Monday, August 24, 2009

University of Minnesota Surgeon Does the Right Thing


"Dr. Polly did the right thing..."


Dr. Joseph Zuckerman, President
American Academy of Orthopedic Surgery (AAOS)

"A University of Minnesota surgeon has resigned from the board of a prominent orthopedic medical society following a controversy over the more than $1 million he was paid by Medtronic Inc. for consulting work."

From the Star-Tribune:


U surgeon resigns from medical board over Medtronic consulting work

By JANET MOORE

In an Aug. 19 letter to the president of the American Academy of Orthopaedic Surgeons, Dr. David Polly said media attention concerning his "consulting activities has become an unnecessary distraction" to the society's "important efforts."

Polly, the head of the U's spine surgery department, has been a target in a Congressional investigation exploring the financial relationships between doctors and medical device makers. Initiated by Sen. Charles Grassley, R-Iowa, the probe found that Polly was paid $1.2 million between 2003 and 2007 by the Fridley-based medical technology company for consulting, expenses and honoraria.

Such relationships are common -- and legal -- in the $140 billion medical technology industry. Doctors offer medical device makers advice on how to improve products; sometimes they are paid royalties for inventions commercialized by device manufacturers.

Grassley's investigation revealed that by 2007 Medtronic paid Polly $4,750 a day, or $594 an hour, with an annual cap of $400,000, and that Polly gave congressional testimony on spine surgery research without disclosing his relationship with Medtronic.

Medtronic said last month it was launching its own investigation of Polly's consulting arrangement.

Polly began working at the U in 2003 after retiring as the head of Orthopaedic Surgery at Walter Reed Army Medical Center, one of the nation's top military hospitals.

In his letter to AAOS President Dr. Joseph Zuckerman, Polly said he continues to "strongly believe in the need for physician-industry collaboration in order to develop better treatment for patients." But "physicians are entitled to fair market value compensation for their time," he wrote, noting he has disclosed his relationships "whenever asked."

With approximately 25,000 members, the AAOS describes itself as a "premier" not-for-profit organization that provides educational programs and support for surgeons who commonly replace knees and hips and repair ailing backs in patients.

Polly was elected to the society's board in February for a three-year term.

Zuckerman said Polly's resignation was not requested by the society, but that he agreed with the decision nonetheless. "Dr. Polly did the right thing," he said. "I think that the issues that recently played out in the media were a distraction to him."

He said the society has strict disclosure rules regarding board members' consulting relationships with industry. The board was aware of Polly's ties to Medtronic, he noted.
They may have been aware of the ties, but were they aware of the amount of money involved? Perhaps the society needs some disclosure rules of its own?

And of course the "whenever asked" comment makes it even clearer how inappropriate is the behavior of the University of Minnesota in foot-dragging on conflict of interest matters.

Some of my colleagues say that the term foot dragging is too soft and that stone-walling is actually a better description of what has been going on.

Sunday, August 23, 2009




Hopelessly Bad Opinion Piece...

Margaret Soltan give a second opinion on the recent pitiful effort by President Bruininks to justify foot dragging at the University of Minnesota. He has an Op-Ed in the Sunday Tribune entitled, can you believe it: "Transparency at the U."

Hopelessly bad opinion piece … in the Minneapolis Star-Tribune from the president of hopelessly conflicted University of Minnesota. He had to say something; the newspaper’s been all over the many ongoing conflict of interest scandals in the UM medical school.

What he’s produced, though, is too lacking in content for SOS to take hold of anything from it for discussion purposes. The piece makes no reference to particular COI cases — a basic requirement under the circumstances.

If you’re in the mood for meaningless reassurance and groundless self-congratulation, go to it.



Saturday, August 22, 2009

USNews Rankings of Public Schools of the BigTen

yellow - same as previous year
green - improved
red - declined


If we haven't cracked the top half of the BigTen by now, how are we ever going to attain the goal stated by the current University of Minnesota administration?

"Starting in 2004, the University began the first comprehensive strategic planning process it had undergone in almost 15 years. Under the leadership of Provost Sullivan, the University community articulated an ambitious aspiration for the University--to be one of the top three public research universities in the world [sic] within a decade."
Time to set some realistic priorities - given our land grant mission and duty to the citizens of the state?

Time to pursue these realistic priorities within our available resources?

President Bruininks?

Provost Sullivan?


Thursday, August 20, 2009

Central Light-rail Line Gets Key FTA Support

University of Minnesota Threatens to Withhold Land

Rotenberg on vacation

From the Star-Tribune:


A key federal agency has given the green light for the 11-mile Central Corridor light-rail route between downtown Minneapolis and St. Paul, despite a last-minute appeal from University of Minnesota to slow the process.

The federal approval, called a record of decision, does not guarantee federal funding, but is an essential hurdle that needed to be crossed to keep the project alive and on track.

University general counsel Mark Rotenberg wrote to federal officials Tuesday, requesting that they delay issuing the final record of decision until the U and the Met Council "reach a comprehensive written agreement that mitigates the project's adverse environmental effects and preserves the public's enormous investment in the University's research corridor on Washington Avenue."

Officials met as recently as Monday, according to the letter, but have not reached a formal resolution on how to mitigate the impacts. The university's Board of Regents will not contribute land for the corridor's use until the issues are resolved, the letter said.

