… in the Minneapolis Star Tribune notes that the most charitable description of what’s been going on at the clubby University of Minnesota medical school would be “bizarre.”
Sunday, May 31, 2009
Drew Gilpin Faust and the Incredible Shrinking Harvard
From Boston Magazine:
For her first commencement address as president of Harvard University, just a year ago this month, Drew Gilpin Faust spoke in defense of money. The school's endowment, swollen by years of double-digit returns, had grown to almost $37 billion. As a result, Faust explained to her audience, it had become "something of a target, publicly both envied and maligned." Politicians like GOP Senator Charles Grassley were proclaiming that Harvard had so much money, it had a moral obligation to spend down its endowment—then the largest in the world by the comfortable margin of $15 billion or so.
Yet Harvard was not as well-off as it might seem, Faust said. True, the endowment was big. But it supported a growing institution of great public import. Harvard had 20,000 students and 16,000 employees. It contained "a huge and very costly research enterprise," satellite campuses around the globe, and "libraries and museums that house priceless collections of books, manuscripts, artworks, cultural artifacts, and scientific specimens." Paying for it all required staggering sums: To meet its $3 billion annual budget, the university relied on $1.4 billion a year in endowment payouts. Take away that easy cash, and Harvard would be—to paraphrase—up a creek.
While the failed presidency of Lawrence Summers generated more headlines, this quiet crisis is actually a greater threat to Harvard. The university has been so rich for so long that most of its denizens can't remember a time when money was a concern. While Harvard officials are doing their public-face best to downplay the problem, the numbers don't lie, and this economic crunch will leave the school a profoundly changed place. Harvard will have to become smaller and academically more modest, and as it does it will chafe at having grand plans without the resources to fund them. For the first time in decades, it will worry about merely paying its bills. The university will have to decide: If it is no longer so rich that it doesn't have to make choices, what does it really value? What are its priorities? It won't be a comfortable debate.
As Peter Gomes, chaplain of Harvard's Memorial Church and a sociologist of Harvard culture, once told me, "A great Harvard president is made by doing the ordinary job of president extraordinarily well."
Guiding a university through this recession would challenge any president, and some of Harvard's competing institutions—Yale, Princeton, Stanford, MIT—also find themselves under financial duress. But the situation at Harvard is worse and the consequences will be more dire.
One reason is the growth in university spending, most notably in the Faculty of Arts and Sciences. The last time the endowment stood at $25 billion, in 2005, the FAS budget was $812 million. Now it's $1.2 billion—a particular problem because FAS depends on the endowment to provide more than half its annual budget. During the past decade, FAS embarked on a giddy hiring binge—according to Harvard Magazine, the number of FAS professors has increased by 126, a 22 percent jump—and a building spree including some $800 million in science labs alone.
The buildings cost money, the people to go into them cost money, there is upkeep and maintenance... Again these problems sound strangely familiar.
The roots of Harvard's fiscal crisis go all the way back to 1990, when money manager Jack Meyer left the Rockefeller Foundation and assumed the reins at the Harvard Management Company (HMC). Breaking with the traditionally conservative approach, Meyer was in the forefront of university portfolio managers who integrated complicated financial instruments into endowment investments. He reduced the amount of stocks and bonds in Harvard's portfolio to less than 30 percent and diversified into illiquid assets such as commodities, real estate, timber, hedge funds, and private equity. He also ventured into financial tools such as derivatives and emerging market debt that carried more risk than stocks and bonds but promised much larger returns. "There's not much plain vanilla in our portfolio," Meyer told BusinessWeek in late 2004.
Meyer left in 2005 amid controversy over the multimillion-dollar bonuses paid to some of his money managers. Rumors also swirled that he had clashed with Larry Summers over control of HMC. It's hard to know: Neither man is talking. Still, there is no question that Summers took a much more active role in Harvard's money management than his predecessors.
After Meyer stepped down, he was replaced by Mohamed El-Erian, a managing director at the bond giant Pimco, who lasted just under two years in the post. He was followed by Jane Mendillo, who had been managing Wellesley College's endowment, and whose assumption of the job last July would become the very definition of bad timing.
The turnover may have hurt, because last fall's stock market meltdown seemed to catch HMC asleep at the wheel. As of June 30, 2008, the Harvard endowment was 105 percent invested: HMC had borrowed above the endowment's value in order to make additional bets. With the vast majority of its money tied up in holdings from which it could not easily be extracted, the university was ill prepared when the tanking Dow spurred anxious counterparties to call in their chits. Those margin calls forced Harvard to put up collateral—cash that it did not have. And it couldn't unload its illiquid investments to come up with that money, because their value had fallen so precipitously that no one had any idea what they were really worth.
Further squeezing Harvard was a transaction Summers had pushed it into in 2004, when he successfully argued that the university should engage in a multibillion-dollar interest rate swap with Goldman Sachs and other large banks. Under the terms of the deal, Harvard would pay Goldman a long-term fixed rate while Goldman paid Harvard the Federal Reserve rate. The main goal was to lock in a low rate for future debt, and if the Fed had raised rates, Harvard would have made hundreds of millions. But when the Fed slashed rates to historic lows to try to goose stalled credit markets, the deal turned equally sour for Harvard: By last November, the value of the swaps had fallen to negative $570 million. The university found itself needing to post more collateral to guarantee those swaps, and would ultimately buy its way out of them at an undisclosed cost.
HMC "took the university right to the edge of the abyss," one alumnus, a financier who is privy to details of the university's balance sheet, told me. I asked what he meant. "Meaning, you're out of cash.
"That," he added, "is the definition of insolvency."
"If you can't afford to lose the money"—and a university that depends on its endowment to defray operating costs can't—"don't play the game," says one Harvard grad, an investor who was once involved in the university's finances.
"You had very smart people [at HMC] who never had a real answer to the question 'What would happen if this doesn't work out your way? What if what the black box is predicting doesn't occur?'
"The answer would always be 'That's impossible,' or 'You don't understand.'
"The arrogance," says this alum, "was palpable."
In the midst of its economic pain lies an opportunity for Harvard. It can reconsider itself, restate its core values. It can conduct the kind of soul-searching that should have been sparked by Larry Summers—intentionally or not—but was lost in the mad rush to oust him.
