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August 25, 2009

Margaret Soltan Deflates Fair Market Value, Or Does She?

Margaret Soltan writes an excellent blog, University Diaries, in which she regularly skewers academic and athletic dishonesty. For obvious reasons, the University of Minnesota has a special place on her blog.

For the latest great effort please see this link.

Here are some excerpts:

Dr. Polly and Fair Market Value

David Polly, in his letter of resignation from the board of a medical organization because of the national scandal over his conflicts of interest, writes that "physicians are entitled to fair market value compensation for their time."

Let's think about fair market value for a moment.

It's hard to determine in many cases, and particularly in this one, because, really, what was Medtronic, maker of medical devices, paying the University of Minnesota spine surgeon for? Consulting as a description means everything and nothing. We know, for instance, that Polly charged Medtronic personnel when they simply stood in the same room watching him operate. He charged them for breathing and looking.

We know, more importantly, that he charged Medtronic for Polly's testifying in front of Congress in ways advantageous to Medtronic without Polly telling Congress he was on Medtronic's payroll.

Here are the hard numbers:

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

Round it out to six hundred dollars an hour.

Six hundred dollars an hour. How much of each hour was spent directly whoring for Medtronic? I mean, he probably spent only a few minutes talking about them in front of Congress...

Well, we know that he billed Medtronic at these rates for a Medtronic person simply entering his office. He billed them when he called them to chat, billed them when he did this, when he did that... Again, it's very hard to quantify these things. Does a whore charge for taking off her bra and making small talk? Or is she just charging for the act itself?

It gets even worse, if you can believe it. But I think you get the idea.

Dr. Polly Does the Right Thing and the Strib Allows no Comments

[The above headline is now only partially correct. At approximately 9:30 am this morning - August 25 - comments were enabled on the Strib article. Thanks. To someone.]


The Strib has an article about our favorite orthopedic surgeon, Dr. David Polly. An annotated version is available at The Periodic Table.

For some strange reason, comments are not being allowed on this article. Comments were allowed on President Bruininks opinion piece on Sunday about, er, transparency. Since Dr. Polly's actions are one of the reasons why the U is finally moving on conflict of interest, it is strange no comments are allowed.

And of course the article exemplifies the U's special pleading and use of the straw-man argument, from Dr. Cerra on down.

For example:

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."

No one is arguing that there should be NO physician-industry collaboration. And no one is arguing that physicians are not entitled to fair market value for their services. The conflict of interest conflict is not what this is about and Dr. Polly knows this full well.

His statement that he has disclosed his relationships "whenever asked" is an illustration of the problems we face. How can the University manage his conflict when they don't know the facts about the magnitude of his compensation, because they did not ask the right question.

Put another way, the Hippocratic oath says: First do no harm. Where exactly is it spelled out what that means? Why is Dr. Polly resigning this position? Because it looks bad for him to be in it, given his past/current Medtronic associations, given the amount of money he is taking.

And why does it look bad, Dr. Polly?

As to the Strib allowing no coments on this-

They have been having comment problems, as has the Daily. In fact the Daily's comments section is becoming almost useless due to spam.

The Strib seems to have some internal decision-making mechanism about what sorts of articles will not be allowed to have comments. Given what has gone on at the U and continuing interest, it is hard to imagine why this story was picked to have no comments allowed.

August 22, 2009

Transparency at the U - A really disappointing Op-Ed by President Bruininks

From the Strib:

In an Aug. 16 editorial, the Star Tribune suggested that the University of Minnesota should lead the way nationally in setting standards for the management of conflicts of interest. As the president of the state's only research university, I could not agree more.

In fact, more than a year ago, its robust university-wide conflicts review program underwent a rigorous examination. I recognized that relationships between researchers and industry and the scope of potential conflicts have grown in complexity. This reexamination enables it to consider what more it can do to review and manage these relationships and potential conflicts. Our goal is to be known as a national model of transparency and high standards.



More than a year ago? And what was the result of this rigorous examination? Were the results promulgated to faculty for discussion? Why has no action been taken since this claimed year ago rigorous examination?


"National model of transparency and high standards." Given what has been going on around here for the last several years I am amazed that you can make such a statement. Either you have been oblivious to what is happening here or you have ignored it.

The university's existing conflict management program is one of the earliest in higher education and is still considered to be a strong, effective program.


Oh, really? We okayed Dr. Polly's situation stating that his conflict was "manageable" without the people making the decision realizing that he was making almost a million dollars over the time period in question. All they knew is that he made in excess of $10K.

At the same time, the comprehensive review of the university's conflict of interest management practices and policies is ongoing. A task force focused on existing policies and how they might be revised and broadened to address the relationships and interactions of Medical School faculty with the device and pharmaceutical industries. Since then this work has been extended to cover the breadth of our academic and research operation. The effort, undertaken by an all-university leadership team, includes review of the prevailing practices at other research institutions, consultation with representatives from industry and advice from national organizations. The result will be well worth the time it takes to do a thorough job.

I'm sorry but the above paragraph is adminspeak. Anyone who wants to look into the disgraceful conflict of interest proceedings over the last few years will see this for the smoke screen that it is.

And you rationalize the foot dragging by claiming that when we finally do the right thing, it will be worth it. Will the damage done to our reputation by this foot dragging have been worth it?

University research is essential to the economic health and well-being of our state. It creates jobs, leads to stunning discoveries in medicine, the sciences and the arts, and enhances our education mission. The relationship between university researchers and industry helps advance these discoveries and make them more accessible. However, we all recognize that appropriate safeguards are essential to ensure public confidence in the integrity of the life-changing work done by our faculty.

More adminspeak. Yes we do all recognize "that appropriate safeguards are essential..." Do something about it?


New federal disclosure standards are needed to strengthen efforts like ours. I recently sent a letter of support of Iowa Republican Sen. Charles Grassley's Physician Payments Sunshine Act. Cosponsored by Sens. Amy Klobuchar and Al Franken, the bill provides for important disclosures by drug, device and medical supply manufacturers of payments made to physicians, bringing much needed transparency to these relationships. It will simplify conflict of interest management at major research universities like ours, and will provide for a more comprehensive approach instead of inconsistent reporting systems among the 50 states. We intend our revised program and policies to reflect these proposed legislative changes.

And why don't you mention that Senator Grassley recently sent you a letter? And what, exactly, was in it? And you have to respond by when? The above paragraph is pathetically disingenuous.