Rotenberg was on vacation and unavailable to comment on Wednesday's federal decision to move ahead with the project, according to an assistant.

Bell said that he was disappointed by the U's last-minute appeal, because any slowdown would have delayed construction for a year, costing an additional $30 to $40 million.

Wednesday, August 19, 2009

"I'm not getting a good sense that there is a workable business model here ... This thing defies gravity, in my view."

Can Biotech Boom In the State?


"I'm not getting a good sense that there is a workable business model here," said Peter Bianco, director of life-science business development at Halleland Health Consulting and a former CEO of University Enterprise Laboratories in St. Paul. "This thing defies gravity, in my view."

The state has begun work on $15 million worth of improvements, including a new interchange connecting Hwy. 52 near Pine Island to the facility. Tower Investments, which owns the 3.6-square-mile site, hopes to complete the facility in five to seven years. John Pierce, an executive with the firm, said in July that 10 companies already have committed to Elk Run, although he declined to name them.

Burrill, a Wisconsin native, has pledged to raise $1 billion by the end of the year, a difficult task in the current economy. He says he will use the money to lure biotech companies to Elk Run and to commercialize technology originating from the University of Minnesota and Mayo Clinic.

Several states have tried, with little success, to carve out a biotech niche from scratch. The Midwest, in particular, has focused on biotech to replace lost manufacturing jobs. But to create a successful biotech incubator, a state needs venture capital, a location adjacent to a major research institution, a skilled workforce and breakthrough scientific research -- things you wouldn't necessarily expect to find in Pine Island, a city of about 3,300 located 15 miles north of Rochester.

Tower never planned to build a bioscience center when it bought the 2,325-acre Bird Island property in 2006. The company envisioned hotels, schools, a wellness center, shops, office and warehouse space -- even a water park. Tower added a bioscience center only after it had failed to win state money for infrastructure improvements.

While experts applaud the plan's size and ambition, they question its logic. While venture capital-backed incubators have succeeded in places like Seattle and Menlo Park, Calif., the real estate portion of the fund adds a layer of unpredictability, said Randy Olson, vice president of economic development at the Initiative Foundation in Little Falls, Minn.

Olson also wonders whether the state will subsidize the rents or leases of the companies that move to Elk Run. An experiment with a similar incubator concept fizzled earlier this decade in the Twin Cities. Finding companies that could pay University Enterprise Laboratories' operating costs hobbled its mission to incubate start-ups, said Olson, a former general manager of University Enterprise Laboratories.

"There is a risk profile here that is probably off the charts," Olson said.

Despite some impressive research, Mayo and the University of Minnesota have long struggled to transfer ideas from lab to market, as both institutions tried to reconcile making money with their nonprofit missions.

Some experts wonder about Burrill's relationship with Mayo. The two parties say there is no legal partnership that gives Burrill first crack at Mayo technology, only a vague "working relationship." Whether that's good enough for investors remains to be seen.

Elk Run's biggest risk may be its sheer size.

"This project has a 'big-bang' feel to it and I don't know of any areas of the country where this has produced sustained economic and entrepreneurial growth," said Marti Nyman, a former director of global alliances at Best Buy and founder of Altavail Partners, a business incubator.

Medtronic Consultant Kuklo Resigns from Washington University

From the New York Times:


Surgeon Tied to Bone Product Inquiry Resigns

A former Army surgeon accused of falsifying a study on a bone growth product used on severely injured Iraq war veterans has resigned his teaching position at Washington University in St. Louis, a spokeswoman said Tuesday night.

The surgeon, Dr. Timothy R. Kuklo, 48, was placed on leave earlier this year while the university investigated charges against him. Medtronic, a maker of the bone growth product Infuse, also suspended his consulting contract. The company paid him nearly $800,000 the last few years.

“Dr. Kuklo has agreed to voluntarily resign from the university, effective September 30, 2009,” Joni Westerhouse, a spokeswoman for the medical school, said in an e-mail message Tuesday. “Dr. Kuklo will have no clinical, research, or educational duties for the University between now and that date.”

Dr. Kuklo tendered his resignation on July 30, according to Don Clayton, associate vice chancellor and director for medical public affairs. University officials declined to comment further.

An investigation last year by Walter Reed Army Medical Center in Washington, where Dr. Kuklo worked before joining the university, concluded that he had falsified parts of a study that claimed greater benefits than other Army surgeons reported for the Medtronic bone growth product.

The Army reported its findings to the university and a medical journal. Dr. Kuklo was also found to have forged the signatures of four listed co-authors, who told Army investigators that they did not approve the study.

The British Journal of Bone and Joint Surgery retracted the study earlier this year. The New York Times first reported on the controversy in May.

Medtronic and the university, which had given Dr. Kuklo tenure shortly after hiring him in 2006, have been investigating. The university previously said that it also found he had confidential medical information on Army soldiers on his university computer.

Dr. Kuklo, a West Point graduate, listed his house in Wildwood, Mo., outside St. Louis for sale for $2.7 million last month, real estate records show. He did not respond to an e-mail message Tuesday, and a woman who answered the phone at his house declined comment.

