ANOTHER CONFLICT OF INTEREST:
Duke investigated Potti a year ago,
ready to make tens of millions of dollars
if he were cleared. He was.
University of Michigan scientist says Potti
stole his work for 2006 medical journal article.
Two more medical journals question their Potti / Nevins articles
In the past 36 hours, Fact Checker and Deputies have learned of three explosive developments in the Potti - Nevins scandal. Moreover, President Brodhead has not changed his opinion that everything went well in vetting Potti before Duke hired him; relax, the system is working!
We will do the easy one first.
✔Dr. David George Beer, Professor of Thoracic Surgery, Professor of Radiation Oncology, respected genomic researcher and co-director of the University of Michigan Comprehensive Cancer Center, author of more than 140 journal articles and an investigator with the the National Cancer Institute's Director's Challenge Consortium, which means he received a coveted $2.5 million grant for his work.
Dr. Beer said Potti improperly obtained raw genome data from him and his co-researchers. Data that Beer specifically told Potti he could not have.
Sorry, those are the best words Fact Checker has at the moment: "improperly obtained." Loyal Readers should watch for the substitution of the verb "stole" in the near future.
Beer says Potti muddled analysis of the data, came up with "highly suspect" conclusions and published an article under his own name in the prestigious New England Journal of Medicine in 2006.
Muddled? Beer specifically said that when Potti came across a patient whose data did not add to his theories, he threw that data out.
We're checking with the Journal.
Late add: two other journals that published Potti have started investigations: Nature and the Journal of Clinical Oncology. At one point Potti and Nevins sent Nature a large number of corrections of a 2006 article, but experts say they were erroneous too.
Beer says he reported the plagiarism to Duke, to Potti's mentor, Dr. Joseph Nevins, and was stonewalled.
Beer's allegations are the first of their kind that Fact Checker knows of: plagiarism. Other personal allegations against Potti focused on his inventing a Rhodes Scholarship and prizes from at least three learned societies.
Since the word plagiarism has a particular resonance in academia, Beer's allegations will make it very much harder for the Brodhead administration to brush Potti's fake credentials off with a censure letter placed in his file as has been rumored. Those rumors reached a crescendo this week when President Brodhead finally surfaced and told the Herald-Sun that we have truth, we have lies and we have "intermediate explanation." Loyal Readers reacted with a combination of outrage, ridicule and humor, one suggesting Brodhead was an intermediate explanation of a leader.
We will undoubtedly hear more of Beer when The Cancer Letter, which has led all other journalists in coverage of this scandal, which has a detailed statement from Dr. Beer, returns from a three week vacation.
My fellow Dukies, this is not good.
And now it gets worse. Conflict of interest!!
The following is written not only for people who have been with Fact Checker all summer, but in some detail for freshmen and for returning Fellow Dukies.
✔A year ago, Associate Professor Anil Potti was riding high. He had generous grants from the Department of Defense to research breast cancer, and from a pharmaceutical company and the American Cancer Society for lung cancer. He was publishing regularly in the most prestigious journals.
He was very much in favor among administrators at Duke, so much so that the University used him in promotional videos and brochures touting Duke Medicine. He went from researcher to assistant professor to associate professor rapidly; Duke PR won't say if he has tenure (which would really be quick) or is in a tenure track position.
He also claimed a discovery that was huge. He said he had developed a protocol to examine a cancer patient's DNA and RNA -- as well as tissue from the cancer itself -- to give each patient a score, and then determine very precisely what chemotherapy would work best for that individual. And at what limited dose. Medicine tailored for the individual.
The precise name is "lung metagene score." There would be other scores too, because as noted above, Potti was working on breast cancer as well.
RIght now chemotherapy is just hit or miss, with patients suffering through massive doses of many different chemicals and only 30 percent showing any response at all. This was the Holy Grail: the new field of translational medicine, taking genome discoveries and tailoring therapies. Think the Lasker Award. Think Nobel Prize.
Surely Potti and Nevins must have known their work would receive the utmost scrutiny. So how come they got us into this mess?