Of course our nation's universities and research institutions, talented research faculty, and industry partners must all do our part well. I can assure you that the University of Minnesota is up to the task.

And if that is the case, President Bruininks, why has it taken so long and why has our reputation been tarnished by so many ethically questionable activities?

ROBERT H. BRUININKS, MINNEAPOLIS; PRESIDENT, UNIVERSITY OF MINNESOTA


Progress Toward Our Top Three Goal?

As mentioned below, the most recent release of USNews rankings of national universities does not augur well for our administration's continued use of the ambitious aspirations marketing slogan.

Recall:

"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."

We are now approaching half way through the decade since 2004 and it seems fair to ask: Where do we stand now in making progress toward our administration's stated goal?

Looking back we note USNews ranking of public universities of the BigTen for the last four years:

BigTenRankings.png

The color scheme is: yellow - the same as the previous year, red - worse, green - better

The trend is obvious. The top five BigTen schools seem solidly separated from the bottom five. The last time a school other than Michigan, Wisconsin, Illinois, Penn State or Ohio State broke into the top five was four years ago when Iowa and Purdue managed to tie Ohio State. Currently we are tied with Purdue for the sixth slot, Purdue having improved its ranking from the previous year.

So the likelihood of Minnesota becoming one of the top three public universities in the world by 2014 seems infinitesimally small. We haven't even been able to break into the top half of the Big Ten.

Continuing with this strategic propaganda initiative makes us look naive and foolish. Time to give this nonsense a rest? Time to shoot for the top half of the BigTen - a goal that should be attainable with proper support from the state?

Why should the state increase support for the U, if our administrators wish to set an unrealistic goal? It is time to focus on legitimate priorities without distractions like MoreU Park that are clearly not in our mission. Vanity building projects before legitimate maintenance of education and research buildings is part of the problem. Can you say Follwell, Bell, and Northrop?

How about realistic priorities that all can support?

And please do not claim that people making such arguments are "doubters," Dr. Bruininks.


August 20, 2009

USNews Rankings 2010, Minnesota at 61, tied for sixth in BigTen

From USNews:

Public BigTen Schools

1. Michigan 27 (US News rank)

2. Wisconsin 39
2. Illinois 39

4. Penn State 47

5. Ohio State 53

6. Minnesota 61
6. Purdue 61

8. Indiana 71
8. Iowa 71
8. Michigan State 71

For comparison with last year

26 Michigan
35 Wisconsin
40 Illinois
47 Penn State
56 Ohio State

61 Minnesota

66 Purdue
66 Iowa
71 Indiana
71 Michigan State

The most notable change is the Purdue/Iowa split, with Purdue moving up five slots to be tied with us, and Iowa moving down five to join Indiana and Michigan State.

The obvious question is: Why don't we seek to be one of the best public schools in the BigTen? We are still in the bottom half after several years of hubris from Morrill, e.g.,

"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."

August 19, 2009

Key US Agency Gives OK to Central Corridor Light Rail Line

From the Strib:

The Central Corridor light-rail project remains on track, despite unresolved issues with the University of Minnesota.


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 Transit Administration determined that the $928 million project satisfies environmental and transportation requirements, clearing the way for it to proceed to a final design phase.

"It's a significant milestone in our attempt to secure federal funding for the Central Corridor," said Peter Bell, chairman of the Metropolitan Council. "For the past four months, this is what the project's focus has been. It feels very good."

The council is the lead agency for planning, designing and constructing the line, and for receiving local, state and federal funds to pay for it.

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. Eventually, federal funds will pay for about half of the project if its final design is approved in about a year.

The route would link the downtowns and State Capitol complex via Washington and University Avenues, and the tracks would go straight through the heart of the University of Minnesota's Minneapolis campus, near several buildings with super-sensitive laboratory equipment.

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."

The university and the Metropolitan Council have been discussing vibrations, electromagnetic interference and other impacts from the light rail trains for the past several months. 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. "I plan to work with the U on resolving their legitimate issues" as the project proceeds, Bell said.

The next step will be for the Met Council to present its final design for the project to federal officials in October. It is anticipated that review and approval will likely take nearly a year. Bell said that the council also will file requests that would allow some construction to begin on the line in 2010, even before federal grants are awarded later in the year. The line would include 15 new stations, would link with the Hiawatha light-rail line and the Northstar commuter rail line in downtown Minneapolis, and would open in 2014.

It is interesting that Counsel Rotenberg is able to take vacation in the midst of all this excitement. Presumably his response to Senatory Grassley on another matter is under control, since he had to ask for a delay in order to complete the task.

Meanwhile, in reading the record of decision, it is not clear that the university has a lot of room to maneuver although the implied threat of not releasing the necessary land for the project would make for an interesting confrontation not likely to endear the university to politicians or citizens. But they have made that mistake often in the past.

It appears that the Central Corridor light rail is a go...

From Jessica Hill at the Met Council:

We got it everyone! We got the Record of Decision (ROD) from the FTA! This means the Central Corridor Light Rail project is a go!


See Met Council web site for Record of Decision and many other downloadables...


There's lots of work to do at the U - let's get busy!

U of M Bioethicist Carl Elliot quoted in NYT on Medical Ghostwriting

"How long does it have to go on before it actually is stopped? One way to stop it would be if the actual authors were punished in some way," said Dr. Carl Elliott, a professor at the Center for Bioethics of the University of Minnesota. "But the academics who are complicit in it all never seem to be punished at all."

From the NYT


A growing body of evidence suggests that doctors at some of the nation's top medical schools have been attaching their names and lending their reputations to scientific papers that were drafted by ghostwriters working for drug companies -- articles that were carefully calibrated to help the manufacturers sell more products.

Experts in medical ethics condemn this practice as a breach of the public trust. Yet many universities have been slow to recognize the extent of the problem, to adopt new ethical rules or to hold faculty members to account.

Those universities may not have much longer to get their houses in order before they find themselves in trouble with Washington.

With a letter last week, a senator who helps oversee public funding for medical research signaled that he was running out of patience with the practice of ghostwriting. Senator Charles E. Grassley, an Iowa Republican who has led a long-running investigation of conflicts of interest in medicine, is starting to put pressure on the National Institutes of Health to crack down on the practice.

That is significant because the N.I.H., a federal agency in Bethesda, Md., underwrites much of the country's medical research. Many of the nation's top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines on the universities.

