitalize on his years at Duke, presenting himself as a cancer doc extraordinaire, misleading with a regurgitation of a seven year old press release announcing a humanitarian award. So far as we can find out, Duke has filed no report on Potti with the North Carolina Medical Board.
✔ 9) A Raleigh law firm that has taken on Duke University in the past says it is doing "research" on the Potti Mess. The firm Henson Fuerst has now sent out several press releases seeking information from Potti patients, which seems to FC like a thinly disguised effort to sign them up for lawsuits. 
✔✔ What will February hold? Brace yourself, fellow Dukies. At Bingham Young University, Baggerly (the whistle blower from MD Anderson Comprehensive Care Center) reviewed the Duke mess for the fourth joint international meeting of the IMS (Institute of Mathematical Statistics) and ISBA (International Society for Bayesian Analysis). 
They deal with highly technical stuff, but everyone will be able to understand this prediction: 
"Hold on folks, the ride’s just beginning." 
Thank you for reading Fact Checker.

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