✔ Good day, my Fellow Dukies.
When Anil Potti first applied to Duke, the discrepancies were popping out of his resume. Or more accurately the six versions of his resume that then existed.
This university should have asked some very basic questions. For example, Potti claimed he served a fellowship at an Australian university with a mentor who happens to be from the University of North Dakota. No one bothered to check to find out what the mentor thought of him.
In fact as the scandal developed, we learned there is no university with the name Potti provided, though there is one that is similar, and the mentor was "flabbergasted" because he had never even heard of Potti.
This information was sitting out there, just waiting to be discovered before we hired this clown.
Not to mention the faked Rhodes Scholarship; anyone in academia should have known this award is for study at Oxford University and not, as Potti put it, "Rhodes, 'Australia.'"
Uncle Dick has responded to all this by saying:
"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."
No Brodhead, your system works well. And there is no need at all to change it. This quotation, this indictment of our President should have been part of today's Chronicle editorial.
✔ Today's editorial could be read to suggest that Potti's work was challenged for three months. This would be a wrong conclusion.
The specific review for "faculty misconduct" as provided in faculty handbooks and federal grant procedures has been underway for three months and will continue despite his resignation. But since 2007, there has been a rising chorus in the genome community about his work.
A chorus that Duke chose to ignore.
✔ FC would also like to comment on Potti's taking "full responsibility." Those seemingly sweeping words have critical limitations, for they apply only to mistakes or "anomalies" in the administration's view, "in data handling, analysis and management."
"Full responsibility" for flubbing yes, but Potti has never acknowledged willful misconduct. The magnitude of what is now being discovered suggests there is intentional, fraudulent conduct.
The Chronicle has never told its readers how Dr Nevins -- who endorsed Potti's research as one of many co-authors -- finally "dug down" to the first level of research in one study and looked at 59 initial samples of ovarian cancer Potti was analyzing.
16 of those samples are not this kind of cancer at all. Nevins: "At this point, I cannot trace the origin or nature of these samples."
Of the remaining 43 samples, the news is not much better. "The tumor ID labels for these samples are incorrect. In a large number of these cases, the mis-identification results in reversal of the clinical annotation of response vs. non-response." In other words, chemotherapy that helped a patient was recorded as not helping, and chemotherapy that did no good was recorded as helping.
This is not just sloppiness. Particularly when the results of your "science" are going to lead to clinical trials, which translated into English means experiments on human beings.
Nevins co-authored at least eight medical journal articles with Potti. So far he's reviewed two and found validity in none. Faster your seat belts!
✔ There are two investigations underway, replete with problems.
The first is a faculty misconduct investigation by other faculty who have not been identified. We do not know if anyone other than Potti is under investigation. The final report on this may never be public.
The second is being conducted "outside" the University, at its request, by the Institutes of Medicine (IOM) Previously we endorsed this and in most times, we'd be impressed with the involvement of this august body. But we have learned 81 of 2,000 members are from Duke -- an entanglement that could sully if not nullify the inquiry thru conflicts of interest. This must be addressed head on.
Moreover, we have no idea about the reach of the IOM review or whether it will end with a public report. Who is under investigation, for what? Nor do we know if critical questions involving administrators that let this matter fester will be raised at all.
Fellow Dukies, that kind of inquiry does not cut it. We were promised transparency and accountability.
✔ The Chronicle properly notes one emphasis must now be on Potti's patients, people who were treated according to a scheme of his, a protocol that has no validity.
At the board of trustee meeting coming up on Friday and Saturday, the status of these patients should be reviewed, to insure that Duke is doing and will do all it can to help them. The Trustees must put their imprimatur on this guarantee.
But I will bet they will leave campus not caring at all. Private jets will be standing by at Raleigh Durham Airport.
If patients sue, this university must not engage in another Bernard defense -- named for general counsel Pamela Bernard who has wiggled and obfuscated and delayed plaintiff after plaintiff in other matters, to the point of being a burden on our conscience.
Fact Checker has made initial conduct with one Potti patient, and her emotions are overwhelming to write about. We hope to bring you this within the week; unfortunately the Chronicle only allows posts that are responsive to its stories.
✔ Thank you for reading FC.
Archive: http://dukefactchecker.blogspot.com/
email Duke.Fact.Checker@gmail.com
11/29/2010
11/23/2010
Drunk driving asshole tries to wiggle out of Duke Police charges with extraneous legal argument
Source WRAL
Christian imagery is not hard to spot on Duke's campus.
DURHAM N.C. — A man charged with driving while impaired by Duke University police is arguing that the school doesn’t have the legal right to make the arrest. In a motion to dismiss the charge filed Tuesday, attorneys William J. Thomas II and James H. Monroe argue that because Duke is a religious institution, a university police department is an illegal entanglement of church and state.
The attorneys cite Duke’s Divinity School and the prominence of Duke Chapel on campus and as a representation of the university.
Thomas Holloway was stopped by Duke police Oct. 11 near the intersection of Main and Ninth streets in Durham. He was cited for DWI and driving after drinking by someone under 21.
His attorneys laid out an eight-page explanation of why Duke University should be considered a religious institution.
Current students disagreed.
"I'm not quite sure what it is about the university aside from its founders and charter would make it Methodist," graduate student Brian Goldstone said.
"I think it's very open to pretty much any religious denomination or practice,” freshman Cameron Crawford said.
Holloway’s lawyers quoted the Duke by-laws, which read, in part:
The aims of Duke University are to assert a faith in the eternal union of knowledge and religion set forth in the teaching and character of Jesus Christ, the Son of God.
They cite as an example a case where Campbell University was found to be a religious institution.
"The cases that have been brought before the court involve institutions whose policies and practices we believe are significantly different from Duke," said Mike Schoenfeld, Duke vice president for Public Affairs and Government Relations.
Schoenfeld said Duke doesn't even require students to attend a religious course.
The lawyers also point out in the filing that two-thirds of the members of Duke’s Board of Trustees are elected by the United Methodist Church.
Schoenfeld said while some trustees are approved by the church, they aren’t required to be Methodist
Christian imagery is not hard to spot on Duke's campus.
DURHAM N.C. — A man charged with driving while impaired by Duke University police is arguing that the school doesn’t have the legal right to make the arrest. In a motion to dismiss the charge filed Tuesday, attorneys William J. Thomas II and James H. Monroe argue that because Duke is a religious institution, a university police department is an illegal entanglement of church and state.
The attorneys cite Duke’s Divinity School and the prominence of Duke Chapel on campus and as a representation of the university.
Thomas Holloway was stopped by Duke police Oct. 11 near the intersection of Main and Ninth streets in Durham. He was cited for DWI and driving after drinking by someone under 21.
His attorneys laid out an eight-page explanation of why Duke University should be considered a religious institution.
Current students disagreed.
"I'm not quite sure what it is about the university aside from its founders and charter would make it Methodist," graduate student Brian Goldstone said.
"I think it's very open to pretty much any religious denomination or practice,” freshman Cameron Crawford said.
Holloway’s lawyers quoted the Duke by-laws, which read, in part:
The aims of Duke University are to assert a faith in the eternal union of knowledge and religion set forth in the teaching and character of Jesus Christ, the Son of God.
They cite as an example a case where Campbell University was found to be a religious institution.
"The cases that have been brought before the court involve institutions whose policies and practices we believe are significantly different from Duke," said Mike Schoenfeld, Duke vice president for Public Affairs and Government Relations.
Schoenfeld said Duke doesn't even require students to attend a religious course.
The lawyers also point out in the filing that two-thirds of the members of Duke’s Board of Trustees are elected by the United Methodist Church.
Schoenfeld said while some trustees are approved by the church, they aren’t required to be Methodist
11/22/2010
Inside the Potti Mess: A Fact Checker Special Report
Search words Anil Potti Duke University
✔ Fact Checker here. Fellow Dukies, good day.
FC's essay today has substantial focus on Potti's patients. We also review Duke's leadership during this scandal, focus on Potti's co-workers as well as the doctor himself, and finally turn to the intrepid researchers Keith Baggerly and Kevin Coombes at the renowned MD Anderson Comprehensive Care Center in Houston, and The Cancer Letter and its editor, Paul Goldberg '81.
✔✔ LEADERSHIP
FC does not give out accolades often. Nor without grand reason.
This morning we express complete confidence in the leadership of our medical enterprise, and the sincerity of efforts to understand the way the Potti mess unfolded and to insure it cannot repeat itself. Here or anywhere else.
Both Chancellor Dzau and Huntington Willard, director of the Duke Institute for Genome Sciences and Policy, have been fully responsive to our many questions -- many questions -- and most generous -- unexpectedly generous and immediate -- with their time in providing answers. Moreover, we believe the answers are candid and comprehensive.
This doesn't mean FC always agrees with the Chancellor and Director, nor certainly Dzau and Willard with FC; but we think it fair to say that all share the philosophy that reasonable people can disagree.
Nor does our confidence mean we will not raise new questions based on new evidence and perspectives, as we do today: whether there is any conflict of interest, potential conflict, perceived conflict or possibly a perceived potential conflict in one of the most fundamental decisions -- to invite the Institute of Medicine to conduct an unfettered inquiry. This review will begin in January. See below.
This is an important caveat: Loyal Readers should not assume that unattributed information in our reports comes from official sources. Fact Checker is deluged with tips. In fact yesterday (Sunday) Willard marveled how quickly FC posted his internal memo on Friday announcing Potti's resignation, correctly concluding we have a mole within his organization.
At the risk of yelping from Continuous Carpers (new sub-set of Loyal Readers being recognized today for the first time), we add that FC does not have a favorable view of President Brodhead's handling of one of the great crises of his tenure (yes, along with lacrosse and the financial meltdown).
We do not find that Uncle Dick has taken any profile at all, that is to say exhibited any leadership. In particular, he has not expressed appropriate concern for the patients.
His only important comment came just after The Cancer Letter reported Potti's fake claim of a Rhodes Scholarship and the Rhodes Trust confirmed there was no award. With other credential issues looming at the time, Brodhead cautioned the editorial board of the Herald-Sun not to reach rapid conclusions of truth or lie, for there could also be "intermediate explanation."
Pathetic. Dick, just pathetic.
✔✔ THE PATIENTS
While different numbers have surfaced, we believe 1,518 people came to Duke in desperation, people with life-threatening cancers, people grasping for hope who were channeled to Potti's office for review for possible inclusion in his clinical trials -- which is to say human experiments employing his theories that DNA and RNA -- the human genome -- contained information on how to fight specific cancers.
We do not know how many patients were accepted. We do know 109 people were in the trials at the point last winter when Duke, questioning Potti's science, suspended new enrollments for several months, a decision that did not affect the 109.
As Loyal Readers know, Duke subsequently re-opened enrollment after an internal review turned out glowing. We do not know how many more joined at that point.
All of these people signed "informed consent" forms -- meaning they were fully briefed on the experiments and the chances. What they expected, however, was a good faith experiment, not bunk. Not bunk within the walls of a university medical center that had plenty of warning Potti's science held no water.
Even the people who were merely screened were deeply affected. It is our understanding that many underwent painful, sometimes dangerous procedures to get tissue from lung and ovarian cancers for analysis.
At least 109 were given specific chemotherapy based upon Potti's "discovery" of what would work; they gave up other possible treatments.
Duke maintains they were not harmed. We believe this is a very cynical approach derived from the following: before Potti claimed otherwise, no one knew what therapy would work best against an individual's cancer -- or if it would work at all. It was hit or miss. So Duke figures that everyone in the Potti trials could have been given the precise chemotherapy Potti gave them, and thus the patients are not any worse off for his phony science.
Worse off physically that is; no one is speaking of the stress and mental turmoil that would occur when you learn your cancer doc is a quack.
That's our interpretation; we await confirmation.
We have heard no one outside the boundaries of this campus who is speaking up to say the patients were not harmed.
The Cancer Letter -- which has broken most of the news in the Potti scandal -- turned to Dr. George Sledge, the President of the American Society of Clinical Oncology, a professor at Indiana University, for interpretation. "It is safe to assume that patients might have been assigned to treatments that were unlikely to benefit them and possibly even to harm them."
And Dr. David Carbone, chair of cancer research at Vanderbilt: because of errors in Potti's research, "you may be withholding an effective treatment from some people or giving an ineffective targeted drug" suggested by the research. And "there is the possibility of patient harm."
From Dr.John Ruckdeschel, director and CEO of the Nevada Cancer Institute: "The potential for patients to have been treated differently than they might have otherwise been is present."
My fellow Dukies, one person who writes FC all the time, often with funny flippant information, says he has chartered a bus to bring plaintiffs' lawyers to Duke.
FC is concerned because Duke has developed a reputation for being pretty nasty in litigation. Yes lacrosse, but let's look beyond.
Six years ago, two hospitals run by Duke -- not on campus -- negligently used recycled hydraulic fluid from elevator maintenance to sterilize surgical instruments, rather than a special detergent. This went on for months with 3,648 patients exposed. Oh yes, it went on despite surgeons who kept on saying their instruments felt greasy and slippery.
Ronald Buchanan was operated on during this period -- but for five years Duke would not tell him if he was one of the endangered patients. Five years. Finally, mindful of the statute of limitations, he sued.
Earlier this near, Duke provided evidence that Buchanan had not been exposed to the hydraulic fluid and won dismissal of his lawsuit.
And guess what. Vindictive Duke is now suing Buchanan trying to recover the university's legal costs. This is a disgrace; general counsel Pamela Bernard should be ashamed of this tactic.
Fellow Dukies, we should not tolerate any of this with the cancer patients. Duke must own up to its responsibilities for malpractice.
We will be watching to see if Duke salts away any money to pay these plaintiffs, for we believe hundreds of millions of dollars are ultimately at risk. We note that some of Duke's insurance is handled through a corporation Duke created called Durham Casualty Company. The casualties are malpractice victims, and all this is not in Durham at all, but a corporation founded on an island in the deep Caribbean and most recently moved to Bermuda to shield all from prying eyes.
This university should be better than that; it should be transparent and accountable.
Next step: FC is requesting copies of the letter that Duke sent to all patients, advising them of this mess.
✔✔ ANIL POTTI, MD
A FC friend called. He said Potti is done. I replied there is a lot of redemption in the world. Last week I watched former President George W. Bush, pushing his new autobiography on the Tonight Show, talk about his being a worthless drunk until age 40. (Please, no nasty political comments). Right now as I write, I am half-watching the Giants - Eagles game, where the resurgent Michael Vick has just scored a touchdown.
On the other side, a highly placed administrator told us flatly, his career is "not recoverable" no matter how continuing investigations turn out.
Fact Checker has learned from three sources that since the scandal began, Potti has been largely isolated in his Chapel Hill home but in regular contact with two people, including one Duke colleague with whom he had developed a particularly close friendship. Their contacts started on the phone. The format changed to in-person conversations when Potti's co-author Joseph Nevins renounced their work and asked the Journal of Clinical Oncology to retract an article dealing with ovarian cancer.
There were several long face to face meetings, the theme to keep Potti realistic about his options.
Then last Monday, a new dimension: Nevins wrote Potti an e-mail informing him he was asking the journal Nature Medicine to retract a second article. Potti apparently -- not confirmed -- agreed to join in requesting the retraction; it is not known at all whether he joined in the first retraction from the Journal of Clinical Oncology (JNO). It is customary for all authors of a article to ask for retractions, rare as they are.
With the gathering storm, on Wednesday Potti took his conversations with his one-time colleague and one other contact to a new level -- asking what to do. He was counseled to resign immediately -- before even more bad news came out. Indeed, Nevins was already looking beyond the two papers into more joint publications with Potti; Nevins' on-line resume, obviously out of date, lists eight such papers in the 2006-08 period alone.
Loyal Readers will recall our report months ago that Potti was getting the same advice from several Duke colleagues who met with him. This time he agreed.
On Thursday afternoon lawyers became involved, and Thursday night the murmur was Potti had signed papers. Friday morning the documents reached the Chancellor's office. By early afternoon, Duke made the announcement that made headlines around the world. Literally. Embracing an elite university, this is one of the largest scientific scandals imaginable.
There was a surprise element in the announcement on Friday that very few knew about. Five days earlier Duke had quietly called it quits on all of Potti's experiments and got the patients to other doctors.
One source in an excellent position to know full details says at no time was Potti pushed to resign from Duke.
What we do not know is the terms of his leaving: whether Potti asked for or was given any financial incentive. Our sources -- at least two in a position to know -- hedged their words sufficiently so that we believe there was.
We do not know if there is a confidentiality agreement so the sordid details are locked up in case Potti ever begins a process of rehabilitating himself.
Is there any deal involving language in a notification to the NC Medical Board which handles licenses to practice medicine? Have federal or state prosecutor's expressed interest. What about the inspectors general of the two federal agencies that gave Potti grant money.
And if Duke has to give money back -- as to the American Cancer Society -- will it swallow the loss or seek indemnification from Potti.
Key point: While Duke's official announcements say Potti has taken "full responsibility," those seemingly sweeping words have limitations.
Text: “[Potti] accepted full responsibility for a series of anomalies in data handling, analysis and management that have come under scrutiny in the past months,” Willard wrote in a Friday e-mail to the genome staff.
"Full responsibility" for mistakes made with data, yes, but Potti has never acknowledged willful misconduct.
We should note here that Nevins request to the JNO for retraction revealed that one aspect of Potti's research involved 59 samples of ovarian cancer. Or what was supposed to be ovarian cancer.
16 of those samples are not this kind of cancer at all. Nevins: "At this point, I cannot trace the origin or nature of these samples."
Of the remaining 43 samples, the news is not much better. "The tumor ID labels for these samples are incorrect. In a large number of these cases, the mis-identification results in reversal of the clinical annotation of response vs. non-response." In other words, chemotherapy that helped a patient was recorded as not helping, and chemotherapy that did no good was recorded as helping. Oh lord.
With discrepancies of this magnitude, FC thinks it is an uphill battle to establish there was no willful misconduct. Even so, a key source says "I have not seen a smoking gun."
The Chronicle, which provided excellent, speedy, accurate coverage on Friday, first under the byline of Zachary Tracer, later joined by Taylor Doherty, got the only reaction from Potti himself that FC has seen throughout this mess. “It has been a difficult time, as you might imagine,” he wrote in an e-mail.
✔✔ THE POTTI LAB
There is no doubt that Potti was close to the people in his lab. His website for example has picture after picture of the Christmas party he has thrown for them each year. And word is, he has expressed concern now for "collateral damage" to trainees whose careers might be affected.
Precious little has been said about these people. They now work directly for Willard, who took over Potti's grants as Principal Investigator. "At the moment no one has lost his job," said Willard.
Key issue: did anyone know? Can anyone be held to the professional standard that they should have known.
✔✔ THE INVESTIGATIONS
There are two investigations underway. They will continue.
Unfortunately we do not know the scope of either, particularly since the Institute of Medicine is defining its own path. We have no idea who will be investigated.
In the case of the faculty misconduct review, we do not even know the people on the judgment panel.
This does not cut it. We were promised transparency.
We have new information about the key investigation by the Institute of Medicine, which we were initially very enthused about. This is an august body more concerned with public policy than science per se. It does not seem to have any specific qualification in scientific fraud. There are about 2,000 members of the Institute, with a surprising 81 from Duke, including the chancellor and medical school dean. We had the impression we were divorced from the organization doing the review.
This investigation must be lily white. No conflicts. No potential conflicts. No appearance of conflict. No appearance of potential conflict. The 81 from Duke should be required to stand down, suspend their membership, whatever device effectively severs them from all active work of the Institute at this critical time.
As this scandal metastasized, the list we wonder about in either inquiry has grown longer:
Dr Nevins, Potti co-author and his mentor, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology. Target of the internal review last winter.
Dr Bernard Mathey-Prevot, Research Professor of Pharmacology & Cancer Biology, Professor in Pediatrics, Potti co-author, husband of Medical School Dean Nancy Andrews.
Dr Wm Barry, in Potti's lab and target of the internal review last winter. Co-author
Dr. David Harpole, Potti co-author, Professor of Surgery, vice chief of the surgical services division, associate professor of pathology.
Dr. Phillip Febbo, co-author, departed Duke for UCSF.
