1/31/2011

While Brodhead read Milton poems, Duke got smothered by Potti Mess in January

Search terms: Duke University Anil Potti

Note: In preparation of this report on the Potti Mess and a coming special report on the campus-wide leadership of President Brodhead, FC asked VP for PR Michael Schoenfeld for input, for information and suggestions. He has ignored our request.

✔✔ In January, the Potti Mess spun out of control, pushing Duke deeper and deeper into a quagmire. FC shall detail what happened in a moment.

First, we want to address the leadership that President Brodhead has provided during this crisis, now eight months old.

We find only two statements by Brodhead, both made during routine start-of-the-academic-year conversations with the editorial boards of the Herald-Sun and News and Observer.

Neither comment was significant enough to be reported in the Chronicle.

Immediately after The Cancer Letter revealed Potti's fake claim of a Rhodes Scholarship and the Rhodes Trust confirmed there was no award, with other credential issues looming, Brodhead cautioned editors and reporters not to reach rapid conclusions of truth or lie, for there could also be "intermediate explanation."

And in another editorial board meeting, Brodhead was asked how in hell Potti ever got a job on our faculty:

Brodhead: "The university will in general continue to accept credentials on their face as presented by the people who present them... We're not going to start running background checks and police checks on everybody... You can't reasonably do that, nor is there a need to."

Dare we point out that the President was immediately contradicted by Schoenfeld:

“In terms of faculty, [hiring] is a very thorough and rigorous process and involves extensive checking of references, conversations with people who worked with faculty members and reviewing work they do.”

✔ This is not leadership; the request to wait for an "intermediate explanation" is mush from an English professor, not the mighty declaration of principle we needed from the guy in charge, that anyone falsifying credentials would be thrown out on their ass. And the waffling on how Duke vets its employees is bewildering.

✔✔ Loyal Readers know of our repeated concern for Potti's patients. We believe there were far more than generally reported: the total of 107, 108 or 110 represents only those enrolled when Duke finally pulled the plug on his "clinical trials," which is to say experiments on human beings. We believe -- but have been unable to confirm -- that over time more than 300 people participated in these experiments, with perhaps as many as 1500 undergoing invasive tests to see if they qualified.

Has Brodhead ever said a word to any of these people? People who came to Duke in desperation, who got a quack instead of help and care.

Wouldn't it be appropriate for our Preident to address these people, to express our remorse, to reassure them, to bring them together for group therapy to help them cope with their mental anguish, to pledge that Duke will help them now obtain the best cancer care possible?

These people got ignored. They got silence from our President.

And needless to say, in a rosy Happy New Year sent belatedly to all alumni on January 21, Uncle Dick did not mention the Potti crisis at all.

Pathetic. Dick, just pathetic.

✔✔ And now the horrible month of January, with the Potti Mess spinning out of control:

✔ 1) As the Chronicle reports today, a third research paper that Potti published with his mentor Dr. Joseph Nevins has been retracted, which is a nice way to say withdrawn in disgrace. More to come.

✔ 2) In January, Nevins, Barbara Levine University Professor of Breast Cancer Genomics, saw the research center he headed disappear from the face of this campus. That is, the Center for Applied Genomics and Technology where Potti worked.

We have been cautioned against reading too much into this -- for two other centers that neither Potti nor Nevins were involved in were also terminated as part of a review of the entire genome enterprise prior to its 10th year. The Cancer Letter, which has broken most of the Potti stories, does not agree with that interpretation.

✔ 3) As the Institutes of Medicine (IOM), which is supposed to conduct a well financed "unfettered" investigation of the Potti Mess arrived on campus to begin its work, The Cancer Letter gave us a peek at some of the documents the IOM has amassed.

BOMBSHELL: The National Cancer Institute, which was using federal money to pay for some of Potti's research, became so concerned that on June 29, it summoned top Duke officials to its offices in Maryland for a showdown. For purposes of our analysis, the key person there was Sally Kornbluth, PhD, professor of pharmacology and cancer biology, and vice dean of the medical school.

This would not have been the first time that a highly authoratative challenge to Potti's work landed in her lap: Loyal Readers will recall how the previous November, as Duke's first internal investigation into Potti was beginning, she and Dr. Michael Cuffe, another vice dean, received an extraordinary letter from the eminent MD Anderson Comprehensive Cancer Center in Houston, with Dr. Keith Baggerly outlining in new detail precisely what was phony about Potti's research.


This letter was concealed from the investigation. Concealed. Repeat, not sent to the investigators, concealed.

We are told by a reliable source that Kornbluth and Cuffe were only some of the people in this decision; one account says "leadership": of Duke signed off -- in writing -- on this course. FC is at work trying to pin this down. (Later, Cuffe told Nature that if a similar situation were to ever occur again, he would forward “every shred” of evidence to the review panel. Whew.)

And even after the internal Duke investigators gave rousing approval to Potti's work, the letter was not send along as part of a reconsideration.

Rather, Kornbluth and Cuffe signed off on the investigation -- allowing clinical trials to continue.

Thus, Kornbluth was in a unique position to know the full dimensions of the implosion. But she -- and others -- did nothing. Only in the past horrible month, these details fell together.

✔4) It appeared more and more that the Institute of Medicine isn't delving into the nooks and crannies of Potti at all, but rather is more interested in a broad survey of standards in the emerging field of genome studies. This is undoubtedly important -- but not at the expense of a thorough investigation into Potti.

✔ 5) BOMBSHELL We learned that the Food and Drug Administration is on Duke's tail too. Part of Potti's clinical trials fell under their jurisdiction, because the tests that he used to determine who might benefit from what cancer drug are considered a "device."

No one can plead ignorance. On other similar trials, Duke doctors, including Nevins, secured FDA approval. Yet in documents just revealed, Duke’s Institutional Review Board put N/A for non-applicable next to checkboxes intended to indicate whether this form of FDA clearance had been obtained.

Investigators are on campus.

✔6) BOMBSHELL During the month of January, we learned that some of the people in Potti's clinical trials for lung cancer, received a chemotherapy cocktail that he concocted -- that is -- a combination of very powerful drugs used in a way not approved by drug regulators.

This should be a criminal offense.

✔ 7) Also in January, Duke surrendered the last of the Potti research funds, multi-year grants from the federal government involving cancer research, one with one year and $200,000 left, and the other with six months and $100,000. Potti's lab -- once vibrant with hope of a major scientific breakthru -- had shrunk to four employees, and they learned they are being laid off.

✔ 8) As FC reported, Potti started to emerge from the seclusion of his Chapel Hill home... building his Facebook site, sending out tweets (http://friendfeed.com/anilpottimd) and worse, apparently trying to capitalize on his years at Duke, presenting himself as a cancer doc extraordinaire, misleading with a regurgitation of a seven year old press release announcing a humanitarian award. So far as we can find out, Duke has filed no report on Potti with the North Carolina Medical Board.

✔ 9) A Raleigh law firm that has taken on Duke University in the past says it is doing "research" on the Potti Mess. The firm Henson Fuerst has now sent out several press releases seeking information from Potti patients, which seems to FC like a thinly disguised effort to sign them up for lawsuits.

✔✔ What will February hold? Brace yourself, fellow Dukies. At Bingham Young University, Baggerly (the whistleblower from MD Anderson Comprehensive Care Center) reviewed the Duke mess for the fourth joint international meeting of the IMS (Institute of Mathematical Statistics) and ISBA (International Society for Bayesian Analysis).

They deal with highly technical stuff, but everyone will be able to understand this prediction:

"Hold on folks, the ride’s just beginning."

Thank you for reading Fact Checker.
Duke.Fact.Checker@Gmail.com

1/27/2011

With money tight, universities scramble to profit from intellectual property

Search terms Duke University Anil Potti.

The following was written in response to a Chronicle editorial telling how the University of Missouri snagged 25 percent of a new app developed by a student.

✔ Fact Checker here. Good day.

FC has been following the growth of Duke's Office of Licensing and Ventures for some time -- the office set up to make sure that the University grabs its share of any intellectual property.

To be sure, most of this involves the faculty. But there are lessons to be learned for students.

We are troubled for two reasons:

First, much of our research is paid for by public money from the federal government. Or by entities like the American Cancer Society which enjoy tax breaks on their contributions and activities.

In these instances, we believe that all discoveries should be in the public realm, not subject to licensing fees or profit. If private industry paid for the research, then a financial gain would be understandable.

Second, our society has built walls around intellectual property so high, that unlike other societies in history that benefited from discoveries, our advances are held so that few citizens gain advantage immediately.

✔ Loyal Readers, there is big big bucks in this for Duke.

Two weeks ago one of the most distinguished senior faculty members, Dr. Allen Roses, director of Duke's Deane Drug Discovery Institute, licensed a test for Alzheimer's disease (very complicated genome test), to be made and sold by a Japanese firm. Up front price: $9 million.

The test determines if someone 60 years of age is likely to develop Alzheimer's within five or seven years. And the Japenese firm, making a drug for people at risk of Alzheimers, hopes to sell more of it because of the tests. If all this pans out, there will be additional payments of $78 million.

Roses acted thru a company he founded called Zinfandel (presumably named for his favorite wine?). While the corporate entanglements are not clear, these situations often involve a slice for Duke. And often Duke sells off nibbles of its slice to venture capitalists in order to cash out immediately.

Update: The good professor advises his favorite wine is Cabernet Sauvignon. And while FC said it is not unusual to have Duke owning a slice, in this instance Prof Roses says there is no relationship to Duke.

(The Duke ventures website is filled with information for potential investors. http://olv.duke.edu/index )

In the case of Dr Anil Potti, Loyal Readers may recall that after the heat really built up, Duke was charged with having a conflict of interest in seeing that Potti's work panned out -- standing to make BIG bucks.