The full scope of the ghostwriting problem is still unclear, but recent revelations suggest that the practice is widespread.
Dozens of medical education companies across the country draft scientific papers at the behest of drug makers. And placing such papers in medical journals has become a fundamental marketing practice for most of the large pharmaceutical companies.

"Just three days ago, I got a request to be the author of a ghostwritten article about the effectiveness of a cholesterol-lowering drug," Dr. James H. Stein, professor of cardiology at the University of Wisconsin School of Medicine, said this month. "This happens all the time." He declined to attach his name to the paper.

Allegations of industry-sponsored ghostwriting date back at least a decade, to scientific articles about fen-phen,
the diet drug combination that was taken off the market in 1997 amid concerns that it could cause heart-valve damage. But evidence of the breadth of the practice has come to light only gradually, most recently in documents released in litigation over menopause drugs made by Wyeth.

The documents offer a look at the inner workings of DesignWrite, a medical writing company hired by Wyeth to prepare an estimated 60 articles favorable to its hormone drugs. In one publication plan, for example, DesignWrite wrote that the goal of the Wyeth articles was to de-emphasize the risk of breast cancer associated with hormone drugs, promote the drugs as beneficial and blunt competing drugs. The articles were published in medical journals between 1998 and 2005 -- continuing even though a big federal study was suspended in 2002 after researchers found that menopausal women who took certain hormones had an increased risk of invasive breast cancer and heart disease.

Some of the authors of the Wyeth hormone articles played significant roles in the work, while others made minor changes to drafts that were prepared for them, the documents show. But, in the main, the articles did not disclose that they had been drafted by outside writers paid to advance the drug company's views.

Many universities have been slow to react to evidence about the extent of the practice. In December, for example, Mr. Grassley released documents indicating that DesignWrite had drafted an article that was published under the name of a gynecology professor at New York University School of Medicine.

Eight months later, a spokeswoman said the school had not looked into the matter.

"If we had received a complaint, we would have investigated," said Deborah Bohren, the vice president for public affairs at New York University Langone Medical Center. "But we have not received a complaint."

She added N.Y.U. never condoned ghostwriting and was now drafting a written policy to that effect. Faculty members, however, are responsible for the integrity of their own work, she said.

But bioethicists said that medical schools must take responsibility for faculty members whose publications do not explicitly acknowledge the work of writers receiving industry support. Such subsidized articles allow pharmaceutical companies to use the imprimatur of respected academics -- and by extension, the stature of their institutions -- to increase sales of certain drugs, ultimately skewing patient care, they said.

"To blow this off is not acceptable,"
said Dr. Ross McKinney, the director of the Trent Center for Bioethics at Duke University Medical Center. Duke has a policy that prohibits ghostwriting and advises faculty to keep records of their participation in preparing scientific articles.

DesignWrite scoured the scientific literature on hormone therapy for the article, she said. "I would never undertake this without some help," said Dr. Warren, who is the Wyeth-Ayers Professor of Women's Health at Columbia. "It's too much work. I am not getting paid for it."

A new policy at Columbia took effect in January. It prohibits medical school faculty, trainees and students from being authors or co-authors of articles written by employees of commercial entities if the author's name or Columbia title is used without substantive contribution. The policy, which does not retroactively cover articles like Dr. Warren's, requires any article written with a for-profit company to include full disclosure of the role of each author, as well as any other industry contribution.

But Dr. Elliott, the bioethicist, said universities should go further than mere disclosure, prohibiting faculty members from working with industry-sponsored writers. Policies asking only for disclosure "allow pharmaceutical companies to launder their marketing messages," he said.


August 18, 2009

EFS at UMN?

EFS.gif

Actually, for EFS, it is a couple of years...

August 16, 2009

We make both local papers this Sunday - for different reasons...

See story immediately below for editorial in Strib calling for leadership [sic] at U of M on COI stuff..

Meanwhile, across the river, the Pioneer Press lays out possible economic hardships in the glorious House That Bob Built.

A retweet:

wbgleason UD will let the citizens of MN do the talking on the subject of The House That Bob Built and its money problems. http://bit.ly/13zNJU #UMN

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

Gen-George-Patton-1945-Vienna.jpg


Lead, follow, or get the hell out of the way...


From the Strib:


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.


And yet, more than a year ago, we saw statements like this from Morrill Hall:

"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. See: "Iowa Does the Right Thing on COI - They started in January of this year." 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 came from Children's Rehab:


"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?

OnTheWaterfront1.jpg

"I could have been a contender."

(Not any more...)

August 13, 2009

Want to leave comments? Do it on Minnpost...

I've gradually been withdrawing from making comments on the Minnesota Daily's website. Mostly because folks there don't seem to actually be interested in discussing the content of Daily articles. Recently I was called a racist after complaining about Chinese and Arabic spam. Also Twitter is making the site obsolete, but that is a matter for another post.

Meanwhile, I've pretty much decided to restrict any comments I have to MinnPost, the Strib, or MPR. MPR has an opportunity to be a player in Twin Cities news coverage and they seem to be keeping a tighter rein on comments posted. I am not happy about stopping comments on the Daily site, since I'd hoped that some sort of reasonable discussion could be held there. I have enormous respect for Daily people, because they have had to work - over the last few years - with an administration that has a strong tendency to stonewalling.

Hopefully the Daily will come to its senses over the commenting issue. They used to require registration and I suggest that they return to that practice. People should also be required to post under their own names. Right now MinnPost has the best handle on comments and their moderation. The Daily should adopt the policies of MinnPost in this area.

Recently DJ Leary discontinued his blog on the Strib because of the unmoderated nature of the comments, some of which are pure garbage. I will still use the Strib occasionally because I am not as pessimistic as DJ about the general level of discussion. If you search the comments based on the number of "votes" usually the good comments are at the top and the general judgment about them seems to be reasonable. The whackos we will always have with us. Fortunately, their comments do seem to gravitate to the bottom.

Joel Kramer, an old time Twin Cities newspaper guy, put it very well in a recent article:


MinnPost and the art of civil comment

By Joel Kramer | Published Thu, Aug 13 2009 8:48 am

A couple of weeks ago, a pair of posts by David Brauer here and here about the almost-anything-goes commenting at startribune.com attracted more than 50 comments about comments.

I was pleasantly surprised that so many of the commenters stated their conclusion that MinnPost's policy produced the most civil comment threads of all local media. My favorite was by Bill Gleason, who wrote: "Having left a lot of comments on a lot of sites -- I have to reluctantly conclude that MinnPost's rules are the best...."