Associate Deans Cuffe and Kornbluth who signed off on last winter's review. Cuffe has just gotten new religion: “In retrospect, these trials should not have been done." Both should be barred from making statements on behalf of Duke University for the duration of this controversy for they have too much at stake personally, not to mention their conflict because they were promoted by and continue to report to Dean Andrews.
We just do not know what it means to be co-author of a medical journal article, how much work you do yourself, how much of the effort of other people you are charged with knowing. That's a question we will explore next.
Please read this is from the Cancer Letter: "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." FC has no assurance whatsoever, that at the end of the two investigations, this ground will have been covered.
And speaking of conflict of interest issues, Duke divested itself of interest in licensing of Potti science, rather than face conflict charges that it was supporting Potti because it would make hoards from royalties if his theories provided a screening test for cancer patients. (The same issue is present in the Hellinga investigation, but ignored)
How much did Duke receive for its interests, from whom, and will they now get their money back since the science is bunk. The head of Duke licensing and VP Michael Schoenfeld both ignored FC e-mails.
✔✔ HEROES
Loyal Readers, since Potti first put forth his "discoveries" and was allowed to bring this bunk to clinical trials -- which is to say experiments on human beings -- the scientific community outside our Gothic Wonderland has raised questions. For four years, some entrenched people at Duke tried to discredit these challenges in any way they could, including disparaging remarks that bio-statisticians were not scientists are all, and that the MD degree yields more expertise in the emerging genome field than a Ph.D. At one point a Dean asked aloud who would believe a bunch of internet fools.
After a crescendo of concern, Duke was forced last winter to take an organized look at Potti -- an internal review with three outside consultants. While much of their secret report (Duke has refused to release it; anyone wanting a copy write Duke.Fact.Checker@gmail.com ) is highly technical, there are some unmistakable conclusions in plain English.
✔“the approaches (being used by Potti et al)... are viable and likely to succeed.”
✔ "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..... "
✔"...scientifically valid and with a few additions can be fully responsive to the comments of Drs. Baggerly and Coombes."
✔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."
It takes a lot of guts, a lot of fortitude to stand up to a University so self confident and so arrogant, but luckily people with great inner strength were on the horizon. They should be recognized for the good they have done.
Uncle Dick, here's how you can recover and show some leadership at last:
Next Founder's Day, Duke should give its highest honor -- called the Medal of Honor I believe -- to Baggerly and Coombes. It should give its highest alumni honor to Paul Goldberg '81, editor of The Cancer Letter.
Further, Duke as an institution should nominate Baggerly, Coombes, Goldberg and The Cancer Letter for a special Lasker Award for public service, the highest US honor in medicine.
And Duke as an institution should nominate its son, Paul Goldberg '81 and The Cancer Letter, for journalism's highest recognition, the Pulitzer Prize.
✔✔ CONCLUSION AND PERSPECTIVE
Allow, FC please, to put Dr. Anil Potti into perspective.
Last week was a great one for Duke Medicine and its 25,000 employees. It started on Monday when Chancellor Dzau received the annual Research Achievement Award at the American Heart Association. The citation: “in recognition of his monumental contributions to knowledge of intricate disease processes affecting the heart and blood vessels, insightful discoveries that are positively impacting the health of millions.”
In case you forgot, a year earlier, another Dukie won: Dr. Robert Lefkowitz, Howard Hughes Medical Institute investigator, for "transformative discoveries of cellular receptors, seminal findings that have created a cascade of biomedical innovation leading to more effective treatments for human disease."
The week at Duke Medicine saw release of an important study on a new drug to prevent people with heart beat irregularities (called atrial fibrillation) from getting strokes. There was also release of the world's largest study of acute heart failure, clearing up questions about side effects from a key drug in use for five years but raising the question of "why trials of this magnitude, or even greater, are not required earlier in the course of drug development,” according to Dr. Robert Califf, vice chancellor for clinical research.
Also involving the heart -- some of the news tied to the Heart Association meeting in Chicago -- we learned about Duke discovery of a protein secreted from stem cells that could reduce scarring from a heart attack, leaving more of the muscle alive and pumping.
Duke was picked to monitor the standards of world-wide efforts to fight HIV and AIDS, with one goal being a vaccine. Right now there is too much inconsistency in the way scientists test and record their data. From Dean Andrews of the Medical School: "Patients, physicians and researchers all need to feel confident that a test on a blood sample performed in New York will yield the same results as the same test performed in London or South Africa as an example. Today, you might not find that.”
Meanwhile, a Duke research team believes it found out how the AIDS virus defeats antibodies that are dispatched by the human body to fight it.
From the medical school we run in Singapore came word that research into fruit flies had discovered the protein Zif, and the long range hope the protein can be manipulated in humans to fight the worst kind of brain cancer. Fruit flies.
And back in Durham, there was even a finding about how fungi protect themselves from genetic mutation during sex. Don't laugh please. It has a lot of implications for humans.
Beyond the Potti headlines, it wasn't such a bad week after all.
Thank you for reading Fact Checker. GO DUKE!
✔ Fact Checker here. Fellow Dukies, good day.
FC's essay today has substantial focus on Potti's patients. We also review Duke's leadership during this scandal, focus on Potti's co-workers as well as the doctor himself, and finally turn to the intrepid researchers Keith Baggerly and Kevin Coombes at the renowned MD Anderson Comprehensive Care Center in Houston, and The Cancer Letter and its editor, Paul Goldberg '81.
✔✔ LEADERSHIP
FC does not give out accolades often. Nor without grand reason.
This morning we express complete confidence in the leadership of our medical enterprise, and the sincerity of efforts to understand the way the Potti mess unfolded and to insure it cannot repeat itself. Here or anywhere else.
Both Chancellor Dzau and Huntington Willard, director of the Duke Institute for Genome Sciences and Policy, have been fully responsive to our many questions -- many questions -- and most generous -- unexpectedly generous and immediate -- with their time in providing answers. Moreover, we believe the answers are candid and comprehensive.
This doesn't mean FC always agrees with the Chancellor and Director, nor certainly Dzau and Willard with FC; but we think it fair to say that all share the philosophy that reasonable people can disagree.
Nor does our confidence mean we will not raise new questions based on new evidence and perspectives, as we do today: whether there is any conflict of interest, potential conflict, perceived conflict or possibly a perceived potential conflict in one of the most fundamental decisions -- to invite the Institute of Medicine to conduct an unfettered inquiry. This review will begin in January. See below.
This is an important caveat: Loyal Readers should not assume that unattributed information in our reports comes from official sources. Fact Checker is deluged with tips. In fact yesterday (Sunday) Willard marveled how quickly FC posted his internal memo on Friday announcing Potti's resignation, correctly concluding we have a mole within his organization.
At the risk of yelping from Continuous Carpers (new sub-set of Loyal Readers being recognized today for the first time), we add that FC does not have a favorable view of President Brodhead's handling of one of the great crises of his tenure (yes, along with lacrosse and the financial meltdown).
We do not find that Uncle Dick has taken any profile at all, that is to say exhibited any leadership. In particular, he has not expressed appropriate concern for the patients.
His only important comment came just after The Cancer Letter reported Potti's fake claim of a Rhodes Scholarship and the Rhodes Trust confirmed there was no award. With other credential issues looming at the time, Brodhead cautioned the editorial board of the Herald-Sun not to reach rapid conclusions of truth or lie, for there could also be "intermediate explanation."
Pathetic. Dick, just pathetic.
✔✔ THE PATIENTS
While different numbers have surfaced, we believe 1,518 people came to Duke in desperation, people with life-threatening cancers, people grasping for hope who were channeled to Potti's office for review for possible inclusion in his clinical trials -- which is to say human experiments employing his theories that DNA and RNA -- the human genome -- contained information on how to fight specific cancers.
We do not know how many patients were accepted. We do know 109 people were in the trials at the point last winter when Duke, questioning Potti's science, suspended new enrollments for several months, a decision that did not affect the 109.
As Loyal Readers know, Duke subsequently re-opened enrollment after an internal review turned out glowing. We do not know how many more joined at that point.
All of these people signed "informed consent" forms -- meaning they were fully briefed on the experiments and the chances. What they expected, however, was a good faith experiment, not bunk. Not bunk within the walls of a university medical center that had plenty of warning Potti's science held no water.
Even the people who were merely screened were deeply affected. It is our understanding that many underwent painful, sometimes dangerous procedures to get tissue from lung and ovarian cancers for analysis.
At least 109 were given specific chemotherapy based upon Potti's "discovery" of what would work; they gave up other possible treatments.
Duke maintains they were not harmed. We believe this is a very cynical approach derived from the following: before Potti claimed otherwise, no one knew what therapy would work best against an individual's cancer -- or if it would work at all. It was hit or miss. So Duke figures that everyone in the Potti trials could have been given the precise chemotherapy Potti gave them, and thus the patients are not any worse off for his phony science.
Worse off physically that is; no one is speaking of the stress and mental turmoil that would occur when you learn your cancer doc is a quack.
That's our interpretation; we await confirmation.
We have heard no one outside the boundaries of this campus who is speaking up to say the patients were not harmed.
The Cancer Letter -- which has broken most of the news in the Potti scandal -- turned to Dr. George Sledge, the President of the American Society of Clinical Oncology, a professor at Indiana University, for interpretation. "It is safe to assume that patients might have been assigned to treatments that were unlikely to benefit them and possibly even to harm them."
And Dr. David Carbone, chair of cancer research at Vanderbilt: because of errors in Potti's research, "you may be withholding an effective treatment from some people or giving an ineffective targeted drug" suggested by the research. And "there is the possibility of patient harm."
From Dr.John Ruckdeschel, director and CEO of the Nevada Cancer Institute: "The potential for patients to have been treated differently than they might have otherwise been is present."
My fellow Dukies, one person who writes FC all the time, often with funny flippant information, says he has chartered a bus to bring plaintiffs' lawyers to Duke.
FC is concerned because Duke has developed a reputation for being pretty nasty in litigation. Yes lacrosse, but let's look beyond.
Six years ago, two hospitals run by Duke -- not on campus -- negligently used recycled hydraulic fluid from elevator maintenance to sterilize surgical instruments, rather than a special detergent. This went on for months with 3,648 patients exposed. Oh yes, it went on despite surgeons who kept on saying their instruments felt greasy and slippery.
Ronald Buchanan was operated on during this period -- but for five years Duke would not tell him if he was one of the endangered patients. Five years. Finally, mindful of the statute of limitations, he sued.
Earlier this near, Duke provided evidence that Buchanan had not been exposed to the hydraulic fluid and won dismissal of his lawsuit.
And guess what. Vindictive Duke is now suing Buchanan trying to recover the university's legal costs. This is a disgrace; general counsel Pamela Bernard should be ashamed of this tactic.
Fellow Dukies, we should not tolerate any of this with the cancer patients. Duke must own up to its responsibilities for malpractice.
We will be watching to see if Duke salts away any money to pay these plaintiffs, for we believe hundreds of millions of dollars are ultimately at risk. We note that some of Duke's insurance is handled through a corporation Duke created called Durham Casualty Company. The casualties are malpractice victims, and all this is not in Durham at all, but a corporation founded on an island in the deep Caribbean and most recently moved to Bermuda to shield all from prying eyes.
This university should be better than that; it should be transparent and accountable.
Next step: FC is requesting copies of the letter that Duke sent to all patients, advising them of this mess.
✔✔ ANIL POTTI, MD
A FC friend called. He said Potti is done. I replied there is a lot of redemption in the world. Last week I watched former President George W. Bush, pushing his new autobiography on the Tonight Show, talk about his being a worthless drunk until age 40. (Please, no nasty political comments). Right now as I write, I am half-watching the Giants - Eagles game, where the resurgent Michael Vick has just scored a touchdown.
On the other side, a highly placed administrator told us flatly, his career is "not recoverable" no matter how continuing investigations turn out.
Fact Checker has learned from three sources that since the scandal began, Potti has been largely isolated in his Chapel Hill home but in regular contact with two people, including one Duke colleague with whom he had developed a particularly close friendship. Their contacts started on the phone. The format changed to in-person conversations when Potti's co-author Joseph Nevins renounced their work and asked the Journal of Clinical Oncology to retract an article dealing with ovarian cancer.
There were several long face to face meetings, the theme to keep Potti realistic about his options.
Then last Monday, a new dimension: Nevins wrote Potti an e-mail informing him he was asking the journal Nature Medicine to retract a second article. Potti apparently -- not confirmed -- agreed to join in requesting the retraction; it is not known at all whether he joined in the first retraction from the Journal of Clinical Oncology (JNO). It is customary for all authors of a article to ask for retractions, rare as they are.
With the gathering storm, on Wednesday Potti took his conversations with his one-time colleague and one other contact to a new level -- asking what to do. He was counseled to resign immediately -- before even more bad news came out. Indeed, Nevins was already looking beyond the two papers into more joint publications with Potti; Nevins' on-line resume, obviously out of date, lists eight such papers in the 2006-08 period alone.
Loyal Readers will recall our report months ago that Potti was getting the same advice from several Duke colleagues who met with him. This time he agreed.
On Thursday afternoon lawyers became involved, and Thursday night the murmur was Potti had signed papers. Friday morning the documents reached the Chancellor's office. By early afternoon, Duke made the announcement that made headlines around the world. Literally. Embracing an elite university, this is one of the largest scientific scandals imaginable.
There was a surprise element in the announcement on Friday that very few knew about. Five days earlier Duke had quietly called it quits on all of Potti's experiments and got the patients to other doctors.
One source in an excellent position to know full details says at no time was Potti pushed to resign from Duke.
What we do not know is the terms of his leaving: whether Potti asked for or was given any financial incentive. Our sources -- at least two in a position to know -- hedged their words sufficiently so that we believe there was.
We do not know if there is a confidentiality agreement so the sordid details are locked up in case Potti ever begins a process of rehabilitating himself.
Is there any deal involving language in a notification to the NC Medical Board which handles licenses to practice medicine? Have federal or state prosecutor's expressed interest. What about the inspectors general of the two federal agencies that gave Potti grant money.
And if Duke has to give money back -- as to the American Cancer Society -- will it swallow the loss or seek indemnification from Potti.
Key point: While Duke's official announcements say Potti has taken "full responsibility," those seemingly sweeping words have limitations.
Text: “[Potti] accepted full responsibility for a series of anomalies in data handling, analysis and management that have come under scrutiny in the past months,” Willard wrote in a Friday e-mail to the genome staff.
"Full responsibility" for mistakes made with data, yes, but Potti has never acknowledged willful misconduct.
We should note here that Nevins request to the JNO for retraction revealed that one aspect of Potti's research involved 59 samples of ovarian cancer. Or what was supposed to be ovarian cancer.
16 of those samples are not this kind of cancer at all. Nevins: "At this point, I cannot trace the origin or nature of these samples."
Of the remaining 43 samples, the news is not much better. "The tumor ID labels for these samples are incorrect. In a large number of these cases, the mis-identification results in reversal of the clinical annotation of response vs. non-response." In other words, chemotherapy that helped a patient was recorded as not helping, and chemotherapy that did no good was recorded as helping. Oh lord.
With discrepancies of this magnitude, FC thinks it is an uphill battle to establish there was no willful misconduct. Even so, a key source says "I have not seen a smoking gun."
The Chronicle, which provided excellent, speedy, accurate coverage on Friday, first under the byline of Zachary Tracer, later joined by Taylor Doherty, got the only reaction from Potti himself that FC has seen throughout this mess. “It has been a difficult time, as you might imagine,” he wrote in an e-mail.
✔✔ THE POTTI LAB
There is no doubt that Potti was close to the people in his lab. His website for example has picture after picture of the Christmas party he has thrown for them each year. And word is, he has expressed concern now for "collateral damage" to trainees whose careers might be affected.
Precious little has been said about these people. They now work directly for Willard, who took over Potti's grants as Principal Investigator. "At the moment no one has lost his job," said Willard.
Key issue: did anyone know? Can anyone be held to the professional standard that they should have known.
✔✔ THE INVESTIGATIONS
There are two investigations underway. They will continue.
Unfortunately we do not know the scope of either, particularly since the Institute of Medicine is defining its own path. We have no idea who will be investigated.
In the case of the faculty misconduct review, we do not even know the people on the judgment panel.
This does not cut it. We were promised transparency.
We have new information about the key investigation by the Institute of Medicine, which we were initially very enthused about. This is an august body more concerned with public policy than science per se. It does not seem to have any specific qualification in scientific fraud. There are about 2,000 members of the Institute, with a surprising 81 from Duke, including the chancellor and medical school dean. We had the impression we were divorced from the organization doing the review.
This investigation must be lily white. No conflicts. No potential conflicts. No appearance of conflict. No appearance of potential conflict. The 81 from Duke should be required to stand down, suspend their membership, whatever device effectively severs them from all active work of the Institute at this critical time.
As this scandal metastasized, the list we wonder about in either inquiry has grown longer:
Dr Nevins, Potti co-author and his mentor, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology. Target of the internal review last winter.
Dr Bernard Mathey-Prevot, Research Professor of Pharmacology & Cancer Biology, Professor in Pediatrics, Potti co-author, husband of Medical School Dean Nancy Andrews.
Dr Wm Barry, in Potti's lab and target of the internal review last winter. Co-author
Dr. David Harpole, Potti co-author, Professor of Surgery, vice chief of the surgical services division, associate professor of pathology.
Dr. Phillip Febbo, co-author, departed Duke for UCSF.
Associate Deans Cuffe and Kornbluth who signed off on last winter's review. Cuffe has just gotten new religion: “In retrospect, these trials should not have been done." Both should be barred from making statements on behalf of Duke University for the duration of this controversy for they have too much at stake personally, not to mention their conflict because they were promoted by and continue to report to Dean Andrews.
We just do not know what it means to be co-author of a medical journal article, how much work you do yourself, how much of the effort of other people you are charged with knowing. That's a question we will explore next.
Please read this is from the Cancer Letter: "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." FC has no assurance whatsoever, that at the end of the two investigations, this ground will have been covered.
And speaking of conflict of interest issues, Duke divested itself of interest in licensing of Potti science, rather than face conflict charges that it was supporting Potti because it would make hoards from royalties if his theories provided a screening test for cancer patients. (The same issue is present in the Hellinga investigation, but ignored)
How much did Duke receive for its interests, from whom, and will they now get their money back since the science is bunk. The head of Duke licensing and VP Michael Schoenfeld both ignored FC e-mails.
✔✔ HEROES
Loyal Readers, since Potti first put forth his "discoveries" and was allowed to bring this bunk to clinical trials -- which is to say experiments on human beings -- the scientific community outside our Gothic Wonderland has raised questions. For four years, some entrenched people at Duke tried to discredit these challenges in any way they could, including disparaging remarks that bio-statisticians were not scientists are all, and that the MD degree yields more expertise in the emerging genome field than a Ph.D. At one point a Dean asked aloud who would believe a bunch of internet fools.
After a crescendo of concern, Duke was forced last winter to take an organized look at Potti -- an internal review with three outside consultants. While much of their secret report (Duke has refused to release it; anyone wanting a copy write Duke.Fact.Checker@gmail.com ) is highly technical, there are some unmistakable conclusions in plain English.
✔“the approaches (being used by Potti et al)... are viable and likely to succeed.”
✔ "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..... "
✔"...scientifically valid and with a few additions can be fully responsive to the comments of Drs. Baggerly and Coombes."
✔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."
It takes a lot of guts, a lot of fortitude to stand up to a University so self confident and so arrogant, but luckily people with great inner strength were on the horizon. They should be recognized for the good they have done.
Uncle Dick, here's how you can recover and show some leadership at last:
Next Founder's Day, Duke should give its highest honor -- called the Medal of Honor I believe -- to Baggerly and Coombes. It should give its highest alumni honor to Paul Goldberg '81, editor of The Cancer Letter.
Further, Duke as an institution should nominate Baggerly, Coombes, Goldberg and The Cancer Letter for a special Lasker Award for public service, the highest US honor in medicine.
And Duke as an institution should nominate its son, Paul Goldberg '81 and The Cancer Letter, for journalism's highest recognition, the Pulitzer Prize.