"If Harvard is honest," says one high-powered alum active in university affairs, "we'll say, ‘We want a sustainable, long-term, top-notch university. And we can't be all things to all people. What we can do is excel, and that means we have to live within our means.'"
These last two paragraphs are crucial. Simply substitute University of Minnesota for Harvard.
The question for us at Minnesota is: "Do we have the courage and leadership to excel and to live within our means?"
Friday, May 29, 2009
or, Cui Bono?
or, ALL UR DNA BLONG 2 US?
From Politics in Minnesota:
Freedom of consent, total galactose & intellectual property: Minnesota's infant DNA Mayo-Gopher industrial complex
A new round of documents obtained from the Minnesota Department of Health (MDH) regarding the state's Newborn Screening Program (NBS) show interesting implications about the difference between its role catching certain dangerous genetic diseases, and the various genetic research and testing programs that the samples ultimately get sent to. There's quite a difference between the "trip-wire" disease screening program and the DNA studies; the role of DNA research as intellectual property suddenly pops up.
The study project authorizations approved by the Department of Health involve DNA research; critics of the policies around the newborn DNA samples want to know what happens to all the genetic data, and who might profit from it. Two big players around here, the Mayo Clinic and the University of Minnesota, do work on the blood samples. The operative contracts, which include defining the "intellectual property" of what could almost be called the "derivative works" of newborn DNA, of the U of M and Mayo were obtained by lawyer Nathan Hansen, working in concert with the Citizens Council on Health Care, via Data Practices requests.
Here is the University's newborn screening contract and the Mayo's [PDFs]. Fans of cellular rights might find the parts on the State apparently owning their chromosomes a bit profound!
The puzzle over infant DNA data handling revolves around a conflict between the state's 2006 genetic privacy law, which is fairly protective of individual rights, and the statute that controls the newborn screening program. In March 2007, administrative law judge Barbara Neilson ruled that the Department of Health was not compliant with the privacy law, and in 2008, SF3138, a bill that leaned towards the program (and backed by the Mayo) got vetoed by Gov. Tim Pawlenty over privacy concerns.
From where should the basic principles about intellectual ownership of one's DNA come, especially when dealing with the property of people that were just born? Parental informed consent is the pathway out. To reform the legally hazy situation, DFLers have basically wanted to make a more clear consent form available to new parents, and roughly speaking, tighten up the sample rules.
We'll make a dare for the Department of Health to try: the new parental informed consent form should have a separate checkbox: if the DoH is going to offer their child's DNA to research programs, all derivative works and intellectual property should be under the "Creative Commons" license -- none of this scooting off the chewed up data into the sphere of corporate patents and trade secrets!
One other factor: as public-private partnerships have moved into the area of genetic research, the compensation structures of various researchers have been shifting. The proposed, so-called "Tubby Smith" shift in data classification of public employee outside compensation would obscure how these are set up -- and indeed, if the "derivative works" from the infant DNA data isn't always traced (let alone handled in a comprehensive ethical framework), what's really happening to those little red spots? As always, who profits?
One program serves to improve a commercial "Total Galactose" testing kit from the Finnish group Perkin Elmer [PDF], in effect doing the R&D runs. On the documentation like the MDH Institutional Review Board (IRB) "Re-Reviews of Exempt Research," sometimes children are marked affirmatively on the "Vulnerable Populations Checklist" and, at least on some studies, they are supposed to be evaluated because they "are either not competent or not free to give their own consent;" so why are the studies inconsistent as to whether children are actually involved? In any case, the exhaustive social and economic effect of having their DNA poured into to research projects isn't fully traced in these IRB approval forms.
Hansen's sharing more about where else the paper trail leads at his blog. One funny item from the letters Hansen got from Lynn Belgea at the MDH legal office said MDH [PDF] "does not conduct 'DNA collection' from infant children; the department collects dried infant bloodspots, of which DNA is one constituent."
[Get the whole, fully searchable multi-part PDF here, 105 MB including the U of M and Mayo Contracts, the total galactose project, MDH correspondence, years of NBS meeting agendas, and other items. Acrobat 8+ required.]
Wowser! It will be very interesting to see how this unfolds. The old open and transparent thing - as the famous philosopher once said: Deja vu all over again.
From the Chronicle:
Copyright-Law Curricula Face Each Other in a Duel
The foundation’s program, “Teaching Copyright,” includes a Web site and five 60-minute lessons that the foundation hopes will give students what it calls “the real story” about their rights when it comes to downloading movies, music, and other media from the Internet.
Tracy Mitrano, who is director of IT policy at Cornell University and also director of the university’s computer-policy and law program, says it’s important to remember that both organizations have their own points of view and motivations.
“If you get something form the RIAA, it’s going to have its own motivation for its perspective implicit in its curriculum,” Ms. Mitrano says. “If you get something from a not-for-profit, you may want to know something about its positions on other matters, and where it may fall on the political spectrum.”
“If I was teaching copyright law as an undergraduate course, I’d offer both up,” she adds. “That’s what democracy is all about. That’s what debate is all about.” —Marc Beja
[Some U of M administrators might want to read this stuff also. Especially those who are lawyers.]
Monday, May 25, 2009
Despite protestations from a University of Minnesota physician - not coincidentally also a Medtronic orthopedics consultant - Dr. Timothy R. Kuklo has recently taken leave of Wash U.From the NYT:
Dr. Timothy R. Kuklo, a former Army physician accused of falsifying research involving injured soldiers, has taken a leave of absence from the Washington University School of Medicine in St. Louis and its affiliated hospitals, the medical school said Friday.
Dr. Kuklo, an associate professor of orthopedic surgery, will not perform operations, conduct research or teach students, said a medical school spokeswoman, Joni Westerhouse. The university granted the leave, she said, so that Dr. Kuklo “can focus on responding to queries about his research and consulting.”
Ms. Westerhouse declined to say whether the leave, which began Thursday, was paid or unpaid. She said she did not know its duration or whether Dr. Kuklo requested it or it was imposed on him. The university has declined to say whether it was investigating Dr. Kuklo.
“We know this is a major situation,” Ms. Westerhouse said.
Dr. Kuklo, who previously worked at the Walter Reed Army Medical Center in Washington, had been accused by four former colleagues there of falsifying research on a bone-growth product made by Medtronic that was used on severely injured soldiers. He was also accused of forging the other doctors’ signatures when he submitted a research report to a medical journal last year.