MinnPost requires commenters to register with their real names, and all comments are screened by volunteer moderators before being posted.

MinnPost's commenters, for the most part, police themselves. Of 17,466 comments submitted from launch less than two years ago through yesterday, only 968 -- less than 6% -- have been rejected.

But even a good policy can be improved upon, and we see a need for a tweak. We already reject comments for name-calling and inflammatory speech, for self-promoting, and for irrelevance to the topic, but we're seeing an uncivil pattern among some comments that we have been accepting: snideness, or gratuitous insult of the intelligence or character of fellow commenters and others.

From now on, we will reject comments that refer to other people's comments (or the commenters themselves) as vapid, nonsensical and so on.

The vast majority of MinnPost's commenters do a great job of adding value to our stories with facts, personal experiences and substantive arguments. The few who don't will find more of their submissions rejected.

If you think that my position here is mindless, or I'm some kind of nut or petty dictator, you're entitled to your opinion, of course. But don't bother submitting a comment expressing it, because it won't be published here.

In the old days, people of integrity made decisions and stood by them. We need to see more of this behavior today. Thanks, Joel.

August 12, 2009

Psst... Wanna park that car? For $1000 I can make that possible

Oh, and that is in addition to the $140 for the parking ticket(s)

You wanna tailgate, students? Does Uncle Bob have a deal for you!

From the Daily:


Students hoping to tailgate at nearby parking lots for Gophers football games this season will have to put in a $1,000 donation if they want to purchase the $140 parking pass.

"A lot of our premium season ticket holders have parking passes there because of the donations they've made to the stadium," Brent Holck, Minnesota's athletic ticket manager, said. "I assume the majority of students don't want to pay that."

While he is unsure of whether or not students would be able and willing to donate the $1,000, Holck said it was good to give them the option.

"If they do have that money it might be of interest to them to be close to the stadium and have a tailgate lot that's close to the stadium," Holck said.

"As far as those donation levels, those will probably stay here for at least a few years but they may go up depending on the demand," Holck said.

How touching that our students will be allowed to tailgate with the big boys and girls once they cross Bob's palm with (a lot of) silver.

But then we all know that students are the first priority at this University, don't we?

"People will begin to talk about the University of Minnesota in a world conversation"

Stop the Bleeding? Or, Don't Worry, Be Happy

What's it going to be?

I've got a lot of inflammatory material on the left side of my other blog: The Periodic Table. It is pretty depressing what has been going on here under the current administration.

One of the more interesting boasts to come out of Morrill Hall is:

[Provost Tom] Sullivan said the goal's value for current students is clear. It'll be even more impressive to have the school listed on your résumé, he said.

"People will begin to talk about the University of Minnesota in a world conversation, in China, in India, all of the places that are emerging as great markets," Sullivan said. "The University of Minnesota's name will be in that small group of universities."

Well, Tom, it is starting to come true.

We're internationally talked about (see New Scientist) but unfortunately not for good reasons. Here it is stem cell fraud.

"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.

And we've made the NYT, the Wall Street Journal, Canadian papers and God knows what else - for conflict of interest questions.

And the double dippers are still of wide interest - witness continuing hits on my blog(s).

I could go on, but it is too depressing.

Time for a change?

Provost Sullivan?

President Bruininks?

Anyone?

August 11, 2009

Peter Bell Responds to Tim Mulcahy About LRT

Breslin.jpg

From the MPR website:


Met Council has gone the extra mile
to address U's concerns

by Peter Bell

In recent public statements, University of Minnesota officials have suggested that the Metropolitan Council has been indifferent to the university's concerns about the possible impact of the Central Corridor light rail transit (LRT) line on its research facilities. That simply is not true. Over the last year, we've held countless meetings with university officials, employed special consultants and devoted thousands of staff hours to the issues raised by the university.

We have developed and committed to implementing a plan that will effectively mitigate the noise, vibration and electromagnetic impacts of LRT on sensitive university research equipment located along Washington Ave. in Minneapolis.

Rather than harm the university, we believe the $914 million Central Corridor project will bring enormous benefits. Our plan will remove more than 20,000 vehicles a day from Washington Ave. and create a transit/pedestrian mall that will be the envy of campuses across the nation.

It will unite the East Bank and West Bank campuses as never before. It will reduce the need for costly parking structures on campus. And it will provide faculty, staff and students with access to first-class transportation worth millions of dollars a year.

In our protracted discussions, university representatives initially insisted that the Met Council provide mitigation for vibration and electromagnetic impacts for both current and future lab equipment placed in buildings along Washington Ave. This would require us to cover costs into the indefinite future.

To keep this project on track, the Met Council must stay within budget and comply with federal cost-effectiveness requirements. Meeting the university's demands would make it very difficult to do either -- and it would limit the resources available to meet other legitimate needs along the 11-mile corridor.

The Met Council already has committed more than $27 million to mitigate LRT impacts at the university, including $11 million for the Washington Ave. transit/pedestrian mall and $7.3 million to address vibration and electromagnetic issues.

Our staff and consultants believe these measures will allow the U's current research equipment to function as well in the future as it does today.

In fact, in many locations the project will significantly improve research conditions along Washington Ave. -- by removing thousands of heavy trucks and reducing the number of buses that now rumble along that street every day.

University Vice President Tim Mulcahy has suggested the University of Washington as a model for us to follow. The LRT project at the University of Washington is different in many important ways. That project requires the use of a tunnel-boring machine that will drill LRT tunnels underneath sensitive University of Washington labs, with trains eventually operating in the tubes.

Construction will last for several years in an area of campus not previously affected by vibration sources like those currently existing on Washington Ave.

Recently, Mulcahy released a report of a faculty committee that examined the impact of LRT on university research facilities. Strangely, the committee completed its analysis without even talking to the experts in our Central Corridor project office or to our consultants, relying only on incomplete written information from their work.

The Central Corridor LRT line is a vital element in the Met Council's plan to develop a network of bus and rail transitways to serve our region. It offers an exciting opportunity to build upon the success of the Hiawatha line, providing improved access to employment, economic and educational opportunities along the corridor and beyond.

We urge the university to join us in working to develop a cost-effective mitigation strategy that will allow this vital transit improvement project to stay on track as we work against very real time and budget contraints.