✔✔ CONCLUSION AND PERSPECTIVE
Allow, FC please, to put Dr. Anil Potti into perspective.
Last week was a great one for Duke Medicine and its 25,000 employees. It started on Monday when Chancellor Dzau received the annual Research Achievement Award at the American Heart Association. The citation: “in recognition of his monumental contributions to knowledge of intricate disease processes affecting the heart and blood vessels, insightful discoveries that are positively impacting the health of millions.”
In case you forgot, a year earlier, another Dukie won: Dr. Robert Lefkowitz, Howard Hughes Medical Institute investigator, for "transformative discoveries of cellular receptors, seminal findings that have created a cascade of biomedical innovation leading to more effective treatments for human disease."
The week at Duke Medicine saw release of an important study on a new drug to prevent people with heart beat irregularities (called atrial fibrillation) from getting strokes. There was also release of the world's largest study of acute heart failure, clearing up questions about side effects from a key drug in use for five years but raising the question of "why trials of this magnitude, or even greater, are not required earlier in the course of drug development,” according to Dr. Robert Califf, vice chancellor for clinical research.
Also involving the heart -- some of the news tied to the Heart Association meeting in Chicago -- we learned about Duke discovery of a protein secreted from stem cells that could reduce scarring from a heart attack, leaving more of the muscle alive and pumping.
Duke was picked to monitor the standards of world-wide efforts to fight HIV and AIDS, with one goal being a vaccine. Right now there is too much inconsistency in the way scientists test and record their data. From Dean Andrews of the Medical School: "Patients, physicians and researchers all need to feel confident that a test on a blood sample performed in New York will yield the same results as the same test performed in London or South Africa as an example. Today, you might not find that.”
Meanwhile, a Duke research team believes it found out how the AIDS virus defeats antibodies that are dispatched by the human body to fight it.
From the medical school we run in Singapore came word that research into fruit flies had discovered the protein Zif, and the long range hope the protein can be manipulated in humans to fight the worst kind of brain cancer. Fruit flies.
And back in Durham, there was even a finding about how fungi protect themselves from genetic mutation during sex. Don't laugh please. It has a lot of implications for humans.
Beyond the Potti headlines, it wasn't such a bad week after all.
Thank you for reading Fact Checker. GO DUKE!
11/21/2010
A Real Rhodes Scholar at Duke!!
Just announced an hour ago: Duke senior Jared Dunnmon from Cincinnati, Ohio, has won a Rhodes Scholarship.
This is the 43rd real Rhodes Scholarship for a Duke student in our history -- not counting the fake among the faculty.
FC tip: several sources now report we also have a Marshall Scholarship winner, so Duke will be well represented at Oxford for the next few years. Name still confidential, sorry.
Dunnmon is a mechanical engineering and economics major who has researched novel renewable energy sources. He is an A B Duke Scholar (a merit award.) When he received an additional scholarship -- the federally financed Barry Goldwater Science Award -- he said he intends to obtain both a Ph.D. and a law degree, hoping to address how to work with the government to solve energy issues.
The National Academy of Engineering named him a member of its 2009 Grand Challenge Scholars program, which aims to equip students to address societal engineering needs.
As a freshman, Dunnmon signed up for the joint Trinity Arts and Sciences and Pratt Engineering certificate. One of the first students to join the program, he said at the time that he thinks the certificate is impressive in encompassing all the different angles of the sustainable energy problem.
"There are not many programs like this," he said. "It's really representative of what Duke's trying to do with integration of interdisciplinary studies."
Ironically, just this month, he lost out on Duke's Faculty Scholar Award, being named a runner up.
Uncle Dick chimed in this morning from the Allen Building:
"Jared Dunnmon has been a model Duke student in the breadth of his engagements, his pursuit of excellence and his use of academic learning to solve real-world problems,” President Richard Brodhead said in a canned statement.
Following from the PR handout:
Working with Duke engineering professors Earl Dowell and Jonathan Protz, Dunnmon designed and tested clusters of micro-turbine devices in a wind tunnel to determine how much power they could produce from unusual wind flows, such as those between tall urban buildings.
He also worked as an environmental policy intern for the mayor of San Francisco, sang with the Duke Chapel Choir, and served with student organizations related to sustainability and social entrepreneurship at Duke.
At Oxford, Dunnmon plans to research the use of renewable fuels and other fuel-efficient measures in both industrial gas turbines and jet engines. Following his graduate studies at Oxford, he intends to develop a career in energy policy as well as energy research.
"The major challenge for my generation is to develop innovative technological and economic solutions that address the realities of dwindling resources without jeopardizing those that still remain," Dunnmon wrote in his Rhodes application. "I want my life's work to address what I believe to be the most difficult aspect of this challenge -- making environmentally and economically sustainable development possible on a global scale by providing accessible energy from renewable sources."
Dunnmon said he is still in a "state of disbelief" that he was chosen for the Rhodes, adding, "I am extremely grateful to all of the people who have helped me in the last few years to get here."
Dunnmon said he celebrated by going out to dinner with his mother and a friend Saturday night, but that he has a take-home test due Tuesday, "so it's back to the usual."
This is the 43rd real Rhodes Scholarship for a Duke student in our history -- not counting the fake among the faculty.
FC tip: several sources now report we also have a Marshall Scholarship winner, so Duke will be well represented at Oxford for the next few years. Name still confidential, sorry.
Dunnmon is a mechanical engineering and economics major who has researched novel renewable energy sources. He is an A B Duke Scholar (a merit award.) When he received an additional scholarship -- the federally financed Barry Goldwater Science Award -- he said he intends to obtain both a Ph.D. and a law degree, hoping to address how to work with the government to solve energy issues.
The National Academy of Engineering named him a member of its 2009 Grand Challenge Scholars program, which aims to equip students to address societal engineering needs.
As a freshman, Dunnmon signed up for the joint Trinity Arts and Sciences and Pratt Engineering certificate. One of the first students to join the program, he said at the time that he thinks the certificate is impressive in encompassing all the different angles of the sustainable energy problem.
"There are not many programs like this," he said. "It's really representative of what Duke's trying to do with integration of interdisciplinary studies."
Ironically, just this month, he lost out on Duke's Faculty Scholar Award, being named a runner up.
Uncle Dick chimed in this morning from the Allen Building:
"Jared Dunnmon has been a model Duke student in the breadth of his engagements, his pursuit of excellence and his use of academic learning to solve real-world problems,” President Richard Brodhead said in a canned statement.
Following from the PR handout:
Working with Duke engineering professors Earl Dowell and Jonathan Protz, Dunnmon designed and tested clusters of micro-turbine devices in a wind tunnel to determine how much power they could produce from unusual wind flows, such as those between tall urban buildings.
He also worked as an environmental policy intern for the mayor of San Francisco, sang with the Duke Chapel Choir, and served with student organizations related to sustainability and social entrepreneurship at Duke.
At Oxford, Dunnmon plans to research the use of renewable fuels and other fuel-efficient measures in both industrial gas turbines and jet engines. Following his graduate studies at Oxford, he intends to develop a career in energy policy as well as energy research.
"The major challenge for my generation is to develop innovative technological and economic solutions that address the realities of dwindling resources without jeopardizing those that still remain," Dunnmon wrote in his Rhodes application. "I want my life's work to address what I believe to be the most difficult aspect of this challenge -- making environmentally and economically sustainable development possible on a global scale by providing accessible energy from renewable sources."
Dunnmon said he is still in a "state of disbelief" that he was chosen for the Rhodes, adding, "I am extremely grateful to all of the people who have helped me in the last few years to get here."
Dunnmon said he celebrated by going out to dinner with his mother and a friend Saturday night, but that he has a take-home test due Tuesday, "so it's back to the usual."
11/19/2010
Official statement: Duke says a 2nd Potti paper is headed for the garbage heap. And his experiments on humans stopped.
Duke continues to dribble out information. This is the Friday afternoon trick that PR people at the university have used before -- hoping everyone is in weekend mode and won't focus on the bad news. Please scroll down to two earlier posts for Potti resignation and text.
The new tidbit is a blockbuster: a second journal article, with Dr Potti in the lead and his mentor Dr Joseph Nevins as co-author is going to be withdrawn.
Text of PR announcement:
"Dr. Potti's collaborator, Joseph Nevins, Ph.D., has initiated a process intended to lead to a retraction request regarding a paper previously published in Nature Medicine. This process has been initiated due to concerns about the reproducibility of reported predictors, and their possible effect on the overall conclusions in this paper. Other papers published based on this science are currently being reviewed for any concerns.
"The three clinical trials based on this science for which new enrollment was suspended in mid-July, have been closed."
That last line means that Potti's experiments on human beings are being stopped. Duke has insisted that this research caused no harm -- but there are some heavyweights lined up in the other direction.
More later.
The new tidbit is a blockbuster: a second journal article, with Dr Potti in the lead and his mentor Dr Joseph Nevins as co-author is going to be withdrawn.
Text of PR announcement:
"Dr. Potti's collaborator, Joseph Nevins, Ph.D., has initiated a process intended to lead to a retraction request regarding a paper previously published in Nature Medicine. This process has been initiated due to concerns about the reproducibility of reported predictors, and their possible effect on the overall conclusions in this paper. Other papers published based on this science are currently being reviewed for any concerns.
"The three clinical trials based on this science for which new enrollment was suspended in mid-July, have been closed."
That last line means that Potti's experiments on human beings are being stopped. Duke has insisted that this research caused no harm -- but there are some heavyweights lined up in the other direction.
More later.
POTTI RESIGNS - TEXT - CONTINUED
TEXT OF UNIVERSITY ANNOUNCEMENT SIGNED BY HUNTINGTON WILLARD.
As some of you may have heard already, Anil Potti announced today that he will officially resign from his faculty position at Duke.
In a letter to me, he accepted full responsibility for a series of anomalies in data handling, analysis and management that have come under scrutiny in the > past months. This provides some closure for Anil and now allows all of us to refocus our attention on the ongoing efforts in genome science and its translation, in time, into clinical medicine.
While this news represents a turning point of sorts, it is important to note that the various investigations will continue, as will our own efforts in the IGSP to review and evaluate the science in question.
Let there be no doubt that this turn of events represents a tragedy for Anil and his family, as well as for those who have worked closely with Anil in his lab, throughout the IGSP and in the Department of Medicine.
I hope you all join me in wishing Anil well and will offer support to
those -- especially in his lab and among his collaborators -- who have
been most impacted by this news.
As dismaying as this series of events is, it provides an opportunity for
reflection about what we do and how we do it, and it offers important, if painful, lessons for us all. I will have more to say about those in the days and weeks ahead.
in the meantime, let us remember, especially at this time of year, all
that Anil has done to positively influence the lives of many of his > colleagues, trainees, friends and Patients. The loss of any member
of our family is difficult, and I ask you to keep that in your thoughts
today.
>
>
> Hunt
>
>
As some of you may have heard already, Anil Potti announced today that he will officially resign from his faculty position at Duke.
In a letter to me, he accepted full responsibility for a series of anomalies in data handling, analysis and management that have come under scrutiny in the > past months. This provides some closure for Anil and now allows all of us to refocus our attention on the ongoing efforts in genome science and its translation, in time, into clinical medicine.
While this news represents a turning point of sorts, it is important to note that the various investigations will continue, as will our own efforts in the IGSP to review and evaluate the science in question.
Let there be no doubt that this turn of events represents a tragedy for Anil and his family, as well as for those who have worked closely with Anil in his lab, throughout the IGSP and in the Department of Medicine.
I hope you all join me in wishing Anil well and will offer support to
those -- especially in his lab and among his collaborators -- who have
been most impacted by this news.
As dismaying as this series of events is, it provides an opportunity for
reflection about what we do and how we do it, and it offers important, if painful, lessons for us all. I will have more to say about those in the days and weeks ahead.
in the meantime, let us remember, especially at this time of year, all
that Anil has done to positively influence the lives of many of his > colleagues, trainees, friends and Patients. The loss of any member
of our family is difficult, and I ask you to keep that in your thoughts
today.
>
>
> Hunt
>
>
POTTI RESIGNS from Duke Genome Institute ! ! ! ! ! !
✔✔✔✔✔
✔✔✔✔✔
✔✔✔✔✔
Dr Emil Potti - liar and faker - has resigned from Duke University’s Institute for Genome Sciences and Policy. It is not immediately clear if this covers all of his involvement at Duke. As well as being a researcher, he is a faculty member in the medical school and has privileges to admit patients to the medical center.
He has been on suspension with pay.
The announcement came in an e-mail to the IGSP staff from Director Huntington Willard.
✔✔✔✔✔
✔✔✔✔✔
Dr Emil Potti - liar and faker - has resigned from Duke University’s Institute for Genome Sciences and Policy. It is not immediately clear if this covers all of his involvement at Duke. As well as being a researcher, he is a faculty member in the medical school and has privileges to admit patients to the medical center.
He has been on suspension with pay.
The announcement came in an e-mail to the IGSP staff from Director Huntington Willard.
11/18/2010
Brodhead Equates Himself to Uncle Terry Sanford ! ! !
✔ Fact Checker here. Of course.
What is most surprising about President Brodhead's e-mail on undergraduate "culture" is that he wrote it at all.
For one of the great lessons of the six plus years with Brodhead at our helm is that he stands apart from raging undergraduate fires. FC does him a favor by saying "stands apart": we might have said he stands aloof if not arrogant.
What involvement did he have and did he spawn for example, as budget cuts sliced into undergraduate life? Killing the separate International House and Multi-Cultural Center. Closing the student pharmacy. Cutting back on housekeepers in the dorms. Not to mention chemistry labs and the coming dagger into the ranks of Arts and Science professors.
Why did he not invite undergraduates to partner on these decisions?
Indeed, not only undergraduates, but all stakeholders did not hear from the President for almost a year during the height of the financial crisis, as noted in a pair of Chronicle editorials blistering his leadership.
What involvement did he have when the Campus Republicans discriminated against their chair, ousting him because he came out? Brodhead even refused and refused again to see the victim of this organized homophobia which stabbed the heart of our culture and values, finally granting 5 minutes, only to say he knew little about the controversy. Nice staff work, Dick!!!
And what involvement has he had as evidence of GOP racial discrimination was sent to his administrators?
✔✔ And if Brodhead finally did want to engage stakeholders, he surely came forward at the wrong time.
✔ First, because the are whispers on campus that an alcohol and mephedrone scandal is about to make headlines -- the precise kind of image-busting publicity Brodhead lamented. FC knows more, but tells Loyal Readers no more this morning! If this materializes as it looks now, the e-mail will be regurgitated along with every other negative aspect of life on campus, dragging the name Brodhead front and center.
✔ Second, we are only six weeks from the first phase of K-Ville -- and nothing, nothing illustrates the culture crisis more than this months-long infusion of spirits, with the claim that unfettered use somehow bolsters our spirit. Students will be ignoring Brodhead's pleas for a "conversation," or as one put it in a note to FC, "I'll get drunk to that."
Yes, the great danger to Brodhead is that he will be totally ignored. Wrong word. Disobeyed. Oh guys like the student government president will see him and discuss. But hundreds of students making individual decisions to tent will act in his face.
Brodhead has let K-Ville fly under the radar, for example during the lacrosse crisis, accepting a report on "campus culture" that he commissioned that dwelt in depth on Tailgate and mentioned Last Day of Classes, but put K-Ville on an altar of silence.
This sort of official hypocrisy will now rebound and hurt Brodhead.
Hundreds of students, probably more than a thousand -- most of them our youngest freshmen who live on "dry" East Campus -- will be allowed to immerse themselves in the never-ending West bacchanalia that is K-Ville. Need I remind Loyal Readers that the last time a Deputy Fact Checker went over the protective line of deans and campus cops keeping out ABC authorities, the Deputy was greeted by hundreds of empty bottles and cans, several students urinating in public, and one act of fellatio in public between the tents. Not bad for 15 minutes of observation.
The lack of proper food, much less a place to eat it; the unhealthy, unsanitary mob conditions in front of our athletic complex; the middle of the night tent attendance checks and the near harassment of tenters by upperclassmen during them, not to mention the noise night and day, and the lack of an academic atmosphere with study space -- well.... in short we are about to see a repeat of the exact opposite of the kind of Duke our President envisions.
Brodhead has ducked involvement in the past. Not evening passing K-Ville during intense times to our knowledge. But this year, with his e-mail, K-Ville is going to embarrass him mightily as it begins and continues.
There are clear alternatives to K-Ville. For example students could pledge community service hours -- checked by line monitors -- and get tickets based upon their engagement. And with Brodhead's curious e-mail in our backpacks, it is time for all stakeholders to think anew.
✔ The Chronicle columnist identifies the heart of Brodhead’s message: "You will show yourselves true Duke students to the extent that you regard this university as yours to envision and yours to make.” He tells us to “speak openly” and “visualize a change.”
This is an idea Brodhead has expressed often, in Convocations for example. But he is the person who disables the ability of students to influence policy -- by being so secretive, by being so insular, by providing no information that would empower.
Take something specific: chemistry labs. How can an undergraduate possibly suggest an alternative budget cut, when the budget is not released and only administrators know -- only administrators own -- the details.
And another Brodhead quote: “We’ve had our eyes opened to the serious costs of apparently harmless fun.” Hence the references to negative press, canceled tailgate and the assertion, “we have too much drinking on this campus.”
Mr President, this is not new. In fact two years, three months have gone by since you signed the Amethyst Initiative, with your calling for a national conversation on the drinking age, muddling your position by failing to say if you believe a return to 18 would be responsible or not.
Isn't it time for the leadership you promised on this issue?
✔ Final notes: Brodhead wrote undergraduates, but FC cannot find a PR pick up. The text does not appear on his website; I do not find any news release.
And Chronicle should get a new pic of the President. From his tie, I date the front page picture used the other day (looks like he had a mustache tho it is hard to tell) from the first PR photo-shoot in 2004.
Thank you for reading FC!
4:37 AM
November 18, 2010
AntiFeminist
* reply
THANK YOU. Brodhead is acting exactly like Keohane did. It's been 17 years now since we've had a president who actually liked the undergraduates.
I can't believe he used Sanford's language too. What sort of delusional does he have to be to think he's anything like Terry Sanford, or worthy of pretending to be?
5:58 AM
November 18, 2010
Fact Checker
* edit
* reply
AntiFeminist - I came close to starting my essay commenting on Brodhead's self serving comparison with Terry Sanford. Uncle Dick!! Imagine!!!!!
I was thinking about the Vice Presidential debates before the election of 1988, when the Republican, Sen Dan Quayle, faced Senator Lloyd Bentsen.
Asked how he was qualified to be president, the 41 year old Quayle noted "I have as much experience in the Congress as Jack Kennedy did when he sought the presidency."
Bentsen spoke up "Senator, I served with Jack Kennedy, I knew Jack Kennedy, Jack Kennedy was a friend of mine. Senator, you're no Jack Kennedy."
What is most surprising about President Brodhead's e-mail on undergraduate "culture" is that he wrote it at all.
For one of the great lessons of the six plus years with Brodhead at our helm is that he stands apart from raging undergraduate fires. FC does him a favor by saying "stands apart": we might have said he stands aloof if not arrogant.
What involvement did he have and did he spawn for example, as budget cuts sliced into undergraduate life? Killing the separate International House and Multi-Cultural Center. Closing the student pharmacy. Cutting back on housekeepers in the dorms. Not to mention chemistry labs and the coming dagger into the ranks of Arts and Science professors.
Why did he not invite undergraduates to partner on these decisions?
Indeed, not only undergraduates, but all stakeholders did not hear from the President for almost a year during the height of the financial crisis, as noted in a pair of Chronicle editorials blistering his leadership.
What involvement did he have when the Campus Republicans discriminated against their chair, ousting him because he came out? Brodhead even refused and refused again to see the victim of this organized homophobia which stabbed the heart of our culture and values, finally granting 5 minutes, only to say he knew little about the controversy. Nice staff work, Dick!!!
And what involvement has he had as evidence of GOP racial discrimination was sent to his administrators?
✔✔ And if Brodhead finally did want to engage stakeholders, he surely came forward at the wrong time.