The Army, which investigated the matter, issued a report rebuking him. It took no further disciplinary action, Army officials said, because Dr. Kuklo is now retired from the military. But Walter Reed notified Washington University of its findings five months ago.
The Journal of Bone and Joint Surgery, a British publication, retracted Dr. Kuklo’s article in March after receiving a report of the investigation from the Army. But the episode largely escaped public notice until last week.
Army investigators said Dr. Kuklo’s study had cast Infuse, a bioengineered bone-growth product sold by Medronic, in a misleadingly favorable light compared with conventional bone grafts in repairing severely shattered shin bones of American soldiers injured in the Iraq war.
From an earlier NYT article:
A former Walter Reed colleague, Dr. David W. Polly Jr., who is also a Medtronic consultant, said he believed that Dr. Kuklo’s data was “strong” and the episode had been overblown.[Unfortunately, Dr. Polly, in addition to being a Medtronic consultant, is also a physician at the University of Minnesota. Overblown, Dr. Polly? I don't think so...]
"That is why, walking across a school campus on this particular December morning, I keep searching the sky. As if I expected to see, rather like hearts, a lost pair of kites hurrying toward heaven."Truman Capote, A Christmas Memory
Sunday, May 24, 2009
“Decreasing the duration of medical education offers the greatest potential for reducing the financial burden of medical education.”
Oddly enough, the current push at the University of Minnesota Medical School seems to be to lengthen the amount of time that elapses in obtaining a medical education - in which the administration seems to take pride - see the late MED2010 initiative.
But what really ought to be happening is a re-tooling of undergraduate and graduate medical education to reduce the time, and especially expense, of medical education. The tools to do this have been around for a long time. One example is the six year combined MD-undergrad program at Northwestern. Another worthwhile shortening is the suggestion that one term of organic chemistry would suffice in the education of many physicians. Whether they need to know about nucleophilic aromatic substitution is dubious.
Another possibility is shortening the medical curriculum so that it is completed in three, rather than four years. This seems eminently doable. Unfortunately the attempt to totally mash up the academic side of programs makes it difficult for a med student to skip say, biochemistry, if she has had an excellent undergrad course and paid attention.
From Web Weekly, News From the Harvard Medical Community
To Cut the Costs of Medical Education, Trim Training
It is no secret that medical training is long. Whether at cocktail parties or family reunions, the student doctor stays on alert for the well-meaning if often-repeated question: “How much longer do you have left?”
Opportunity knocks for the first entrepreneur since the 1970s who can establish a three-year American medical school pathway.
At the college level, premed requirements of the Association of American Medical Colleges (AAMC) take about one and a half years. The expectation is that this period allows adequate preparation and that all medical school applicants take the standardized MCAT. But concern remains among medical educators that science education is not equal across campuses, so much time is lost during the first year of medical school getting everyone up to speed.
Potential solutions include:
• Formalizing curriculum accountability between medical and undergraduate faculties at institutions that have both schools;
• Accrediting premedical programs;
• Improving MCAT psychometrics.
Making the Cut
During the early 1970s nearly one quarter of American medical schools established flexible three-year programs, but these fell quickly out of favor by the end of the decade. Yet in 1988, Robert Ebert, who was the HMS dean from 1965 to 1977, and Eli Ginzberg, Columbia economist and presidential adviser, raised a similar call to action in a Health Affairs article. Though AAMC reports in the early 1990s acknowledged the cogency of their argument for increasing flexibility in medical education, the four-year pedagogy grew more ingrained, particularly in the context of flourishing basic science departments.
Today, medical debt headlines as a priority for the AAMC, American Medical Association, and nearly every student group who can post a blog, but the hand-wringing tends to push aside solutions from other sectors: cutting costs (i.e., reducing training length) and growing top-line revenue (i.e., increasing housestaff salaries).
Enter E. Ray Dorsey et al.’s 2006 Academic Medicine study, once again providing a compelling economic perspective: “Decreasing the duration of medical education offers the greatest potential for reducing the financial burden of medical education.”
The findings include:
• One year less of medical school yielded a net present value (NPV) benefit ranging from $160,000 to $230,000 (using a 6 percent discount rate in the calculation);
• Increasing residency compensation to that of a first-year physician assistant yielded an NPV benefit ranging from $60,000 to $100,000;
• Reducing medical school tuition by 25 percent had the smallest financial impact—$30,000.
Economics is important, but would a three-year MD play in Peoria?
To allay concerns about shaking up the four-year precedent, I would cite the 34 BS/MD programs that typically last six years, as well as the shorter total duration of most foreign medical schools (usually entered as an undergraduate).
As for logistics, the standard four-year track could take a haircut either at the front or the back. Time and energy invested in premedical courses (from general chemistry to molecular biology to statistics) should tee up matriculants to tackle the exciting science of clinical medicine. Even allowing room for a short refresher course, this classroom-based work could be completed in one year, enabling future physicians to start laying hands on patients—the soul of a healer’s training—in their second year. And on the back end, the predominance of electives in the fourth year could be combined rather easily with internship to recreate a more transitional year.
Change is unlikely under the auspices of committees and task forces. The ideas are before us, and as in so many areas of clinical services, we need leaders who will start pilot programs. For a profession grounded in the scientific method, it is surprising that providers are so reluctant to experiment with entirely different training methods.
Saturday, May 23, 2009
Droppin' Like Flies,
Med School Deans
But fortunately we have someone at the University of MInnesota, Dr. Frank Cerra, who can be the dean and also do his other job. Of course he needs an Executive Vice Dean and three Vice Deans to help him. This is a wonderful way to cut down on administrative costs, nicht wahr? [And a great way to play the old executive game, my org chart is bigger than yours..]
From Free Press Medical Writer, Patricia Anstett
Wayne State's med school dean steps aside
CLARIFICATION: An earlier version of this story said Dr. Robert M. Mentzer Jr. resigned from his position as dean of Wayne State University’s School of Medicine. He stepped aside, according to university officials.
The dean of Wayne State University’s School of Medicine has stepped aside from his job, citing personal reasons.Comment (same source)
In a letter late Thursday to WSU President Dr. Jay Noren, Dr. Robert M. Mentzer, Jr. requested the university “appoint someone to serve in my place and stead.” He said he would return to campus June 2 for the School of Medicine commencement.