-----

Peter Bell is chair of the Metropolitan Council, the lead agency for the Central Corridor LRT Project.

So, ah, who's being reasonable here? Tim?

August 10, 2009

Gag Me With A Stick - The Lake Wobegon Schtick, Again.

Just when you think that maybe someone at the U was going to be reasonable:

(From MPR)

Since when is 'average' good enough for the U? by Tim Mulcahy August 10, 2009

So we start off with the mother of all straw men arguments. No one ever said that the U should aim for average or for mediocrity. Some of us have called for the U to set a goal of being one of the best schools in the Big Ten - we've been called "doubters" by this administration.

Like the children of Lake Wobegon, the University of Minnesota has never settled for being average. Ever since its founding in 1851, it has strived [sic] to be exceptional.

That's a bad word to use around here, Tim. I know that you are new around here but the U med school was officially declared exceptional by NIH a few years ago, but that is another story...

The pending arrival of the Central Corridor Light Rail Transit line across campus, however, gives us great concern about our ability to carry on our traditions of excellence, because those responsible for designing the line seem to feel that "average" should be good enough for the university, and for Minnesota.


Traditions of excellence? Could we please get real here, Tim. I am not crazy about rankings but even the U's own data collection office casts doubt on that claim.

The Central Corridor line is an important development for our community and for the university. Students, staff and faculty at the U constitute one of Metro Transit's largest user groups, and we strongly support a strengthened metropolitan area transit system that includes the line.

And motherhood, and apple pie, and double-dippers, and a strong conflict of interest policy?

What gives us pause is the threat it poses to our critical research mission, unless appropriate measures are taken to protect our facilities and equipment from harmful vibrations and electromagnetic interference (EMI).

Much of our research takes place in labs located along and near Washington Ave., where the light rail trains will run. The 195-foot trains, each weighing 265,000 pounds, put at risk research programs in as many as 80 labs in 17 buildings -- some located only 30 feet away from the tracks.

OK, now let's get real here. The lab that is 30 feet away can be moved and in fact plans are made to do just that if NIH funding can be found.


Light rail construction and operation are far from "light" in terms of noise, vibration and EMI. While these phenomena exist and are accounted for in the current environment, the presence of a huge, multi-year construction site and the constant passage of massive trains each day present much bigger problems.

And they are problems the U and the Metropolitan Council, the agency responsible for the project, need to resolve before construction begins.

And perhaps it would have helped if, instead of making blanket and expensive demands that things stay as they are, that the financial consequences of mitigation - to the U - be spelled out. Perhaps you might get a more sympathetic hearing?

We have explained our concerns to the Metropolitan Council on many occasions, and in at least four official filings over the last 14 months. The lack of progress has been discouraging and worrisome, particularly because the stakes are so high.
And exactly whose feet should this be laid at? Your boss fought long and hard, long after the battle was over, to stay the Washington Avenue route. The intransigence of the U in this matter did not exactly win friends and influence legislators.
The response from the project management thus far has been that the project will mitigate vibration and EMI to the present tolerance of the U's research equipment -- the "average" between current conditions and the outside tolerance levels of the equipment -- and that should be sufficient.

"Average" is not acceptable for the U, and certainly not in this situation. If the project proceeds and the proposed "average" mitigation does not meet our research needs, it will be too late.

Why don't you look very hard at what Peter Bell has said about mitigation and hold him to it? There have been some pretty strong assurances made.

Research in affected labs will have to be suspended, and in many cases funding -- and the world-class faculty it supports -- will be lost.

Proceeding before these issues are resolved would be a risky, unnecessary gamble that would place the public's enormous investment in the university in jeopardy.

This past year, U researchers were awarded nearly $700 million in competitive grants and contracts. Research currently taking place in our labs holds the promise of curing some of mankind's most serious illnesses and solving some of the world's most difficult problems.

Sorry, but this really smacks of special pleading. There are how many R1 research institutions that could say the same thing? And with recent scandals in the stem cell area and our poor record at conflict-of-interest policy perhaps as VP for research there is something you could do about this to strengthen our credibility in making such claims as above to the public?


Research at the U is also vitally important to the economy of the region and state. Our research grants directly support more than 22,000 jobs. Thousands of students, many of whom will work for Minnesota companies upon graduation, are trained in our research labs.

The good news is that we know that these sorts of challenges have been overcome elsewhere. The University of Washington in Seattle asked that light rail not harm its research work, requesting engineering that guarantees the rail will not increase vibration and EMI beyond the conditions existing before operation of the line, as well as the installation of monitoring systems to ensure that operation of the line remains within these standards.


And you can just guess what the response of Peter is going to be - Wash U. To continue to ignore this alternative and not explain the differences (if there are any) is disingenuous.

These concerns were not only considered reasonable and legitimate by the Seattle rail project leadership, the project accepted the terms stipulated by the university, and agreed to provide all necessary mitigation to insure that the project "does no harm" to the current environmental conditions along the rail line's path through campus.

Again, a really bad choice of phrases - "do no harm." This comes from the Hippocratic oath. We have a few problems in that area right now in the med school. Is "do no harm" only something that gets worried about north of and including Washington Avenue?

Garrison Keillor once said, "Sometimes you have to look reality in the eye, and deny it." We at the U hope that the Metropolitan Council and the Central Corridor management will not follow that advice.

This is called, in chess parlance, the Lake Wobegon gambit. So tired, so old, so inappropriate.

We have work to do, Tim. Let's get on with it.


-----

Tim Mulcahy is vice president for research at the University of Minnesota. Coming Tuesday: The Metropolitan Council's perspective on the issue.

August 9, 2009

Eleventh in the Big Ten? Forbes Latest Rankings

From Forbes College Rankings:

Northwestern - #17

University of Illinois - #132

University of Michigan - #200

Indiana University - #266

Penn State University - #324

Michigan State University - #341

Ohio State University - #361

Univerity of Wisconsin - #415

University of Iowa - #430

Purdue University - #507

University of Minnesota - #543


Fortunately, our administration believes in stature and not rankings. Also we have ambitious aspirations to be one of the top three public research universities in the world [sic].

Perhaps it would be a good idea to try to be competitive in the Big Ten?

The Strib Makes a Business Decision - To Whose Benefit?

Recently Tom SenGupta had his monthly meeting round the pot-bellied stove. The topic was the future of newspapers and those attending were representative of journalism in general - large paper, small papers, MPR, etc.