✔ First, because the are whispers on campus that an alcohol and mephedrone scandal is about to make headlines -- the precise kind of image-busting publicity Brodhead lamented. FC knows more, but tells Loyal Readers no more this morning! If this materializes as it looks now, the e-mail will be regurgitated along with every other negative aspect of life on campus, dragging the name Brodhead front and center.
✔ Second, we are only six weeks from the first phase of K-Ville -- and nothing, nothing illustrates the culture crisis more than this months-long infusion of spirits, with the claim that unfettered use somehow bolsters our spirit. Students will be ignoring Brodhead's pleas for a "conversation," or as one put it in a note to FC, "I'll get drunk to that."
Yes, the great danger to Brodhead is that he will be totally ignored. Wrong word. Disobeyed. Oh guys like the student government president will see him and discuss. But hundreds of students making individual decisions to tent will act in his face.
Brodhead has let K-Ville fly under the radar, for example during the lacrosse crisis, accepting a report on "campus culture" that he commissioned that dwelt in depth on Tailgate and mentioned Last Day of Classes, but put K-Ville on an altar of silence.
This sort of official hypocrisy will now rebound and hurt Brodhead.
Hundreds of students, probably more than a thousand -- most of them our youngest freshmen who live on "dry" East Campus -- will be allowed to immerse themselves in the never-ending West bacchanalia that is K-Ville. Need I remind Loyal Readers that the last time a Deputy Fact Checker went over the protective line of deans and campus cops keeping out ABC authorities, the Deputy was greeted by hundreds of empty bottles and cans, several students urinating in public, and one act of fellatio in public between the tents. Not bad for 15 minutes of observation.
The lack of proper food, much less a place to eat it; the unhealthy, unsanitary mob conditions in front of our athletic complex; the middle of the night tent attendance checks and the near harassment of tenters by upperclassmen during them, not to mention the noise night and day, and the lack of an academic atmosphere with study space -- well.... in short we are about to see a repeat of the exact opposite of the kind of Duke our President envisions.
Brodhead has ducked involvement in the past. Not evening passing K-Ville during intense times to our knowledge. But this year, with his e-mail, K-Ville is going to embarrass him mightily as it begins and continues.
There are clear alternatives to K-Ville. For example students could pledge community service hours -- checked by line monitors -- and get tickets based upon their engagement. And with Brodhead's curious e-mail in our backpacks, it is time for all stakeholders to think anew.
✔ The Chronicle columnist identifies the heart of Brodhead’s message: "You will show yourselves true Duke students to the extent that you regard this university as yours to envision and yours to make.” He tells us to “speak openly” and “visualize a change.”
This is an idea Brodhead has expressed often, in Convocations for example. But he is the person who disables the ability of students to influence policy -- by being so secretive, by being so insular, by providing no information that would empower.
Take something specific: chemistry labs. How can an undergraduate possibly suggest an alternative budget cut, when the budget is not released and only administrators know -- only administrators own -- the details.
And another Brodhead quote: “We’ve had our eyes opened to the serious costs of apparently harmless fun.” Hence the references to negative press, canceled tailgate and the assertion, “we have too much drinking on this campus.”
Mr President, this is not new. In fact two years, three months have gone by since you signed the Amethyst Initiative, with your calling for a national conversation on the drinking age, muddling your position by failing to say if you believe a return to 18 would be responsible or not.
Isn't it time for the leadership you promised on this issue?
✔ Final notes: Brodhead wrote undergraduates, but FC cannot find a PR pick up. The text does not appear on his website; I do not find any news release.
And Chronicle should get a new pic of the President. From his tie, I date the front page picture used the other day (looks like he had a mustache tho it is hard to tell) from the first PR photo-shoot in 2004.
Thank you for reading FC!
4:37 AM
November 18, 2010
AntiFeminist
* reply
THANK YOU. Brodhead is acting exactly like Keohane did. It's been 17 years now since we've had a president who actually liked the undergraduates.
I can't believe he used Sanford's language too. What sort of delusional does he have to be to think he's anything like Terry Sanford, or worthy of pretending to be?
5:58 AM
November 18, 2010
Fact Checker
* edit
* reply
AntiFeminist - I came close to starting my essay commenting on Brodhead's self serving comparison with Terry Sanford. Uncle Dick!! Imagine!!!!!
I was thinking about the Vice Presidential debates before the election of 1988, when the Republican, Sen Dan Quayle, faced Senator Lloyd Bentsen.
Asked how he was qualified to be president, the 41 year old Quayle noted "I have as much experience in the Congress as Jack Kennedy did when he sought the presidency."
Bentsen spoke up "Senator, I served with Jack Kennedy, I knew Jack Kennedy, Jack Kennedy was a friend of mine. Senator, you're no Jack Kennedy."
Tar Heel Covers Discrimination Complaint against Duke -- and Chronicle ignores it!
Fact Checker reported the skeleton of this story two days ago, and is pleased to let The Daily Tar Heel provide details.
By SETH CLINE | The Daily Tar Heel
After six months of wrangling with Duke University administration over his harassment claims, senior Justin Robinette has filed a complaint with the U.S. Department of Education against the school.
The complaint contends that administrators discriminated against him because he is gay and failed to take appropriate action when he claimed he was being harassed by students and fellow members of the Duke College Republicans.
Robinette was chairman of the club before being impeached in April, an action he claims was taken because of his sexuality.
The group’s executive board has maintained it was for poor leadership.
Since leaving the club, Robinette and former member Cliff Satell allege they have been continually harassed and threatened by club members and other Duke students.
When the last of their attempts to go through the student government to resolve claims failed, Robinette met privately with several administrators, including Dean of Students Stephen Bryan and President Richard Brodhead.
“The meeting with Bryan proved to be the most humiliating,” Robinette said. “He told me he had a theory that as a closeted gay guy in the organization, I had developed sexual feelings and was rejected, and that explains this scorn I have towards them.”
Both Bryan and Larry Moneta, the vice president of student affairs who also met with Robinette, declined to comment.
Following the meeting, Robinette and Satell consulted lawyers and decided the best course of action was to file a complaint with the U.S. Department of Education.
“We feel that (the complaint) would be the most effective and least burdensome,” Satell said. “You’re never guaranteed anything in a court of law, but the Department of Education is looking at a very narrow issue of whether Duke’s response was sufficient.”
The allegation will be investigated by the department’s Office of Civil Rights, which deals with discrimination claims and issues involving Title IX, a law that keeps people from being denied access to educational programs that receive federal funding on the basis of sex.
The next steps in the complaint process will be basic fact-finding interviews with those involved, namely Duke administrators and Robinette and Satell. But the members of the College Republicans who originally were the subjects of harassment claims will likely not be involved in the complaints, Robinette said.
“While I would like that they investigate the College Republicans matter, the reality is they won’t have the chance to do that,” said Robinette, who is graduating in December. “And that’s not as important to me as this investigation.”
More important is the acknowledgement that Duke handled the whole situation poorly, he said.
“It’s part vindication, but another part of it is for future Duke students who want to come to them for help,” Satell said.
By SETH CLINE | The Daily Tar Heel
After six months of wrangling with Duke University administration over his harassment claims, senior Justin Robinette has filed a complaint with the U.S. Department of Education against the school.
The complaint contends that administrators discriminated against him because he is gay and failed to take appropriate action when he claimed he was being harassed by students and fellow members of the Duke College Republicans.
Robinette was chairman of the club before being impeached in April, an action he claims was taken because of his sexuality.
The group’s executive board has maintained it was for poor leadership.
Since leaving the club, Robinette and former member Cliff Satell allege they have been continually harassed and threatened by club members and other Duke students.
When the last of their attempts to go through the student government to resolve claims failed, Robinette met privately with several administrators, including Dean of Students Stephen Bryan and President Richard Brodhead.
“The meeting with Bryan proved to be the most humiliating,” Robinette said. “He told me he had a theory that as a closeted gay guy in the organization, I had developed sexual feelings and was rejected, and that explains this scorn I have towards them.”
Both Bryan and Larry Moneta, the vice president of student affairs who also met with Robinette, declined to comment.
Following the meeting, Robinette and Satell consulted lawyers and decided the best course of action was to file a complaint with the U.S. Department of Education.
“We feel that (the complaint) would be the most effective and least burdensome,” Satell said. “You’re never guaranteed anything in a court of law, but the Department of Education is looking at a very narrow issue of whether Duke’s response was sufficient.”
The allegation will be investigated by the department’s Office of Civil Rights, which deals with discrimination claims and issues involving Title IX, a law that keeps people from being denied access to educational programs that receive federal funding on the basis of sex.
The next steps in the complaint process will be basic fact-finding interviews with those involved, namely Duke administrators and Robinette and Satell. But the members of the College Republicans who originally were the subjects of harassment claims will likely not be involved in the complaints, Robinette said.
“While I would like that they investigate the College Republicans matter, the reality is they won’t have the chance to do that,” said Robinette, who is graduating in December. “And that’s not as important to me as this investigation.”
More important is the acknowledgement that Duke handled the whole situation poorly, he said.
“It’s part vindication, but another part of it is for future Duke students who want to come to them for help,” Satell said.
Potti Mess Update - Medical Journal Retracts Key Research Publication
✔✔✔ The announcement tonight is no surprise: the Journal of Clinical Oncology has retracted -- which is to say denounced and denuded -- a 2007 research article on ovarian cancer by Duke University's Dr Anil Potti and Dr Joseph Nevins.
Loyal Readers will recall how Nevins revealed two weeks ago that at every turn, he now found the science bogus. Nevins is a heavyweight in Duke medicine, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology. He was Potti's mentor. Potti himself remains suspended from all Duke activities -- getting paid.
The Journal has already posted the retraction right next to the original article on its web edition, including this line:
"We deeply regret the impact of this action on the work of other investigators."
Before the retraction, other scientists had cited the article as authority 49 times.
✔✔✔ Key question: has Potti himself and other Duke authors come clean and joined in the retraction. These include two big shots: Dr. David Harpole, professor of cardiovascular and thoracic surgery, and vice chief of the entire Division of Surgical Services. And Dr. Phillip Febbo, a specialist in prostate cancer who has since left Duke for the University of California - San Francisco. The Journal's policy: "Prior to retracting any paper, JCO must receive a signed statement from each author saying that he or she agrees that the article should be retracted and that the wording of the retraction is satisfactory to him or her."
There are many other medical journal articles with both Potti and Nevins. We have no word on their status at the moment.
Below is a reproduction of the FC post of November 1 with hair-raising details about this "research."
Monday, November 1, 2010
Potti Patients Harmed by His Treatment ! ! !
✔Good day fellow Dukies.
The big news -- first reported by Fact Checker early Thursday evening but now with stunning new detail:
✔✔✔✔✔ The mentor of Dr. Anil Potti -- after four years of defending their joint research and claims to a break-thru in cancer treatment -- has stated their work has no validity. Or in the mentor's words, "no meaning."
The mentor is Dr. Joseph Nevins, a heavyweight in Duke medicine, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology.
Nevins has sent an e-mail to the Journal of Clinical Oncology (JCO) requesting that it retract a 2007 research paper that he co-authored. The editors have yet to respond.
This paper claimed that locked in the DNA and RNA of each individual -- and in their cancer -- was information that revealed which form of chemotherapy would work best. Up until then, it was hit or miss; this was a major advance, major. Think Lasker, think Nobel Prize.
✔✔✔✔✔ Immediately, as news of Nevins' retraction request rippled thru the scientific community, a new storm engulfed Duke.
Experts say that Nevins has admitted that the clinical trials that followed the laboratory research -- more accurately described as experiments with human beings -- harmed patients. Up until this moment, Duke has steadfastly denied this; and in a Halloween statement, Duke affirmed "we do not believe that patients were endangered."
This sets up an interesting confrontation: who do you believe? The faculty member who was involved in the trials? Or the administrators responsible for oversight?
✔✔✔✔✔ Nevins revealed one aspect of Potti's research involved 59 samples of ovarian cancer. Or what was supposed to be ovarian cancer.
16 of those samples are not this kind of cancer at all. Nevins: "At this point, I cannot trace the origin or nature of these samples."
✔✔✔✔✔ Of the remaining 43 samples, the news is not much better. "The tumor ID labels for these samples are incorrect. In a large number of these cases, the mis-identification results in reversal of the clinical annotation of response vs. non-response."
Translation: with the tumors being mis-identified, no one could tell what was what. In fact Potti concluded some patients were helped when they were not. He concluded some patients were not helped but they were. And out of this crap, he developed his theories about unlocking secrets contained in DNA and RNA and was allowed to experiment with human beings.
The Cancer Letter -- which has broken most of the news in the Potti scandal -- turned to Dr. George Sledge, the President of the American Society of Clinical Oncology, a professor at Indiana University, for interpretation. "It is safe to assume that patients might have been assigned to treatments that were unlikely to benefit them and possibly even to harm them."
And Dr. David Carbone, chair of cancer research at Vanderbilt: because of errors in Potti's research, "you may be withholding an effective treatment from some people or giving an ineffective targeted drug" suggested by the research. And "there is the possibility of patient harm."
From Dr.John Ruckdeschel, director and CEO of the Nevada Cancer Institute: "The potential for patients to have been treated differently than they might have otherwise been is present."
✔✔ There's more: Duke's first official review of the Potti mess finally came last winter (after almost four years of questions, not one as the Chronicle states). This was a hush hush behind closed doors internal review; Fact Checker alone has reported it was led by Dr. John Harrelson, professor of orthopedic surgery and associate professor of pathology. A Deputy Fact Checker found 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.
Duke occludes this internal review, by mentioning its outside consultants -- and inferring it was an outside review. Wrong.
During this review, Potti was not suspended but he was not allowed to recruit more volunteers for his experiments. The people already in the trials were allowed to remain.
This weekend, Duke's medical PR man, Douglas Stokke, was sent out after Nevins denounced his own work to concede that the same 59 samples that Nevins looked at anew, had been analyzed last winter and found OK.
What???????
Dr. Sally Kornbluth, Duke Medical School vice dean for research, said last year's investigation did not "drill down" to re-check the actual raw data. She said the review team was "not aware that there were data integrity issues with the work."
Whoa. Whoa. Whoa.
We turn to the intrepid bio-statisticians at the M D Anderson Comprehensive Cancer Center, Keith Baggerly and Kevin Coombes, in a guest editorial in The Cancer Letter:
"In November, 2009, we identified and reported the exact problems now cited for retracting the paper.... Given that Duke knew of these problems, why were (Potti's) clinical trials reopened in January 2010?"
Kornbluth was one of two vice deans who signed off on the winter-time investigation. So she's got a lot at stake in its scoope and integrity. And that was just one of four investigations that we know of into the Potti mess.
Nevins' retraction request is not part of any of those investigations. So where did it come from? How did it occur? From Duke PR: "We cannot speak for Dr. Nevins and his team who analyzed the data and came to the conclusion regarding the need to request a retraction."
Keep reading, there's more.
✔ Speed check number one involves other Duke scientists who co-authored the JCO (Journal of Clinical Oncology) article that Nevins wants withdrawn. Where do they stand? Why are they silent?
These include two big shots: Dr. David Harpole, professor of cardiovascular and thoracic surgery, and vice chief of the entire Division of Surgical Services. And Dr. Phillip Febbo, a specialist in prostate cancer who has since left Duke for the University of California - San Francisco. There are also other junior Duke physicians and scientists, several of whom have left for other places including UNC.
✔ Speed check number two involves the request to retract the JCO paper. It's rather unusual -- to say the least -- for a co-author to initiate a retraction request -- and even more unusual for one co-author to proceed unilaterally without consent of all the other authors.
The Cancer Letter -- whose original reporting on the Potti mess has prompted, forced and embarrassed Duke into action and is fully worthy of major awards for investigative journalism -- says that Nevins sent an email October 22 to his 13 co-authors to advise them. That's a whole lot different from their consent.
Key issue: Did Potti respond? Did he agree to sign this correspondence? Did all of the co-authors sign? Are all of the co-authors in agreement that the paper should be retracted?
Key issue: Over the Halloween weekend -- yes some of this stuff is so scary that I threw that in again -- Chancellor Victor Dzau sent all medical personnel an E-mail. He referred to "A scientific misconduct investigation regarding Dr. Potti that began several weeks ago." In fact, while the Institute of Medicine has agreed to do this external, unfettered, complete investigation, it will not begin until next year.
Yes this is the same Dr.Dzau who told us in an earlier e-mail that the very investigation would be into "the science conducted by Drs. Potti and Nevins."
Or as they'd say in Brooklyn, hey Victor, what happened to Joe?
FC does not believe the above Chronicle article is correct when it states Nevins is not under investigation.
Or for that matter, what happened to 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? Loyal Readers will remember FC's taking the wraps off Duke's secret report dated last December. That's when welearned tdhat Barry -- along with Potti and Nevins -- was investigated.
✔ ✔✔✔ Speed check number three involves the tests that were run to confirm Potti's data -- the precise time-line being in question.
What a tug of war it must have been between Nevins and his superior, Huntington Willard, Ph.D., Vice Chancellor for Genome Sciences and Nanaline Duke (James B's widow)Professor in the Institute for Genome Sciences & Policy!!!!!
(Nevins has refused all media requests for an interview; Willard responded immediately to a Fact Checker inquiry over the weekend on another aspect of the Potti matter. We are still at work trying to sort out other things to ask Willard who has indicated he would respond. Monday morning Duke PR announced Willard will take on new duties as senior adviser to the king of undergraduate deans, Steve Nowicki)
A consistently reliable mole tells FC that Willard called a meeting with everyone in Potti's lab -- believed to be about 20 people, a total derived from pictures of those attending the annual Christmas party that Potti has thrown. Willard said he was taking over as Principal Investigator for Anil’s grants.
(This is more than a technicality. The rules for most grants provide that the Principal Investigator -- PI -- cannot be absent for more than three months. One key grant for this research expires November 1 and it will be interesting to see how Duke handles continuing the lab. If some disgruntled employees are let go, FC wants to hear from them!!!!).
And Willard put Bala Balakumaran, Ph.D., Research Associate, Senior Staff, Center for Applied Genomics & Technology in charge of repeating the Potti experiments -- with specific instructions to report to him, Willard.
Nevins apparently contradicted that, telling Balakumaran that only portions of the Potti experiments should be repeated -- and forget Willard, the results should be given to him.
The mole tells FC there were several rounds in the tug of war with Balakumaran being "cajoled" by Nevins and receiving "conflicting orders" from two superiors.
Loyal Readers, this is not a novel. All this is going on in Fitzpatrick!!
✔✔The FC mailbox overflowed this weekend. Here are some excerpts:
"Is Nevins falling on his sword or throwing Potti under the bus?"
"The rest of the investigation will determine who was responsible and if deliberate fabrication or falsification were involved. Admission of reckless incompetence may be the only way out for Potti and Nevins."
✔✔ Potti remains on administrative leave. Paid. "No change" in status, said Michael Schoenfeld, Duke PR in response to the latest outrages. Loyal Readers, I do not know what a Duke faculty member, Duke researcher, or Duke doctor has to do to get canned.
Nor do I know who is protecting this clown.
✔✔✔About 25,000 people in the medical enterprise at Duke, and their continuing discoveries and care have earned this university renown. As the Chronicle notes, they are led by Chancellor Dzau, and FC expresses complete confidence in his integrity.
He alone among Duke's administrators has kept his pledge to keep the Potti mess "transparent."
FC and he have had substantial discussions of not only this, but other issues, with FC given more time than ever anticipated, allowed to explore every angle.
Unfortunately our essay this morning -- as happens so often in journalism -- is not about the good being done by so many but about a few who are sinking their ship. The only issue on the horizon is how many will go under with the vessel.
✔ Thank you for reading Fact Checker on good days and bad.
Posted by To reach Fact Checker at 1:22 AM
Loyal Readers will recall how Nevins revealed two weeks ago that at every turn, he now found the science bogus. Nevins is a heavyweight in Duke medicine, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology. He was Potti's mentor. Potti himself remains suspended from all Duke activities -- getting paid.
The Journal has already posted the retraction right next to the original article on its web edition, including this line:
"We deeply regret the impact of this action on the work of other investigators."
Before the retraction, other scientists had cited the article as authority 49 times.