Mentzer had been at odds with Noren about key programs and training at the school. He had been dean for more than three years.
Mentzer and his Bloomfield Hills attorney, Sue Ellen Eisenberg, who has acted as his spokesman, could not be reached for comment Thursday, but Michael Wright, WSU spokesman, confirmed he will leave his job temporarily. Wright said Mentzer did not resign, but he wouldn’t give any other reasons for Mentzer’s departure.
Dr. Valerie Parisi, vice dean, will fill in for Mentzer “until further notice,” Noren said in a letter to the medical school’s faculty leaders.
And the students are not getting regular updates? Pathetic. The dean of the medical school is supposed to be the student advocate - turmoil like this should be discussed with the student body.(What a novel concept...)
Thursday, May 14, 2009
From the Strib:
Gov. Tim Pawlenty said he will use line-item vetoes and his authority to pull back spending to balance the state budget.
He said there will be no special session or government shutdown.
The Republican governor said he would prefer to work out a budget deal with Democrats who control the Legislature, but he says they are spending more than the state has.
He said the session will end no later than Monday at midnight.
Minnesota faces a projected shortfall of $4.6 billion over the next two years.
Pawlenty said his cuts could hit public health and welfare programs, public schools, higher education and aid to cities and counties.
He vetoed a $1 billion tax increase.
Last Words From Graduate School Dean at University of Minnesota?
Date: May 13, 2009
To: Graduate Faculty
From: Gail Dubrow, Chair, Graduate School Executive Committee
Subject: Graduate School Executive Committee Response to Draft Recommendations on Restructuring Graduate Education
The Constitution of the Graduate School charges its Executive Committee with responsibility for considering proposals for changes in the administration of the Graduate School and continually reviewing the effectiveness of its structure and performance in discharging its missions.
In keeping with its constitutionally mandated responsibilities, the Graduate School Executive Committee has completed its deliberations on the Draft Report of the Committee on Graduate Education, "Recommendations on the Oversight and Support of Graduate Education at the University of Minnesota," released for public comment on April 24.
The Executive Committee concluded that a free-standing Graduate School should continue as an academic unit with a constitution and shared governance. The Executive Committee approved 12 key resolutions related to the future of graduate education at University of Minnesota, with additional comments that specifically address the 15 key findings of the Committee on Graduate Education.
Full text of the Graduate School Executive Committee's response is now available at http://www.grad.umn.edu/news-
events/gradeducation.html. To clearly understand the Executive Committee's recommendations, it is helpful to have in hand a copy of the Draft Recommendations of the Committee on Graduate Education, which can be accessed from the same page.
May 24 is the closing date of the public comment period on the Draft Recommendations of the Committee on Graduate Education. Whatever your views on plans for reorganizing graduate education, The Graduate School Executive Committee encourages you to submit your comments before the deadline so your voices can be heard. Address your comments to the Committee on Graduate Education at firstname.lastname@example.org, which has been charged with responsibility for compiling and forwarding verbatim all comments it receives to the Provost (email@example.com) and President (firstname.lastname@example.org).
Unconfirmed rumors persist that the administration has asked that Dean Dubrow resign or be fired as of May 15. We shall see.
Wednesday, May 13, 2009
[Please see preceding post about this disturbing situation.]
From the Center for Public Integrity
Investigative Journalism in the Public Interest
Accountability: Kuklo, Target of Army Probe, a Top Recipient of Medtronic Travel
By M.B. Pell, Aaron Mehta, Nick Schwellenbach | May 13, 2009, 4:03 pm
If you read today’s New York Times, you’re likely familiar with the story of former Army surgeon Timothy R. Kuklo, a paid consultant to Medtronic, Inc., a medical device developer and manufacturer.
Between 2001 and 2006, Medtronic paid for at least 15 trips taken by Dr. Kuklo, worth more than $13,000, according to travel disclosure records obtained from the Office of Government Ethics. Kuklo, now an associate professor at Washington University medical school in St. Louis, took more than 20 privately-funded trips.
“There’s no lack of creativity in how the industry tries to influence studies,” said Shahram Ahari, a medical ethicist and former drug sales representative. “This is what marketing is about, you take people with that position of respect and credibility, and every once in a while they spin one out that helps the marketing, and it’s hard to distinguish the marketing from the science.”
Kuklo was one of the Defense Department’s top recipients of Medtronic travel money, according to an analysis of Pentagon travel data being conducted by the Center for Public Integrity, Northwestern University’s Medill School of Journalism, and the Associated Press.
A former colleague of Kuklo’s at Walter Reed Army Medical Center, Dr. David W. Polly Jr., took even more expensive trips than Kuklo. Polly went on at least 12 Medtronic-sponsored trips costing about $30,000, including a $10,000 trip to Switzerland. Now at the University of Minnesota School of Medicine, Polly defended Kuklo in the Times’ article, describing Kuklo’s data as “strong.”
From the University of Minnesota's Mini-Med School Website:
“Physicians and industry relations”
There’s no debating it: The relationship between physicians and industry is paramount to the vitality of the medical profession. David Polly, Jr., M.D., professor and chief of spinal surgery in the Department of Orthopedic Surgery, tried his best to prove that point during his presentation at Mini Medical School. To prove his point, he gave numerous examples about cutting-edge surgeries in the fields of hip replacement, trauma care, bone fractures, and spinal surgery. None of the current surgery techniques would be possible without industry partners, he said, because an idea can be great in the lab, but it cannot come to fruition until it goes through the commercialization process. On the flip side, he also said transparency is important. Physicians should always disclose their relationships, and leave it up to the patient to decide whether or not their advice is bias. There are also federal rules in place to make industry relationships remain fair and open. Some of those rules include regulations on how much physicians can be paid, stringent reporting logs while consulting, and completing thorough written contracts. As a consultant to Medtronic, and recipient of research grants from the Department of Defense, Polly is well aware of industry relationships and regulation. He’s an advocate for both, as well as transparency. “As technologies improve we can fix more challenging problems, but it only comes through industry partnerships,” Polly said.What we’re wondering: Were you convinced? Are industry relationships absolutely vital to the medical field? Is it possible for a physician consulting for a medical device company to remain completely unbiased while giving patient advice? Do you believe all physicians are as transparent as Polly? If you weren’t an advocate for industry relationships, was there something Polly said that changed your mind – or at least made you challenge your perspective?
