Image Credit: Wikimedia Commons
Choirboy Defense: Could these lads do anything wrong?
I realize that many Medtronics employees are heart sick over this situation. I extend my sympathies to them. I once had the honor of visiting with Earl Bakken in my lab on a snowy morning when we were the only ones who made it into work. I took the bus, and he crossed the street from the Radisson. Medtronic is a wonderful company and this situation is disgraceful. My bet is that the people responsible for this will soon be gone. Live long and prosper, Medtronic. Our state depends on innovative companies like yours.
Earlier published in the Chonicle of HIgher Education. and used with permission.
Something remarkable has happened. A whole issue—June—of a prominent journal, The Spine Journal, is devoted to destroying industry-funded research supporting the use of a bio-therapeutic agent for spinal fusion, so-called recombinant human bone morphogenetic protein form 2 (rhBMP-2) in the Medtronic product, Infuse.
This remarkable issue features an editorial that is available for download as a pdf: “A challenge to integrity in spine publications: years of living dangerously with the promotion of bone growth factors.” It initially cites seven research publications for scrutiny. Altogether these studies report zero, nada, side effects in 780 protocol patients. The authors dryly add another citation (from Hemingway’s The Sun Also Rises) to the list: “Yes, isn’t it pretty to think so.”
Since then the side-effects of rhBMP-2 have become widely known. These include conditions related to unregulated bone growth as well as other disorders including sterility in males and cancer.
And what did these criticized studies have in common: Megabucks for the investigators from, primarily, Medtronic. Some of the authors of these studies have financial involvements with Medtronic that run in the tens of millions of dollars.
Sadly, this story is nothing really new to those who have been following the medical-industrial complex for years. At our own place one of the docs got in trouble for testifying in favor of Infuse® research before Congress without letting his audience know that he was a consultant for Medtronic. Senator Grassley was annoyed. I’d also point out that Dr. Carl Elliott (against type if one of my Brainstorm colleagues is correct in her aspersions against the cowardly tenured) has been valiantly crusading against using clinical trials for marketing exercises and other unethical practices in clinical trials. Various administrative attempts to discredit him have been unsuccessful, but he is being criticized even to this day by a flack for the Academic Health Center at the University of Minnesota.
The writers of this piece were really on their game. They point out that one of the openings often used by these shills is the choirboy defense: “We are an honest profession; our integrity is unimpeachable; our ethical standards are not in doubt; potential conflicts of interest are only ‘potential’…” I’ve heard these same arguments used by three medical-school deans so far.
The editorial ends with the primum non nocere statement of the Hippocratic Oath. First do no harm. It admits that harm has been done. At first I was a little disappointed in this argument, but on reflection it really is that simple. I’ve heard a medical school dean justify behavior based on the fact that something was not illegal.
Is ethical behavior too much to ask of the medical profession?
ps. Since the first draft, the matter has gone viral. Paul Thacker—who until recently rode shotgun for Grassley—writes “War Breaks Out Over Medtronic’s Infuse®” and The New York Times chips in with: “Spine Experts Repudiate Medtronic Studies.” The Chronicle now has: “Researchers Paid by Medical Company Missed Flaws in Its Spinal Implant, Study Finds.”
But I have promises to keep
And miles to go before I sleep...
"Affordability for students here and at the University's four coordinate campuses remains a primary concern for the Bruininks administration. In 2009, the president announced the rebranding and expansion of the University's need-based aid strategy to include guaranteed aid for all Minnesota students from low- and middle-income families." (source)
Here's the start of an investigation into the shell game that is the so-called Promise Scholarships at the University of Minnesota. These have been held up as an answer to the dilemma posed by a high tuition model at the U. Supposedly students with great financial needs would be sheltered from the devastating costs of college and the resulting staggering debt loads.
The promise is an illusion.
To begin this discussion results may be found below for a cost comparison between two public universities, the University of Minnesota and the University of North Carolina. These results were obtained by entering data in forms provided by both universities on the web to estimate the actual cost of attendance, as well as debt load. If you'd like to try it yourself, go here and sign in as "guest."
Then fill out the forms for these colleges making sure that the so called AGI is zero, so that the student/parents are absolutely unable to contribute to the cost of education. You should get the following numbers. I intend to discuss them in a little more detail shortly, but the results are striking and indicate that Promise Scholarships need re-thinking. The net cost at the U of M is $11,268 and the student/parent is expected to borrow $8,600 per year for a staggering four year debt of $34,400.