Chancellor Dzau ordered Duke to sell off all its interests. This was buried in obscure language in an e-mail he sent to the medical community.

We tried to get additional information on the value of this part of the Potti Mess from the director of our licensing offices, Dr. Rose Ritts, and the ubiquitous VP for PR Michael Schoenfeld, both of whom shamefully did not acknowledge nor answer the Deputy Fact Checker's correspondence.

A good source in a position to know told FC that when fully developed, Potti's screening tests for cancer -- and their ability to tell which drugs would work best in each human -- could have been used by 700,000 people a year. And the source told us -- based upon the cost of similar tests -- the price tag for each test would easily be $1,000.

In the case of Dr. Homme Hellinga, FC has been told that Duke had a similar financial interest in seeing his work pan out. But this conflict of interest apparently was ignored when Duke reached judgment on him -- whatever the secret proceeding decided.

✔ Thank you for reading FC.

1/22/2011

Brodhead tells alumni "university's financial health is again strong." He omits any comment on Potti / Duke Medicine, and Kunshan, China

Search words Duke University Richard Brodhead Anil Potti

✔✔ FC here.

Just 16 months after the chair of the Trustees warned Duke was in "dire financial strait," President Brodhead has sent an extraordinary e-mail to all "alumni, parents and friends" declaring "the university’s financial health is again strong."

Brodhead congratulated himself for "internal discipline" that held down spending, and said "recovering financial markets" have boosted the endowment.

He offered no numbers whatsoever. He did not even refer readers to the special website set up to keep them informed about the financial crisis, which is sadly out of date.

Nor did Brodhead reconcile his claim that finances are "strong" with the planning for substantial cuts in the number of faculty in the Arts and Sciences, starting with the next budget on July 1. The hope is that enough faculty will resign or retire, but lay-offs cannot be ruled out.

Brodhead did not also say if in addition to being "strong," we'd have another budget gap in the new fiscal year starting July 1. This year's budget has $72 million in red ink, covered by a special withdrawal from the endowment.

The special $72 million is only part of the story, too, because trustees doctored the formula for regular withdrawals from the endowment and are now taking far more than the formula previously allowed. Obviously without this secret tinkering, the $72 million would have soared.

All this is at the peril of future generations, which will inherit far less of their fair share of current endowment.

✔ ✔ The e-mail, dressed up as a New Year's greeting for a "particularly positive start," even though it arrived on the 21st of January, listed several achievements, but is curious in ignoring Duke Medicine / Duke Health. And needless to say the Anil Potti scandal.

Brodhead urged alumni to return to Duke, listing reasons to come to Durham including some surprising restaurants and a resurgent downtown. He did not include Duke Medicine / Duke Health, which have given the city its nickname "City of Medicine."

The only appearance of Duke Medicine / Health comes when Brodhead reports on undergraduates who won Rhodes and Marshall Scholarships, mentioning Nick Altemose's research in the genome center.

Similarly there is no mention of Kunshan, China, his signature initiative which FC has previously reported is in serious trouble. Another pet project, DukeEngage, was also omitted.

✔ If there has been an uptick in the endowment, it's not been because of new contributions.

The only major gifts that have been the subject of news releases are $17.2 million for pediatrics left by a doctor who happened to make an early investment in Food Lion supermarkets , and a $5 million pledge from a law school dropout.

Traditionally Duke has refused to issue interim reports during the fiscal year on the value of its endowment. Most of the university's funds are invested in fancy deals like private equity or hedge funds. There is no ready market for these investments and their value is only a highly malleable estimate.

The Brodhead administration, however, has repeatedly released selective statistics to bolster itself.

Brodhead signed the e-mail "Dick Brodhead," reserving "Uncle Dick" for communications with students.

Thank you for reading Fact Checker!

1/21/2011

Reynolds Price 1933 - 2011

✔ Remembering Reynolds Price ‘55

The Fact Checker organization includes five people, soon six. One is an alumnus who studied under Reynolds Price more than half a century ago.

---

✔ In the fall of 1959, as Reynolds Price began his second year as an assistant professor of English at Duke, warned there would be no renewal of his three year contract, he was already a campus phenomenon. A freshman who by luck was assigned to Reynolds' class gained immediate recognition if not awe from his dorm mates.

The mandatory first year English program consisted, each week, of one mass lecture rotated among members of the department, one classroom hour with 12 other students, and a private half-hour appointment with the professor to discuss your weekly essay.

The mass lecture normally involved someone reading his script aloud, (yes it was HIS script, no female professors back then) hardly stirring the windowless auditorium. But Professor William Blackburn made us perk up. And Reynolds Price, when he lectured on Conrad’s “Heart of Darkness” without reference to any notes, drew a standing ovation, an appreciation not repeated again in most people’s undergraduate years.

The classroom hour was eclectic. While other profs labored through discussions of “The Great Gatsby” and the like, pitting Ph.D. dissertations against each other, Reynolds enlivened his class with probative and provocative discussions of faith and focus, family and meaning, history and current events. Sitting atop his desk, his legs folded under him, he led complex, magnetic discourse unlike any other English class you are likely to run into.

When listening, and he was just a good a listener as story teller and speaker in class, Reynolds had a way of moving his tongue to the corner of his mouth; and when he understood your point and was about to pounce, to move his tongue up to his upper lip.

When no one was up to speed on the coming British elections, he flared with his strong deep voice and castigated the vitality of the class in no uncertain terms.

"For many Duke students," he would say later, "the word 'intellectual' has an almost pejorative tone to it. I think of an intellectual as being one of the millions of human beings who pays very close attention to the world and tries to draw intelligent conclusions for his or her own life and the lives of others. It's not a choice someone makes in the 6th grade to be some book wormy, nerdy person who derives no joy from life."

The weekly essays were also eclectic. While others pondered Fitzgerald, Hemingway and other first year authors, Reynolds assigned his students to write on their life experiences. While other freshmen went to their one-on-one critiques and saw their professors reading one line ahead of the discussion, Reynolds had labored in his crowded East Duke Building office over the student's effort, scribbling abundantly in the margin, circling words and phrases in swooping red ink, and taking far more time than the allotted 30 minutes each week to critique.

Oh yes, no one got an A.

During his three year contract, Reynolds wrote his first novel -- and was asked to stay on. He quickly moved beyond mandatory freshman English and later taught courses on creative writing and the 17th-century English poet John Milton, as well as a course on the gospels in which students wrote their own version of a gospel story.

And then there was Halloween, Reynolds Price's annual reading of ghost stories and poems, which became a tradition.

For Dukie's who only know Reynolds from the decades he used a wheelchair, it’s difficult to imagine him as a student in the 50's or an aspiring professor in the 60's. Robust and athletic, a soccer player, someone who gracefully bounded up stairs two if not three at a time, who walked briskly and erect, loafers no socks. He particularly enjoyed the autumn and spring rains, and more than once was found just standing on the Main Quad under his large black umbrella watching the passing crowd.

Notice I said “used a wheelchair,” for Reynolds disdained the words “confined to a wheelchair.” For him, this device enabled his continued participation in the life of a university he so loved, and was not a restriction.

✔ FOUNDERS DAY 1992

It's hard to imagine too how dreary Founders Day was over the decades. I mean, what's to be said for inviting the president of the Tobacco Institute, the lobbying arm of the industry, to give the main address.

And then December, 1992, an invitation went to Reynolds with the blessing of President H. Keith H. Brodie, who knew that people who loved Duke eternally and were loyal to the core could make significant contribution with constructive criticism, a view lost on today's administrators.

Starting by noting Duke's increasing recognition -- "the university faculty has grown in responsible intellectual daring and professional stature to a point at which we may begin at least to think of ourselves as a first-rate academy, presumably the youngest in the world" -- Reynolds soon got to his theme:

When he was a student in the 50's, said Reynolds, undergraduates "gloried in a proportionally greater number of absolutely first-rate student minds, and fruitful personal exchanges between teachers and students were far more common in those days."

And in his early days, he encountered "extraordinary students to keep me teaching."

But as Reynolds said on Founders Day, times changed:

"I likewise encounter -- and all my classes are elective -- the stunned or blank faces of students who exhibit a minimum of preparation, or willingness for what I think of as the high delight and life-long pleasure of serious conversation in the classroom and elsewhere."

(In an interview, he later said, "It just is a tradition at Duke that students don't come to see their teachers. I sit in my office hours two days a week, and I also list 'and by appointment' and, generally speaking, nobody comes by. Here I am, and I mark the time reading a book or getting through my own homework and just nobody comes.")

Pointing fingers, he said alcohol was having devastating effect on students because it decreases their hunger for knowledge. When he was a student, Duke was certainly "no garden of Eden of intellectual serenity... but there really (has been) a gigantic change. It was a sober place."

With the stage thus set, Reynolds attacked with even more specificity.

Finding Greek life to be "play and violence and the occasional charitable project," fostering a "prevailing cloud of indifference, of frequent hostility, to a thoughtful life," he exhorted, "Join me in an earth-moving act which this university has delayed many decades and for lack of which it has punished all its members."

"... take firm steps to move briskly every fraternity and sorority among us; they would not return."

"I was once a member of a fraternity that survives on this campus. (Phi Delta Theta) This was before alcohol became our grim solvent."

With Greeks gone, "freed of that burden, we'd move with deliberate speed to organize life throughout the university on a residential college model...

"We'd redesign or rearrange individual quads and buildings, each with the shortest corridors possible, with private bedrooms for every student and with a dining room in each quad where students could meet like sane adult members or a group dedicated to legitimate principles of thoughtful social life, punctuated by normal bouts of revel."

In subsequent interviews, Reynolds wondered aloud why fraternities have exclusive rights over prime pieces of campus real estate.