Dr. Kuklo, who is also a graduate of Georgetown University Law Center, has never commented publicly on the matter.
I have previously posted on this situation. For example:


So the guy's a West Point grad, a lawyer, and a doc...

Duty, honor, country?

Monday, August 17, 2009

Latest on Money

and the House That Bob Built

As OurLeader's favorite philosopher and management role model once said:

"Prediction is very hard,

especially about the future."


Somehow, what is reported below is unsurprising to this observer. There has been a hubris - e.g., ten million scoreboard - about this project from the very beginning that is breathtaking. Maybe we'll squeak by. I hope so. But the lack of appropriate priorities of the current administration is stunning. Education, research, panem et circensa - in that order - should be our priorities. And of course we do have a land grant mission that is woefully misunderstood by the current occupants of Morrill Hall.


From the Pioneer-Planet


Recession and alcohol ban crimp revenue from luxury seating at U's new TCF Bank Stadium

U officials are saying the new TCF Bank Stadium could bring in about $2 million less its first year than initially forecast.

They blame a slumping economy that stalled sales of the priciest luxury seats and a Legislature-induced decision to ban alcohol, which drove more people away and prompted price reductions for those who remained.

With a month to go till Opening Day, about half the indoor club seats at TCF Bank Stadium and a quarter of the private suites are unsold, and both have now been made available for single-game purchase.

The luxury seats are a key part of the overall stadium revenue picture.

Along with the desirable but less-pricey "preferred" seats, they are supposed to generate 40 percent of overall revenue at the new facility, according to Elizabeth Eull, the U's senior associate director and chief financial officer for athletics.

"I believe this is manageable," Eull said. "It's difficult, to say the least."

The university's Board of Regents approved the sale of liquor in premium seating areas in December, and as the new year began, the sales staff was confident of moving most or all of the premium packages, said David Crum, the U's associate athletics director for development.

But then the worsening economy slowed things down, and in May, state lawmakers passed a provision that forbade selling alcohol in any part of the stadium unless it was sold throughout.

Complaining that their hands were tied, regents banned liquor in June.

"Everything came to a screeching halt" once legislators became involved in the alcohol issue, Crum said. The Legislature's action "put a real, real challenge toward us," said athletics director Joel Maturi.

Before the economy went south and alcohol was banned, they were planning for 95 percent. That would have brought in about $5 million.

As of late May, when the athletics department budget was finalized, it was clear sales were lagging, and projected revenues from premium seat sales were just under $4 million, Eull said.

But that was before alcohol was taken away and customers were offered 10 percent refunds. The givebacks, plus potential additional cancellations related to the alcohol decision, could create an additional $1 million in lost revenue for the department this year, Eull said, adding that the exact financial hit this year is by no means certain.

But there is still another shoe to drop.

Mariucci and Williams arenas — where the Gophers play hockey and basketball — are also included in the alcohol ban. Both had areas where premium customers could drink alcohol, and losses are expected from cancellations and/or discounts at those facilities as well, but the impact is not yet known.

Maturi says he intends to protect athletics program budgets initially while waiting to see if revenues come in higher, but he said it might mean the department seeks university permission to finish this year in the red.




Sunday, August 16, 2009

Strib Editorial Calls for Leadership and Disclosure at the University of Minnesota

"I think we need to put ourselves in the position of acting according to the highest ethical principles. I believe our people do that now and I believe our people will be doing that in the future as well."
President Bruininks (Daily: 6-18-08)

Iowa started on a conflict-of-interest revamp in January and their policy has recently gone into effect. We are still foot dragging after two years.

And how about the double-dippers, President Bruininks? You do remember them? Or were you hoping that everyone had forgotten about this situation? Last I heard from U of M leadership on the matter was:

"I think people will think what they want to think," Cerra said, in response to possible criticisms of appointing someone who is under investigation. [Daily: 30 July 2008]
Note the date. Cerra is Frank Cerra, our new medical school dean.

And we recently learned of yet another stem cell scandal. The University is being embarrassed at the national level over these matters. Third best what, Dr. Bruininks?

If we do not have integrity at this institution, we have nothing.

Time for a change?


From the Star-Tribune:

[Note added Monday, August 17: As of right now there are a total of 3 comments left on the Strib page for the article below. One of them is mine. The second one is entitled: "Wow! More pharma demonizing" and concludes: "Keep your head up, Dr. Polly." The third comment babbles about: "all the formularies financially pressure the docs to save tens of millions thru the wayward use of generics." Pretty depressing. No wonder we're in the mess we're in. Or maybe everyone is on vacation this month - I don't know.]

U should lead on conflict of interest

Iowa Sen. Chuck Grassley is also pushing for an overdue overhaul on a different medical front: disclosing physicians' lucrative financial ties to industry.

The Iowa Republican sent a stern letter to U President Robert Bruininks ...

The missive opened a window on spine surgeon Dr. David Polly's eyebrow-raising consulting relationship with Medtronic, the Twin Cities-based medical device manufacturer. Among the findings: Polly, a medical school professor, received well over $200,000 a year from the company for four years running.

Safeguards have not kept pace with the proliferation of these consulting arrangements.

"We have not been interested in regulating this; we've been interested in stimulating it,'' said Art Caplan, a well-known University of Pennsylvania medical ethicist. [And former U of M faculty member] "Management of this area has been completely lacking...