From the comments section:
What we’re wondering: Were you convinced? ... Not really.
Are industry relationships absolutely vital to the medical field? ...Yes
Is it possible for a physician consulting for a medical device company to remain completely unbiased while giving patient advice? ...No
Do you believe all physicians are as transparent as Polly? ...No
First, Do No Harm...
Then, Forge No Signatures
And Finally, Fudge Not Lest Ye Be Fudged
From a Retraction Notice:
Withdrawal of a paper
A paper entitled “Recombinant human morphogenetic protein-2 for type grade III open segmental tibial fractures from combat injuries in Iraq” was submitted to the JBJS[Br] with a covering letter dated 9 October 2007 which was signed by the authors. The corresponding author was Dr. T. Kuklo. The letter of transmittal included the statement that each of the authors had read and approved the final manuscript. It also said that the authors were employees of the United States Government and that the submitted work was performed as part of their official duties.
Shortly after the paper was published we received correspondence from one of the persons identified as a co-author indicating that the alleged co-authors had not seen the manuscript prior to publication and that they had not signed the letter of transmittal. It was further disclosed that much of the paper was essentially false.
Appropriate representations were made to the Walter Reed Army Medical Center in Washington DC, the alleged source of the paper, even though Dr Kuklo had retired from the US Army and left Walter Reed well before his paper was submitted for publication. A local investigation was instigated and we received further correspondence dated 6 November 2008 including the following
“The results of the investigation establish
that Dr Timothy R Kuklo did not submit the article through the Office of Clinical Investigations or the Public Affairs office, as required by Army regulations, before he submitted the article to your publication;
that the signatures of the supposed co-authors of the article were, in fact, forged;
that Dr Kuklo acted without any involvement of personnel at the Walter Reed Army Medical Center;
and that the article was in no way vetted through Walter Reed’s Publication process before publication.
As you are aware, once the article was reviewedby the purported co-authors of the article, a number of serious questions were raised regarding the validity of the information and the conclusions made in the article."
Under these circumstances the paper published by this Journal has been formally withdrawn from the scientific literature and Dr Kuklo banned from submitting further papers to this Journal.
J. Scott, MA, FRCS, Editor
Journal of Bone and Joint
J Bone Joint Surg [Br]
Well the NYT has finally tumbled to this situation and has an article with some local color. Perhaps this is an indication that self-policing is not going to be effective here either?
From the New York Times:
A former surgeon at Walter Reed Army Medical Center, who is a paid consultant for a medical company, published a study that made false claims and overstated the benefits of the company’s product in treating soldiers severely injured in Iraq, the hospital’s commander said Tuesday.
An investigation by Walter Reed found that the study cited higher numbers of patients and injuries than the hospital could account for, said the commander, Col. Norvell V. Coots.
“It’s like a ghost population that were reported in the article as having been treated that we have no record of ever having existed,” Colonel Coots said in a telephone interview on Tuesday. “So this really was all falsified information.”
The former Army surgeon, Dr. Timothy R. Kuklo, reported that a bone-growth product sold by Medtronic Inc. had much higher success in healing the shattered legs of wounded soldiers at Walter Reed than other doctors there had experienced, according to Colonel Coots and a summary of an Army investigation of the matter.
Dr. Kuklo, 48, now an associate professor at the Washington University medical school in St. Louis, did not respond to numerous e-mail messages and telephone calls to his office and home seeking comment over the last two weeks. Walter Reed officials say he did not respond to their inquiries during their investigation.
Army investigators found that Dr. Kuklo forged the signatures of four Walter Reed doctors on the article before submitting it last year to a British medical journal, falsely claiming them as co-authors. He also did not obtain the Army’s required permission to conduct the study.
“This was a real letdown for us to have one of our former members do something like this,” one of those doctors, Lt. Col. Romney C. Andersen, wrote in an e-mail message Tuesday. Dr. Andersen, now posted at a combat hospital in Baghdad, said he could not comment further without the permission of his commanders.
It was Dr. Andersen who brought the problem to the Army’s attention last year, prompting the inquiry. In its March edition, at the Army’s request, the journal retracted the article — something that has gone largely unnoticed outside orthopedic circles.
The Army released an executive summary of its investigation to The New York Times last Friday in response to a reporter’s questions, followed by the Tuesday interview with Colonel Coots.
While at Walter Reed and since, Dr. Kuklo has given talks to other doctors around the country about the bone-growth product, a protein called Infuse, according to meeting agendas and published documents.
A Medtronic spokeswoman, Marybeth Thorsgaard, confirmed that Dr. Kuklo was a paid consultant to the company and that the company financially supported some of his research at Walter Reed, through a foundation affiliated with the hospital.
But she said Medtronic did not finance or review the Infuse study, which was published in Britain last August in The Journal of Bone and Joint Surgery. She declined to say when Medtronic had hired Dr. Kuklo or how much it had paid him over the years.
Infuse is widely used in civilian hospitals and trauma centers around the country for spinal surgeries and to treat broken bones. The Food and Drug Administration issued a safety alert last year that Infuse, if used in neck surgeries — for which it has not been approved — could cause breathing difficulties.
Since last year, the Justice Department and Senator Charles E. Grassley of Iowa, ranking Republican on the Senate Finance Committee, have been investigating whether Medtronic illegally promoted unapproved uses of Infuse by paying doctors, among other measures. The company has denied those charges.
During the six-month period ending last October, sales of Medtronic’s bioengineered products, principally Infuse, reached $419 million, according to a company filing.
Dr. Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said he was unaware of any previous cases in which medical studies involving injured soldiers had been retracted because of such allegations. “People are very careful when they deal with this patient population,” he said. “I think they understand that the stakes are pretty high.”
The study claimed to be a review of soldiers who were treated at Walter Reed for gaping lower-leg wounds with open fractures caused by explosions in the Iraq war from March 2003 to March 2005.
Colonel Coots said that Walter Reed surgeons had used Infuse with good results on some soldiers — but not at the 92 percent success rate Dr. Kuklo claimed.
Several colleagues of Dr. Kuklo, who has published more than 100 articles on orthopedic topics, said they had recently become aware of the allegations and they were not in keeping with what they know of his work.