✔✔✔ Key question: has Potti himself and other Duke authors come clean and joined in the retraction. These include two big shots: Dr. David Harpole, professor of cardiovascular and thoracic surgery, and vice chief of the entire Division of Surgical Services. And Dr. Phillip Febbo, a specialist in prostate cancer who has since left Duke for the University of California - San Francisco. The Journal's policy: "Prior to retracting any paper, JCO must receive a signed statement from each author saying that he or she agrees that the article should be retracted and that the wording of the retraction is satisfactory to him or her."
There are many other medical journal articles with both Potti and Nevins. We have no word on their status at the moment.
Below is a reproduction of the FC post of November 1 with hair-raising details about this "research."
Monday, November 1, 2010
Potti Patients Harmed by His Treatment ! ! !
✔Good day fellow Dukies.
The big news -- first reported by Fact Checker early Thursday evening but now with stunning new detail:
✔✔✔✔✔ The mentor of Dr. Anil Potti -- after four years of defending their joint research and claims to a break-thru in cancer treatment -- has stated their work has no validity. Or in the mentor's words, "no meaning."
The mentor is Dr. Joseph Nevins, a heavyweight in Duke medicine, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology.
Nevins has sent an e-mail to the Journal of Clinical Oncology (JCO) requesting that it retract a 2007 research paper that he co-authored. The editors have yet to respond.
This paper claimed that locked in the DNA and RNA of each individual -- and in their cancer -- was information that revealed which form of chemotherapy would work best. Up until then, it was hit or miss; this was a major advance, major. Think Lasker, think Nobel Prize.
✔✔✔✔✔ Immediately, as news of Nevins' retraction request rippled thru the scientific community, a new storm engulfed Duke.
Experts say that Nevins has admitted that the clinical trials that followed the laboratory research -- more accurately described as experiments with human beings -- harmed patients. Up until this moment, Duke has steadfastly denied this; and in a Halloween statement, Duke affirmed "we do not believe that patients were endangered."
This sets up an interesting confrontation: who do you believe? The faculty member who was involved in the trials? Or the administrators responsible for oversight?
✔✔✔✔✔ Nevins revealed one aspect of Potti's research involved 59 samples of ovarian cancer. Or what was supposed to be ovarian cancer.
16 of those samples are not this kind of cancer at all. Nevins: "At this point, I cannot trace the origin or nature of these samples."
✔✔✔✔✔ Of the remaining 43 samples, the news is not much better. "The tumor ID labels for these samples are incorrect. In a large number of these cases, the mis-identification results in reversal of the clinical annotation of response vs. non-response."
Translation: with the tumors being mis-identified, no one could tell what was what. In fact Potti concluded some patients were helped when they were not. He concluded some patients were not helped but they were. And out of this crap, he developed his theories about unlocking secrets contained in DNA and RNA and was allowed to experiment with human beings.
The Cancer Letter -- which has broken most of the news in the Potti scandal -- turned to Dr. George Sledge, the President of the American Society of Clinical Oncology, a professor at Indiana University, for interpretation. "It is safe to assume that patients might have been assigned to treatments that were unlikely to benefit them and possibly even to harm them."
And Dr. David Carbone, chair of cancer research at Vanderbilt: because of errors in Potti's research, "you may be withholding an effective treatment from some people or giving an ineffective targeted drug" suggested by the research. And "there is the possibility of patient harm."
From Dr.John Ruckdeschel, director and CEO of the Nevada Cancer Institute: "The potential for patients to have been treated differently than they might have otherwise been is present."
✔✔ There's more: Duke's first official review of the Potti mess finally came last winter (after almost four years of questions, not one as the Chronicle states). This was a hush hush behind closed doors internal review; Fact Checker alone has reported it was led by Dr. John Harrelson, professor of orthopedic surgery and associate professor of pathology. A Deputy Fact Checker found 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.
Duke occludes this internal review, by mentioning its outside consultants -- and inferring it was an outside review. Wrong.
During this review, Potti was not suspended but he was not allowed to recruit more volunteers for his experiments. The people already in the trials were allowed to remain.
This weekend, Duke's medical PR man, Douglas Stokke, was sent out after Nevins denounced his own work to concede that the same 59 samples that Nevins looked at anew, had been analyzed last winter and found OK.
What???????
Dr. Sally Kornbluth, Duke Medical School vice dean for research, said last year's investigation did not "drill down" to re-check the actual raw data. She said the review team was "not aware that there were data integrity issues with the work."
Whoa. Whoa. Whoa.
We turn to the intrepid bio-statisticians at the M D Anderson Comprehensive Cancer Center, Keith Baggerly and Kevin Coombes, in a guest editorial in The Cancer Letter:
"In November, 2009, we identified and reported the exact problems now cited for retracting the paper.... Given that Duke knew of these problems, why were (Potti's) clinical trials reopened in January 2010?"
Kornbluth was one of two vice deans who signed off on the winter-time investigation. So she's got a lot at stake in its scoope and integrity. And that was just one of four investigations that we know of into the Potti mess.
Nevins' retraction request is not part of any of those investigations. So where did it come from? How did it occur? From Duke PR: "We cannot speak for Dr. Nevins and his team who analyzed the data and came to the conclusion regarding the need to request a retraction."
Keep reading, there's more.
✔ Speed check number one involves other Duke scientists who co-authored the JCO (Journal of Clinical Oncology) article that Nevins wants withdrawn. Where do they stand? Why are they silent?
These include two big shots: Dr. David Harpole, professor of cardiovascular and thoracic surgery, and vice chief of the entire Division of Surgical Services. And Dr. Phillip Febbo, a specialist in prostate cancer who has since left Duke for the University of California - San Francisco. There are also other junior Duke physicians and scientists, several of whom have left for other places including UNC.
✔ Speed check number two involves the request to retract the JCO paper. It's rather unusual -- to say the least -- for a co-author to initiate a retraction request -- and even more unusual for one co-author to proceed unilaterally without consent of all the other authors.
The Cancer Letter -- whose original reporting on the Potti mess has prompted, forced and embarrassed Duke into action and is fully worthy of major awards for investigative journalism -- says that Nevins sent an email October 22 to his 13 co-authors to advise them. That's a whole lot different from their consent.
Key issue: Did Potti respond? Did he agree to sign this correspondence? Did all of the co-authors sign? Are all of the co-authors in agreement that the paper should be retracted?
Key issue: Over the Halloween weekend -- yes some of this stuff is so scary that I threw that in again -- Chancellor Victor Dzau sent all medical personnel an E-mail. He referred to "A scientific misconduct investigation regarding Dr. Potti that began several weeks ago." In fact, while the Institute of Medicine has agreed to do this external, unfettered, complete investigation, it will not begin until next year.
Yes this is the same Dr.Dzau who told us in an earlier e-mail that the very investigation would be into "the science conducted by Drs. Potti and Nevins."
Or as they'd say in Brooklyn, hey Victor, what happened to Joe?
FC does not believe the above Chronicle article is correct when it states Nevins is not under investigation.
Or for that matter, what happened to 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? Loyal Readers will remember FC's taking the wraps off Duke's secret report dated last December. That's when welearned tdhat Barry -- along with Potti and Nevins -- was investigated.
✔ ✔✔✔ Speed check number three involves the tests that were run to confirm Potti's data -- the precise time-line being in question.
What a tug of war it must have been between Nevins and his superior, Huntington Willard, Ph.D., Vice Chancellor for Genome Sciences and Nanaline Duke (James B's widow)Professor in the Institute for Genome Sciences & Policy!!!!!
(Nevins has refused all media requests for an interview; Willard responded immediately to a Fact Checker inquiry over the weekend on another aspect of the Potti matter. We are still at work trying to sort out other things to ask Willard who has indicated he would respond. Monday morning Duke PR announced Willard will take on new duties as senior adviser to the king of undergraduate deans, Steve Nowicki)
A consistently reliable mole tells FC that Willard called a meeting with everyone in Potti's lab -- believed to be about 20 people, a total derived from pictures of those attending the annual Christmas party that Potti has thrown. Willard said he was taking over as Principal Investigator for Anil’s grants.
(This is more than a technicality. The rules for most grants provide that the Principal Investigator -- PI -- cannot be absent for more than three months. One key grant for this research expires November 1 and it will be interesting to see how Duke handles continuing the lab. If some disgruntled employees are let go, FC wants to hear from them!!!!).
And Willard put Bala Balakumaran, Ph.D., Research Associate, Senior Staff, Center for Applied Genomics & Technology in charge of repeating the Potti experiments -- with specific instructions to report to him, Willard.
Nevins apparently contradicted that, telling Balakumaran that only portions of the Potti experiments should be repeated -- and forget Willard, the results should be given to him.
The mole tells FC there were several rounds in the tug of war with Balakumaran being "cajoled" by Nevins and receiving "conflicting orders" from two superiors.
Loyal Readers, this is not a novel. All this is going on in Fitzpatrick!!
✔✔The FC mailbox overflowed this weekend. Here are some excerpts:
"Is Nevins falling on his sword or throwing Potti under the bus?"
"The rest of the investigation will determine who was responsible and if deliberate fabrication or falsification were involved. Admission of reckless incompetence may be the only way out for Potti and Nevins."
✔✔ Potti remains on administrative leave. Paid. "No change" in status, said Michael Schoenfeld, Duke PR in response to the latest outrages. Loyal Readers, I do not know what a Duke faculty member, Duke researcher, or Duke doctor has to do to get canned.
Nor do I know who is protecting this clown.
✔✔✔About 25,000 people in the medical enterprise at Duke, and their continuing discoveries and care have earned this university renown. As the Chronicle notes, they are led by Chancellor Dzau, and FC expresses complete confidence in his integrity.
He alone among Duke's administrators has kept his pledge to keep the Potti mess "transparent."
FC and he have had substantial discussions of not only this, but other issues, with FC given more time than ever anticipated, allowed to explore every angle.
Unfortunately our essay this morning -- as happens so often in journalism -- is not about the good being done by so many but about a few who are sinking their ship. The only issue on the horizon is how many will go under with the vessel.
✔ Thank you for reading Fact Checker on good days and bad.
Posted by To reach Fact Checker at 1:22 AM
11/16/2010
Chronicle says spend, spend, spend. But tells us nothing about where the money is coming from.
✔ Fact Checker here
OK we follow the Chronicle's advice. The research expense goody bag -- and that's what is under discussion, not core grants -- for Arts and Sciences faculty is restored.
Moreover, we will keep the same number of professors.
✔ ✔ Now, tell me where the money is coming from. This editorial would have had some validity if it explored:
A) alternative cuts that can be made.
B) how to increase the university's income. Which is another way of saying, would you pay higher tuition?
C) how much deeper we can eat into our endowment -- that is, spending money now that we should be leaving for future generations. In the last academic year, the Trustees spent 7.2 percent of the endowment reserved for financial aid, and 5.8 percent of the rest of the endowment. (We have no idea what this year's rate is, since these people operate in secret) The Trustees traditional spending formula looks like 5.5 percent at first blush, but when you factor in an average value of the endowment over three years, the real spending rate has only been 4.8 percent. Our generation is being a parasite.
D) And if our regular endowment spending were not enough, there's three years of special appropriations easing the way to "a smaller Duke" so the financial meltdown did not hit this campus with a sudden thud. The special appropriations are covering $72 million in red ink this year. And scheduled to cover $40 million next year -- assuming employees are put into the third year of a wage freeze. With a modest hike, we're looking at a $70-75 million special appropriation to cover red ink in the next budget.
And my fellow Dukies, don't count on the administration's three year timetable scheduled to end with next year's budget.
✔ ✔ ✔ Chronicle editors, you did not read last week's Fact Checker, quoting Peter the Provost:
"... we have people who still believe that someday in the not too distant future, things will just go back to the way they were. I don't think that's going to happen. We're now in the new normal. We will need to continue to operate in much the same way as we have the last couple years. There are lots of places where we've made changes, and that will be the new normal."
✔ And finally I want to get to the student-faculty ratio. This newspaper has never given us the number of freshmen this year -- so here it is. 1,748. We got some vague explanation from the Dean of Admissions as to how we ended up with extra people. And never a clear explanation if this were an aberration or if he has a new target number.
Without knowing where we are headed with admissions -- if we are going to get back to our authorized level of 1675 to 1700 each year -- FC cannot calculate the future ratio.
But I can tell you the growth in faculty has far exceeded the growth in students in the past decade. We have gone from 2,243 regular faculty in 2000-01, to 3,019 last year, and more at the moment. While students on all levels have moved from 11,000 to 13,000.
In other words, Loyal readers, 1 faculty for 4.9 students a decade ago, to approximately 4.3 at the moment.
✔ ✔ The Fact Checker solution: First, no more surprises. After two years of cuts, finally on a November afternoon we find out about the decimation of the A and S research slush fund. That's got to stop. We need all information now.
If the faculty does not want to be cut, then they should give up a round of sabbaticals. Right now, after working 12 semesters, you can get one off. In other words, sabbaticals add 8 percent to salary costs. The suspension of sabbaticals occurred at the City U of NY without disaster in the 1970's financial pinch.
Also on sabbaticals, we can tighten the rules. Sorry Larry Moneta, but your sabbatical last year going to Serbia to study how universities there deliver services like dining and housing for students does not make the cut. (Moreover, he had federal money! A Fulbright.)
Sorry Dean Crumbliss. You seem to be at retirement age and no more sabbaticals as a final going away present. Moreover, you, a chemist, were going to Genoa Italy; under the FC rules, there would have to be a clear showing of the benefit to Duke and the ties to one's discipline.
And when we are done with sabbaticals, we need to address the number of hours each professor has to put into the classroom each academic year. Work load! We shall start by examining the load elsewhere including U of Texas where state statute specifies double what Duke professors experience. And we shall read together Former Provost Taylor Cole's biography where he slams his fellow professors for their slack.
I have more ideas, but it is late. And I want to give you reason to return to read FC!!
email Duke.Fact.Checker@gmail.com
additional posts not seen on the Chronicle and archive: http://dukefactchecker.blogspot.com/
OK we follow the Chronicle's advice. The research expense goody bag -- and that's what is under discussion, not core grants -- for Arts and Sciences faculty is restored.
Moreover, we will keep the same number of professors.
✔ ✔ Now, tell me where the money is coming from. This editorial would have had some validity if it explored:
A) alternative cuts that can be made.
B) how to increase the university's income. Which is another way of saying, would you pay higher tuition?
C) how much deeper we can eat into our endowment -- that is, spending money now that we should be leaving for future generations. In the last academic year, the Trustees spent 7.2 percent of the endowment reserved for financial aid, and 5.8 percent of the rest of the endowment. (We have no idea what this year's rate is, since these people operate in secret) The Trustees traditional spending formula looks like 5.5 percent at first blush, but when you factor in an average value of the endowment over three years, the real spending rate has only been 4.8 percent. Our generation is being a parasite.
D) And if our regular endowment spending were not enough, there's three years of special appropriations easing the way to "a smaller Duke" so the financial meltdown did not hit this campus with a sudden thud. The special appropriations are covering $72 million in red ink this year. And scheduled to cover $40 million next year -- assuming employees are put into the third year of a wage freeze. With a modest hike, we're looking at a $70-75 million special appropriation to cover red ink in the next budget.
And my fellow Dukies, don't count on the administration's three year timetable scheduled to end with next year's budget.
✔ ✔ ✔ Chronicle editors, you did not read last week's Fact Checker, quoting Peter the Provost:
"... we have people who still believe that someday in the not too distant future, things will just go back to the way they were. I don't think that's going to happen. We're now in the new normal. We will need to continue to operate in much the same way as we have the last couple years. There are lots of places where we've made changes, and that will be the new normal."
✔ And finally I want to get to the student-faculty ratio. This newspaper has never given us the number of freshmen this year -- so here it is. 1,748. We got some vague explanation from the Dean of Admissions as to how we ended up with extra people. And never a clear explanation if this were an aberration or if he has a new target number.
Without knowing where we are headed with admissions -- if we are going to get back to our authorized level of 1675 to 1700 each year -- FC cannot calculate the future ratio.
But I can tell you the growth in faculty has far exceeded the growth in students in the past decade. We have gone from 2,243 regular faculty in 2000-01, to 3,019 last year, and more at the moment. While students on all levels have moved from 11,000 to 13,000.
In other words, Loyal readers, 1 faculty for 4.9 students a decade ago, to approximately 4.3 at the moment.
✔ ✔ The Fact Checker solution: First, no more surprises. After two years of cuts, finally on a November afternoon we find out about the decimation of the A and S research slush fund. That's got to stop. We need all information now.
If the faculty does not want to be cut, then they should give up a round of sabbaticals. Right now, after working 12 semesters, you can get one off. In other words, sabbaticals add 8 percent to salary costs. The suspension of sabbaticals occurred at the City U of NY without disaster in the 1970's financial pinch.
Also on sabbaticals, we can tighten the rules. Sorry Larry Moneta, but your sabbatical last year going to Serbia to study how universities there deliver services like dining and housing for students does not make the cut. (Moreover, he had federal money! A Fulbright.)
Sorry Dean Crumbliss. You seem to be at retirement age and no more sabbaticals as a final going away present. Moreover, you, a chemist, were going to Genoa Italy; under the FC rules, there would have to be a clear showing of the benefit to Duke and the ties to one's discipline.
And when we are done with sabbaticals, we need to address the number of hours each professor has to put into the classroom each academic year. Work load! We shall start by examining the load elsewhere including U of Texas where state statute specifies double what Duke professors experience. And we shall read together Former Provost Taylor Cole's biography where he slams his fellow professors for their slack.
I have more ideas, but it is late. And I want to give you reason to return to read FC!!
email Duke.Fact.Checker@gmail.com
additional posts not seen on the Chronicle and archive: http://dukefactchecker.blogspot.com/
Chronicle is asleep for two important stories
First Veterans Day. And second, the federal civil rights complaint filed by Justin Robinette and Cliff Satel.
VETERANS DAY
For the first time in decades, Duke has honored its veterans with an appropriate ceremony on Veterans Day.
This follows a concerted effort by several alumni to force the issue, much of the drive aimed personally at President Brodhead who shamefully over a period of four years never answered a single E-mail on this. Typical line in a letter to the editor: "Our classmates fulfilled their duty and served with courage and honor; Mr. Brodhead, you are shirking yours."
The failure to honor veterans -- on Memorial Day too -- stood in sharp contrast to the University's laying a wreath each year at the memorial for the six Dukies who happened to be in the World Trade Center on 9-11, and for the week long observation of Martin Luther King's birthday.
For Vets Day, a news release stated the alumni office was going to lay a wreath at the Memorial Wall listing those who died in combat. But the official calendar never told us when.
There was an 11 AM ceremony at the Allen Building flag pole -- apparently scheduled for the convenience of the people involved rather than respect for the flag which traditionally is raised at dawn. The speaker was the human rights VP Kyle Cavanaugh, quite down on the pecking list.
There is no information on whether Brodhead or other senior administrators attended any event.
Last year the University -- responding to alumni howls at last -- ended 50 years of neglect and updated the Memorial War to include Korea, Vietnam and the Gulf Wars.
It is not known if Duke will sleep through Memorial Day again or not. It became an official campus holiday for the first time last year.
-----------
More later. Working on details. The federal Department of Education is launching a civil rights investigation into allegations by Robinette and Satell.
VETERANS DAY
For the first time in decades, Duke has honored its veterans with an appropriate ceremony on Veterans Day.
This follows a concerted effort by several alumni to force the issue, much of the drive aimed personally at President Brodhead who shamefully over a period of four years never answered a single E-mail on this. Typical line in a letter to the editor: "Our classmates fulfilled their duty and served with courage and honor; Mr. Brodhead, you are shirking yours."
The failure to honor veterans -- on Memorial Day too -- stood in sharp contrast to the University's laying a wreath each year at the memorial for the six Dukies who happened to be in the World Trade Center on 9-11, and for the week long observation of Martin Luther King's birthday.
For Vets Day, a news release stated the alumni office was going to lay a wreath at the Memorial Wall listing those who died in combat. But the official calendar never told us when.
There was an 11 AM ceremony at the Allen Building flag pole -- apparently scheduled for the convenience of the people involved rather than respect for the flag which traditionally is raised at dawn. The speaker was the human rights VP Kyle Cavanaugh, quite down on the pecking list.