Polly's payments illustrate why more oversight is needed locally and federally

Among the most unsettling revelations in Grassley's letter is that U officials did not know how much Polly earned from Medtronic. The current policy, which is under review, only requires Polly and other physicians to report that they have received outside payments of $10,000 or more a year.

Not even the U's own Conflict Review and Management Committee -- which reviewed Polly's ties to Medtronic and recommended a conflict of interest "management plan" for him in 2006 -- knew Polly's total compensation.

How is it possible to assess a conflict of interest, much less manage it, if officials don't know how much money is involved?

The university should have recognized this policy's shortcomings and reacted before receiving Grassley's embarrassing letter.

The University of Minnesota medical school should seize the opportunity provided by Grassley's high-profile letter to not only set its own new standards, but lead the way forward nationally.


It is too late for the University of Minnesota to be a leader in this area. In fact they are being dragged into compliance, kicking and screaming - while trying to make it appear that they welcome change. The evidence of foot dragging is simply overwhelming.

Patton used to say something like: Lead, follow, or get the hell out of the way.

Since Administrative leadership at the University has already declined the first two options, perhaps they should take the third?

Saturday, August 15, 2009

Spam - and other stuff - on the University of Minnesota Daily's comments board

There's been a kind of backlash in the Twin Cities media lately over the general quality of comments on web sites related to the news. Some examples may be found on the Star-Tribune and the Pioneer Planet as well as our beloved Minnesota Daily.

Joel Kramer, of MinnPost, had a nice article about the policy at his shop, a good one that everyone should emulate.

"MinnPost and the Art of Civil Comment"

A recent onslaught of anonymous attacks has shown up on the Daily site. As an example, I was called a racist by some moron because I complained about Chinese and Arabic spam...

The good folks at the Daily have recently done tootsie roll patrol on the site. [This is what my neph calls cleaning up after his German shepherds.] But I note again this morning that 9/10 comments are spam. The birthers appear not to have visited, however.

Rumors are coming from the Daily office that some sort of new rules for posting will be in effect this Fall. Unsurprisingly, the Daily will probably get this problem fixed a helluva lot faster than the Morrill Hall & Children's Rehab folks operate. Can anyone say conflict-of-interest reform?

Have a nice weekend.

Thursday, August 13, 2009

Penny Wise, but Pound Foolish

Eventually, when the U has managed to alienate enough people, maybe this kind of behavior will stop? Probably not...

From the Strib:


PREFERRED PARKING AT U

Long Time Patron Finds It Unfair

On Saturday, we received notice that three parking lots at the University of Minnesota will be designated preferred parking to the tune of $225 per vehicle for Gopher hockey.

This is outrageous and, frankly, discriminatory. They are telling me that I'm good enough to spend the $1,200 for two season tickets, but not good enough to park in the lot that I have been for the last six years or so. Why? The lot that I park in was doubled in size for football parking last year. It's never filled for hockey.

The university refuses to explain this change in policy. I'm sure that some people will pay this, but it's my fervent hope that the university will find these preferred lots empty.

DAN ONDICH, ROSEMOUNT

Wednesday, August 12, 2009

From the California Stem Cell Report:

The research inquiries at the University of Minnesota involve scientists who worked in Verfaillie's lab or who were affiliated with her. She is now working at Katholieke Universiteit Leuven in Belgium but is still associated with the University of Minnesota. New Scientist once described her as running “one of highest-profile teams in stem-cell biology.”

Here is how Chris Williams of The Associated Press began his story last week on the research investigation,
“The University of Minnesota has launched its third internal investigation in two years into allegations of research misconduct....”
Jeremy Olson of the St. Paul Pioner Press wrote,
“In a familiar pattern, reporters from New Scientist magazine found images in a published study that appeared questionable and alerted U officials.

“The university already has retracted one stem cell study and corrected two others because of concerns raised by New Scientist. Having to launch yet another inquiry is an embarrassment for a university that has been viewed as a global expert in stem cell research....”
Arthur Caplan, director of the Center for Bioethics at the University of Pennsylvania, said that the Minnesota case has implications that go beyond one researcher or institution.

According to reporter Williams,
"'What's unusual here is that you're starting to get other people involved," (Caplan) said. 'It's become a problem of a group, not an individual.'"
Williams continued,
“The Minnesota situation is also unusual, Caplan said, in that its researchers have been getting special scrutiny from New Scientist. He suspects there would be more questions of sloppiness or fraud at other universities if more outsiders were watching.

“There is particular pressure on scientists working in the stem cell field, with its mix of politics, the prestige of breakthroughs and the potential profits from patents.

"'I really can't think of too many areas that are more set up for somebody to cut corners than stem cell work,' he said.”
Peter Aldous and Eugenie Samuel Reich have been investigating the work at the University of Minnesota over several years. Their most recent piece on Aug. 5 said,

“Other stem cell biologists are disturbed that so many problems have been found in papers from a single institution. 'It's pretty discouraging," says Arnold Kriegstein of the University of California, San Francisco.

Tuesday, August 11, 2009

University of Minnesota Daily points out the current conflict of interest situation is "beyond absurd"

From the Daily

A standard failure?