“It surprises me to hear this swirling around him,” said Dr. Todd J. Albert, chairman of orthopedic surgery at Thomas Jefferson University Hospital in Philadelphia. “He’s a guy, anything he tells me, I take to the bank.”
A former Walter Reed colleague, Dr. David W. Polly Jr., who is also a Medtronic consultant, said he believed that Dr. Kuklo’s data was “strong” and the episode had been overblown.
[Unfortunately, Dr. Polly, in addtion to being a Medtronic consultant is also a physician at the University of Minnesota. Overblown, Dr. Polly? I don't think so...]
Army officials said that Colonel Coots sent the results of their investigation late last year to Medtronic’s chief executive and to the dean of the Washington University School of Medicine. A university official declined to say whether it was investigating Dr. Kuklo but added that he remained on the faculty.
Colonel Coots said he decided to handle the matter by notifying the journal, university and Medtronic, as well as several orthopedics professional groups, rather than recalling Dr. Kuklo from retirement to face possible Army discipline.
As recently as February, two months after Medtronic received the findings of the Army’s investigation, Dr. Kuklo made a general presentation about Infuse at the orthopedic academy’s national meeting in Las Vegas. In a disclosure filing for the event, he noted that he was a paid consultant, speaker and researcher for Medtronic. The filing did not specify any dollar amounts.
Back in 2005, while still at Walter Reed, Dr. Kuklo listed Medtronic as a financial supporter “in excess of $500” in a disclosure statement accompanying a preliminary report about the use of Infuse on American soldiers injured in Iraq. The Army is not disputing those early results.
Infuse was approved by the F.D.A. in 2002 for use in the lower spine and in 2004 for fractures of the shinbone. The studies on which the F.D.A. approved shin-bone treatment involved patients injured in accidents like car crashes and falls.
But because doctors are free to use any product approved by the F.D.A. for whatever purposes they see fit, surgeons at Walter Reed used the product to see if it could help soldiers with far more severe, combat-related injuries.
During his time at Walter Reed Dr. Kuklo was extensively involved in research and writing about various Medtronic products, including editing two books published by the company and conducting three studies that were approved by his Army superiors, according to his list of publications and an Army report.
The results reported by Dr. Kuklo in his Infuse study “suggested a much higher efficacy of the product being researched in the article than is supported by the experience of the purported co-authors,” according to the Army’s investigation.
Colonel Coots said Tuesday that the total number of patients Dr. Kuklo reported as having been treated for extensive lower leg wounds at Walter Reed during the study period — 138 soldiers — was greater than the number for which the hospital could find records.
“It is a significant breach of academic protocol,” Colonel Coots said. “It’s a breach of trust.”
This episode has been overblown, Dr. Polly? Wow.
I thank a regular reader for calling this situation to my attention.
Sunday, May 10, 2009
Friday, May 8, 2009
Sadly, it sometimes takes legislation...
Jeremy Olson and Paul Tosto won the Premack award this year for excellence in investigative or analytical reporting about public affairs for their series “The Death of Subject 13” published in the Pioneer-Planet May 18, 19 and 20, 2008. For background see an earlier post.
The Frank Premack Public Affairs Journalism Award competition is one of Minnesota's most coveted and celebrated journalism honors. Started after the death in 1975 of Frank Premack, a reporter, city editor and assistant managing editor at the Minneapolis Tribune, the competition has recognized Minnesota media doing public affairs journalism in their community or region for more than 30 years.
The Olson/Tosto series called to public attention events that illustrated the need for this legislation. As with the current conflict at the University over conflict of interest at the Academic Health Center, a weary public and impatient state legislature will take matters into their own hands if the University continues to drag its feet.
Legislature approves bill limiting mentally ill patients' participation in drug trials
By Jeremy Olson
Updated: 05/07/2009 12:58:10 PM CDT
A bill before Gov. Tim Pawlenty would restrict the ability of clinical drug researchers to enroll mentally ill patients who are under court commitment orders.
The House and Senate both voted unanimously this week in favor of the bill, which was motivated by the suicide of schizophrenic Dan Markingson. Friday marks five years since his death in a group home in West St. Paul.
At the time, Markingson was enrolled in a comparative drug trial at the University of Minnesota — despite objections from his mother that he was coerced into the trial and should be withdrawn.
The initial legislation would have banned clinical drug trials from enrolling any patients under stayed commitments, which are court orders that keep people out of locked mental institutions but under strict conditions.
This outright ban drew opposition from the National Alliance on Mental Illness, or NAMI, which argued that mentally ill patients benefit from experimental drugs or treatments when traditional therapy fails them.
The approved bill gives court judges discretion — allowing patients under stayed commitments to participate in clinical trials if they have the wherewithal to make such a decision and have tried traditional therapies first.
The bill also requires that a psychiatrist enrolling a patient into a drug trial cannot be the primary treating psychiatrist for that patient.
A single psychiatrist at the U of M treated Markingson, advised the court on whether
he should be committed, and enrolled him into a study funded by AstraZeneca. The study compared the effectiveness and side effects of three existing antipsychotics.
"There's a lot more transparency and people watching out for the patient" under this bill, said Rep. Karla Bigham, DFL-Cottage Grove, who authored the bill. "That was our goal."
Kudos to the U of M's own bioethicist, Carl Elliot, for his efforts in making this legislation possible. This important action is the result of a free press, an involved legislature, and - yes, indeed - some parts of the University of Minnesota. Congratulations to them all.
Wednesday, May 6, 2009
David Brauer writes in Minnpost:
By David Brauer | Published Wed, May 6 2009 6:25 pm
According to the Minnesota Daily, editor-in-chief and co-publisher Vadim Lavrusik resigned Wednesday, just days after being suspended for impermissibly sharing content with the Star Tribune, where he was a journalist on classroom assignment.
Lavrusik was suspended for a week as of last Sunday. On Tuesday, he went into the paper's computer system and downgraded "to less prominent placement on the Daily homepage" a letter written by two Daily editors criticizing management bonuses.
The Daily story notes Lavrusik's resignation "came before The Minnesota Daily Board of Directors determined whether or not this action violated his suspension."
Lavrusik told the Daily that he re-ranked the online piece to "the way [it] would appear in the paper." The implication is that staffers left the letter in a more prominent position than it otherwise would have been.