Duke didn't wait to find out. The University, which had been building a major Office of Licensing and Ventures (http://olv.duke.edu/index), swung into action, selling the right to use the Potti / Nevins work -- retaining some of the equity in the "discovery" for itself, and seeking to collect a fee from every patient who got scored, perhaps as many as 700,000 a year.
Who were the purchaser or purchasers that Duke sought? At what price? We do not know. Nevins owns a company that apparently acquired some rights but this is not yet been pinned down.
(Excerpts from one of three prospectuses that Duke used to try to make a sale appear at the end of this essay.)
There was a problem, however, standing in the way of the sale to outsiders, much of it being caused by researchers at the MD Anderson Comprehensive Cancer Center at the University of Texas in Houston, one of the nation's premier institutions.
Doctors there were intrigued by Potti, but also very suspicious. They assigned two bio-statisticians to examine his work.
The two took their assignment very seriously, very luckily.
A Fact Checker salute to Keith Baggerly and Kevin Coombes, bio-statisticians at MD Anderson Cancer Center, University of Texas, for their intrepid pursuit of truth, even in the face of Duke's official animosity while clearing Potti-Nevins during its first investigation.
Try as hard as they might, Baggerly and Coombes found only bunk.
1500 hours of work checking and rechecking Potti, only bunk. They discovered some errors in Potti's data, told him, and then found errors in the corrections.
The two were relentless and were causing more and more heat. Duke was cornered into starting an investigation of the science emerging from Associate Professor Potti's lab. And Potti's mentor too, was swept in: Dr. Joseph Nevins, Barbara Levine University Professor of Breast Cancer Genomics, the word University according him even greater status and meaning Levine kicked in bigger bucks for the endowment. Nevins wears another prestigious hat, Director of Duke's Institute for Genome Sciences and Policy, Center for Applied Genomics and Technology.
Pending the outcome, Duke kept both Potti and Nevins on the job, but suspended their taking in new patients.
With impressive speed, the investigation was completed and in January of 2010, Duke endorsed the science of Potti and Nevins and allowed them to resume recruiting. Compare please, this four month timetable into warnings from Duke now that the science investigation will go very very slow.
Duke never publicized any of this. Stakeholders did not even know it was going on. A Chronicle search of Potti's name prior to 2010 yields only Porta-Potty used at an event on the quad and discussion of a potty-mouthed comedian. A search of Duke Magazine did not even yield that.
Last February the tsunami started. First, two independent investigators that Duke hired to work with its internal review unzipped, complaining their findings were being used selectively, with bad findings withheld, favorable findings overemphasized. They also pointed out that Duke had limited their inquiry to two questions -- while others loomed.
Duke's administration fell silent. No questions, please. Who were the internal Duke faculty who sat in judgment. Who limited the investigation to two questions? Quiet please. The campus grew so toxic that when a graduate student rose in a meeting called to discuss biochemistry department issues asked about the festering, years old inquiry into the science of Homme Hellinga, James B. Duke Professor, that the Dean of the Medical School Nancy Andrews threw the student out of the meeting. Fact Checker is at work on this analogous situation. A full report soon.
Separately, 15 scientists who had published an article with Potti in the prestigious British journal Lancet Cancer renounced their own work. And then the kicker: an unprecedented world-wide Who's Who in genome research publicly demanded Duke stop Potti and Nevins.
And what really grabbed the headlines, the Cancer Letter discovered Potti did not have the Rhodes Scholarship he claimed -- nor many other qualifications either. An updated list of the fibs appears at the end of this post.
By late July, Duke could tolerate the heat no more, and was forced to start an internal review of Potti's credentials and a second review -- this time by independent external experts -- of the science of Potti and Nevins. Administrators pledged the reviews this time would be "unfettered," offering a weak explanation of why the first was so restricted.
The original timetable would have completed the internal credentials review by July 30. Two weeks ago today. Who knows.
Duke is trying to line up a subsidiary of the National Academy of Sciences for the external investigation. Ten days ago this seemed very likely. Who knows.