There is no information on whether Brodhead or other senior administrators attended any event.
Last year the University -- responding to alumni howls at last -- ended 50 years of neglect and updated the Memorial War to include Korea, Vietnam and the Gulf Wars.
It is not known if Duke will sleep through Memorial Day again or not. It became an official campus holiday for the first time last year.
-----------
More later. Working on details. The federal Department of Education is launching a civil rights investigation into allegations by Robinette and Satell.
11/14/2010
Duke doc cleans up with secret payments from drug companies.
From Herald Sun. Please note that FC tipped the Chronicle on Oct 20 and the paper has had NOTHING.
By Monica Chen
mchen@heraldsun.com; 419-6636
DURHAM -- On Duke Medicine's website, David Rizzieri is an oncologist specializing in bone marrow and stem cell transplants. He has cancer treatments in clinical trials and dozens of published articles to his name.
What's not shown about Rizzieri is that in the past two years, he was paid $240,150 by drug companies, receiving $36,000 from GlaxoSmithKline for speaking engagements and more than five times that amount -- $204,150 -- from Cephalon under the vague title of "honoraria."
Rizzieri and about 17,700 other doctors across the country were thrown in the spotlight recently in "Dollars for Docs," a project by investigative news website ProPublica that compiled compensation disclosures from seven drug companies in 2009 and 2010, totaling $258 million.
In North Carolina, 16 doctors were paid more than $100,000 by drug companies, which put them in the project's "Top Earners" category. Of the 16 Top Earners, 10 are in the Triangle, and all except one teach and/or practice with Duke Medicine and UNC Hospitals.
Fees for speaking and consulting, as well as gifts in the form of samples and paid meals, are allowed by hospitals and universities because they are believed to foster the exchange of information between a drug maker and the prescribing doctor, who has real world experience on how a drug works outside of a laboratory. These interactions can lead to new innovations in drug development and refine patient care, proponents say.
However, in recent years, such practices have come under fire, with critics arguing that they are little more than marketing ploys in which the reputation of a doctor (and his affiliated hospital) is used to market the product to other doctors. For instance, at speaker events, information about a drug is restricted to the dosages and side effects already outlined by the U.S. Food and Drug Administration, which basically makes the information provided by doctor's lecture the same as that of any drug company representative.
Public sentiment has also begun to turn against such practices. According to a recent Consumer Reports survey, 74 percent of respondents said they disapproved of doctors being paid by drug companies for promoting drugs. About half of respondents said they'd be concerned about the quality of care from a doctor who received as little as $500.
When reached for a comment, Rizzieri, who was the ninth-highest-paid doctor in the Dollars for Docs report, defended his payments from GSK and Cephalon by pointing out that he has to disclose those relationships to Duke. The lectures also satisfy a need from other health care providers for information on the drugs, he said.
The honoraria he received from Cephalon was also for lectures, he and Cephalon both confirmed.
Asked whether the substantial sums he has received from drug companies could lead to ethical issues, Rizzieri replied, "I respect this concern and feel the multiple layers of oversight and conflict of interest management planning ... help assure appropriate application and presentation of the data."
The Herald-Sun also contacted the other Top Earner doctors in the Triangle. Although some doctors initially responded to the inquiry, none agreed to comment.
Revising policies
Duke and UNC officials said this week they have looked into the ProPublica report and had already begun reform efforts. Both universities are revising their conflict of interest policies.
UNC spokeswoman Karen McCall said none of the three UNC doctors on the Top Earners list violated current conflict of interest rules.
Ross McKinney, director of Duke's Trent Center for Bioethics, Humanities and History of Medicine, said he has personally met with most of the doctors who received more than $50,000 in the report. None was found to be in violation of the conflict of interest and disclosure policies at Duke.
The American Medical Student Association, which grades universities on their conflict of interest policies, gave Duke a "C" and UNC a "B" on their most recent scorecards. Duke earned a "D" last year.
UNC's new policy will emphasize and restrict financial relationships. At Duke, revisions will be made for both the university and the health system, to cover all doctors who may also be faculty members.
McKinney said the new policies will also have to consider the existing culture among doctors.
"It is hard to set restrictions when that is the existing culture. This isn't the Mayo Clinic where everybody is just a salaried employee," McKinney said.
Chris Manz, a third-year medical student at Duke and chairman of AMSA's PharmFree campaign to promote evidence-based prescribing, also acknowledged that culture is an issue.
"There is certainly a sense that once you go through medical school and you go through residency, you're kind of entitled to these gifts from industry, or to be paid well enough for speaking," Manz said.
At Duke, McKinney said the culture also gives leeway to faculty and doctors when it comes to industry relationships.
"We have taken a more liberal approach of allowing our faculty to have outside activities," McKinney said. "Starting to restrict faculty would go against the historic traditions. It goes against a longstanding cultural norm."
"But the times, they're a-changing," McKinney added, "and people need to recognize that."
Blemished records
One key concern for Duke and other institutions now is that some drug companies have hired doctors with blemishes on their records.
In the ProPublica report, a Georgia doctor who was once fired for taking liberties with female patients was Cephalon's third-highest-paid speaker last year, receiving $194,450 in 2009 and 2010. Five of the seven companies in the report acknowledged that they don't routinely check state board websites for discipline against doctors. Only Johnson & Johnson and Cephalon said they review the state sites, according to ProPublica.
In North Carolina, Keshavpal Reddy, a psychiatrist in Greensboro, received $109,540 from drug companies but was issued a reprimand by the state Medical Board in August for neglecting to evaluate a patient after repeated changes in prescription.
At Duke, Anil Potti, an assistant professor who has been on paid leave since the summer for padding his resume and falsely claiming to have been a Rhodes Scholar, was paid $86,950 by Eli Lilly and GSK in 2009 and 2010.
The Herald-Sun checked the records of all Top Earner doctors in the Triangle and did not find blemishes on their Medical Board records.
However, being on the list at all raised some concerns.
When it comes to Rizzieri, McKinney commented, "Being that high on a speakers list does call undesirable attention to somebody."
"On the other side, it comments on his reputation. The company wanted to pay him because he has a reputation," McKinney said. "But the other top 10 speakers, other than Rizzieri, don't exactly have academic luster."
When reached about their payments to doctors, spokespersons with GSK, Cephalon and Eli Lilly said the speakers are selected for their expertise. Cephalon states on its website that it believes speaker events and consulting services do not influence doctors' prescribing decisions.
GSK said its speakers sign a contract to certify clean records at the federal level. When it comes to state records, the company assesses the severity of infractions on a case-by-case basis.
Lilly representatives said they have suspended association with Potti and will hire an outside organization to screen doctors at the state level.
Looking biased
But some say the problem goes beyond the rigor with which drug companies screen their speakers.
Adam Linker, health policy analyst at the N.C. Justice Center, said the ethical concern should be particularly acute at universities, which are seen as models for research and should lead the way to reform.
"It's troubling when drug companies are sending money to people in medical schools," Linker said. "[Universities] should be pointing the way out of a reliance on drug companies to sponsor medical research and provide medical education."
According to McKinney and others, the problem of drug company payments to doctors is not confined to one campus or hospital. It's a systemic and cultural problem that needs to be addressed.
In 2013, the Affordable Care Act will seek to do that with a sunshine policy: All drug companies will be required to disclose their payments to doctors.
"We need academics to be the people to say honestly whether something is being used correctly or not," McKinney said. "In order to do so, they need to be unbiased. When you're talking about this kind of money, you start to look biased."
Manz, the Duke medical student, has been working with faculty on developing Duke's new conflict of interest policies.
"As a medical student, one of the things concerning me is that I'm trying to learn everything about the practice of medicine and how to practice appropriately," Manz said. "If my professor has a significant conflict of interest, I have to wonder whether I'm learning evidence-based medicine, or I'm learning marketing-based medicine."
"Tranparency is a step in the right direction," he added. "Though it's probably just the tip of the iceberg."
Read more: The Herald-Sun - Dollars for Docs hits home
By Monica Chen
mchen@heraldsun.com; 419-6636
DURHAM -- On Duke Medicine's website, David Rizzieri is an oncologist specializing in bone marrow and stem cell transplants. He has cancer treatments in clinical trials and dozens of published articles to his name.
What's not shown about Rizzieri is that in the past two years, he was paid $240,150 by drug companies, receiving $36,000 from GlaxoSmithKline for speaking engagements and more than five times that amount -- $204,150 -- from Cephalon under the vague title of "honoraria."
Rizzieri and about 17,700 other doctors across the country were thrown in the spotlight recently in "Dollars for Docs," a project by investigative news website ProPublica that compiled compensation disclosures from seven drug companies in 2009 and 2010, totaling $258 million.
In North Carolina, 16 doctors were paid more than $100,000 by drug companies, which put them in the project's "Top Earners" category. Of the 16 Top Earners, 10 are in the Triangle, and all except one teach and/or practice with Duke Medicine and UNC Hospitals.
Fees for speaking and consulting, as well as gifts in the form of samples and paid meals, are allowed by hospitals and universities because they are believed to foster the exchange of information between a drug maker and the prescribing doctor, who has real world experience on how a drug works outside of a laboratory. These interactions can lead to new innovations in drug development and refine patient care, proponents say.
However, in recent years, such practices have come under fire, with critics arguing that they are little more than marketing ploys in which the reputation of a doctor (and his affiliated hospital) is used to market the product to other doctors. For instance, at speaker events, information about a drug is restricted to the dosages and side effects already outlined by the U.S. Food and Drug Administration, which basically makes the information provided by doctor's lecture the same as that of any drug company representative.
Public sentiment has also begun to turn against such practices. According to a recent Consumer Reports survey, 74 percent of respondents said they disapproved of doctors being paid by drug companies for promoting drugs. About half of respondents said they'd be concerned about the quality of care from a doctor who received as little as $500.
When reached for a comment, Rizzieri, who was the ninth-highest-paid doctor in the Dollars for Docs report, defended his payments from GSK and Cephalon by pointing out that he has to disclose those relationships to Duke. The lectures also satisfy a need from other health care providers for information on the drugs, he said.
The honoraria he received from Cephalon was also for lectures, he and Cephalon both confirmed.
Asked whether the substantial sums he has received from drug companies could lead to ethical issues, Rizzieri replied, "I respect this concern and feel the multiple layers of oversight and conflict of interest management planning ... help assure appropriate application and presentation of the data."
The Herald-Sun also contacted the other Top Earner doctors in the Triangle. Although some doctors initially responded to the inquiry, none agreed to comment.
Revising policies
Duke and UNC officials said this week they have looked into the ProPublica report and had already begun reform efforts. Both universities are revising their conflict of interest policies.
UNC spokeswoman Karen McCall said none of the three UNC doctors on the Top Earners list violated current conflict of interest rules.
Ross McKinney, director of Duke's Trent Center for Bioethics, Humanities and History of Medicine, said he has personally met with most of the doctors who received more than $50,000 in the report. None was found to be in violation of the conflict of interest and disclosure policies at Duke.
The American Medical Student Association, which grades universities on their conflict of interest policies, gave Duke a "C" and UNC a "B" on their most recent scorecards. Duke earned a "D" last year.
UNC's new policy will emphasize and restrict financial relationships. At Duke, revisions will be made for both the university and the health system, to cover all doctors who may also be faculty members.
McKinney said the new policies will also have to consider the existing culture among doctors.
"It is hard to set restrictions when that is the existing culture. This isn't the Mayo Clinic where everybody is just a salaried employee," McKinney said.
Chris Manz, a third-year medical student at Duke and chairman of AMSA's PharmFree campaign to promote evidence-based prescribing, also acknowledged that culture is an issue.
"There is certainly a sense that once you go through medical school and you go through residency, you're kind of entitled to these gifts from industry, or to be paid well enough for speaking," Manz said.
At Duke, McKinney said the culture also gives leeway to faculty and doctors when it comes to industry relationships.
"We have taken a more liberal approach of allowing our faculty to have outside activities," McKinney said. "Starting to restrict faculty would go against the historic traditions. It goes against a longstanding cultural norm."
"But the times, they're a-changing," McKinney added, "and people need to recognize that."
Blemished records
One key concern for Duke and other institutions now is that some drug companies have hired doctors with blemishes on their records.
In the ProPublica report, a Georgia doctor who was once fired for taking liberties with female patients was Cephalon's third-highest-paid speaker last year, receiving $194,450 in 2009 and 2010. Five of the seven companies in the report acknowledged that they don't routinely check state board websites for discipline against doctors. Only Johnson & Johnson and Cephalon said they review the state sites, according to ProPublica.
In North Carolina, Keshavpal Reddy, a psychiatrist in Greensboro, received $109,540 from drug companies but was issued a reprimand by the state Medical Board in August for neglecting to evaluate a patient after repeated changes in prescription.
At Duke, Anil Potti, an assistant professor who has been on paid leave since the summer for padding his resume and falsely claiming to have been a Rhodes Scholar, was paid $86,950 by Eli Lilly and GSK in 2009 and 2010.
The Herald-Sun checked the records of all Top Earner doctors in the Triangle and did not find blemishes on their Medical Board records.
However, being on the list at all raised some concerns.
When it comes to Rizzieri, McKinney commented, "Being that high on a speakers list does call undesirable attention to somebody."
"On the other side, it comments on his reputation. The company wanted to pay him because he has a reputation," McKinney said. "But the other top 10 speakers, other than Rizzieri, don't exactly have academic luster."
When reached about their payments to doctors, spokespersons with GSK, Cephalon and Eli Lilly said the speakers are selected for their expertise. Cephalon states on its website that it believes speaker events and consulting services do not influence doctors' prescribing decisions.
GSK said its speakers sign a contract to certify clean records at the federal level. When it comes to state records, the company assesses the severity of infractions on a case-by-case basis.
Lilly representatives said they have suspended association with Potti and will hire an outside organization to screen doctors at the state level.
Looking biased
But some say the problem goes beyond the rigor with which drug companies screen their speakers.
Adam Linker, health policy analyst at the N.C. Justice Center, said the ethical concern should be particularly acute at universities, which are seen as models for research and should lead the way to reform.
"It's troubling when drug companies are sending money to people in medical schools," Linker said. "[Universities] should be pointing the way out of a reliance on drug companies to sponsor medical research and provide medical education."
According to McKinney and others, the problem of drug company payments to doctors is not confined to one campus or hospital. It's a systemic and cultural problem that needs to be addressed.
In 2013, the Affordable Care Act will seek to do that with a sunshine policy: All drug companies will be required to disclose their payments to doctors.
"We need academics to be the people to say honestly whether something is being used correctly or not," McKinney said. "In order to do so, they need to be unbiased. When you're talking about this kind of money, you start to look biased."
Manz, the Duke medical student, has been working with faculty on developing Duke's new conflict of interest policies.
"As a medical student, one of the things concerning me is that I'm trying to learn everything about the practice of medicine and how to practice appropriately," Manz said. "If my professor has a significant conflict of interest, I have to wonder whether I'm learning evidence-based medicine, or I'm learning marketing-based medicine."
"Tranparency is a step in the right direction," he added. "Though it's probably just the tip of the iceberg."
Read more: The Herald-Sun - Dollars for Docs hits home
11/12/2010
Projected budget deficit zooms!!! Brodhead unlikely to make three year goal of a sustainable budget.
✔ Fact Checker here
My fellow Dukies, the financial health of this university is not getting better. It is not staying the same. It is getting worse.
And any member of the faculty or any administrator who even suggests cuts like those made to the Arts and Sciences Research budget will be restored needs a wake up call.
Read, please, the words of Peter the Provost, who was "interviewed" by a Duke PR man for November 2 article in the employee publication Working@Duke:
"... we have people who still believe that someday in the not too distant future, things will just go back to the way they were. I don't think that's going to happen. We're now in the new normal. We will need to continue to operate in much the same way as we have the last couple years. There are lots of places where we've made changes, and that will be the new normal."
This same article -- little noticed on campus, not picked up by the Chronicle, but luckily a Deputy Fact Checker was alert -- revealed the red ink in the coming fiscal year (starting July 1, 2012) is not the $40 million that President Brodhead has been talking about. Exec VP Trask said that total does not include any money to end the two-year salary freeze nor to pay for soaring fringe benefit costs.
(Loyal Readers will recall that the freeze does not affect employees at Duke Health, which has its own revenue stream from patients. But FC can report that at Duke Health, the highest administrators agreed to have their personal contracts recast and their pay frozen, a previously unknown fact)
President Brodhead said in an e-mail to staff on September 22 that the new budget most likely would have a "modest" pay hike. FC assumed he meant this was within the boundaries of our income, rather than as it now appears, only adding to the deficit that will have to be covered by another special appropriation from our endowment.
The new total projected deficit: $70 million. As bad as this year.
More ominously, that red ink number -- coupled with the continuing problems in Arts and Sciences -- mean that the fiscal crisis will extend into a fourth year, and not be resolved by three years of staging to "a smaller Duke."
✔From Trask, some peaks into the future:
"We are going to have to have some conversations about benefits. Our benefits package is valued at the high-end among other universities and is well above the rest of the market. I'm not sure we can sustain that in the future."
"We probably need to pull out about 100 more positions by (June 30, 2012). It's unlikely that every person who does leave will be in positions that we will be able to do without. So there will need to be some rearrangement of people and responsibilities to help deal with that." Translation: more layoffs. Duke has never revealed the total number of people who have been laid off so far in the fiscal meltdown.
And from Peter the Provost: "The increasing expense for total compensation -- pay and benefits -- is going to run up against some of our programmatic goals." Translation: we cut the grounds keepers, we cut the thermostats, we started using two sides of paper. Programmatic goals -- additional tough decisions about the academic core -- are next.
✔Trask said "the single biggest thing we have left" is to try to save on university purchases, which run $650 million a year. Everything from paper towels to laboratory test tubes to light bulbs and vehicles.
Duke has recently contracted with an outside firm that has a program that sounds like Google Shopping; it leads us to the lowest cost supplier of everything we need. It's not known if suppliers will be paying the outside firm -- CyQuest of Cary NC -- to be listed, or for preferential positions.
The outside firm will be costing Duke -- not saving -- in the next fiscal year as it gets up to steam. Then Trask is hoping... well praying might be more accurate... for savings. Sheepishly, he mentioned five percent savings, or $30 million a year.
Trask may be skeptical though he's going along with buying the program, paying its annual fees, and installing its hardware. In a October 22 story, the Chronicle quoted him: “Don’t count on $30 million yet.”
As Trask told Working@Duke "interview," "The big push will be on the procurement side. We know we have too many transactions where we don't get the best pricing we could get."
✔ In this so-called "interview" by a PR man for Working@Duke (Trask and Lange ought to sit down with Fact Checker for a real interview!!) and in other comments, FC can report one area Duke is really gunning for: computer purchases.
After discovering you can get a better price if the entire university buys in bulk rather than department by department each buying a couple -- you need a PhD to figure that out -- Duke has now concluded that everyone is ordering with bells and whistles as if they were doing atomic research. The push is on to strip down, with one estimate showing $250,000 savings if new rules had been enforced in the last three months alone.
✔✔ There are some huge unknowns in the new budget:
A) Can we sustain the rate of spending from our endowment? We plan on a long-term return of 8.5 percent, but in the past decade it's only been 6.5 percent. If we have to lower our spending, the new crisis will be every bit as tough as the current one.
B) How much of federal stimulus funds -- Duke got more than $200 million -- expire this year, and how much next year.
C) How much will Republicans succeed in cutting university research in general. There's a short-visioned buffoon named Ralph Hall, congressman from Texas, who will become, in all probability, head of the House science committee with authority over the key budgets for the National Science Foundation and the Energy Dept's Office of Science. He wants to hold spending down to the current level for three years -- wiping out Democratic plans for an increase -- and during the three years figure out how deeper cuts can be made. The federal government is the largest supporter of Duke, providing far more money than tuition, or our own endowment, or lackluster contributions.
✔ Trask's estimate of the amount of money needed to break the two-year-old wage freeze is interesting, in that it points to a very very modest increase. With most of the pot drained by fringe benefits, Fact Checker made this calculation: in some instances, people who earned less than $50,000 and thus got a $1,000 one shot payment in the first year of the freeze, and people who earned less than $80,000 and thus got a one shot payment of $1,000 in the second year, may find their increases smaller than $1,000.