The general consensus is that papers are - surprise, surprise - in deep doo-doo and that the main problem is lack of revenue. If you give it away, who will pay for it?

People like Maura Lerner, Jeremy Olson, Dom Papatolla, Nick Coleman, add your own name to the pantheon, cannot continue to do the work they do unless they have a job... And who will pay? We kicked around MPR as the most likely candidate now, although I know this is a dicey propostion. We also kicked around the idea of public funding along the lines of the BBC.

Ducks...

Today the Strib published an article in the Sunday paper that is not available on the web. Apparently this is an effort to force people to buy the paper in order to read the article. I thought about transcribing it and putting it up, but have decide not to - out of sympathy for the ink-stained wretches. But how is someone who didn't buy the paper already going to know about the article so that they can go out and buy it? This doesn't seem like a very good strategy to me, but I'd be happy to be set straight if I am wrong.

Full disclosure: I am a daily subscriber to the Strib. I read it on the web, FIRST, in the morning. But then look at the print version. I never fail to find something interesting/useful in the print vesion that I would have missed by only looking at the web version.

Nevertheless, Maura Lerner has an incredibly important article about shennanigans at the U. I don't think it will get as much attention as it warrants because of this business strategy.

My colleague at the U. Gary Schwitzer, has a post up on the matter which I re-post:


Murky mess for U of Minnesota with MMPI conflict of interest issues
By Gary Schwitzer on August 9, 2009 9:51 AM | 2 Comments

Who hasn't heard of the MMPI test? Used to assess the "emotional stability of millions of people," according to the Star Tribune, the Minnesota Multiphasic Personality Inventory test is now in the crosshairs of


In an article for which I can't offer a link because the Star Tribune published it as one of its "only in Sunday's paper" articles, Maura Lerner reports:

"The 70-year-old test has undergone a dramatic makover recently, sparking a bitter feud among its leading scholars. The debate, which started in professional journals, has boiled over into courtrooms and triggered at least two internal investigations at the university.


...But critics say the changes...damaged the tests's credibility and backfired on some patients. ...

University investigators found nothing inappropriate about the MMPI changes. But they did fault the University of Minnesota Press for relying on an advisory board that consisted entirely of two scientists...who co-wrote the new test and stand to profit from its sales."

The well-detailed, enterprise story suggests a murky mess over the MMPI in psychology and in the University of Minnesota - where murky messes seem to be increasingly common these days. Buy the paper and read for yourself.



From the comments section:


Richard Rumer, Ph.D. | August 9, 2009 1:39 PM | Reply

The Star-Tribune article you mentioned was noted in a Psychology-Law Discussion group, so when I went looking for the source article I found only a teaser. Is this the common practice of this newspaper not to publish certain articles on the Web? From afar, it has the appearance of the newspaper pulling its punches.

Gary Schwitzer | August 9, 2009 1:58 PM | Reply

I'm not here to defend Star Tribune editorial or business practices by any means.

But this is clearly a business decision to help keep the old dead-tree version of their newspaper alive by saving some premium content for the print version only.

Given the news industry economy, I can't argue with that.

It does, however, make your searching from afar more difficult. Almost like the pre-Internet days again. Remember when?

August 7, 2009

Wow, Pat Reusse nails it - who would have thought!

I'm not usually a fan of sportswriting. Something about sycophantic drool and the Sidnification of it all bothers me.

But Pat Reuse has nailed it in this wonderful piece:

>I've worked for a daily newspaper in the Twin Cities for the past four decades. Whether in St. Paul or now Minneapolis, we monitored the content that was attached to our names.

There was a dignity to the pursuit of news and an ethical threshold that had to be reached in expressing opinion. Certainly, outsiders often questioned the direction of that pursuit, and the threshold might not have been difficult to reach as many people desired.

For sure, you couldn't make up out of whole cloth a collection of lies, or say anything about anyone you choose, and do so under the banner of the St. Paul Dispatch, the St. Paul Pioneer Press and the Minneapolis Star Tribune.

This included the time-honored letters to the editor. These were read and edited by a trained journalist, and the addresses were checked before appearing in the newspaper.

I was reminded again on Friday morning of how far we have fallen in recent years, what with the financial crisis in the newspaper business and the desperate attempts to find a way to make money with websites.

David Brauer, the media reporter for minnpost.com, recently offered a couple of articles on the willingness of newspapers to allow readers to make anonymous comments on nearly all articles posted on their websites. We had Brauer on the morning show a couple of weeks ago to talk about the issue.

My understanding for the motive is that posting and reading comments gets readers to stay on the site for a longer period of time
- and the longer the average stay, the better the chance to convince advertisers that there's potential in advertising at sites such as startibune.com.

We have paid a tremendous price when it comes to dignity, ethics and standing behind content while taking this dubious step ... when was it, four, five years ago?

Behind the dream of helping on-line ad sales, the people making the decision no doubt comforted themselves with the thought that this would give the public a chance to offer insight or participate in a reasoned debate on the subject at hand, and to do so with immediacy.

There were major flaws in this, including the following:

A) The people posting comments could so anonymously, unlike those folks who penned letters to the editor for the previous 150 years of daily newspapering in Minnesota.

B) In an era of newspaper cutbacks, there was no manpower provided to monitor comments and to delete those that went beyond the limits of decency. My observation is that the monitoring actually has lessened as the comment sections have become more popular.

C) Most normally functioning have better things to do with their lives than to come up with a Web name, and then navigate to a site, in order to engage in a diatribe against Nick Punto, or to suggest that Barack Obama is purposely ruining America because he's a secret Muslim and wasn't born in this country anyway.

As a long-time sports columnist in the Twin Cities, there was no requirement for a comment section for me to attract negative reaction. Letter writers and then e-mailers have been besmirching my opinions, knowledge of the sports topics and girth since the day I became a columnist.

That was on Feb. 5, 1979, for the afternoon St. Paul Dispatch. And as Frank Howard, the coaching legend at Clemson and then retired, said when I called for an interview before the 1985 Independence Bowl:

"St. Paul DISS-Patch ... does that paper get out of the city limits, boy?''

To me, I enjoy getting folks worked up. It's part of the job. And as for the fat part, geeze, that shocks me every time that someone would suggest that I have a problem with my weight.

Keep those coming. I could care less. But when the hand grenades are aimed at the bystanders, I get nauseated over what has happened to our standards for content.