The ideas spawned much soul searching. At one public follow up forum, Dukies heard from a young professor in the sciences named Steve Nowicki.

Though FC does not remember, an obituary in The New Yorker by his student Ian Crouch, notes he took "a special pride, it seemed, in horrifying his students by sharing his distaste for Duke’s men’s basketball."

✔ EARLY LIFE

Macon, North Carolina. A town north of Durham along the Virginia border which in the 2000 census harbored 115 people.

It apparently has lost people over the generations, for Edward Reynolds Price once described it as “227 cotton and tobacco farmers nailed to the flat red land at the pit of the Great Depression."

Reynolds' father was a traveling salesman, and while Reynolds was born in Macon, his family moved from town to town as it eked out a living in north-eastern North Carolina.

The New York Times obituary this morning notes Reynold's affinity to and affection for rural North Carolina, ordinary Tar Heels, finding, struggling in the world. The people he would write about as he became one of the most important voices in Southern fiction. His first novel featured the young woman Rosacoke Mustian, desperate to pin down her relationship with a feral boyfriend, Wesley Beavers. "A Long and Happy Life" thus began:

“Just with his body and from inside like a snake, leaning that black motorcycle side to side, cutting in and out of the slow line of cars to get there first, staring due-north through goggles towards Mount Moriah and switching coon tails in everybody’s face was Wesley Beavers.”

The literary world spun to pay attention. And Harper's Magazine, then the most highly regarded magazine, published the novel in its entirety as a supplement.

And the Times quoted the critic Theodore Solotaroff in Saturday Review: “Some beginning — of a book, of a career.... Its sheer virtuosity is like that of a quarterback who on the first play of his first professional game throws a 60-yard pass on the run, hitting the receiver exactly at the instant he breaks into the clear; a tremendous assertion of agility, power, timing and accuracy.”

On the next possession, to keep the metaphor alive, a year later, Reynolds scored another TD with his story collection "The Names and Faces of Heroes."

Early on in his life, Reynolds had begun to grasp the South that he would write about, much of his knowledge coming as relatives spun stories that fascinated him.

Fascinated him so much that his mother frequently urged her son to get out of the house and go play with children his age. But soon he would be back inside. He wrote "Clear Pictures: First Loves, First Guides" in 1989 about these years, explaining “I’m the world’s authority on this place. It’s the place about which I have perfect pitch.”

"Without having any consciousness of it at all and without having anybody in the family making a decision to train up somebody to be a writer or teacher, I was probably born with some genetic bent for using the English language in an interesting narrative fashion."

UNDERGRADUATE YEARS

Reynolds first saw Duke on a spring day in 1943, a day trip from his home which was now in Raleigh, and the lush of the place -- in sharp contrast to the grim of the nation during World War II -- lingered in his mind.

Neither of his parents were college people. But his mother had a nephew and his wife who had been at the old Trinity College, entranced by their experience.

He enrolled in 1951, an Angier B. Duke Scholar.

His roommate of two years, Fred Chappell, recalls his wall posters were not like others, who favored pin-up girls. Reynolds had a Matisse.

Pledging a fraternity was quite different then: "When I was an undergraduate from '51 to '55, if you were caught with a bottle of alcohol in your room, you were just out of here. There was no mercy about it; they put you on the next bus out of town. It's amazing what a difference sobriety makes because we did come along in a generation where students who came to college at age 18 had not been accustomed to alcohol's having been a very large part of their high school and middle school life. In that sense, it was a different world, and it has been extraordinary the difference that alcohol has made on campus."

Not long after pledging, Reynolds quit Phi Delta Theta.

Tapped into an honorary society called the Red Friars, he refused to accept admission, explaining later the absurdity of an organization that contended it was secret holding a ceremony on the Chapel steps, its members appearing several times a year wearing red carnations in their lapels and denying the flowers were there. Seriously. It was the beginning of the quick end for the society.

He also felt that the group -- designed to bring together seven select seniors as good friends in service of Duke -- just was not functional, friendships having been forged long before the tapping and other organizations part of the members' lives for their first three years at Duke taking up much of their free time.

He got his first break as a writer at the end of his senior year at Duke, when the writer Eudora Welty visited campus and he showed her a short story he had written. She asked if she could show it to her agent, who took on a new client, and "Michael Egerton" appeared in a national magazine.

And then there was the Rhodes Scholarship, the boy from Macon, North Carolina, became the young intellectual who sailed for England to write a thesis on Milton, to have personal encounters with Stephen Spender, W.H. Auden and Lord David Cecil. He said his greatest regret was that his father died before his graduation summa cum laude from Duke and the Rhodes award.

As the NY Times notes, Spender was an important contact. He published the story “A Chain of Love” in the journal Encounter, a coup that led to an offer to teach at Duke when Reynolds returned from Oxford. (Later he wrote "Ardent Spirits" about this time)

Reynolds enjoyed a greater rank, assistant professor, than the proliferation of instructors in the freshman writing program. And let's be honest. Reynolds' easy southern drawl gave way slowly, with increasing hints of his four terms in England appearing year by year.

✔ CANCER

1984. Walking on West Campus, a friend noticed a slight hesitation, a slight limp. And then another discovered that when Reynolds took a step, one of his feet plopped to the ground.

Doctors found an eight to ten inch cancer called an astrocytoma wrapped around his spinal cord, suffocating it.

He underwent aggressive radiation to kill the tumor which he called, as the Times obit recalls, "the gray eel," and was left paralyzed from the waist down.

Three years later, he underwent delicate neurosurgery with Duke's great Dr. Allan Friedman, but still had no use of his legs.

"Once the immediate shock has passed, I wish someone had said to me, 'You are no longer Reynolds Price. Who do you want to be?' Your only real choice is to invent a whole new life."

And that was the title of his autobiographic account of his ordeal. "A Whole New Life: An Illness and a Healing."

Interestingly, inexplicably, Price played no significant role as Duke was slow to meet requirements of the new federal disability act. He did lament on occasion the slate sidewalks and how the wheelchair bumped every four feet through them. His office, moved now to Allen Building, was reachable by only one back elevator. At home he had the services of a full-time aide, frequently a student studying under him.

✔ BEING GAY. OR QUEER AS HE PREFERRED.

It was interesting too how he played no role in the difficult journey of gays to have full acceptance on campus.

In fact he was lucky to survive as a student, for the atmosphere in those years is best summed up by one contemporary dean who said, "There are two things we cannot have around here. Thieves and homosexuals."

Students disappeared overnight, and so did a prominent member of the faculty in the Divinity School.

Returning from Oxford, where his sexuality exploded and he had a relationship with an older mentor he would never name, his draft status no longer protected by deferment, he unabashedly stated for the first time that he was "homosexual" and thus excluded from the military.

For decades, while most people knew anyway and could care less, Reynolds did not come out on campus, an issue raised when Charlie Rose '64 interviewed him upon publication of the book in which he did.

Reynolds said he felt it was not anyone's business. And then in a warmer response, he said he did not think a homosexual story would sell.

And he described himself as "queer," not gay. "Potent genes may well have been at work,” with five “queer” relatives in two generations in his family."

His view was that the word “gay” made homosexuals seem “giddy irresponsible, negligible creatures.”

Looking back to his return to Duke from Oxford in 1958 and the years that followed immediately, “Without quite knowing it, I was slowly being inducted into the writer’s life with its unavoidable isolation and its demand for internal resources that can so easily be replaced by drink, other drugs, and the supreme narcotic of other human bodies.”

He took the supreme narcotic, later calling himself a “sexual wolverine,” noting wryly “an enduring partnership was not among my immediate projects.”

Published a year ago, Reynolds looked back in "Ardent Spirits," where he outed himself: “What I didn’t quite know, in the last year of high school, was how fiercely most Americans were then opposed to the whole reality of male homosexuality, if they knew of it at all. It was a life then called queer. .. Nonetheless, I kept my strong suspicion undercover—and rather enjoyably so. I was after all at the I-love- a-mystery stage.”

✔ ON FAITH

Reynolds was as iconoclastic in his faith as in the rest of life. He identified himself as an “outlaw” Christian, a reference which FC believes incorporates his belief in Christ, perhaps not His divinity, and certainly not any established religion. A reference that may include his homosexuality, condemned in limited sections of the Bible, but as Reynolds would note, not by Jesus.

Corrections of this view, nuances, would be appreciated.

Most notably in 1978, he published the first of two Biblical translations, "A Palpable God." In 1996, he followed up with "The Three Gospels.” And religion played a deep role in his 2007 tribute to his godson “Letter to a Godchild."

“My teaching, however, slowly became my primary means of attempting to practice the life of a good man, a responsible child of God.”

"The fact that my legs were subsequently paralyzed by 25 X-ray treatments ... was a mere complexity in the ongoing narrative which God intended me to make of my life."

Reynolds reveled in teaching freshmen Chaucer, Shakespeare, Donne and Milton, and asking mysteries of faith and doubt, “who or what made us, for what purpose. . . raising Leibniz’s troubling question — ‘Why is there something and not nothing?’”

Later works, “Roxanna Slade” (1998) and “The Good Priest’s Son” (2005), saw fallible characters fighting moral choices, a deepening moral tinge as one reviewer put it.

✔ HONORS

In 1962, "A Long and Happy Life" received the William Faulkner Award for a notable first novel. His novel "Kate Vaiden" received the National Book Critics Circle Award in 1986.

In his early days as a published writer, Price took offense at reviewers labeling him as the heir to Faulkner.

"The search for influences in a novelist's work is doomed to trivial results," he wrote in the New York Times. "A serious novelist's work is his effort to make from the chaos of all life, his life, strong though all-but-futile weapons, as beautiful, entire, true but finally helpless as the shield of Achilles itself."