Recent allegations underscore the need to adopt a stronger University ethics policy.


EDITORIAL BOARD

PUBLISHED: 08/11/2009

In an effort to bring transparency to relationships between private industry and medical academia, Sen. Charles Grassley, R-Iowa, launched an investigation into the activities of several prominent researchers, including Dr. David Polly of the University of Minnesota’s Department of Orthopedic Surgery.

According to information gathered by Grassley’s staff, Polly received $1.2 million from leading technology manufacturer Medtronic between 2003 and 2007. Grassley alleges severe conflict of interest breaches and highlights the failures of a medical ethics policy that allowed Polly to operate as primary investigator in a study of Medtronic bone growth technology and to supposedly disclose, contrary to a University conflict review and committee stipulation, sensitive research findings to Medtronic before they were made public.

Under federal regulations , it is the University’s responsibility to manage faculty conflicts of interest.

But Polly claims to have fully complied with the University’s disclosure process, which simply required him to reveal the private financial relationship in excess of $1 million as “in excess of $10,000,” and eventually found Polly’s conflict “manageable.”

Grassley criticized the disclosure limit in a July letter to President Bruininks: “It is unclear to me how [University officials] are able to make proper assessments of research conflicts without considering the level of financial interest ...”

While the Office of General Counsel compiles a response to Grassley’s letter under extended deadline, the University Medical School drags its feet on desperately needed medical ethics reform.

Whatever the University response, that a researcher receiving more than $1 million from related private industry was found to have a “manageable” conflict of interest level is beyond absurd.

To protect the integrity of students, faculty and research, the University must ensure that the new ethics standards are thorough enough to prevent such seemingly clear failures.


Sunday, August 9, 2009

From the Department of How Others See Us...

Although, based on emanations from Morrill Hall and Children's Rehab, you might not believe this, there are indeed serious repercussions for the national reputation of the University of Minnesota from recent sad events.

Examples of which include: faked stem cell research, squabbles over MMPI, foot dragging on conflict-of-interest, administrative game playing in the AHC (my org chart is bigger than yours...), and a general weary negligence in Morrill Hall about salvaging our once proud reputation.
E.g., are those double-dippers still on the payroll? Has ANY disciplinary action ever taken place? Did they give back any money? How did that last translational research proposal fare?

The fish rots from the head?

Time to clean the Aegean stables?


There is little doubt that recent developments are leading to serious erosion of our academic reputation. For an example of how the U of M is perceived by a very credible commentator on things academic, I here re-post Margaret Soltan's piece teeing off on our own David Polly:

August 9th, 2009

David Polly: Like Schatzberg, Biederman, and Nemeroff, An Involuntary COI Reformer.

David Polly couldn’t have imagined, years ago, how his grasping, conflicted, bill-industry-for-each-breath ways would eventually become known, and, as a result of becoming known, spur changes in the health industry.
UD then continues and quotes from the Pioneer-Press

Back in 2005, Dr. David Polly participated in a review of a new technology in spine surgery by an influential nonprofit group.

After he concluded the work, the University of Minnesota expert submitted a bill for some of his time to Fridley-based Medtronic.

Four years later, leaders of the nonprofit group — the Bloomington-based Institute for Clinical Systems, or ICSI — say they wouldn’t have let Polly participate in the review had they known about the billing arrangement. Technology reviews by ICSI are supposed to be impartial, they say, and a Medtronic device was among those being evaluated.

“I was shocked,” said John Sakowski, the chief operating officer at ICSI, who learned of Polly’s bill with the recent release of Polly’s records by Sen. Charles Grassley, R-Iowa.

… ICSI leaders say they probably will change the way they police conflicts of interest because of the Polly episode. In the future, physicians who work with the organization likely will be asked directly whether they are submitting bills to third parties for that work, said Sakowski, the group’s chief operating officer…


Captain Renault: I'm shocked, shocked to find that gambling is going on in here!

[Dr. David Polly bills Medtronic for impartial review...]

From the Pioneer Press:


Doctors and health care industry consulting: Ethicists prescribe reform

University of Minnesota expert billed Medtronic for impartial review

Back in 2005, Dr. David Polly participated in a review of a new technology in spine surgery by an influential nonprofit group.

After he concluded the work, the University of Minnesota expert submitted a bill for some of his time to Fridley-based Medtronic.

Four years later, leaders of the nonprofit group — the Bloomington-based Institute for Clinical Systems, or ICSI — say they wouldn't have let Polly participate in the review had they known about the billing arrangement. Technology reviews by ICSI are supposed to be impartial, they say, and a Medtronic device was among those being evaluated.

"I was shocked," said John Sakowski, the chief operating officer at ICSI, who learned of Polly's bill with the recent release of Polly's records by Sen. Charles Grassley, R-Iowa.

Medical ethicists say they have questions about how both ICSI and Polly acted during the episode, but they conclude that the moral of the story goes to a much broader point: Disclosure requirements throughout the health care industry have been woefully lacking.

"More independent control of financial relations is needed, clear conflict-of-interest rules are needed, and investigators have to receive proper education about conflicts of interest," said Trudo Lemmens, a medical ethicist at the University of Toronto.