✔Chancellor Dzau's July 29 e-mail to the medical faculty announcing the twin investigations had a cryptic paragraph. If you check your file of Fact Checker essays, Loyal Readers will find we stated at the time we did not know what he was referring to but pledged to find out.
"In order to remove any possible appearance of conflict of interest, Duke has decided to permanently divest all equity and potential royalties associated with this science that had been licensed to an outside company. Although there are appropriate and comprehensive conflict of interest management plans in place for inventors, Duke's decision is to completely relieve itself of any perceived conflict or pressure."
Thus, Dzau cured the possible conflict of interest in the new investigations, but tacitly, he admitted the same possibility loomed over last winter's investigation. Duke -- the ringing of a cash register blinding it -- took no steps then.
Tacitly. What a disappointing, round-about way to learn of this serious ethical breach, particularly in light of the continuing pledges of "transparency" that we hear from administrators.
Why didn't Dzau lay out the facts, say we had a vested interest that we did not reveal, instead of just slipping in a short paragraph that no one would understand?
✔Loyal Readers will recall that Fact Checker pointed out recently another serious potential conflict of interest.
Vice Dean of the Medical School Michael Cuffe MD 91 (he has other titles too) became the point man in the new internal investigation of credentials, since replaced by Provost Peter The Silentious Lange.
In addition, Cuffe and Vice Dean Sally Kornbluth signed off in January on investigation #1 of the science.
The problem is that both were promoted to their positions by the Dean of the Medical School Nancy Andrews shortly after she arrived from Harvard. They continue to report to her; she's boss.
And who is her husband? Bernard Mathey-Prevot, Ph.D., a noted cancer researcher who left the renowned Dana-Farber Cancer Institute in Boston to accompany his wife and now works at Duke. He co-authored a major medical journal article with Potti and Nevins, and is a candidate to face review himself as this scandal metathesizes.
President Brodhead, we cannot have critical roles in these investigations played by people who are beholden to the Medical Dean, when her husband is in the spotlight. Period. Nor can we afford your failure to engage any of these issues.
✔One estimate is that Duke stood to make $5 million in profits annually if all had gone well with its licensing venture. Anytime Duke wants to provide a more precised number, Fact Checker is ready.
Potti and Nevins themselves have been making use of the score in three trials. Fact Checker note: the doctors call them trials; to me they are experiments with human patients.
Obviously if the trial is built upon bum science, the patients are going to get the wrong treatment.
As it did for the first investigation, Duke suspended new enrollment in the three trials, one for breast cancer, two for lung cancer. But 107 to 109 people already enrolled were allowed to continue.
Translation: those people have cancer and are getting treated right now according to the bum science of Potti / Nevins. The Who's Who sees great danger. Chancellor Dzau does not. Fact Checker hopes to explore this more in an essay real soon.
One key question: has Duke even informed these patients of all this mess? That is the least we can do morally.
Sheldon Krimsky, professor, Tufts University and author of the book Science in the Private Interest: "There are just too many things that are not resolved. It's not transparent.”
✔Beyond the patients, Fact Checker thinks it sucks when researchers get federal money or money from the public weal like the American Cancer Society, and their discoveries are not added to the free common pool of knowledge, but are used to line the pockets of the scientists or their home bases like Duke.
If a private drug company paid for the research, you'd expect this. But not from public money.
Friday's New York Times discusses an important advance in Alzheimer's research, so important it is the lead story on page one:
"The key to the Alzheimer’s project was an agreement as ambitious as its goal: not just to raise money, not just to do research on a vast scale, but also to share all the data, making every single finding public immediately, available to anyone with a computer anywhere in the world. No one would own the data. No one could submit patent applications..."
“It was unbelievable,” said Dr. John Q. Trojanowski, an Alzheimer’s researcher at the University of Pennsylvania. “It’s not science the way most of us have practiced it in our careers. But we all realized that we would never get (advances in the fight against Alzheimer's) unless all of us parked our egos and intellectual-property noses outside the door and agreed that all of our data would be public immediately.”