This morning, The New York Times noted his passing with a headline and small paragraph on page one -- a highly unusual tribute -- and an extensive obituary on an inner page.

He received the highest honors: as an alum and as a faculty member for his service to Duke, and will have a professorship living on in his honor.

He left us, by count on the FC bookshelf, 38 full length volumes, and untold memories.

Thank you for reading FC.

1/20/2011

The death of Reynolds Price

The following is the Duke University press release. FC will have an essay posted by Friday morning.

Reynolds Price, author and long-time Duke English professor, dies

DURHAM, N.C. -- Reynolds Price, the celebrated writer of fiction, poetry, memoirs, essays and plays who turned a three-year teaching appointment into more than 50 years on the faculty at Duke University, died Thursday afternoon. He was 77.

Price, the James B. Duke Professor of English at Duke, his alma matter, had a major heart attack early Sunday.

"With a poet's deep appreciation for language, Reynolds Price taught generations of students to understand and love literature," said Duke President Richard H. Brodhead. "Reynolds was a part of the soul of Duke; he loved this university and always wanted to make it better. We can scarcely imagine Duke without Reynolds Price."

A native of Macon, N.C., Price graduated summa cum laude from Duke in 1955, where he studied creative writing under influential professor William Blackburn, whose other Duke students included noted authors William Styron '47 and Anne Tyler '61.

Price was a Rhodes Scholar and studied in Oxford, England, with W.H. Auden and Lord David Cecil. He returned to the United States and took a teaching job at Duke in 1958. The letter offering Price that job warned that the position was a three-year appointment -- with no chance of being extended.

"That seemed a little discouraging, but I thought, 'Well, three years is three years,'" Price recalled in a 2008 interview. During those three years he wrote his first novel and was asked to stay on. He remained a Duke faculty member for the next 53 years.

In 1962, his novel "A Long and Happy Life" received the William Faulkner Award for a notable first novel. Price published numerous books after that, including the novel "Kate Vaiden," which received the National Book Critics Circle Award in 1986.

In his early days as a published writer, Price took offense at reviewers labeling him as the heir to Faulkner. "The search for influences in a novelist's work is doomed to trivial results," Price wrote in a 1966 piece for The New York Times. "A serious novelist's work is his effort to make from the chaos of all life, his life, strong though all-but-futile weapons, as beautiful, entire, true but finally helpless as the shield of Achilles itself."

Price became a member of the American Academy of Arts and Letters and received the John Tyler Caldwell Award for the Humanities from the North Carolina Humanities Council. In 1987, Price received the University Medal for Distinguished Meritorious Service at Duke, the university's highest honor, and the Distinguished Alumni Award. A professorship in creative writing honoring Price was established at Duke in 2008.

He had a commanding presence in the classroom, using his deep, rich voice to convey the beauty of the English language. For many years, Price taught courses on creative writing and the work of 17th-century English poet John Milton, as well as a course on the gospels in which students wrote their own version of a gospel story. Price's Halloween reading of ghost stories and poems became a tradition on campus that lasted more than a decade. Price said he experienced two main rewards as a professor: reading and teaching great writing by other people, and getting to know his students, who included Tyler, writer Josephine Humphreys and actress Annabeth Gish.

In a fiery Founders' Day speech in 1992, Price took aim at what he deemed a lack of intellectualism at Duke, describing students as enthusiastic about partying but marred by a "prevailing cloud of indifference, of frequent hostility, to a thoughtful life," reported Duke Magazine. Some university officials cited that speech as an impetus for a greater emphasis on recruiting more intellectual students to Duke, according to the magazine article.

Price, who considered himself an "outlaw" Christian, wove his faith into his writings. His 2007 book "Letter to a Godchild," for example, was a christening gift to his godson, intended as a brief guide for the child's spiritual future. He also published two biblical translations: "A Palpable God" (1978) and "The Three Gospels" (1996).

Price became confined to a wheelchair in 1984 when a cancerous tumor affecting his spinal cord left him paralyzed from the waist down. A 2006 article in The News & Observer of Raleigh, N.C., noted that Price had pondered and accepted the truths articulated in the Book of Job: that God's ways are often beyond understanding or finding out.

"The fact that my legs were subsequently paralyzed by 25 X-ray treatments ... was a mere complexity in the ongoing narrative which God intended me to make of my life," he said. Price's account of cancer survival is captured in his 2003 book, "A Whole New Life: An Illness and a Healing."

Price's third volume of memoir, "Ardent Spirits: Leaving Home, Coming Back," was published in the spring of 2009. The book explores six crucial years in Price's life, from leaving home in 1955 to attend Oxford University to his return to North Carolina and the start of his career as a university teacher.

According to Price's wishes, there will be no public funeral. Duke University has not yet announced plans to honor Price.

1/16/2011

Duke Police won't count muggings of two graduate students as on-campus crimes in Clery Report

Chronicle story: An autopsy released during winter break revealed that a woman who died at Duke University Medical Center was poisoned by a pain reliever and common antihistamine. But Duke Police are stalling in classifying this as homicide.

✔ FC here.

By "continuing the investigation," Duke Police are avoiding adding this death to the Clery Report on campus crime in 2010.

This is an all too familiar tactic that distorts the picture of campus crime that Clery is designed to convey.

Certainly by the reporting deadline of December 31st, in addition to the autopsy, the police would have reviewed hospital hall surveillance tapes from October 5 that will reveal precisely who entered the victim's room. And also they certainly should have completed fingerprint and DNA testing on the syringes.

These steps alone should be enough to establish how this death occurred and classify it either as a homicide, or as assisting with suicide. Classifying is quite different from bringing criminal charges and requires a different standard of proof.

Fact Checker has been concerned for some time about statistical totals from Duke Police.

✔✔✔✔✔ We have confirmed, for example, via the ubiquitous PR VP Schoenfeld, that the two most serious crimes against students in the fall semester will not be in the next Clery Report.

These are the armed robberies of graduate students on consecutive nights near the intersection of Erwin Road and LaSalle Street.

The south side of Erwin Road at this intersection is all Duke. The corner includes major facilities like the Synderman Building, part of Duke Health.

The Clery Report requires Duke to "disclose crime statistics for the campus, public areas immediately adjacent to or running through the campus, and certain non-campus facilities and remote classrooms.."

We believe the north side of Erwin Road, location of a garden apartment complex filled with Dukies, just yards from Snyderman, qualifies. The robberies occurred by the driveway from LaSalle into the parking lot.

Schoenfeld refused to be drawn into a discussion that would explain Duke's contrary position.

This is not the same time Duke has used this trick. We were alerted to it first by a discrepancy in statistics for 2009.

Duke Police listed nine robberies and 11 victims during the course of a 12 month period in logs that it is required to keep and in press releases, but its Clery count totals only seven robberies.

We have received only obfuscation trying to determine what's going on here.

✔✔✔✔✔ And on another issue, Schoenfeld got downright testy when we pushed to know the number of Duke officers fully trained and available for patrol. We were mindful of years of turmoil and personnel changes in Duke Police, the abrupt and unexplained departure last semester of the associate VP Graves assigned to Police, and the recognition party that President Brodhead threw at the Nasher a year earlier when officers with a combined 372 years of experience took early retirement.

We also noted that at one point, Duke Police had three officers ranked as majors. Today it has none this high.

We wanted to contrast the actual number with the number available for patrol and investigations with the total presented in the Clery Report as "authorized."

Schoenfeld said the number was "adequate." We responded this was a conclusion, and we repeated we wanted the actual numbers. At which point we were told to write that Duke would not tell us.

✔✔ In reaction to the armed robberies of the graduate students and other crimes, Duke Police promised extra patrols in Ninth Street, Trinity Park/Heights and Erwin Road. They have also committed to provide extra patrols on Central Campus.

We have been unable to find out if these patrols continue, and if so, where the officers came from, what area is being cut back. A preliminary check by Deputy Fact Checkers who visited each of these four sites and counted passing police cars over a period of time fails to establish that there is a significant police presence.

✔ Thank you for reading FC.

1/14/2011

Duke picks Commencement speaker

Search words Duke University

✔The Chronicle is reporting that President Brodhead told some seniors that the Commencement speaker will be John Chambers, CEO of Cisco Systems. He attended Duke for two years before transferring, but under our rules, he's an alumnus.

✔ Fact Checker has already checked him out

Forget a commencement address. Next May at Duke, John Chambers will seem like an evangelist, promptly leaving the podium, stepping down from the stage, moving through the seated graduates as he speaks, coursing over to the faculty and parents to face them head-on.

His right hand is never still: a finger pauses on his lip in contemplation, he reaches as if to heaven, then clasps both hands in front of him as if in prayer, and a moment later his right hand arcs through the air to emphasize his point.

Then he leans over, right down to the level of a graduate seated nearby, quietly advising her with a juggling motion of his arms and hands to balance life between work and family.

Slicing through the seriousness of the occasion, he advises “Learn to laugh. Most things in life are not near as serious as you think they are.“

Chambers been on the commencement circuit for more than a decade (Wake Forest, 2000 was one of the earliest, about time we caught up) and is an accomplished speaker. No notes, and obviously no teleprompter and no podium.

And most of all, for those of us who remember speakers of recent vintage at Duke, merciful brief. FC timed one address at only 13 minutes!!! Take that Barbara Kingsolver.

On yes, John Chambers loves basketball. It’s unclear at this writing whether he played, but when he was a graduate student at Indiana University he developed a friendship with one of Bobby Knight’s graduate assistants, a 26 year old named Michael Krzyzewski. He speaks of a dinner with our team seven years ago and what he learned. No, I won't steal the thunder.