Polly worked for 2 1/2 hours at a work group meeting July 26, 2005, according to Grassley's records, and billed Medtronic for $1,250.

In an interview, Polly said he billed Medtronic for the time because the company wanted to learn from him how technology-assessment groups were analyzing data about spine technology under review — artificial discs for use in the lumbar spine.

"The nonprofit made a mistake, although it's a common one," said Dr. Adriane Fugh-Berman, a medical ethicist at Georgetown University. "They asked someone with a financial interest to assess a therapy objectively."

"Being paid by a device company for attending a meeting in which one of its products is being discussed seems to me a clear example of a situation that under standard conflict-of-interest guidelines has to be disclosed," Lemmens said.

"If the not-for-profit organization requested disclosure of 'consulting relations,' it seems to me clear that it expected, back in 2005 or even much earlier, to be informed of the fact that an expert was being paid by a company for attending the meeting in which its products are being discussed," he added.

But Polly said such judgments were not so clear at the time and still are a matter of some debate.

"People can have legitimate differences of opinion on this," he said last week. "I complied with all disclosure requests asked of me."


Friday, August 7, 2009

Hi, Mom:

If you want to explain why you think the discussion on the Daily site should be censored please comment.... Your remarks will not be censored unless they contain profanity or links to porno sites.

Your boy,

Bill
More on Stem Cell problems at U of M

From the Star-Tribune:


Questions raised; U investigating stem cell study

For a third time, the British magazine New Scientist spotted potential problems in a University of Minnesota report. Dr. Jizhen Lin defended his research.

By MAURA LERNER, Star Tribune


A prestigious University of Minnesota research center is under scrutiny again following a magazine report about the possible manipulation of data in several studies on stem cell technology.

University officials confirmed Thursday that they are looking into questions raised by the British magazine New Scientist about research by Dr. Jizhen Lin, a scientist at the university's Stem Cell Institute. The magazine said it found what appeared to be "duplicated and manipulated images" in Lin's published studies dating back to 2001.

Lin defended his research in an interview with the Star Tribune on Thursday, saying he used accepted techniques to illustrate an experiment on the use of stem cells to treat hearing loss. "We are not trying to falsify the data," he said.

It is the third time that disclosures by the magazine have prompted an internal University investigation into research at the Stem Cell Institute.

On Wednesday, the magazine reported that a study published in December by Lin, listing Verfaillie as a coauthor, used what appeared to be duplicate images to illustrate different findings. The magazine said a close examination also raised questions about whether some images had been manipulated or "spliced together."

"After combing through more of Lin's research, we found possible duplications within images in six further papers, published between 2001 and 2007," the magazine reported. It notified the university of its findings in April.

The university issued a statement confirming that it had begun an inquiry.

"When an allegation of misconduct is made, we examine the evidence thoroughly and fairly," the statement said, "taking appropriate action to ensure that our standard of conduct is upheld and that the integrity of the scientific record is protected." Officials said there would be no further comment because the matter is under review.

The New Scientist found similar duplication of images in three previous studies coauthored by Verfaillie, who has since left the university. Verfaillie apologized after two separate university investigations confirmed the problems in her research or found additional ones.

On Thursday, Lin, an assistant professor in the department of otolaryngology, acknowledged that some duplicate images had appeared in his paper. But he said they were not misleading; they were images of the same gene used as a control in multiple experiments. He said the images were used this way to "show what we have observed."

Larry Goldstein, an embryonic stem cell researcher at the University of California, San Diego, said it is rare for such repeated investigations to be connected to one researcher.

"It's still not clear whether they were a case of sloppiness or deliberate alteration," he said. "Scientists are like all other people. Virtually all are fundamentally honest, trying to do a good job. When you investigate, you are going to find deviation."

He said scientific journals are not likely to catch deliberate falsification or errors, because the scientists who review studies are not cops. "Reviewers have to believe that what they were given was honestly put together," he said.

He believes that most research papers would stand up to this kind of scrutiny. At the same time, he said, "there are many fine scientists at the University of Minnesota and my faith in them is unaltered."
Things have been pretty hush-hush at the U with respect to these matters. Perhaps this is not such a good idea? Maybe we should let it all hang out so that everyone is aware that this kind of behavior is unacceptable and that it will not be tolerated?

Thursday, August 6, 2009

Here we go again....


Stem cell researchers at the University of Minnesota are once again under investigation for falsifying data, New Scientist reported this week.


Earlier this year, New Scientist identified at least two potentially manipulated or duplicated images in a 2008 American Journal of Physiology paper coauthored by Jizhen Lin, a researcher in the Department of Otolaryngology in the university's medical school.


The paper reported that stem cells from the inner ears of mice could be differentiated to create neurons and sensory hair cells. Based on their own investigation, New Scientist identified one photograph of a gel that appeared to have duplicated bands spliced into the image, and two other images that seemed identical, though they were meant to represent results for two different genes. Further exploration uncovered possibly duplicated images in six additional papers published by Lin between 2001 and 2007. In April, New Scientist alerted the university to their findings, and an investigation was launched last month.