Contacted shortly before today's story appeared, acting editor-in-chief and letter co-writer Mike Rose would not comment on what was afoot, so I was unable to ask him about the placement issue.
Gayle Golden, a U journalism lecturer and Daily board member, said her group would meet Wednesday to discuss the matter, adding, "Vadim has been a highly effective leader the lion's share of the year, and his instincts have been great. Beyond that, I have no other comment."
The resignation caps a tense several months at student-run media organization, where plunging revenues forced cancellation of the Friday print edition as some staffers absorbed 50 percent pay cuts.
Lavrusik's fall began in the late hours of April 24, when more than 500 revelers from the U's Spring Jam tore down street signs, built fires, damaged cars and battled police. Lavrusik helped coordinate the Daily's coverage, sending out Twitter updates as the breaking news rolled out.
A Star Tribune staffer saw the tweets, and knowing Lavrusik worked at that paper, asked an editor to contact the student for more information. Lavrusik shared details; as an unasked-for reward, the editor gave him a byline, Strib managing editor Rene Sanchez says.
In an interview before Lavrusik's resignation became public, Rose said some Daily staffers were outraged, feeling Lavrusik had shared proprietary reportage beyond his own fact-gathering. The Strib later amended the story to credit the Daily staff.
In a pre-resignation interview, Lavrusik acknowledged mistakenly wearing two hats that evening. "I've been sick about it all week," he said, adding that he apologized, held a meeting with the reporters directly affected, and staged an open newsroom discussion.
Sanchez defends the young journalist, saying "We had a pressure-packed situation and simply a miscommunication on a hasty phone call after midnight in the middle of a growing street disturbance. I don't believe either the editor or the intern intended to have any of the facts misplaced or not credited the right way."
Nevertheless, Rose says some staffers wanted Lavrusik's resignation immediately; others were impressed with the editor's apology and contrition and felt it was "time to move on."
For his part, Rose says he believed "some kind of punishment was necessary."
The board independently levied the one-week suspension. (Sanchez notes no one called him for the Strib's perspective.) Lavrusik said he also lost a $3,000 bonus the board had awarded just days before.
Similar bonuses — given to the two other member of the Daily's "Office of the Publisher," or OP — touched off the controversy's next phase: the front-page letter from Rose and city editor Andy Mannix.
In it, the pair contrasted the bonuses with "massive pay cuts ... discontinuing a Friday print edition and cutting entire departments and sections of the newspaper."
Rose says most reporters now work for $3 a published column inch. "You cut an inch off a story, that's a meal," he notes.
Meanwhile, Lavrusik and business-side co-publishers John Scholz and Robin Perez were working under employment contracts signed before the economy tanked; Golden says the deals were not renegotiated. She would not disclose pay, stating "as a nonprofit independent organization, we have no obligation to disclose salaries and compensation."
However, Rose says the three OP members' pay was approximately $16.50 an hour for a 30-hour week, or about $500 a week.
As part of that agreement, the triumvirate was also eligible for summer, fall, and spring bonuses, though Golden indicates it was more like base compensation.
The bonuses were "put in place, quite frankly, to make sure seniors don't slump in the spring," she says. "There might be a better word than bonus, but that's the word we're using."
In solidarity with other Daily employees, Lavrusik, Scholz and Perez voluntarily gave up their fall bonuses; Lavrusik indicated in a December email to the newsroom that spring bonuses would be given up as well.
That expectation helped fuel the outrage that erupted on the Daily's pages this week.
Rose says the staff swallowed the pay cuts and elimination of publishing days and sections "under the premise that the OP would forgo bonuses; Vadim indicated it would be for spring."
It's unclear whether Scholz or Perez agreed to give up the money; speaking for both, Perez declined comment beyond a statement published Wednesday that does not address the decision.
Golden says she had no discussion with OP members about giving up the spring bonuses. For his part, Rose says if there was $6,000-$9,000 available at year's end, "it should compensate the folks making less than minimum wage."
From the board perspective, Golden says awarding the bonuses was practically mandatory.
"Despite going through a really difficult time, the OP left the organization [with a] $47,000 [surplus], created new revenue streams and significantly improved the product," Golden notes. "They met their goals."
Rose says he has some second thoughts about giving his and Mannix's letter such prominence, which unintentionally became Lavrusik's undoing.
Rose acknowledges the controversy might have been better covered as a news story, though he wasn't sure who would write it. And he notes that that he gave Scholz and Perez the opportunity to publish a side-by-side rebuttal Tuesday; they passed, only to respond the following day.
Still, given the Daily's $500,000 from student fees, he has no regrets about publicizing the financial dirty laundry. "Institutions cover themselves all the time; think of Par Ridder, or the Star Tribune's bankruptcy. We just felt it was something readers should know."
As for Lavrusik, he almost made it to the finish line in tough times that have stressed experienced professionals; his resignation came just two days before the Daily's final issue of the semester.
I don't know Lavrusik well; we met for the first time that fateful Spring Jam night at a Daily alumni banquet. He struck me as a bright, earnest guy. Speaking to him this morning before he resigned, I could feel the agony of a guy beating the crap out of himself for a boneheaded move, which only helped enable a second boneheaded move. At least to me, he seemed genuinely chastened and also a bit at sea.
As a former Daily section editor, I can tell you the paper was my best college experience because it was so real: the fights with the business side, trying to manage peers — and yourself — while thousands of students, hundreds of faculty, and dozens of administrators examine your words with a microscope.
The Daily is an awesome finishing school, as editors nationwide can attest. Many current staffers will kick ass in the real world, whether in journalism or someplace else. It would be a damn shame if a few bad days doomed the career of one of them.
No Beer for the Peasants, No Swill for the Swells?
U of M president opposes expansion of alcohol sales at TCF stadium
by Tim Post, Minnesota Public RadioMay 5, 2009
The president of the University of Minnesota opposes a legislative effort to expand alcohol sales at the U's new football stadium.
St. Paul, Minn. — A Minnesota House measure, now in conference committee at the capitol, would allow alcohol to be served throughout the TCF football stadium. The stadium is set to open in September.
The U of M wants to serve alcohol only to people in expensive premium seats and private suites.
U officials say that would help the school monitor and limit the purchase of alcohol in the 50,000 seat stadium.