Chambers says he landed at Cisco when he was looking for a job “purely because of the way i treated somebody seven years earlier. He said, 'John, this is the company for you because of your skills in dealing with other people.'“

If only someone had told you to invest $10 in Cisco stock.. with the right timing on buying and the right timing on selling, you'd be a millionaire today. (The stock has since lost value.)

Though the company name is not likely to be on much that you own, its hardware and software is at the heart of technology, its reputation one of the best in Silicon Valley.

He has been richly rewarded by his company -- and speaks of sharing.

Last December, Pratt’s Fitzpatrick Institute for Photonics announced a new award, the John T. Chambers Scholars. Two graduate students will be selected each year, to receive $40,000 apiece each year for two years. The winners are graduate students Stephanie Chiu of biomedical engineering and Ma Luo of electrical and computer engineering.

FC has to believe, all this is only a start for new involvement with Duke. Or to put it another way, those people salivating over on the sidelines are from the development office.

Some points from a recent speech: Take risks, he said. take risks. “You will not achieve what you are capable of in life unless you reach out and give it a try. ... you will periodically fall. That will make you stronger.”

And with his right hand raised as if answering a teacher, “How many of you like change. Isn't change great! Raise your hand. ... during your life you will probably work in five or ten different roles and you've got to learn to adjust to change. Darwin had it right. It isn't the strong in species that survive. It is they who learn how to adapt.”

“All of our top competitors from 15 years ago at Cisco are gone. Not because of what we did. because of what they did. they did not adapt, and did not change with time.”

Drew Everson autopsy released

The following was posted on the WTVD website.

DURHAM (WTVD) -- The Office of the Chief Medical Examiner released autopsy results Friday that show a Duke University senior was intoxicated before a fall on campus that led to his death.

Drew Everson was discovered unconscious and severely injured near a stairwell at the East Union, also known as Marketplace, on Duke's campus October 22.
Related Content

Documents from the medical examiner say Everson suffered multiple skull fractures and was declared brain dead two days later. His family agreed to donate his organs for transplants.

The documents say Everson's blood-alcohol content was .133. In North Carolina, .08 is considered to be legally intoxicated.

Police said in October their investigation indicated Everson's injuries were the result of an accidental fall, but exactly how it happened was still under investigation.

Friday, Duke's vice president for public affairs and government relations Michael Schoenfeld issued a statment:

"The medical examiner's report released today provides finality to the extensive investigation by the Duke Police, which has concluded that Drew Everson's death occurred as a result of an accidental fall into an open stairwell. The Duke community is deeply saddened by this tragedy and continues to mourn Drew's death. His legacy at Duke will be long-lasting, and we offer our thoughts and prayers to Drew's many family and friends."

A member of the Duke Debate Team, Everson also coached student members of the East Chapel Hill High School debate team. He was involved in many other student organizations, including the Inside Joke comedy troupe, Campus Council and other campus committees.

As Potti begins to tweet, lawyers circle Duke, sensing big bucks for malpractice

Search terms Anil Potti Duke University

There are two Fact Checker posts on Potti today; make sure you scroll down for the earlier.

✔ FC here.

As Dr Anil Potti starts to emerge from the seclusion of his Chapel Hill home... building his Facebook site, sending out tweets (http://friendfeed.com/anilpottimd).....

and apparently being behind the misleading regurgitation of a seven year old press release announcing a humanitarian award...

a Raleigh law firm that has taken on Duke University in the past says it is doing "research" on the Potti Mess.

The firm Henson Fuerst put out a PR release seeking information from Potti patients, which seems to FC like a thinly disguised effort to sign them up for lawsuits. Other Raleigh injury lawyers -- the Temple firm, and Brent and Adams -- have frequently used this tactic too, so expect them on the bandwagon.

Henson Fuerst represented plaintiffs in the Duke hydraulic fluid case in 2004, where two community hospitals run by Duke supposedly fully up to its standards (but not the principal hospital on West Campus) washed surgical instruments in dirty, used hydraulic fluid from an elevator instead of antiseptic detergent.

For months, surgeons complained of greasy and slippery instruments. In other words, Duke did not move to investigate and correct immediately -- and plaintiffs' lawyers loved it.

In many cases, instruments used in surgery are disposed after one use. But not so with clamps (to cut off the flow of blood), holders for the blades of scalpels, and other things.

Interestingly, in that case, Duke's point guard was Dr. Michael Cuffe, who then had the title vice president for medical affairs of Duke Health.org (he has since added Vice Dean of the Medical School). Very highly regarded in Duke's hierarchy, photogenic and well spoken, Cuffe came to Duke to earn his MD '91, stayed for all his additional medical training and burnished his credentials with an MBA '09. He has taken on a similar role in the Potti Mess, repeatedly making statements and giving interviews.

In the hydraulic case, Duke created an extensive website with information for patients; not so in the Potti Mess where patients and reporters alike have to dig for every scrap.

3500 people had surgery with the elevator fluid. 3500! It's never been clear how many patients were infected because their surgeries occurred with instruments not properly sterilized. And infected with what? Bacteria? Or even blood born diseases.

Nor do we know how residual chemicals that may have gotten directly into surgical wounds affected people.

We don't know either the total cost of malpractice claims that Duke paid -- this university doing everything under cover of darkness. People who settled with Duke were required to shut up, to sign a confidentially agreement. That's the course that Duke finally took with the Henson Fuerst clients.

The total was very substantial. Very.

Fellow Dukies, you haven't seen anything yet. The Potti Mess is a plaintiff's lawyers dream:

-- A defendant with lots of money and institutional arrogance.

-- Plaintiffs who will have great emotional impact on a jury.

-- Plaintiffs who signed contracts for clinical trials -- informed consent forms -- that were violated, so the basis for the lawsuits is not the slippery slope of malpractice alone.

-- Plaintiffs who suffered from malpractice. This is always tough to prove, and requires far more than just an unexpected or bad outcome from treatment. But if anyone is up to the challenge, Potti is!!

-- And most importantly to add on the bucks in any settlement, deliberate acts by Duke administrators -- like concealing the Baggerly e-mail that would have blown Potti out of the water far earlier.

FC has yet to pin down the number of potential plaintiffs. We know 107, 109 or 110 people were in the clinical trials -- experiments on human beings -- when they were abruptly ended. We believe in all 300 people participated, and many times that number went through invasive tests to see if they qualified.

These people got a rough ride when they came to Duke as patients. Wait until you see what happens to them when they return as plaintiffs, for Duke has a reputation of dragging out litigation and being very scrappy.

Fellow Dukies, this is bad.

1/13/2011

Potti Mess: Duke relinquishes last of his grants.

Search words Anil Potti Duke University

There are two Potti posts today. Please read the one before this.

✔✔ With two strokes of the pen, Duke University has just rid itself of the last of Dr. Anil Potti's research grants.

Both were multi-year grants from the federal government involving cancer research. One had one year and $200,000 left, and the other six months and $100,000.

FC has learned that one grant paid for clinical trials -- experiments on human beings -- that have been ended. And the other paid for cancer research that no longer has any validity.

Unlike Potti grants from the American Cancer Society, which demanded and got all its money back, the substantial funds that have been spent already from the last two grants apparently will not have to be refunded.

As the new semester began, Potti's lab -- once vibrant with the hope of major scientific breakthru -- had shrunk to four employees, and they heard the lay-off word earlier this week. One told FC that Dr. Huntington Willard, head of genome research at Duke, is trying to help them find new positions.

Duke made no announcement; one of the people affected is a Loyal Reader who tipped us.

1/12/2011

Potti BOMBSHELL -- Administrators concealed key evidence of Potti fraud

Search words Anil Potti Duke University

Fact Checker here. Explosive material. Please read.

✔✔✔✔✔
✔✔✔✔✔
✔✔✔✔✔

In November, 2009, as Duke began its first formal investigation into the cancer research of Dr Anil Potti, two Vice Deans of the Medical School -- Drs. Kornbluth and Cuffe -- received a startling e-mail.

A researcher at the renowned M D Anderson Comprehensive Cancer Center at the University of Texas, Keith Baggerly, Ph.D., a statistician, was offering proof that Potti's science was defective if not faked. In other words, blowing one of the stars of Duke Medicine right out of the water.

But neither Kornbluth nor Cuffe passed Baggerly's material along to the investigators.

Instead, they -- or people they did give it to -- concealed it.

FC posted the initial, skimpy information on this most ominous development late last week. Chancellor Victor Dzau told FC in an unusual exchange of e-mails on Saturday that Kornbluth and Cuffe did not act alone, but with others in making this decision. Because of travel problems caused by the snowstorm that closed the Atlanta airport, FC has been unable so far to follow this up -- to get names of those involved said by the website Nature.com to be in the "leadership" of Duke.

We are confident we can get those names from Dzau, who has pledged transparency and kept his word. We have continued confidence in him.

Every Dukie has a stake in this: to hold officials accountable for a horrendous decision and to take steps to insure it does not recur.

✔✔✔ So far, the explanation offered by Kornbluth and Cuffe for concealing Baggerly’s documentation smells, to put it bluntly. They contend if they had sent Baggerly's documentation to the investigators -- who worked under Duke's Institutional Review Board -- the probe would have been "biased."

They offer no evidence much less proof that this would have been the case.

In fact, a strong case can be built that the Review Board -- with carefully crafted established procedures and a panel made up of distinguished MD's and Ph.D's from the ranks of our faculty -- would have given a fair reading to Baggerly‘s material.

✔✔✔ Some critics also point out, that in addition to concealing the Baggerly material, administrators limited the role of the Review Board to answering just two questions. Unfortunately both missed the heart of the matter: that Potti’s starting point of 59 samples of ovarian cancer was flawed.

Or what was supposed to be ovarian cancer.

In asking that a medical journal article be withdrawn, Potti’s mentor, Dr. Joseph Nevins, revealed 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."