Their sole consolation is that the increases will be added to their bases, which are unlikely ever to be restored to pre-meltdown levels.
There is no word from the Brodhead Team if lower paid employees will receive a larger slice of the pay hike. As FC has written, their personal budgets were particularly squeezed. They had no where to turn, while members of one of the highest paid faculties in the country had more flexibility. I view this as a very important moral issue.
✔ Lastly I would like to know how come it is on November 12 2010 that we learn the faculty research budget was sliced by 75 percent. All stakeholders deserve to know information like this immediately -- rather than having administrators dribble out what they want, often serving only their own perpetuation.
I am also puzzled by Dean Crumbliss saying “The promise was that those funds would be given back when the University’s situation had improved. I hope that’s next year.”
This conflicts with my understanding of the Duke budget process, where various Deans are given certain allocations -- but they determine what to cut. This indicates to me the 75 percent cut was made by Crumbliss' predecessor, George McLendon, who has departed for Rice.
Have a good weekend@. Go Duke.
Email Duke.Fact.Checker@gmail.com
Archive http://dukefactchecker.blogspot.com/
My fellow Dukies, the financial health of this university is not getting better. It is not staying the same. It is getting worse.
And any member of the faculty or any administrator who even suggests cuts like those made to the Arts and Sciences Research budget will be restored needs a wake up call.
Read, please, the words of Peter the Provost, who was "interviewed" by a Duke PR man for November 2 article in the employee publication Working@Duke:
"... we have people who still believe that someday in the not too distant future, things will just go back to the way they were. I don't think that's going to happen. We're now in the new normal. We will need to continue to operate in much the same way as we have the last couple years. There are lots of places where we've made changes, and that will be the new normal."
This same article -- little noticed on campus, not picked up by the Chronicle, but luckily a Deputy Fact Checker was alert -- revealed the red ink in the coming fiscal year (starting July 1, 2012) is not the $40 million that President Brodhead has been talking about. Exec VP Trask said that total does not include any money to end the two-year salary freeze nor to pay for soaring fringe benefit costs.
(Loyal Readers will recall that the freeze does not affect employees at Duke Health, which has its own revenue stream from patients. But FC can report that at Duke Health, the highest administrators agreed to have their personal contracts recast and their pay frozen, a previously unknown fact)
President Brodhead said in an e-mail to staff on September 22 that the new budget most likely would have a "modest" pay hike. FC assumed he meant this was within the boundaries of our income, rather than as it now appears, only adding to the deficit that will have to be covered by another special appropriation from our endowment.
The new total projected deficit: $70 million. As bad as this year.
More ominously, that red ink number -- coupled with the continuing problems in Arts and Sciences -- mean that the fiscal crisis will extend into a fourth year, and not be resolved by three years of staging to "a smaller Duke."
✔From Trask, some peaks into the future:
"We are going to have to have some conversations about benefits. Our benefits package is valued at the high-end among other universities and is well above the rest of the market. I'm not sure we can sustain that in the future."
"We probably need to pull out about 100 more positions by (June 30, 2012). It's unlikely that every person who does leave will be in positions that we will be able to do without. So there will need to be some rearrangement of people and responsibilities to help deal with that." Translation: more layoffs. Duke has never revealed the total number of people who have been laid off so far in the fiscal meltdown.
And from Peter the Provost: "The increasing expense for total compensation -- pay and benefits -- is going to run up against some of our programmatic goals." Translation: we cut the grounds keepers, we cut the thermostats, we started using two sides of paper. Programmatic goals -- additional tough decisions about the academic core -- are next.
✔Trask said "the single biggest thing we have left" is to try to save on university purchases, which run $650 million a year. Everything from paper towels to laboratory test tubes to light bulbs and vehicles.
Duke has recently contracted with an outside firm that has a program that sounds like Google Shopping; it leads us to the lowest cost supplier of everything we need. It's not known if suppliers will be paying the outside firm -- CyQuest of Cary NC -- to be listed, or for preferential positions.
The outside firm will be costing Duke -- not saving -- in the next fiscal year as it gets up to steam. Then Trask is hoping... well praying might be more accurate... for savings. Sheepishly, he mentioned five percent savings, or $30 million a year.
Trask may be skeptical though he's going along with buying the program, paying its annual fees, and installing its hardware. In a October 22 story, the Chronicle quoted him: “Don’t count on $30 million yet.”
As Trask told Working@Duke "interview," "The big push will be on the procurement side. We know we have too many transactions where we don't get the best pricing we could get."
✔ In this so-called "interview" by a PR man for Working@Duke (Trask and Lange ought to sit down with Fact Checker for a real interview!!) and in other comments, FC can report one area Duke is really gunning for: computer purchases.
After discovering you can get a better price if the entire university buys in bulk rather than department by department each buying a couple -- you need a PhD to figure that out -- Duke has now concluded that everyone is ordering with bells and whistles as if they were doing atomic research. The push is on to strip down, with one estimate showing $250,000 savings if new rules had been enforced in the last three months alone.
✔✔ There are some huge unknowns in the new budget:
A) Can we sustain the rate of spending from our endowment? We plan on a long-term return of 8.5 percent, but in the past decade it's only been 6.5 percent. If we have to lower our spending, the new crisis will be every bit as tough as the current one.
B) How much of federal stimulus funds -- Duke got more than $200 million -- expire this year, and how much next year.
C) How much will Republicans succeed in cutting university research in general. There's a short-visioned buffoon named Ralph Hall, congressman from Texas, who will become, in all probability, head of the House science committee with authority over the key budgets for the National Science Foundation and the Energy Dept's Office of Science. He wants to hold spending down to the current level for three years -- wiping out Democratic plans for an increase -- and during the three years figure out how deeper cuts can be made. The federal government is the largest supporter of Duke, providing far more money than tuition, or our own endowment, or lackluster contributions.
✔ Trask's estimate of the amount of money needed to break the two-year-old wage freeze is interesting, in that it points to a very very modest increase. With most of the pot drained by fringe benefits, Fact Checker made this calculation: in some instances, people who earned less than $50,000 and thus got a $1,000 one shot payment in the first year of the freeze, and people who earned less than $80,000 and thus got a one shot payment of $1,000 in the second year, may find their increases smaller than $1,000.
Their sole consolation is that the increases will be added to their bases, which are unlikely ever to be restored to pre-meltdown levels.
There is no word from the Brodhead Team if lower paid employees will receive a larger slice of the pay hike. As FC has written, their personal budgets were particularly squeezed. They had no where to turn, while members of one of the highest paid faculties in the country had more flexibility. I view this as a very important moral issue.
✔ Lastly I would like to know how come it is on November 12 2010 that we learn the faculty research budget was sliced by 75 percent. All stakeholders deserve to know information like this immediately -- rather than having administrators dribble out what they want, often serving only their own perpetuation.
I am also puzzled by Dean Crumbliss saying “The promise was that those funds would be given back when the University’s situation had improved. I hope that’s next year.”
This conflicts with my understanding of the Duke budget process, where various Deans are given certain allocations -- but they determine what to cut. This indicates to me the 75 percent cut was made by Crumbliss' predecessor, George McLendon, who has departed for Rice.
Have a good weekend@. Go Duke.
Email Duke.Fact.Checker@gmail.com
Archive http://dukefactchecker.blogspot.com/
11/11/2010
Chronicle reveals student faces kiddie porn charges -- but there's far more to the story.
✔ Fact Checker here.
I think that Taylor Doherty handled this sensitive story very well. But he should have gone further.
FC is impelled to put this into a sleazier context, which is the continuing, concerted effort by certain members of the Duke community to see this story in print.
To see it in print with the hope it would destroy a fellow Dukie.
We begin last spring, with Justin Robinette, chair of the Duke Republican Club, struggling with his sexual identity. As e-mails and other documents presented during student Judiciary proceedings show, he handled this very intelligently, even discussing with LGBT center counselors over a months-long period his concern that being gay would impact his role at the club.
Indeed, he was right.
Because step by step, as more and more friends and others on the Duke campus got to know Robinette, leaders of the GOP reacted. First, they reacted with great immaturity, snickles. Then they reacted with hate, taunts, obscene gestures during their political meetings. Simulated masturbation.
And finally the GOP leaders created a specious list of reasons Robinette had to go -- not one of those reasons holding water. They also held a night-time meeting without notice of the agenda, changed their by-laws, awarded themselves the authority, and ousted Robinette.
And yes they revealed their true inner selves in continuing harassment, as when a GOP stalwart told Robinette he had a hickey -- and wanted to know if it were planted by a male or female. Not to mention the proclivity of Republicans to refer to gay men as "Shit on Dicks."
(These same Republicans are racists, and FC has given VP Moneta the name of a witness to certain acts. While responding immediately to thank FC for the information, Moneta has not followed up with the witness.)
The vice chair of the GOP, Cliff Satell, went to Robinette's defense -- and stood with him in repeated appearances before the student Senate and judiciary. He was brave to do this -- for e-mails presented to the Judiciary show he was the subject of blackmail from the moment he first spoke up.
As Chronicle coverage showed, quoting Satell as saying Robinette would still be chair were he not gay, he was making the position of other Republicans very untenable.
The harassment / intimidation continued right on up to President Brodhead's Homecoming Dance this fall.
Shut up, he was told, let us do what we want to Robinette, or we're going to reveal your arrest. The threat to him became more pointed at one Senate session where two people stood to advise Senators to forget the debate over sanctions on the GOP club, adjourn and go down to the court house and find out about Satell. The Chronicle did not report this; I am told but have not confirmed it is in the Senate minutes.
The reprehensible person or persons who tried to blackmail Satell -- I know their names, have traced their emails -- did not give up. Repeatedly, FC has received "tips" from "A Concerned Dukie" and others, with very specific information, right on down to the court docket number to make our tracing of this matter easier.
The last of the e-mails came in last week, even going beyond Satell, and making statements that FC considers libelous per se about others.
I would assume the Chronicle got the same barrage. And in that sense, it is sad to see the Chronicle responding to this low life conduct with today's story.
With publication of today's article, the Chronicle might want to turn to a more introspective story. Indeed the administration may want to examine the e-mails to see if the blackmail -- or attempted blackmail -- violated any law or university policy. Or if they constitute harassment.
In the face of all this, Satell did not back down on his support of Robinette, and for this courage he deserves our commendation. A person of lesser inner strength would have buckled to blackmail.
The child porn charges of course are most serious; Duke's administration has had a full review, and Satell's continued presence on this campus is evidence of the university conclusion.
It is my understanding the facts of the case are by no means clear, and that Satell expects a favorable outcome.
Thank you for reading Fact Checker.
I think that Taylor Doherty handled this sensitive story very well. But he should have gone further.
FC is impelled to put this into a sleazier context, which is the continuing, concerted effort by certain members of the Duke community to see this story in print.
To see it in print with the hope it would destroy a fellow Dukie.
We begin last spring, with Justin Robinette, chair of the Duke Republican Club, struggling with his sexual identity. As e-mails and other documents presented during student Judiciary proceedings show, he handled this very intelligently, even discussing with LGBT center counselors over a months-long period his concern that being gay would impact his role at the club.
Indeed, he was right.
Because step by step, as more and more friends and others on the Duke campus got to know Robinette, leaders of the GOP reacted. First, they reacted with great immaturity, snickles. Then they reacted with hate, taunts, obscene gestures during their political meetings. Simulated masturbation.
And finally the GOP leaders created a specious list of reasons Robinette had to go -- not one of those reasons holding water. They also held a night-time meeting without notice of the agenda, changed their by-laws, awarded themselves the authority, and ousted Robinette.
And yes they revealed their true inner selves in continuing harassment, as when a GOP stalwart told Robinette he had a hickey -- and wanted to know if it were planted by a male or female. Not to mention the proclivity of Republicans to refer to gay men as "Shit on Dicks."
(These same Republicans are racists, and FC has given VP Moneta the name of a witness to certain acts. While responding immediately to thank FC for the information, Moneta has not followed up with the witness.)
The vice chair of the GOP, Cliff Satell, went to Robinette's defense -- and stood with him in repeated appearances before the student Senate and judiciary. He was brave to do this -- for e-mails presented to the Judiciary show he was the subject of blackmail from the moment he first spoke up.
As Chronicle coverage showed, quoting Satell as saying Robinette would still be chair were he not gay, he was making the position of other Republicans very untenable.
The harassment / intimidation continued right on up to President Brodhead's Homecoming Dance this fall.
Shut up, he was told, let us do what we want to Robinette, or we're going to reveal your arrest. The threat to him became more pointed at one Senate session where two people stood to advise Senators to forget the debate over sanctions on the GOP club, adjourn and go down to the court house and find out about Satell. The Chronicle did not report this; I am told but have not confirmed it is in the Senate minutes.
The reprehensible person or persons who tried to blackmail Satell -- I know their names, have traced their emails -- did not give up. Repeatedly, FC has received "tips" from "A Concerned Dukie" and others, with very specific information, right on down to the court docket number to make our tracing of this matter easier.
The last of the e-mails came in last week, even going beyond Satell, and making statements that FC considers libelous per se about others.
I would assume the Chronicle got the same barrage. And in that sense, it is sad to see the Chronicle responding to this low life conduct with today's story.
With publication of today's article, the Chronicle might want to turn to a more introspective story. Indeed the administration may want to examine the e-mails to see if the blackmail -- or attempted blackmail -- violated any law or university policy. Or if they constitute harassment.
In the face of all this, Satell did not back down on his support of Robinette, and for this courage he deserves our commendation. A person of lesser inner strength would have buckled to blackmail.
The child porn charges of course are most serious; Duke's administration has had a full review, and Satell's continued presence on this campus is evidence of the university conclusion.
It is my understanding the facts of the case are by no means clear, and that Satell expects a favorable outcome.
Thank you for reading Fact Checker.
11/08/2010
Duke Medicine soars!
✔✔✔✔✔ Fact Checker here.
In my last post about the Potti mess, I noted there were approximately 25,000 people in Duke Medicine, but that FC, like all journalists, unfortunately wrote largely about the problems caused by a very very few. This weekend, there were several developments that allow us to focus with pride in the work of Chancellor Dzau and his colleagues.
✔First, the new cancer center was topped out, the construction going quicker than expected. In one dimension this new building means jobs. In another, it means hope. The Chronicle article needs no amplification.
✔Second, an article prominent in the Washington Post pointed to the awesome work being done to improve the health of poor people in Durham. FC has been aware of elements of this; I commend this story for its overview:
http://www.washingtonpost.com/wp-dyn/content/article/2010/11/06/AR2010110603254.html
✔Third, Loyal Readers, let's go to the other side of the world. You may have seen stories about President Obama in India, citing trade with that nation as a creator of jobs in the United States. Yes, there were the inevitable wisecracks about everyone’s thinking our involvement began with outsourcing and ended with long delays at call centers.
The list of two dozen projects listed by the White House starts with civil airplanes made by US workers at Boeing, steam generators from General Electric and other heavy duty industrial deals. Read down, and you come to two involving Duke Medicine. Quoting from official papers:
"Medanta Duke Research Institute (MDRI): Duke Medicine, located in Durham, North Carolina, one of the leading academic health systems in the United States, and Medanta Medicity, located in Gurgaon, Haryana, a hospital and medical research complex, are announcing a joint venture agreement to
launch the MDRI, a proof-of-concept clinical research facility within Medanta's hospital. Duke Medicine will provide scientific and operational leadership, while Medanta will contribute financial resources and clinical and operational services.
"Duke Medicine also will be partnering with Jubilant Life Sciences, headquartered in Uttar Pradesh, to conduct research studies and co-develop promising discoveries, with significant funding and in-kind support provided by Jubilant. Subsequent commercialization is expected to result in licensing revenue for Duke Medicine."
The head of Jubilant, Hari Bhartia, is a member of the board of Duke’s Global Health Institute (quite an impressive board, I must say). In connection with Obama's visit, he played a prominent rule in the Mumbai business summit and a Delhi round table with India’s finance minister.
Bhartia is not only into pharmaceuticals, but pizza, with 236 Domino’s stores. Sorry, could not resist passing that along.
FC tip: more Duke Medicine to come in India, watch for name of Ratan Tata.
A good autumn weekend. A football victory! The start of basketball. Duke Medicine shines. GO DUKE!
In my last post about the Potti mess, I noted there were approximately 25,000 people in Duke Medicine, but that FC, like all journalists, unfortunately wrote largely about the problems caused by a very very few. This weekend, there were several developments that allow us to focus with pride in the work of Chancellor Dzau and his colleagues.
✔First, the new cancer center was topped out, the construction going quicker than expected. In one dimension this new building means jobs. In another, it means hope. The Chronicle article needs no amplification.
✔Second, an article prominent in the Washington Post pointed to the awesome work being done to improve the health of poor people in Durham. FC has been aware of elements of this; I commend this story for its overview:
http://www.washingtonpost.com/wp-dyn/content/article/2010/11/06/AR2010110603254.html
✔Third, Loyal Readers, let's go to the other side of the world. You may have seen stories about President Obama in India, citing trade with that nation as a creator of jobs in the United States. Yes, there were the inevitable wisecracks about everyone’s thinking our involvement began with outsourcing and ended with long delays at call centers.
The list of two dozen projects listed by the White House starts with civil airplanes made by US workers at Boeing, steam generators from General Electric and other heavy duty industrial deals. Read down, and you come to two involving Duke Medicine. Quoting from official papers:
"Medanta Duke Research Institute (MDRI): Duke Medicine, located in Durham, North Carolina, one of the leading academic health systems in the United States, and Medanta Medicity, located in Gurgaon, Haryana, a hospital and medical research complex, are announcing a joint venture agreement to
launch the MDRI, a proof-of-concept clinical research facility within Medanta's hospital. Duke Medicine will provide scientific and operational leadership, while Medanta will contribute financial resources and clinical and operational services.
"Duke Medicine also will be partnering with Jubilant Life Sciences, headquartered in Uttar Pradesh, to conduct research studies and co-develop promising discoveries, with significant funding and in-kind support provided by Jubilant. Subsequent commercialization is expected to result in licensing revenue for Duke Medicine."
The head of Jubilant, Hari Bhartia, is a member of the board of Duke’s Global Health Institute (quite an impressive board, I must say). In connection with Obama's visit, he played a prominent rule in the Mumbai business summit and a Delhi round table with India’s finance minister.
Bhartia is not only into pharmaceuticals, but pizza, with 236 Domino’s stores. Sorry, could not resist passing that along.
FC tip: more Duke Medicine to come in India, watch for name of Ratan Tata.
A good autumn weekend. A football victory! The start of basketball. Duke Medicine shines. GO DUKE!
11/05/2010
Hey Chronicle staff: news is news when it happens, not when you get around to it.
For some time Fact Checker has been concerned about the slouching pace at the Chronicle. Moreover, its delay in bringing us important news stories seems to be growing.
Today (November 5) is a good example. There is a major story about a large gift to the Pediatrics Department. But FC reported this October 13th, highlighting what appeared two days earlier in Duke's Annual Financial Report.
Apparently no one at The Chronicle cared enough to read the financial report carefully or to follow up on FC.
The university itself issued a full press release on the gift October 26.
Another example -- today's Chronicle reports on research on a "hard hat" that will potentially aid construction workers. This was in the Durham Herald Sun last August 23rd. Yes August.
You want more -- today's Chronicle carries a story about the cost of obesity to American business. This was the subject of an October 8 handout from Duke's PR department. Yes a month ago.
Another example -- Last week, Fact Checker reported the blockbuster news that Dr Potti's research colleague had admitted their work was phony as a $3 bill. That was early Thursday evening; in the hours before the post, FC tipped several editors of the Chronicle as a courtesy. It was the Chronicle lead story on Monday.
Another example: FC made available to Chronicle editors all the data about salaries and bonuses to administrators three weeks before the Herald Sun published an op-ed. A slim offering of this information appeared in the Chronicle, as the lead story, only after Divinity students held a protest demonstration. Time lapse: six weeks. (Yes, Mr. Brodhead, wiggle all you might, I know you have tried to impeach this research by saying the payments are not bonuses at all, but your official tax filings call these payments "bonuses.")