Last October, a panel at the University of Minnesota ruled that Morayma Reyes, a former PhD student in the lab of stem cell researcher Catherine Verfaillie, had falsified data in a 2001 Blood paper. Blood retracted the paper in March of this year, citing "duplications and other irregularities in multiple figures." This was the second time in two years that Reyes was the subject of such an investigation: In early 2007, New Scientist questioned the validity and originality of the data in a 2002 Nature paper reporting the first adult pluripotent stem cells, and that June, Nature retracted the figures in question. Verfaillie was the corresponding author on both those papers. She was also an author on the 2008 American Journal of Physiology paper with Lin.


Wednesday, August 5, 2009

And then along came Pogie...

Larry Pogemiller has an op-ed in the Strib today:


Naturally, I had to make a comment on the Strib Web-site:

Now, at this late date we hear from Pogemiller?

This is almost comical. Larry, where have you been?

Have you been paying attention for the last couple of years?

Why is it that we haven't heard from you on this until now? Could it be to cover your rear with your constituents so that you could at least say you tried? For shame...

As to the merits of the argument, you've really said nothing new here and nothing that needs a response. It's the money, Larry, we've not got it.

posted by wbgleason on Aug. 4, 09 at 10:34 PM |
32 of 40 people liked this comment.
Calls to mind the old Coasters classic:




Along came Pogie?


"The U's double dipper gets a state appointment!"

Three different people, so far, have called this matter to my attention. One of them used the phrase quoted above. (S)he also commented that the situation was: "unbelievable."

Quotations from Our Leadership

"I think people will think what they want to think," Cerra said, in response to possible criticisms of appointing someone who is under investigation. [Daily: 30 July 2008]

"I think we need to put ourselves in the position of acting according to the highest ethical principles. I believe our people do that now and I believe our people will be doing that in the future as well." President Bruininks (Daily: 6-18-08)

"We will try to piece this together in regard to whether something serious has indeed happened here in regard to so-called double-dipping."

Mark Rotenberg, U of M general counsel

"Obviously, the situation that happened to Francois Sainfort and Julie Jacko has not been a positive one for us," Finnegan said. (Strib, 30 August '08)


Have they been charged, tried or convicted of anything either here or in Minnesota? No? Well that does it, then. They must be guilty. Whatever happened to getting your day in court? [finne001, Aug. 30]


Perhaps Counsel Rotenberg has been too busy with other activities to do his job on this one?

Please see:

The Strib monitors recent developments in the Sainfort/Jacko debacle.

Mentioned in a commentary almost a year old.

Maybe Rotenberg, Finnegan, and Cerra think that if you ignore a problem long enough it will go away, or at least that people will forget about it?

Amazing.

Monday, August 3, 2009

Retweets

on COI Foot Dragging
and the Polly Situation

at the University of Minnesota

I am a big fan of Twitter. Facebook? Not so much.

To demonstrate the usefulness of Twitter, I retweet (RT) posts relevant to current foot-dragging on COI at the U and the Polly situation:

Polly Want a Million (Plus) http://bit.ly/fAN8e "A good chunk of this money went to support marketing, advocacy, and lobbying." #UMN

M. Soltan (GWU English prof) post: "Polly-Acquisitive Disorder" http://bit.ly/gKF4c Set foot in my OR, buster, that’ll cost you $2K! #UMN

RT @garyschwitzer Travel, meals, all in spine surgeon's $4,000-a-day work http://bit.ly/ieMQX {"COI conversation is heating up a bit"} #UMN

Star-Tribune: Travel, meals all in a $4,000 day's work http://bit.ly/8y63e Moore [sic] on #UMN doc Polly...

Amid investigations, Medtronic hires a new top lawyer http://bit.ly/vlgLi #UMN "to help craft new standards of transparency"

Dr. Polly would have been delighted to disclose... http://bit.ly/z6VpS #UMN (but later refused to do so)

"..I would have been delighted to disclose." http://bit.ly/3Mf0Hz #UMN Dr. Polly on MPR Testify tomorrow? Would do things differently.

RT @matthewcw When do we start referring to #UMN med school as "scandal ridden" and will even that be enough to cause change?

Medtronic’s new lawyer to focus on ‘transparency’ - Minneapolis / St. Paul Business Journal: http://bit.ly/3rsYPe #UMN

UD rewrites Jolly Old Saint Nicholas: Jolly Old St. Polly http://bit.ly/gKF4c #UMN

RT @garyschwitzer Surgeon's fees: $2000 for dinner, $900 for conference call. Story: priceless. : Pioneer Press http://bit.ly/8yxEa #UMN

#UMN surgeon's fees face new scrutiny — from Medtronic http://bit.ly/6Gd7M Sounds like investment banker - not like someone in medicine?

Dr. Cerra: "I like short time lines because it promotes focus." http://bit.ly/zLxTA Except for conflict of interest guidelines at #UMN?