✔ Kornbluth has said on this issue, that the limitation to two questions occurred because no one thought they had to "dig down" to the first stages of the research.

More smell. This is like having an investigation into the Leaning Tower of Pisa, checking only the 4th, 6th and 8th floors, and neglecting the foundation.

✔✔✔The mystery surrounding motive for this lack of an enthusiastic pursuit of a Potti investigation has caused great concern in the past few days.

-- Some point to the potential dollar value of Potti's "discoveries" if they had panned out. Right now cancer patients are treated with chemotherapy that may or may not work. Often their chemotherapy is switched, so they must start all over again with powerful drugs that are very debilitating even if they do arrest cancer.

Potti's genome researched promised to tell doctors which chemotherapy would work best for each individual patient and against each type of cancer -- information which he said was locked in patterns of DNA and RNA. Of course the doctors would have to send their patients for testing first -- and Duke, Potti et al would hold the patent.

Three grants were being used -- from the federal government and the American Cancer Society -- to address breast, lung and ovarian cancer. But Potti and his mentor, Dr. Joseph Nevins, along with Duke itself , and apparently outside investors, formed a corporation to capitalize on this research, to receive far more than a couple million dollars in research grants.

One expert interviewed by FC said that if the research had panned out, Duke would be sitting top a gold mine: more 700,000 tests a year in the US alone. The expert estimated -- based upon other tests for breast cancer -- that each would cost $1,000.

That's three quarters of a BILLION dollars right there. Not to mention the prospect for medicine's highest honors, the Lasker and the Nobel, for a break-thru discovery of historic proportions.

Indeed, the appearance or prospect that investigations could be swayed caused Dzau -- at a later date -- to order Duke to divest itself of all holdings in the Potti-Nevins enterprise. By then, of course, with challenges to their science, the value was nil.

FC inquired about this, writing Dr. Rose Ritts, executive director of the Health System’s Office of Licensing and Ventures, as well as Michael Schoenfeld, VP for university PR. Neither acknowledged nor answered -- and that in our opinion gives a chancellor who has promised to be open and transparent about this mess reason to speak to them in no uncertain terms.

✔ Beyond the money angle, there is something even uglier. Like the money angle, there is no hint that this scenario played out, but we share it with Loyal Readers because it surfaces time and time again.

Kornbluth and Cuffe were promoted to their current positions by Dean Nancy Andrews of the Medical School. They report to her.

Her husband is Dr. Bernard Mathey-Prevot, co-author with Potti of at least one of his scholarly papers. In other words, the spreading investigation into Potti was bound to knock at his door. At the door of the husband of Kornbluth's and Cuffe's boss.

As FC has written before, there is at least the appearance of a potential conflict of interest in having Kornbluth and Cuffe involved in the heart of the Potti Mess -- and making official statements for the University. We repeat: there is no scintilla of evidence that they did anything wrong. But appearances and possibilities and potential must play a role here.

✔✔✔ By January, 2010 -- a remarkably quick two months given the extreme complexity of the science involved -- Duke’s Institutional Review Board gave rousing endorsement to Potti’s work -- and Kornbluth and Cuffe allowed more patients to enter Potti’s trials.

✔✔✔ Question: when the Vice Deans Kornbluth and Cuffe received the board’s report -- knowing of the Baggerly material -- why at that point didn’t they remand the report for further consideration?

Instead, Kornbluth and Cuffe signed off on the report.

✔✔✔ Duke has refused to tell us who was on the board that cleared Potti -- much less release the report. Duke has variously cited its own policies and federal research rules -- every explanation occluded. The report became part of the public record and subject to a Freedom of Information Request from The Cancer Letter (and more recently, Nature.com got a version without heavy redaction) when it was filed with the federal agencies that were supporting Potti’s research.

Some excerpts:

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

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

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

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

A Who’s Who in the world of genome research has challenged that.

Is Duke backing away? We are reviewing one recent Duke paper that suggests the University realizes it’s a no-win hard-line view to maintain no patient was harmed.

In part Duke apparently bases its hard-line position on the theory that the patients who got a specific chemotherapy directed by Potti are no worse off than they would have been had they started a routine hit-or-miss treatment.

Well, not really. This neglects that Potti kept patients on the chemotherapy he dictated -- not switching them to new therapies when the first did not work.

And it neglects that with some lung cancer patients, Potti used a drug cocktail -- a mixture of chemotherapy that he himself apparently concocted that is not authorized for use by regulators. This little ditty is just emerging.

✔ We believe the November 2009, Institutional Review Board was chaired by Dr. John Harrelson, retired professor of orthopedic surgery and associate professor of pathology, Trinity '61 and MD '64.

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

✔✔✔ The renewal of the clinical trials set off a howl in early 2010. But it was the discovery of a faked Rhodes Scholarship in Potti’s resume in June that the media could understand. After The Cancel Letter revelation, world-wide headlines sullied Duke’s image.

This was followed by suspension of Potti’s trials for existing patients as well as new, by a declaration by Nevins that a paper he co-authored had no validity whatsoever, and by Potti’s resignation.

From Baggerly: a prediction that there not be a "charitable explanation" for any of this.

FC can only offer these words: to be continued.

✔✔✔✔✔ There are now two investigations into the Potti Mess underway. What is most alarming is that FC cannot assure Loyal Readers that either will touch upon the administrative mis-steps detailed above.

In fact, the Institute of Medicine is being directed away from Potti toward a fuzzy, general inquiry into standards for genome research in general. This may be important to address -- but not at the expense of learning what enabled Potti to get away with his fraud for so long.

And Duke has another round underway with its Institutional Review Board, this time formal faculty misconduct charges.

But who is under investigation? Just Potti? Nevins? Or any of the others in the vortex and on the fringes of this scandal.

Your guess is as good as ours, so if you get a whiff of any new odor, write Duke.Fact.Checker@gmail.com.

Thank you for reading Fact Checker.

1/11/2011

More Duke research challenged: 57 people deliberately infected with a pallet of viruses

Search terms Duke University Anil Potti

✔✔✔✔✔ FC here. Welcome to a new semester.

As the Institute of Medicine (IOM) arrives on campus to begin its investigation of the Potti Mess....

a respected Canadian researcher is charging more Duke genome science is flawed...

and the university was medically and morally wrong to let one doctor go forward with clinical trials -- that is, with experiments on human beings -- that included deliberately infecting 57 people with a pallet of viruses.

The Canadian, Dr. Steven McKinney, is at the British Columbia Cancer Research Centre in Vancouver. He is a statistician with its Molecular Oncology and Breast Cancer Program.

He has filed a complaint with the Institute, an august body of 2,000 U.S. scientists that agreed last fall to undertake an "unfettered" investigation of Dr. Anil Potti starting now. This is expected to take 18 months and include a broad view of ethical questions in genome research. The IOM has already raised $687,000 for the project.

But unlike the Potti case, which involves a faked Rhodes Scholarship, other lies on his resume and possible fraud in laboratory work, the new charges embrace science only.

FC has learned Dr. McKinney's allegations are being taken seriously by Duke's administration, burned for its initial response to questions about Potti. Apart from the IOM, the university itself is said to be ready to promptly launch its own probe.

Each of the 57 patients who got the live viruses underwent genetic testing that predicted what virus he or she might be susceptible to.

The experiment was designed to compare expectations of what might happen with actual illnesses -- colds and flu -- that developed. The long-range goal of the study was to develop guidelines and testing that might be useful in a pandemic.

McKinney says Duke is using a computer program that guarantees the results researchers want -- so they think they see a pattern that arises from a patient's genes when in fact they are only viewing normal frequency of occurrence by chance.

The letter to IOM specifically mentions Dr. Geoffrey Ginsburg for his role with the 57 patients. After stints at Harvard where he was Director of Preventive Cardiology and led a laboratory in applied genetics of cardiovascular disease, and in private industry, Ginsburg came to Duke in 2004. He wears several hats, including Co-Director, Duke Translational Medicine Institute, the initiative designed to speed laboratory findings into patient care.

FC repeats: Ginsburg is not being charged with any personal misconduct.

Duke's Institutional Review Board and review boards at four other institutions that also allowed the human experiments approved Ginsburg's going forward.

In a lengthy interview with a Deputy Fact Checker Tuesday night, McKinney said unequivocally the researchers should not have been allowed to conduct clinical trials. The reason for this is that their hypothesis was "unproven."

McKinney indicated the Duke computer program has been in use since 2001 (with updates) and that other research may be faulty too -- or at least unproved. In addition to Ginsburg, he mentioned other names which FC is withholding since no formal allegations have been filed.

In one case, McKinney said the researcher is "cherry picking" results from his data, a serious allegation.

✔FC continues research on a Potti Mess bombshell. We initially were going to post last weekend, but delayed for several reasons. Stay tuned.

Thank you for reading Fact Checker, and please remember when you read these posts about stumbles, that many miracles occur in Duke Medicine every day.

Potti Mess: Scientist says worst is still to come

✔ As the Institute of Medicine (IOM) begins its formal investigation into Dr. Anil Potti and his colleagues...

there is an ominous prediction from one of the scientists who blew the lid off the Potti Mess.

"Hold on folks, the ride’s just beginning."

Those words came from Dr. Keith Baggerly of the University of Texas, MD Anderson Comprehensive Cancer Center, Houston.

He gave an update at the fourth joint international meeting of the IMS (Institute of Mathematical Statistics) and ISBA (International Society for Bayesian Analysis). Yes, it's highly technical stuff and unless you have a Ph.D. or MD, you do not have a prayer of following it, but here's the link:

http://madison.byu.edu/mcmski/pdfs/KeithBaggerly.pdf

Baggerly revealed the Institute of Medicine -- a learned society which agreed to undertake the investigation of the Duke scandal last fall but which is just now beginning its work -- has received about 550 pages of documents relating to the false science and clinical trials perpetrated by Potti.