University President Robert Bruininks doesn't appreciate the legislature's effort to expand alcohol sales.
"I think this is a bit of micro management in the University's business that I don't think is healthy at this time." Bruininks said.
If the measure is passed by lawmakers Bruininks said the University may have to take a second look at its plans to sell beer and wine at the new facility.
Dr. Frank Cerra of the University of Minnesota Academic Health Center Answers Some of Life's Persistent Questions
Tell me a little bit about where we are with the conflicts of interest policy. I know there’s only one Regents meeting left. Where’s that at?
And then we’ll be ready to put this together and see what the new policy draft looks like, and begin to take it through the consulting process. I think we’re also in the midst of preparing a position statement on the value added from relationships between faculty and the institution and industry where there is really clear value added.
And so what kind of timeline are you working on? Is there a goal for what Regents meeting you’d like to bring the policy to?
And I know a lot of people have expressed disappointment in the way things have gone from the task force recommendations to the draft that was released late January, early February. They want to know what’s next and how will those folks be able to get their voices heard?
And so, let’s talk a little about finances. How has it been this year for the AHC? And looking forward, how do the books look for next year?
There will be a draft policy that will be put in the faculty governance system and the general collegial response system. And they’ll have the chance to voice their opinion either directly or through their elected representatives.
I like that, how do the books look. This year has been a major, major challenge for a variety of reasons. None the least of which is the state rescission. None the least of which is looking at the amount of debts students have and trying to figure out how do we create an economic model that will continue to support health professional education.
To try and create a sufficient margin in the clinical business, to grow and expand Medical School or health sciences program is increasingly difficult because those margins aren’t there.
And how does the state’s budget affect the AHC’s plan for the new biomedical center?
Let’s talk about the transfer of the deanship, come July 1 you’re going to be taking on a lot of responsibility. What are you most looking forward to?
We’re moving ahead with the biomedical facilities. We’re looking at planning that district as a new campus, it’s called the Biomedical Discovery District.
I think this isn’t really a transfer, it’s really an integration of two positions to better accomplish the challenges that face us.
If you’ve been following it, you know we’re on this pathway of convergence with Fairview Health Services, that’s absolutely critical for our future. In order to, as you pointed out, finish up these biomedical facilities and get it done efficiently, effectively and on time, it’s no small feat to recruit 60 to 120 new faculty in five to seven years, that’s a lot of work, in addition to the normal turn over.
At the State of the AHC address, a lot of folks seemed concerned about their schools, outside the Med School. How do you respond to those folks who are maybe concerned that pharmacy, nursing and public health are going to be given less priority to the Med School?
Well I think they’re legitimate concerns, and I congratulate them for expressing them, because if they’re not out there you can’t talk about them and fix them.
Jumping back to the dean, has there been a decision made about Dean Powell and her future within the AHC?
And has she made any indications to whether she has committed to continue as a tenured professor?
No decision. Dean Powell, the discussions continue with her. But nothing has been decided at this point in time. Just to point out, she is a tenured professor here, so at the very least, she has the right to continue as a tenured professor, but beyond that, there’s still ongoing discussion.
You’d have to ask her, I don’t know.
Friday, May 1, 2009
From the Strib:
The latest challenge to Minnesota’s data practices law is known at the State Capitol as the Tubby Smith Act. A well-intentioned attempt by the University of Minnesota’s student newspaper to learn more about the outside income of Smith and other U coaches sparked this year’s legislative squabble pitting public sector transparency vs. individual privacy.
After the U declined the Minnesota Daily’s request, the student journalists took their case to the state Department of Administration, which rules on requests for information under the state’s Data Practices Act. The department agreed with the U, ruling that only income from the university should be disclosed — not outside income from other sources. The department asked the Legislature to clarify its position in the law by inserting the words “employer-paid’’ before “added remuneration’’ into data practices legislation now being debated.
Without broader context, the department’s decision seems relatively harmless. Faced with a flu epidemic, a multibillion-dollar budget deficit and a never-ending U.S. Senate race, do Minnesotans really care how much Tubby Smith earns hosting a basketball camp for junior high kids? Not likely. But the inexorable erosion of the state’s once-groundbreaking Data Practices Act is a concern. What started out in the post-Watergate era as a four-page document that presumed government data should be open to the public and news media is now a maze of exceptions more than 100 pages long. In what has become a troubling annual ritual in St. Paul, various proposed changes would add a couple of pages more.
The desire for openness in public information often collides with a growing appetite for privacy in our daily lives. “It’s bad enough in this day and age people are saying, 'What are public employees making?’’’ police union lobbyist Brian Rice told the Star Tribune. “But now all of a sudden, because you work for the government, you are owned by them?’’
In reality, there’s nothing bad about taxpayers knowing how much public employees are paid. It’s essential for government accountability. And fortunately there’s no dispute at the Legislature over public-salary data. At least not yet.
For now lawmakers are focusing on outside income. A Senate bill would restrict access to data on outside income and freebies; a competing and welcome House bill would make it clear in the Data Practices Act that any added remuneration from an outside source would be made public.
It’s easy to make light of how the House bill could play out. Rice, who serves as a lobbyist for the Minneapolis Police Officers Federation, warned that the bill would require public workers to disclose all outside income — even money earned mowing a lawn. In fact, the House bill would not require agencies to collect new data. It would only make accessible data that they request at their own discretion.
There’s a more realistic threat from the Senate bill. Attorney Mark Anfinson, who represents the Minnesota Newspaper Association, points out that it might be important for the public to know that a high-level government regulator is doing contract work for a private entity. If the remuneration clause is diluted, such serious conflicts could be hidden from public view.
Similarly, the Senate bill could undermine efforts to develop a strong conflict of interest policy for the U’s Medical School. For example, even if the school starts requiring faculty members to disclose sources of outside income internally, it’s likely that passage of the Senate bill would keep such data from being made public.
With the House bill, the Legislature has an opportunity to stem the tide of exceptions to the Data Practices Act. In this era of renewed hope for government accountability, that would be a sign of progress.
"Everything we do at the University of Minnesota is out in the open."
Where do you stand on the Tubby Smith Act, President Bruininks?
How can you support it given the problems pointed out above and your statement about transparency?
How can you expect anyone to pay any attention to you when your actions - or inaction - so clearly contradict your words?