Dr. Cerra responds to questions about foot dragging at #UMN on COI and the Polly situation http://bit.ly/z6VpS short video clip

Health Care Renewal: Polly Want a Million (Plus) http://bit.ly/fAN8e #UMN

Do we need a shot clock on conflict of interest policy deliberations? - Schwitzer health news blog http://bit.ly/T9ob7

Infuse Bone Graft Researcher Failed to Tell Senate Committee He was Paid by Medtronic During 2006 Testimony http://bit.ly/a4TSp #UMN

RT @garyschwitzer More conflict of interest issues for #UMN med school to address: The Wall Street Journal reports http://bit.ly/UgWAs

What a Doctor Did That Was Worth $1 Million to Medtronic - Health Blog - WSJ http://bit.ly/hRLFW #UMN

Margaret Soltan - English Prof at GWU - posts on latest COI problems at #UMN http://bit.ly/RKqAm "Along Came Polly" 2nd try on #UMN

#UMN doc spends minute on wake up call to Medtronic official - for free! http://bit.ly/oQEi7 From the WSJ - a wakeup call for U leaders?

Further Consequences of Footdragging - We Make the New York Times http://bit.ly/WyXQl #UMN

Dr. David Polly - On Grassley's Hit List http://bit.ly/z6VpS Could we finally do something about COI at #UMN? What is it going to take?

First, Do No Harm But Only If My Ox Is Being Gored. http://bit.ly/4F95f #UMN likes no harm meme for light rail, medical COI, not so much...

RT @thinkshrink AMSA - #UMN med school has not even responded to COI issues http://bit.ly/yxdLI {?"they have provided material for review."}


Sunday, August 2, 2009

Travel, meals, lobbying


From the Star-Tribune:

Grassley's July 24 letter, sent to U of M President Robert Bruininks, documents hundreds of charges incurred by Polly from 2003 through 2007. In that five-year period, Polly received $1.2 million from Medtronic for consulting, expenses and honoraria.

By 2007, Polly was paid $4,750 a day, or $594 an hour. The pact has a cap of $400,000 a year, which Polly has not exceeded, and an exclusivity clause that prevents him from engaging in product development for other companies.

But in the wake of the controversy, Medtronic said last week that it is taking a "hard look" at its practices for managing consulting relationships.

"We are investigating specific charges for which Dr. Polly billed us, and determining whether or not they fit our standards and policies, and if newly enhanced standards are required," Medtronic spokesman Steve Cragle said in a statement.

He declined to comment about Polly's line-by-line billing "at this time."

Records indicate that Polly contacted Medtronic officials frequently. In 2006, for example, the year that Polly received his most compensation, $358,588, he billed Medtronic on 233 days -- sometimes multiple times in one day.

He billed to check e-mail, sometimes in 5-minute increments. He also billed to make phone calls; in 2006, there were roughly 125 calls.

On April 30, 2005, he charged the company $750 for 90 minutes of "summarizing thoughts and opportunities" after a medical meeting. And on Feb. 12, 2004, he charged the company $350 to update his consulting log.

Even William Hawkins, now the company's chairman and chief executive, shows up in the records on at least three occasions. On July 21, 2006, Hawkins (then chief operating officer) visited the operating room at Fairview-Riverside Medical Center. For that, Polly billed Medtronic $2,000.

In a statement last week, Cragle said that Hawkins frequently makes trips to view surgical procedures involving the company's products. "In this case, [he] was unaware that Medtronic would be billed," Cragle said.

Polly appears to have traveled worldwide to attend medical meetings on the company's dime. In 2006, for example, he took 14 trips to meetings in places such as Japan, Paris and Phoenix, billing $187,313 for travel and preparation.

Several entries indicate that Polly was discussing topics such as the cost-effectiveness of medical devices and "lobbying" members of Congress for better care for the nation's veterans.

On April 15, 2005, he charged $1,000 (a sum later reduced to $500) to meet with U.S. Rep. Betty McCollum, D-Minn., on new technologies to treat veterans injured in the Iraq war.

In September 2005, he participated with the company's public relations team to craft a "media blitz" before a meeting of the North American Spine Society, a premier event in the spine field. The entry states that Polly called patients on Medtronic's behalf and then charged the company $375.

Saturday, August 1, 2009


Dr. Polly Would Have Been Delighted to Disclose?

So he claimed recently on MPR:

Polly, a spine surgeon in the university's Department of Orthopaedic Surgery, received more than $1 million over five years to consult with medical device maker Medtronic, based in Fridley.

Grassley said the doctor never mentioned that link when he testified to Congress in 2006 about a Defense Department program with ties to the company. Polly only said he was speaking on behalf of the American Academy of Orthopaedic Surgeons.

The senator also said in his letter he was 'alarmed' to learn that Polly later billed Medtronic - not the AAOS - for the costs of that trip to Washington, D.C.

But Polly said it didn't appear there was a forum or venue to make such disclosures that day.

"If there had been, certainly I would have been delighted to disclose," he said. [This was in 2006*] "And if I was asked to testify before Congress tomorrow or currently, I would probably do things differently to be a little more clear about who I have financial ties with."

(*June 5, 2009 - From the New York Times:

"Dr. Kuklo, who moved into a $2.1 million home near St. Louis, was not the first departing Walter Reed doctor to get a consulting deal from Medtronic. For instance, it had struck an arrangement with Dr. Kuklo’s former boss, Dr. David W. Polly Jr., when he left the military hospital in 2003.

Dr. Polly is now one of Dr. Kuklo’s staunchest public defenders. Recently, Dr. Polly blocked a reporter’s request that the University of Minnesota, where he now works, release his financial disclosure statement showing how much he made from Medtronic."

___

Delighted to disclose?

(or Driven to Dissemble?)