And Baggerly posted a list of documents the IOM should seek -- even suggesting that if Duke balks (it has pledged it won't) the National Institute of Cancer, a federal agency, should issue subpoenas.

Representatives from the IOM and the NIC met in late December, with that possibility reportedly under discussion.

As previously stated, FC is at work on significant developments, with research taking far longer than anticipated. Check back.

1/10/2011

Was Yale eying Brodhead? It's moot at least for now.

✔ FC here. With whispers as well as fact today.

When Nan Keohane was president of Duke, the rumors made the rounds that she was going to split to become president of Harvard. Indeed the well sourced student newspaper, the Harvard Crimson, put her on a very short list of possibilities in 2000-2001.

Nan denied any interest, and Larry Summers got the job in any event.

The affection for Keohane was there, however, and in short order she became one of seven members of the highest governing board at Harvard, variously called "the corporation" and "Fellows."

Now it's Uncle Dick's turn to deal with rumors.

For two months the name of Yale's President Richard Levin circulated at the White House as a strong candidate to be chair of the Council of Economic Advisors with Cabinet rank, starting immediately. Yale, which traditionally takes an unusually long time to select a new president, would undoubtedly need a President Pro Tem, and one Senior Fellow (Trustee), Roland Betts, told the Yale Daily News that if Levin departed, the temp would be announced early this semester. (Wow. A trustee identified by name talking to the campus paper!!!)

Who better than Richard Brodhead, close friend of Levin, beset at Duke, beloved in New Haven. He was Dean of Yale College longer than anyone else (meaning he was Supreme Leader of Everything Undergraduate) -- precisely the position that an earlier Yale president pro tem had.

This also might make sense from a personal viewpoint for the 63-year-old Brodhead, giving him two or three more years as an administrator and leaving him good years to return to teaching, which he has hinted at. Moreover, from Duke's perspective, it would allow us to install a new president who would provide continuity throughout the coming major fund drive likely to last ten years or so.

Well President Obama stopped the rumors when he named someone else to the key economic job in the closing days of 2010.

Brodhead, Yale '68, Ph.D. 72, told a Yale Daily News reporter who reached him that all this was “imaginative… Wildly so, in this case.”

Stay tuned. Levin, longest serving president in the Ivy League with a 15 year tenure, apparently has the itch to leave.

1/09/2011

Potti Bombshell: He gave lung cancer patients chemotherapy that was not approved

Search words Anil Potti Duke University

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There is a bombshell in Sunday's News and Observer: Potti gave a drug cocktail to some lung cancer patients -- a combination of very powerful chemotherapy that was not approved by drug regulators.

✔ The man was out of control.

This is not the bombshell FC has been referring to. On Saturday evening we were offered significant interviews on Monday and Tuesday. So we will delay writing.

On December 3, FC reported on the Potti patient who is the focus of today's N and O article. At that time the patient did not want to be quoted or identified, and we posted significant information from her brother.

For some reason the N and O on-line edition does not give a by-line to its very deserving reporter, Sarah Avery.

Headline: Flawed research appalls cancer patient

RALEIGH A string of what-ifs nags at Joyce Shoffner.

Two years ago, when she was 61, she was diagnosed with breast cancer and agreed to participate in a clinical trial at Duke University that was based on now-discredited science by a now-disgraced scientist.

Although Shoffner received standard chemotherapy, she was steered to the treatment using what was supposed to be a genetic predictor for its success. But the treatment did nothing to stem the tumor's growth, and instead led to blood clots and other problems that complicated her care.

"I can't say how much would be different if I had been on a different chemo," said Shoffner, who lives in Raleigh. "I have nothing but questions and no answers."

Her biggest question is how flawed research advanced to being tested on cancer patients. Many others are asking the same thing in a case that reveals the downside of high-stakes, vastly complicated science.

Shoffner was one of 110 Duke patients enrolled in three clinical trials based on the research of Dr. Anil Potti, who resigned in November as an associate professor at Duke. Potti was found to have embellished his credentials.

(( FC note: We believe 300 people participated in the clinical trials. And many many more were subjected to biopsies and other invasive tests as they were screened for participation. At the time Duke shut them down, there were 109 patients remaining in them. ))

At the same time, his once-heralded scientific work crumbled under scrutiny.

Collaborators - led by Dr. Joseph Nevins, whose lab at Duke has reaped millions of dollars in federal and private research grants - had to retract the work in prestigious peer-reviewed scientific journals, including the Journal of Clinical Oncology and Nature Medicine.

(( FC note: On Saturday, Chancellor Dzau stated more retractions are coming. Duke has had to refund a huge grant to the American Cancer Society. And FC has learned that Duke is giving up a second grant, details and figures not yet known. ))

The clinical trials, which were based on the published science, were shut down.

"These trials should not have been done," said Dr. Michael Cuffe, Duke's vice president for medical affairs.

Cuffe said university officials are reaching out to patients and their families.

(( Whoa. Whoa. FC is going to pin down the timetable on that. Very carefully. We want to make sure this is not cosmetics, because patients told us in early December they got only perfunctory calls from their new doctors and did not hear from officials. ))

In the two breast cancer studies, he said, treatments were standard therapies that doctors would have considered for use anyway. The lung cancer study channeled some patients to a combination therapy that was not yet approved for lung tumors.

In addition, Cuffe said, the university is working to improve its own oversight of increasingly complicated scientific research. It is also cooperating with the Institute of Medicine, a health advisory group affiliated with the National Academy of Sciences, to use the incident as a case study establishing more openness among researchers about their data and methods.

The hope is to safeguard patients such as Shoffner. But critics of Duke contend officials had the wherewithal and yet missed opportunities to act more swiftly and thoroughly when questions about Potti arose more than three years ago.

"I'm aware that at some point in the process, people may have accepted the initial arguments in good faith," said Keith Baggerly, a biostatistician at MD Anderson Cancer Center in Texas who first raised concerns about Potti's research in 2007.

"But once questions have been raised where there are legitimate and demonstrable concerns, I would like to think that drives a very high level of rigor and confirmation."

(FC: we are developing specifics on warnings that Duke got from the MD Anderson scientists, warnings that Duke administrators chose to conceal during Duke's internal investigation last winter. ))

For that reason, Shoffner said, she feels betrayed by Duke, an institution she trusted, and by science, an endeavor she has long championed.

(( FC: Shoffner once worked at Duke, as did her brother. Her father retired from Duke after long service. ))

"I'm devastated by this whole thing," she said. "If you have a very serious cancer and two-and-a-half years later you think you are involved in a study that is cutting edge and [it's discredited], it is devastating."

Prediction goes awry

Shoffner, now 63, has invasive ductile adenocarcinoma, a form of breast cancer that begins in the milk ducts. When Shoffner's oncologist at Duke mentioned the clinical trial in July 2008, she eagerly volunteered.

"I believe in clinical trials, and if you have the chance to do something to keep someone else from going through this, you ought to do it," Shoffner said.

The chemotherapy was supposed to shrink her tumor before she underwent surgery to remove it. Potti's predictor steered her to a drug that he claimed worked especially well on her type of tumor.

Involvement in the study required surgery. She had to undergo a second biopsy, and nine titanium clips were implanted around the tumor. The clips served as markers, because doctors were confident the chemotherapy would melt the tumor beyond their ability to see it during a subsequent lump removal surgery.

The opposite happened. The cancer grew and spread to lymph nodes, and as a result of the chemotherapy, she developed blood clots. Before she could even have the tumors removed, she had to have surgery in which a filter was implanted in a heart vein to catch blood clots.

Then she had to have another surgery to remove the filter device before she could undergo radiation.

She said subsequent rounds of chemotherapy caused painful nerve damage in her legs, and she was recently diagnosed with diabetes. She continues to get twice-daily injections of an expensive blood thinner; and to pay for it, she moonlights at a hardware store in addition to her full-time job in a chemistry lab.

An avid fox hunter, horseback rider and antiques collector, Shoffner now walks with a cane and can no longer pursue her hobbies.

"I signed my consent to have a legitimate study done," Shoffner said. "I did not sign up for flawed science, which is what I have gotten."

(( FC note: the doctrine of informed consent will play a very important role in any litigation growing out of this mess ))

Shoffner, who said she has nothing but praise for the care she received at the university's cancer clinic, instead blames top Duke officials and Potti's collaborators.

"Who checked the man's credentials?" Shoffner asked. "Who went behind and checked his science? Dr. Nevins is a co-author - why didn't he check? There needs to be some kind of auditor of the data."

(( President Brodhead has stated no changes will be made in the way Duke hires, that it will take credentials at face value. ))

Finding seems promising

The kind of science Potti's team at Duke conducted is mind-boggling in its complexity.

Using sophisticated arrays of genetic information that is run through mathematical algorithms, Potti claimed to have discovered tell-tale genetic characteristics in cancer tumors that correlated to drug susceptibility.

It appeared to be an enviable breakthrough when the first study was reported in October 2006. Using cancer genetics to steer patients to effective treatments has long been the promise of personalized medicine, and research teams around the country have been pursuing the grail.

Among the prizes are lucrative business opportunities to license or market the prediction models. A month after Potti and Nevins published their first big paper in 2006, they were listed as officers in a startup company called Oncogenomics that would capitalize on their science.

The company later became CancerGuide Diagnostics, raising millions of dollars in startup money to market the cancer signature technology.

Duke also had a stake in the company, although Cuffe said the university pulled out in August amid the allegations over Potti's résumé. He said the company "closed shop" late last year.