On Thursday night, there was a short story posted that said William Pohlad was going to be a partner in the start of a film-making studio. He had been successful in this field since producing the Oscar-winning "Brokeback Mountain.''

William is the youngest of the late Carl Pohlad's sons. Jim and Bob are his brothers. Jim has taken Carl's place as the ultimate authority with the Twins.

So, there were a couple of quotes concerning the Twins, and then came this post from someone using the name "jmlandry'':

POHLAD'S Are Scum of the Earth!!!!

"Free stadiums, tax benefits, values of their DT properties skyrocket as they get their free stadium. At the season opener, all of the Pohlad's came out on the field, everyone cheered and I almost threw up. Why are these people honored, what have they done. NOTHING! Silver spoon in their mouth, government scam contracts and preferential treatment all the way to bank. I hope the Pohlad's end up in Siberia where they belong. A anthema to Capitalism. They are the worst type of scum suckers! hope their movies fail and they go bankrupt.''

Nut jobs like this have done more than highjack newspapers' website. They have stolen our dignity. In the case of startribune.com, they have stolen the heritage of the newspapers I grew up reading as a kid on the Minnesota prairie.

Idiots that don't know the difference between a plural and a possessive are allowed to bark "free stadium'' when the Pohlads will be on the hook for more than $200 million when Target Field opens next spring.

Idiots that throw the word "scum'' at the family of a man who started with nothing and worked his way to a billionaire ... at a family that gives millions upon millions to charity.

The idiot "jmlandry'' offered the comment under the innocuous story on Bill Pohlad's film studio before 10 p.m. on Thursday. It still was there at midafternoon on Friday.

If we can't have dignity and heritage at my favorite newspaper, how about having enough shame to monitor the bile?

Right on, fat Pat. You have my undying respect. Bill

Stem Cells? Stop me if you've heard this before...

Maura Lerner has another excellent article about the latest scandal at the Lake Wobegon Medical School in today's Star-Tribune.

I've got a version of the article with added emphasis on the other site, as well as a remark or two.

The comments are starting to accumulate on Ms. Lerner's article. They're not pretty. Some examples:

"These are very serious charges, and if true, these two are frauds or incompetent. Independent reproducibility by other competent scientists is a fundamental aspect of research. The fact the "New Scientist" won't let this go, and given the prior history of one of the authors of the articles tells me there may be something very fishy here. As an University of MN alumni, I hope these were honest mistakes. Desperation may be the reason why if they in fact did fabricate or alter data. There is lots of grant money available for stem cell research and the competition for the money is brutal."

"If these allegations are found to be true, it's time to clean house. Anyone found to be falsifying data, pictures or whatever should be fired immediately. The fact that these problems keep happening suggests there is some problem with oversight at the U. When the original problems were found, these researchers should have been put on probation and had all their work checked for accuracy by independent panels prior to being released. If these new fraud allegations are true, the Stem Cell Institute may be finished as a reputable scientific organization."

"I work at the U in the biological sciences field. This is completely unacceptable. Anyone can look at my notebooks, I stand behind everything I have written over the last 20 years. Which is not much, relatively speaking, but that is the deal, I could have jammed duplicate information into a second publication, added a little twist to the title, and gotten a second publication on my CV. But it would not have added anything to the body of information. Don't publish unless it is new, useful information. And don't publish until you are sure that your data are legit----that you repeated your results. And if the information is really significant, have someone else repeat the experiment to make doubly sure that you have what you think you have. This makes me mad as it reflect on the entire U and me."

And the beat goes on...

I suggest that perhaps a new set of administrators for the U of M AHC and medical school is perhaps in order? The current occupants have been there for a loonnggg time and yet these problems persist.

Business as usual is no longer acceptable.

August 5, 2009

Oh No, Not Again! New Stem Cell Problems at University of Minnesota

Screenshot-1.jpg

From the New Scientist:


LIGHTNING never strikes again in the same place? Tell that to the University of Minnesota in Minneapolis, which has launched yet another inquiry into research at its Stem Cell Institute after New Scientist raised further concerns about papers that seem to contain duplicated and manipulated images.

Two previous inquiries have led to three papers being corrected, one being retracted, and a finding of misconduct against Morayma Reyes, formerly a PhD student at Minnesota. In October 2008, an expert panel ruled that Reyes falsified images in a 2001 paper in Blood (vol 98, p 2615), describing a versatile type of stem cell from human bone marrow (New Scientist, 11 October 2008, p 8).

LIGHTNING never strikes again in the same place? Tell that to the University of Minnesota in Minneapolis, which has launched yet another inquiry into research at its Stem Cell Institute after New Scientist raised further concerns about papers that seem to contain duplicated and manipulated images.

Two previous inquiries have led to three papers being corrected, one being retracted, and a finding of misconduct against Morayma Reyes, formerly a PhD student at Minnesota. In October 2008, an expert panel ruled that Reyes falsified images in a 2001 paper in Blood (vol 98, p 2615), describing a versatile type of stem cell from human bone marrow (New Scientist, 11 October 2008, p 8).

Reyes, who is now at the University of Washington in Seattle, protested her innocence, blaming "inexperience, poor training and lack of clear standards about digital image handling". She also argued that she followed standards for image processing that were common at Minnesota at the time. So New Scientist decided to look more closely at other papers co-authored by the Stem Cell Institute's former director, Catherine Verfaillie, in whose lab Reyes worked.

In doing so, we stumbled across problems in the lab of another researcher affiliated with the Stem Cell Institute, Jizhen Lin, who published a paper including Verfaillie among the authors in December 2008 (American Journal of Physiology - Cell Physiology, DOI: 10.1152/ajpcell.00324.2008).

This paper explores how stem cells from the inner ears of lab mice can give rise to neurons and specialised "hair cells" that detect sound waves. The question is whether images of gels documenting the activity of various genes have been spliced together, and whether some bands on the gels have been duplicated. In one case, an entire gel appears to have been used twice to describe results for different genes (see images).

In April, New Scientist told the university of our concerns about Lin's work.The university took the decision to begin an inquiry in mid-July, but it has not clarified which papers will be covered. Lin declined to comment on the concerns about his work while the inquiry is under way.

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. Given the pressure on scientists in such competitive fields, he wonders what might emerge at other research centres if their publications were subjected to similarly close scrutiny. "It raises serious issues about how widespread this could be," he says.


Two Year COI Foot Dragging - Chickens Coming Home to Roost?