Chronicle motto: If it is news to you, it's news to us!!
Today (November 5) is a good example. There is a major story about a large gift to the Pediatrics Department. But FC reported this October 13th, highlighting what appeared two days earlier in Duke's Annual Financial Report.
Apparently no one at The Chronicle cared enough to read the financial report carefully or to follow up on FC.
The university itself issued a full press release on the gift October 26.
Another example -- today's Chronicle reports on research on a "hard hat" that will potentially aid construction workers. This was in the Durham Herald Sun last August 23rd. Yes August.
You want more -- today's Chronicle carries a story about the cost of obesity to American business. This was the subject of an October 8 handout from Duke's PR department. Yes a month ago.
Another example -- Last week, Fact Checker reported the blockbuster news that Dr Potti's research colleague had admitted their work was phony as a $3 bill. That was early Thursday evening; in the hours before the post, FC tipped several editors of the Chronicle as a courtesy. It was the Chronicle lead story on Monday.
Another example: FC made available to Chronicle editors all the data about salaries and bonuses to administrators three weeks before the Herald Sun published an op-ed. A slim offering of this information appeared in the Chronicle, as the lead story, only after Divinity students held a protest demonstration. Time lapse: six weeks. (Yes, Mr. Brodhead, wiggle all you might, I know you have tried to impeach this research by saying the payments are not bonuses at all, but your official tax filings call these payments "bonuses.")
Chronicle motto: If it is news to you, it's news to us!!
11/01/2010
Potti Patients Harmed by His Treatment ! ! !
✔Good day fellow Dukies.
The big news -- first reported by Fact Checker early Thursday evening but now with stunning new detail:
✔✔✔✔✔ The mentor of Dr. Anil Potti -- after four years of defending their joint research and claims to a break-thru in cancer treatment -- has stated their work has no validity. Or in the mentor's words, "no meaning."
The mentor is Dr. Joseph Nevins, a heavyweight in Duke medicine, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology.
Nevins has sent an e-mail to the Journal of Clinical Oncology (JCO) requesting that it retract a 2007 research paper that he co-authored. The editors have yet to respond.
This paper claimed that locked in the DNA and RNA of each individual -- and in their cancer -- was information that revealed which form of chemotherapy would work best. Up until then, it was hit or miss; this was a major advance, major. Think Lasker, think Nobel Prize.
✔✔✔✔✔ Immediately, as news of Nevins' retraction request rippled thru the scientific community, a new storm engulfed Duke.
Experts say that Nevins has admitted that the clinical trials that followed the laboratory research -- more accurately described as experiments with human beings -- harmed patients. Up until this moment, Duke has steadfastly denied this; and in a Halloween statement, Duke affirmed "we do not believe that patients were endangered."
This sets up an interesting confrontation: who do you believe? The faculty member who was involved in the trials? Or the administrators responsible for oversight?
✔✔✔✔✔ Nevins revealed one aspect of Potti's research involved 59 samples of ovarian cancer. Or what was supposed to be ovarian cancer.
16 of those samples are not this kind of cancer at all. Nevins: "At this point, I cannot trace the origin or nature of these samples."
✔✔✔✔✔ Of the remaining 43 samples, the news is not much better. "The tumor ID labels for these samples are incorrect. In a large number of these cases, the mis-identification results in reversal of the clinical annotation of response vs. non-response."
Translation: with the tumors being mis-identified, no one could tell what was what. In fact Potti concluded some patients were helped when they were not. He concluded some patients were not helped but they were. And out of this crap, he developed his theories about unlocking secrets contained in DNA and RNA and was allowed to experiment with human beings.
The Cancer Letter -- which has broken most of the news in the Potti scandal -- turned to Dr. George Sledge, the President of the American Society of Clinical Oncology, a professor at Indiana University, for interpretation. "It is safe to assume that patients might have been assigned to treatments that were unlikely to benefit them and possibly even to harm them."
And Dr. David Carbone, chair of cancer research at Vanderbilt: because of errors in Potti's research, "you may be withholding an effective treatment from some people or giving an ineffective targeted drug" suggested by the research. And "there is the possibility of patient harm."
From Dr.John Ruckdeschel, director and CEO of the Nevada Cancer Institute: "The potential for patients to have been treated differently than they might have otherwise been is present."
✔✔ There's more: Duke's first official review of the Potti mess finally came last winter (after almost four years of questions, not one as the Chronicle states). This was a hush hush behind closed doors internal review; Fact Checker alone has reported it was led by Dr. John Harrelson, professor of orthopedic surgery and associate professor of pathology. A Deputy Fact Checker found 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.
Duke occludes this internal review, by mentioning its outside consultants -- and inferring it was an outside review. Wrong.
During this review, Potti was not suspended but he was not allowed to recruit more volunteers for his experiments. The people already in the trials were allowed to remain.
This weekend, Duke's medical PR man, Douglas Stokke, was sent out after Nevins denounced his own work to concede that the same 59 samples that Nevins looked at anew, had been analyzed last winter and found OK.
What???????
Dr. Sally Kornbluth, Duke Medical School vice dean for research, said last year's investigation did not "drill down" to re-check the actual raw data. She said the review team was "not aware that there were data integrity issues with the work."
Whoa. Whoa. Whoa.
We turn to the intrepid bio-statisticians at the M D Anderson Comprehensive Cancer Center, Keith Baggerly and Kevin Coombes, in a guest editorial in The Cancer Letter:
"In November, 2009, we identified and reported the exact problems now cited for retracting the paper.... Given that Duke knew of these problems, why were (Potti's) clinical trials reopened in January 2010?"
Kornbluth was one of two vice deans who signed off on the winter-time investigation. So she's got a lot at stake in its scoope and integrity. And that was just one of four investigations that we know of into the Potti mess.
Nevins' retraction request is not part of any of those investigations. So where did it come from? How did it occur? From Duke PR: "We cannot speak for Dr. Nevins and his team who analyzed the data and came to the conclusion regarding the need to request a retraction."
Keep reading, there's more.
✔ Speed check number one involves other Duke scientists who co-authored the JCO (Journal of Clinical Oncology) article that Nevins wants withdrawn. Where do they stand? Why are they silent?
These include two big shots: Dr. David Harpole, professor of cardiovascular and thoracic surgery, and vice chief of the entire Division of Surgical Services. And Dr. Phillip Febbo, a specialist in prostate cancer who has since left Duke for the University of California - San Francisco. There are also other junior Duke physicians and scientists, several of whom have left for other places including UNC.
✔ Speed check number two involves the request to retract the JCO paper. It's rather unusual -- to say the least -- for a co-author to initiate a retraction request -- and even more unusual for one co-author to proceed unilaterally without consent of all the other authors.
The Cancer Letter -- whose original reporting on the Potti mess has prompted, forced and embarrassed Duke into action and is fully worthy of major awards for investigative journalism -- says that Nevins sent an email October 22 to his 13 co-authors to advise them. That's a whole lot different from their consent.
Key issue: Did Potti respond? Did he agree to sign this correspondence? Did all of the co-authors sign? Are all of the co-authors in agreement that the paper should be retracted?
Key issue: Over the Halloween weekend -- yes some of this stuff is so scary that I threw that in again -- Chancellor Victor Dzau sent all medical personnel an E-mail. He referred to "A scientific misconduct investigation regarding Dr. Potti that began several weeks ago." In fact, while the Institute of Medicine has agreed to do this external, unfettered, complete investigation, it will not begin until next year.
Yes this is the same Dr.Dzau who told us in an earlier e-mail that the very investigation would be into "the science conducted by Drs. Potti and Nevins."
Or as they'd say in Brooklyn, hey Victor, what happened to Joe?
FC does not believe the above Chronicle article is correct when it states Nevins is not under investigation.
Or for that matter, what happened to 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? Loyal Readers will remember FC's taking the wraps off Duke's secret report dated last December. That's when welearned tdhat Barry -- along with Potti and Nevins -- was investigated.
✔ ✔✔✔ Speed check number three involves the tests that were run to confirm Potti's data -- the precise time-line being in question.
What a tug of war it must have been between Nevins and his superior, Huntington Willard, Ph.D., Vice Chancellor for Genome Sciences and Nanaline Duke (James B's widow)Professor in the Institute for Genome Sciences & Policy!!!!!
(Nevins has refused all media requests for an interview; Willard responded immediately to a Fact Checker inquiry over the weekend on another aspect of the Potti matter. We are still at work trying to sort out other things to ask Willard who has indicated he would respond. Monday morning Duke PR announced Willard will take on new duties as senior adviser to the king of undergraduate deans, Steve Nowicki)
A consistently reliable mole tells FC that Willard called a meeting with everyone in Potti's lab -- believed to be about 20 people, a total derived from pictures of those attending the annual Christmas party that Potti has thrown. Willard said he was taking over as Principal Investigator for Anil’s grants.
(This is more than a technicality. The rules for most grants provide that the Principal Investigator -- PI -- cannot be absent for more than three months. One key grant for this research expires November 1 and it will be interesting to see how Duke handles continuing the lab. If some disgruntled employees are let go, FC wants to hear from them!!!!).
And Willard put Bala Balakumaran, Ph.D., Research Associate, Senior Staff, Center for Applied Genomics & Technology in charge of repeating the Potti experiments -- with specific instructions to report to him, Willard.
Nevins apparently contradicted that, telling Balakumaran that only portions of the Potti experiments should be repeated -- and forget Willard, the results should be given to him.
The mole tells FC there were several rounds in the tug of war with Balakumaran being "cajoled" by Nevins and receiving "conflicting orders" from two superiors.
Loyal Readers, this is not a novel. All this is going on in Fitzpatrick!!
✔✔The FC mailbox overflowed this weekend. Here are some excerpts:
"Is Nevins falling on his sword or throwing Potti under the bus?"
"The rest of the investigation will determine who was responsible and if deliberate fabrication or falsification were involved. Admission of reckless incompetence may be the only way out for Potti and Nevins."
✔✔ Potti remains on administrative leave. Paid. "No change" in status, said Michael Schoenfeld, Duke PR in response to the latest outrages. Loyal Readers, I do not know what a Duke faculty member, Duke researcher, or Duke doctor has to do to get canned.
Nor do I know who is protecting this clown.
✔✔✔About 25,000 people in the medical enterprise at Duke, and their continuing discoveries and care have earned this university renown. As the Chronicle notes, they are led by Chancellor Dzau, and FC expresses complete confidence in his integrity.
He alone among Duke's administrators has kept his pledge to keep the Potti mess "transparent."
FC and he have had substantial discussions of not only this, but other issues, with FC given more time than ever anticipated, allowed to explore every angle.
Unfortunately our essay this morning -- as happens so often in journalism -- is not about the good being done by so many but about a few who are sinking their ship. The only issue on the horizon is how many will go under with the vessel.
✔ Thank you for reading Fact Checker on good days and bad.
The big news -- first reported by Fact Checker early Thursday evening but now with stunning new detail:
✔✔✔✔✔ The mentor of Dr. Anil Potti -- after four years of defending their joint research and claims to a break-thru in cancer treatment -- has stated their work has no validity. Or in the mentor's words, "no meaning."
The mentor is Dr. Joseph Nevins, a heavyweight in Duke medicine, Barbara Levine Professor of Breast Cancer Genomics and director of Duke's Center for Applied Genomics and Technology.
Nevins has sent an e-mail to the Journal of Clinical Oncology (JCO) requesting that it retract a 2007 research paper that he co-authored. The editors have yet to respond.
This paper claimed that locked in the DNA and RNA of each individual -- and in their cancer -- was information that revealed which form of chemotherapy would work best. Up until then, it was hit or miss; this was a major advance, major. Think Lasker, think Nobel Prize.
✔✔✔✔✔ Immediately, as news of Nevins' retraction request rippled thru the scientific community, a new storm engulfed Duke.
Experts say that Nevins has admitted that the clinical trials that followed the laboratory research -- more accurately described as experiments with human beings -- harmed patients. Up until this moment, Duke has steadfastly denied this; and in a Halloween statement, Duke affirmed "we do not believe that patients were endangered."
This sets up an interesting confrontation: who do you believe? The faculty member who was involved in the trials? Or the administrators responsible for oversight?
✔✔✔✔✔ Nevins revealed one aspect of Potti's research involved 59 samples of ovarian cancer. Or what was supposed to be ovarian cancer.
16 of those samples are not this kind of cancer at all. Nevins: "At this point, I cannot trace the origin or nature of these samples."
✔✔✔✔✔ Of the remaining 43 samples, the news is not much better. "The tumor ID labels for these samples are incorrect. In a large number of these cases, the mis-identification results in reversal of the clinical annotation of response vs. non-response."
Translation: with the tumors being mis-identified, no one could tell what was what. In fact Potti concluded some patients were helped when they were not. He concluded some patients were not helped but they were. And out of this crap, he developed his theories about unlocking secrets contained in DNA and RNA and was allowed to experiment with human beings.
The Cancer Letter -- which has broken most of the news in the Potti scandal -- turned to Dr. George Sledge, the President of the American Society of Clinical Oncology, a professor at Indiana University, for interpretation. "It is safe to assume that patients might have been assigned to treatments that were unlikely to benefit them and possibly even to harm them."
And Dr. David Carbone, chair of cancer research at Vanderbilt: because of errors in Potti's research, "you may be withholding an effective treatment from some people or giving an ineffective targeted drug" suggested by the research. And "there is the possibility of patient harm."
From Dr.John Ruckdeschel, director and CEO of the Nevada Cancer Institute: "The potential for patients to have been treated differently than they might have otherwise been is present."
✔✔ There's more: Duke's first official review of the Potti mess finally came last winter (after almost four years of questions, not one as the Chronicle states). This was a hush hush behind closed doors internal review; Fact Checker alone has reported it was led by Dr. John Harrelson, professor of orthopedic surgery and associate professor of pathology. A Deputy Fact Checker found 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.
Duke occludes this internal review, by mentioning its outside consultants -- and inferring it was an outside review. Wrong.
During this review, Potti was not suspended but he was not allowed to recruit more volunteers for his experiments. The people already in the trials were allowed to remain.
This weekend, Duke's medical PR man, Douglas Stokke, was sent out after Nevins denounced his own work to concede that the same 59 samples that Nevins looked at anew, had been analyzed last winter and found OK.
What???????
Dr. Sally Kornbluth, Duke Medical School vice dean for research, said last year's investigation did not "drill down" to re-check the actual raw data. She said the review team was "not aware that there were data integrity issues with the work."
Whoa. Whoa. Whoa.
We turn to the intrepid bio-statisticians at the M D Anderson Comprehensive Cancer Center, Keith Baggerly and Kevin Coombes, in a guest editorial in The Cancer Letter:
"In November, 2009, we identified and reported the exact problems now cited for retracting the paper.... Given that Duke knew of these problems, why were (Potti's) clinical trials reopened in January 2010?"
Kornbluth was one of two vice deans who signed off on the winter-time investigation. So she's got a lot at stake in its scoope and integrity. And that was just one of four investigations that we know of into the Potti mess.
Nevins' retraction request is not part of any of those investigations. So where did it come from? How did it occur? From Duke PR: "We cannot speak for Dr. Nevins and his team who analyzed the data and came to the conclusion regarding the need to request a retraction."
Keep reading, there's more.
✔ Speed check number one involves other Duke scientists who co-authored the JCO (Journal of Clinical Oncology) article that Nevins wants withdrawn. Where do they stand? Why are they silent?
These include two big shots: Dr. David Harpole, professor of cardiovascular and thoracic surgery, and vice chief of the entire Division of Surgical Services. And Dr. Phillip Febbo, a specialist in prostate cancer who has since left Duke for the University of California - San Francisco. There are also other junior Duke physicians and scientists, several of whom have left for other places including UNC.
✔ Speed check number two involves the request to retract the JCO paper. It's rather unusual -- to say the least -- for a co-author to initiate a retraction request -- and even more unusual for one co-author to proceed unilaterally without consent of all the other authors.
The Cancer Letter -- whose original reporting on the Potti mess has prompted, forced and embarrassed Duke into action and is fully worthy of major awards for investigative journalism -- says that Nevins sent an email October 22 to his 13 co-authors to advise them. That's a whole lot different from their consent.
Key issue: Did Potti respond? Did he agree to sign this correspondence? Did all of the co-authors sign? Are all of the co-authors in agreement that the paper should be retracted?
Key issue: Over the Halloween weekend -- yes some of this stuff is so scary that I threw that in again -- Chancellor Victor Dzau sent all medical personnel an E-mail. He referred to "A scientific misconduct investigation regarding Dr. Potti that began several weeks ago." In fact, while the Institute of Medicine has agreed to do this external, unfettered, complete investigation, it will not begin until next year.
Yes this is the same Dr.Dzau who told us in an earlier e-mail that the very investigation would be into "the science conducted by Drs. Potti and Nevins."
Or as they'd say in Brooklyn, hey Victor, what happened to Joe?
FC does not believe the above Chronicle article is correct when it states Nevins is not under investigation.
Or for that matter, what happened to 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? Loyal Readers will remember FC's taking the wraps off Duke's secret report dated last December. That's when welearned tdhat Barry -- along with Potti and Nevins -- was investigated.
✔ ✔✔✔ Speed check number three involves the tests that were run to confirm Potti's data -- the precise time-line being in question.
What a tug of war it must have been between Nevins and his superior, Huntington Willard, Ph.D., Vice Chancellor for Genome Sciences and Nanaline Duke (James B's widow)Professor in the Institute for Genome Sciences & Policy!!!!!
(Nevins has refused all media requests for an interview; Willard responded immediately to a Fact Checker inquiry over the weekend on another aspect of the Potti matter. We are still at work trying to sort out other things to ask Willard who has indicated he would respond. Monday morning Duke PR announced Willard will take on new duties as senior adviser to the king of undergraduate deans, Steve Nowicki)
A consistently reliable mole tells FC that Willard called a meeting with everyone in Potti's lab -- believed to be about 20 people, a total derived from pictures of those attending the annual Christmas party that Potti has thrown. Willard said he was taking over as Principal Investigator for Anil’s grants.
(This is more than a technicality. The rules for most grants provide that the Principal Investigator -- PI -- cannot be absent for more than three months. One key grant for this research expires November 1 and it will be interesting to see how Duke handles continuing the lab. If some disgruntled employees are let go, FC wants to hear from them!!!!).
And Willard put Bala Balakumaran, Ph.D., Research Associate, Senior Staff, Center for Applied Genomics & Technology in charge of repeating the Potti experiments -- with specific instructions to report to him, Willard.
Nevins apparently contradicted that, telling Balakumaran that only portions of the Potti experiments should be repeated -- and forget Willard, the results should be given to him.
The mole tells FC there were several rounds in the tug of war with Balakumaran being "cajoled" by Nevins and receiving "conflicting orders" from two superiors.
Loyal Readers, this is not a novel. All this is going on in Fitzpatrick!!
✔✔The FC mailbox overflowed this weekend. Here are some excerpts:
"Is Nevins falling on his sword or throwing Potti under the bus?"
"The rest of the investigation will determine who was responsible and if deliberate fabrication or falsification were involved. Admission of reckless incompetence may be the only way out for Potti and Nevins."
✔✔ Potti remains on administrative leave. Paid. "No change" in status, said Michael Schoenfeld, Duke PR in response to the latest outrages. Loyal Readers, I do not know what a Duke faculty member, Duke researcher, or Duke doctor has to do to get canned.
Nor do I know who is protecting this clown.
✔✔✔About 25,000 people in the medical enterprise at Duke, and their continuing discoveries and care have earned this university renown. As the Chronicle notes, they are led by Chancellor Dzau, and FC expresses complete confidence in his integrity.
He alone among Duke's administrators has kept his pledge to keep the Potti mess "transparent."
FC and he have had substantial discussions of not only this, but other issues, with FC given more time than ever anticipated, allowed to explore every angle.
Unfortunately our essay this morning -- as happens so often in journalism -- is not about the good being done by so many but about a few who are sinking their ship. The only issue on the horizon is how many will go under with the vessel.
✔ Thank you for reading Fact Checker on good days and bad.
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