(( The Duke Ventures office has not answered FC inquiries about Duke's outside partners in this company, how much they paid to get a slice of the action, and how much the value was assigned to the total pie. Shame on them. ))

Beyond sales potential of the Duke team's finding, other cancer doctors were eager to use the predictors for their patients.

A group at MD Anderson in Texas was among the enthusiastic, asking its biostatisticians to check the science and figure out how they could apply it to help their patients.

That's when things began to unravel.

Findings disputed

The key requirement for scientific integrity is replication.

Yet two statisticians at MD Anderson, Baggerly and his colleague Kevin Coombes, immediately ran into problems with the Duke work. They couldn't re-create the findings using Potti's data.

Baggerly asked for more data. Still no success. And subsequent papers from the Duke team about predictors for breast and ovarian cancers yielded equally baffling findings.

Baggerly began to suspect the worst. Some of the data were so fouled up he couldn't help but wonder if the problems went beyond simple error.

"I must acknowledge that during this process, our ability to comfortably ask questions and receive answers from the group at Duke became hindered," Baggerly said. He said he also had trouble getting journal editors who had published the Duke work to acknowledge his concerns.

Cuffe said Duke officials initially considered the challenges by Baggerly and Coombes to be a scientific spat - a common difference of opinion where one side hews to a certain viewpoint and the other clings to the opposite.

But Baggerly and Coombes were relentless in their criticism. Eventually they published a paper and raised their fears in a newsletter called Cancer Letter.

Baggerly said they heightened their calls for action when they learned patients were being enrolled in studies based on Potti's science.

With patients' safety publicly questioned, Duke halted the trials in November 2009 and enlisted outside reviewers to examine Potti's data.

By then, Shoffner had already been through the round of chemotherapy she blames for her declining health. She said she was told nothing of the investigation and had no idea there were concerns about the trials.

Trials resume

Although Duke's review team acknowledged some errors in the data, which Potti and Nevins said they had corrected, the team found no serious problems with how the experiments were conducted.

As a result, the clinical trials resumed last January.

Cuffe said the reviewers were not asked to comb through all of the underlying data, even though Baggerly and Coombes had recently raised their most serious allegations about its integrity, or "providence."

"The information we had at the time was not about research misconduct," Cuffe said. "It was patient safety, and someone needs to look at the methodology."

He said the reviewers tested the methodology using "the premise that the core data was correct. They didn't go back and check the providence of the data."

(( FC here: Let's look at the premise that the core data was correct. Compare please: we have a building that is toppling over and we investigated each floor, but we did not look at the foundation. ))

But everything changed in July. Allegations surfaced that Potti puffed his credentials - he falsely claimed to have won a Rhodes scholarship amid other academic honors - and Duke officials grew alarmed.

"He appears to have been dishonest in a portion of his professional life," Cuffe said. "That's a pretty rare event. It just gives me chills thinking about it. The ability to misrepresent so grossly in one part of life gives me concerns about misrepresenting in other areas.

"Now I have additional worries. ... I'm no longer confident that the outside review was deep enough."

Misconduct charges

A charge of scientific misconduct is a serious matter governed by federal rules and regulations through the Office of Research Integrity. If fraud is suspected - either through plagiarism, manipulation of data or outright lies - institutions are required to mount a thorough investigation.

The United States is one of only a few countries that has such rules governing scientific integrity. And the process of investigation can take years.

Meanwhile, Potti remained on Duke's payroll until his resignation in November, despite an August finding by university officials that he had inflated his accomplishments.

Cuffe said the misrepresentations appeared on Potti's academic résumé, not on a clinical application he submitted when he applied to Duke as a medical resident. The clinical application was thoroughly vetted, Cuffe said, requiring copies of his diplomas, medical licenses and a criminal background check.

In his resignation in November, Potti took responsibility for "a series of anomalies" in the data. But the scandal still reverberates through scientific circles. Three papers have been retracted or put under review, and more may fall.

Additionally, the misconduct investigation against Potti continues. He could face punishment by the N.C. Medical Board, which licenses and disciplines doctors.

(( FC: What has Duke reported to the Medical Board? The state website indicates nothing to this date. There is also the issue of prosecution: the US Attorney, the District Attorney and the Inspectors General of federal agencies that funded this fake research should be following up ))

Duke's handling of the case also remains under scrutiny, both internally and by the Institute of Medicine.

(( FC There is no guarantee that either investigation how underway will touch the admnistrative blunders in not putting a stop to Potti earlier. See FC next week ))

Cuffe said he hopes some good comes of the ordeal, even if the pace of science is slowed to accommodate the additional examination of the underlying assumptions.

"It's clear additional steps need to be taken," Cuffe said. "We owe it to patients ... as these things move forward, to go back and test the providence of the data."

For Shoffner, that approach is heartening, if late.

"I have been told there was no harm done to us," she said. "But no good was done to us, either. I got all the side effects from chemo and none of the benefit. Duke needs to stand up to this thing and say 'We failed. We didn't check [Potti's] credentials properly; we did not check his papers.'

"They need to step up to the plate and admit that, and come up with a new way of doing things so nothing like this happens again."

(( FC: To participate in Potti's trials, patients agreed to forgo other forms of treatment that might have helped them. As of last Friday, Duke was contending no patients were harmed; stay tuned. ))

1/08/2011

Chancellor Dzau braces colleagues for Potti bombshell on Sunday!!!

Search terms: Anil Potti Duke University

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FC is traveling at the moment. I am posting without either analysis or comment a statement from Chancellor Victor Dzau sent to all Duke medicine employees -- a highly unusual communication just after noon on Saturday. FC work on other, very critical developments in the Potti matter, promised earlier in the weekend, is not yet complete. Check back.

Text:

As many of you may know, investigations related to work done by Dr. Anil
Potti and others are continuing in earnest. A research misconduct
investigation is proceeding and several of the pivotal scientific papers
related to this work have now been retracted from the medical literature.
Additionally, Duke is cooperating fully with a major national review of
this particular research and of the field of genomic-guided research
generally, initiated by the Institute of Medicine (IOM).

Periodic news reports continue to follow the ramifications of this
discredited work and I anticipate that a significant article will appear in
the local media tomorrow.

I believe it is important to reinforce that Duke’s approach to this
situation has, from the beginning, been focused foremost on a concern for
the patients who were enrolled in these clinical studies. Many steps were
taken, including in the original design of these trials, to engage expert
opinion to minimize potential risks to our patients, including
recommendations for how patients on actively guided study therapies should
be managed, and assessments about the safety, efficacy and appropriateness
of the arms to which patients could have been assigned in these studies.
Therefore, even as we regret these circumstances, we believe that
appropriate steps were taken to minimize risk to our patients.

Last fall when it became apparent that data integrity issues were at the
root of the problem and these studies were closed, there was mutual
agreement between the clinicians and administration that the treating
physicians should discuss these issues with the patients who were enrolled
in the trials. At this time, Duke administrators are also reaching out to
these patients and their families, to express our apologies and answer any
remaining questions.

We are also a learning organization, so great emphasis has been put on
learning as much as possible from this experience. To that end, I
established a committee comprised of Duke's leading scientists to develop a
quality framework for genomic research intended to improve the checkpoints
and validation of such science before reaching patient studies -- that
work is nearly complete and will better position Duke to prevent similar
incidents.

I want to again say how proud I am of our basic and clinical researchers,
and of our cancer care teams and clinicians. We have taken the issues
raised by this research issue very seriously; patients and our community
can be assured that Duke's cancer care and research programs remain among
the most respected in the country and will be strengthened by the lessons
of this experience.

1/07/2011

Feds postpone civil rights focus panels

✔ Fact Checker here. On duty. No vacation.

Months after formal complaints were filed, and just days before the formal investigative process was to begin with focus groups, Duke University has told the Department of Education it is open to "resolving" issues raised by students Justin Robinette and Cliff Satell.

Kay Bhagat, attorney in the Office of Civil Rights of the education department, says it's postponing for one week the all-day focus groups that had been scheduled for January 12 to begin assessment of problems at Duke. A similar Duke announcement indicated the postponement was indefinite.

Loyal Readers will recall all this started when leaders of the campus Republican Club changed their own rules in the middle of the night, excluded most members of the club from having a role, and proceeded to oust Robinette as chair. Just a coincidence of course that Robinette was coming out gay.

That was just the start. The issues involved went well beyond and spilled over in several directions.

One curiosity has arisen: invitations to the focus groups came from a fourth echelon Student Life functionary with an office in the cellar of Flowers Building -- not from President Brodhead, Vice President Moneta or Supreme Dean Nowicki as one would expect for something so serious.

And the invitations to the focus groups were not extended to everyone -- raising issues of how Duke picked the people to invite to discuss with federal investigators general conditions here as the first step in the formal inquiry.

✔ So we have a last minute switch of tactics by Duke, a familiar tactic to those of us who follow the sad state of the Brodhead administration's handling of our business. In years-old lacrosse litigation, with just hours to go before officials who have never been held accountable and told their story, much less told it under oath, were to respond to subpoenas, Duke changed course to head off the testimony.

This time Duke tries to head off testimony about continuing conditions on campus.

Lawyers on our staff and more firepower brought in from the outside at great cost (how's $2 million for one law firm in one year) under General Counsel Pam Bernard's supervision are notorious for dragging out proceedings, hoping plaintiffs and complainants will get tired or go broke.

FC has recently written about the possibility this immoral course will be followed when patients of Dr Anil Potti begin their inevitable malpractice suits. With the latest number showing 300 patients actually in clinical trials (which is to say medical experiments on human beings), plus many others subjected to screening, the liability here is very likely in the hundreds of millions of dollars.

Another FC theory: The last thing Brodhead and his coterie need is for a procession of students and other stakeholders to tell the feds that we have not only the issues Justin and Cliff are raising, but others as well.

To be continued.