From the Daily:

U surgeon received $1.2 million from Medtronic, a relationship he didn't fully disclose to a Senate committee.

The University of Minnesota has until the end of August to respond to conflict of interest policy inquiries from Congress since that deadline was extended on Monday.

The University is replying to a letter President Bob Bruininks received July 24 from Sen. Chuck Grassley, R-Iowa, requesting information on the consulting relationship between medical product developer Medtronic and Dr. David Polly, a spinal surgeon at the University.

The letter said Polly received about $1.2 million in consulting fees from Medtronic over five years, and did not fully disclose the relationship when advocating funding research in soldiers' injuries to a senate committee in May 2006.

The University asked the Senate Finance Committee to extend the Aug. 7 deadline because they needed to discuss clarifications and narrowing requests with Grassley's staff, University General Counsel Mark Rotenberg said.

Rotenberg called some of the requests "overbroad," citing a request for National Institutes of Health grant data, which he said is not needed because Polly received Department of Defense grants.

The University's medical school is not the only school scrutinized by Grassley's Physician Payments Sunshine Act , which has made conflict of interest inquiries into 23 medical schools across the U.S. since June.

However, there is "huge variation" between U.S. universities regarding what needs to be disclosed and what people are allowed to do, said Eric Campbell, associate professor of medicine at Harvard Medical School and a University of Minnesota alumnus.

Grassley's letter said it did not appear that University physicians were required to disclose the specific amount of income they received for professional activities, or that there was a way to verify what the faculty reported.

The Academic Health Center Conflict Review and Management Committee reviewed Polly's relationship with Medtronic in December 2006.

A memo from the committee to Associate Dean at the Medical School Charles Moldow outlined four steps in a "Conflict Management Plan" including, "Dr. Polly will disclose his consulting relationships with Medtronic when submitting articles for publication or making public presentations about this research."

The memo also said Polly was "receiving in excess of $10,000 for his services annually."

The University's policy that "faculty don't have to disclose how much they earn, they just have to check a box that they earn over $10,000," was the "downfall" in the Minnesota case, Campbell said.

The University's Medical School has been in the spotlight for conflict of interest issues in the past. The school received a "D" for its policies from the American Medical Student Association in 2007.

A task force was created to address conflict of interest issues, but Gary Schwitzer, task force member and associate professor in journalism, said he has seen many of the groups recommendations "fall by the wayside."

Campbell said Grassley's letter provided the University with "a great opportunity to show national leadership."

The University is working on a conflict of interest project independently of Grassley's inquiries, said Rotenberg. He said the initial pace for the project would have seen results in "late fall, early winter." The pace has sped up, and conflict of interest principles may be revised much sooner, but will not be in place before the school year starts.

"If being in the headlines of almost every major news organization in this country and being on a leading senator's hit-list isn't enough to spur you to action, I don't know what would be," Schwitzer said.

Meanwhile, Medtronic is conducting an internal investigation, but has continued its relationship with Polly.

Medtronic determines consultant pay based on annual national surveys of physicians' income by specialty complied by a third party, company spokesperson Marybeth Thorsgaard said in an e-mailed statement.

August 4, 2009

Ghost Writers In The Sky

From the NYT:

Medical Papers by Ghostwriters Pushed Therapy

Newly unveiled court documents show that ghostwriters paid by a pharmaceutical company played a major role in producing 26 scientific papers backing the use of hormone replacement therapy in women, suggesting that the level of hidden industry influence on medical literature is broader than previously known.

The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.

The articles did not disclose Wyeth's role in initiating and paying for the work. Elsevier, the publisher of some of the journals, said it was disturbed by the allegations of ghostwriting and would investigate.

The documents on ghostwriting were uncovered by lawyers suing Wyeth and were made public after a request in court from PLoS Medicine, a medical journal from the Public Library of Science, and The New York Times.

A spokesman for Wyeth said that the articles were scientifically accurate and that pharmaceutical companies routinely hired medical writing companies to assist authors in drafting manuscripts.

The court documents provide a detailed paper trail showing how Wyeth contracted with a medical communications company to outline articles, draft them and then solicit top physicians to sign their names, even though many of the doctors contributed little or no writing. The documents suggest the practice went well beyond the case of Wyeth and hormone therapy, involving numerous drugs from other pharmaceutical companies.

"It's almost like steroids and baseball," said Dr. Joseph S. Ross, an assistant professor of geriatrics at Mount Sinai School of Medicine in New York, who has conducted research on ghostwriting. "You don't know who was using and who wasn't; you don't know which articles are tainted and which aren't."

Because physicians rely on medical literature, the concern about ghostwriting is that doctors might change their prescribing habits after reading certain articles, unaware they were commissioned by a drug company.

"The filter is missing when the reader does not know that the germ of an article came from the manufacturer," said James Szaller, a lawyer in Cleveland who has spent four years going through the ghostwriting documents on behalf of hormone therapy plaintiffs.

Sometime in 2003, a DesignWrite employee wrote a 14-page outline of the article; the author was listed as "TBD" -- to be decided. In July 2003, DesignWrite sent the outline to Dr. Gloria Bachmann, a professor of obstetrics and gynecology at the Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Bachmann responded in an e-mail message to DesignWrite: "Outline is excellent as written." In September 2003, DesignWrite e-mailed Dr. Bachmann the first draft of the article. She also pronounced that "excellent" and added, "I only had one correction which I highlighted in red."

The article, a nearly verbatim copy of the DesignWrite draft, appeared in 2005 in The Journal of Reproductive Medicine, with Dr. Bachmann listed as the primary author. It described hormone drugs as the "gold standard" for treating hot flashes and was less enthusiastic about other therapies.

The acknowledgments thanked several medical writers for their "editorial assistance," not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.

"There was a need for a review article and I said 'Yes, I will review the draft and make sure it is accurate,' " Dr. Bachmann said in an interview Tuesday. "This is my work, this is what I believe, this is reflective of my view."

The doctor needs to think about the words to this song:



August 2, 2009

Travel, meals, lobbying - All in a $4,000 day's work

Polly.jpg

A condensation of an article - with emphasis - that appeared in today's Star-Tribune may be found on my other site: The Periodic Table.

Examples:


"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."

"The documents reveal that the doctors can be paid for activities that seem to have little to do with surgery or medical practice."

"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.

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.

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.

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.


And so it goes...

About that conflict of interest policy, Frank?