Duke is moving in just the opposite direction with its licensing and ventures.
✔It also sucks that Duke is trying to turn the external investigation from Potti / Nevins into an examination of the entire emerging field of translational medicine, with the suggestion that Potti and Nevins merely stubbed their toes against imprecision in accepted practices.
Maybe some additional standards are needed. But let's be honest, Mr. Brodhead, go fully through the Potti / Nevins mess, and then turn, separately, to any broader questions. No hiding.
✔✔ Summary: The Cancer Letter says the entire Brodhead Administration needs to be investigated. "Focusing on the three Duke trials may have been good enough last week, but not now..."
✔Fact Checker made formal inquiry as to whether the Board of Trustees has been briefed, if there is any special meeting planned before the regular Oct 1-2 date, perhaps of the Executive Committee which has full power of the board when it is not in plenary session. NO answer.
There's a long list of questions that we've had NO answer to despite pledges of transparency. No acknowledgment of correspondence, no answers. Does Potti have tenure? He's under suspension, what does that mean? Can he come on campus?
Who is judging him in the internal investigation? What is the standard of proof? Does the panel of Duke faculty reviewing him have to vote unanimously, or by a super majority, or a simple majority. Is one infraction enough to have this clown bounced from our faculty? Or do we need a pattern of lies?
Please note these are procedural questions, part of due process, quite independent of any inquiry into Potti himself.
NO answers. Michael Schoenfeld, VP for public affairs, acting for the Brodhead Administration, is not merely discourteous to F-C by not responding at all. He is showing disrespect for the role of informed stakeholders in the well-being of this university. He is dismantling this awesome place one brick, one "NO" at a time.
He cannot be allowed to make decisions on who gets access to Duke information based upon how supportive they are of Brodhead, as he seemingly has done in the past.
✔Text of introduction to prospectus. Duke file 2635, Office of Technology and Ventures:
"Duke University is seeking a company interested in commercializing a novel and versatile panel of genomic predictors of chemotherapy response. Each year, over 700,000 cancer treatment decisions are made in the US. Decades of clinical investigation have resulted in established guidelines for many cancer decisions across types of cancer and stages of disease. However, only 30% of patients typically respond to a given chemotherapy protocol, and in cases where there are multiple standard of care regimens from which the oncologist can, there is little or no guidance available upon which to base those choices.
"The development of a panel of genomic predictors of chemotherapy response that includes many of the very commonly used chemotherapies and chemotherapy combinations, provides an opportunity to guide these decisions. Importantly, the application of these predictive tools to aid decisions regarding the use of available drugs has the potential to improve the efficacy of treatment while likely adding minimal risk to the patient over current practice."
OK Loyal Readers. Let's vote on the Potti resume.
Remember the Brodhead standard: "We want, therefore, is for people to back off until they can learn whether the allegation was true or whether the allegation was false or if there is some intermediate explanation..."
-- He claims a Rhodes Scholarship. The Rhodes Trust says he never got one. Truth, lie or "intermediate explanation?"
-- He claims a fellowship in Australia in the same years he would have been in England at Oxford for the Rhodes, this at a university that does not exist. Truth, lie or intermediate explanation?
-- He claims he was mentored in Australia by a University of North Dakota professor. The professor says at that time he had never even heard of Potti. Truth, lie or intermediate explanation?
-- He listed on different official documents two different years for his medical degree, and his Medical School offered a third. Truth, lie or intermediate explanation?
-- He listed honor after honor, including awards from the American Society of Clinical Oncology, the Lymphoma Research Foundation and The American Society of Hematology, each of which said he's no winner. Truth, lies or intermediate explanations?
Solicitation: Fact Checker would like e-mail from legal people discussing issues. For example was a crime committed in seeking grants (mail fraud, money under false pretenses)? What is informed consent and what if a patient gives it in response to fake credentials? If Duke admitted its vetting of Potti was deficient, would it face liability. What malpractice might lurk, Duke or Potti/Nevins. Stuff like that. Thanks.
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