Contrast this to the situation at the University of North Carolina where a student with the same financial resources would see a net cost of $2,700 with loans of ZERO to the student/parent.
Some quibbles may be made over this analysis but it is obvious that something smells bad in Morrill Hall and it is not the President's fish.
To illustrate the challenge of getting Morrill Hall to face reality, see a portion of the short video of President Bruininks being interviewed by Esme Murphy this morning on 'CCO. Truly a Five Pinocchio performance.
1. Very few universities have not seen a marked increase in applications: More than 28,000 students applied to be part of UW-Madison's freshman class in the fall, a record number and the biggest increase in at least 20 years
2. The Promise Scholarship pot of gold - $350 million - at 5% will yield $70 per student based on an enrollment of 25,000 undergrads.
3. President Bruininks has the chutzpah to claim: "The quality of education is better now today than it has been in any of the 42 years that I have been at the University of Minnesota."
There is plenty of evidence to counter the President's claim, for example:
There will be more on this in due course. We have a lot of work to do at the University of Minnesota so that we can be an institution of which the state can be proud. I hope the next administration does a much better job and re-establishes our land grant priorities.
However it is important to face up to our problems and not try to sweep them under the rug. This strategy has been a dismal failure.
Mining for sand and gravel, image: Wikimedia Commons
Now that gravel mining has been put off at UMore Park and considerable discussion has occurred recently by the agricultural faculty at the University of Minnesota, perhaps taking a step back and re-evaluating the whole situation would be a good thing to do? A real economic analysis might also prove useful...
Part I. Are We A Land Grant Institution or A Gravel Mining and Development Corporation?
Senate Research Committee
Monday, April 25, 2011
"Professor Linn, Head of Animal Science, said that his department has conducted research on land at UMore Park for over 50 years, including with sheep, dairy and beef cows, and swine, and at present it has research facilities for turkey and beef cattle. Their research facilities are on the edge of the area where the proposed gravel mining will start. They have expressed concern all along about the loss of agricultural land and their animal facilities."
"What is key for them, Professor Linn said, is replacement of the facilities. There has been no discussion of the loss or replacement. This is a multi-million-dollar problem. Second, this is a primary turkey-producing state, but they have no idea what the effect of mining will be on the research facilities. They bring in $300,000 – 500,000 per year to support the facilities the research facilities at UMore Park, and the impact of the mining has to be addressed."
"The land is their laboratory, Dr. Braun explained, and UMore Park turns their labs into a gravel mine. The value of the lab far exceeds the value of the gravel mine. They have asked for alternative land but are skeptical that will be provided with the kind of land that is needed."
"The University is abdicating its land-grant mission, and he[Professor Baker] does not know of another land-grant school that does not have land close to its campus to train undergraduates. To sell off an asset to pay for operations is like selling one's kidney to pay for groceries, he said, which is why they are so upset with the plans for UMore Park."
"The land that has been suggested as an alternative is not equal to what they have now, Professor Orf said, nor does it have the millions of dollars of infrastructure (storage sheds, irrigation, and laboratories for threshing and storage of plants, etc.) that currently exists in the land they use. There was great concern about the impact of the light-rail trains on research on the Minneapolis campus; they have the same concerns about the dust and equipment storage and safety of the people working at their sites."
Professor Hutchison, the Head of Entomology, said that his department still has active research at UMore Park and they have not seen enough consultation with faculty members; he thanked the Committee for hearing about their concerns. Their faculty see these recent discussions as re-arranging deck chairs on the "Titanic."
"A number of faculty members (23) in the College of Food, Agricultural, and Natural Resources Sciences (CFANS) wrote to the Board of Regents in July, 2010 to express their concerns. The Regents wrote back to respectfully disagree about the quality of the land and the lack of a farm for the University."
"Dr. Becker also noted that when the University received the land at UMore Park after WW II, University Agronomists and Soil Scientists conducted surveys and determined the agricultural plots needed to be where they are because most of the landscape at UMore Park was disturbed in building the munitions plant. Topsoil and subsoil were mixed or significantly altered, rendering those areas wholly unsuitable for research other than reclamation research. We cannot just move onto other lands impacted by the plant construction. "
They and others have been doing studies for ten years or more and will not be able to continue because of the gravel dust. E.g., photosynthate measurements will be erratic and altered because of widespread gravel dust deposition.
These sites encompass the entire Agronomy farm research areas, and he would not want to be around them, nor would he want his students working on the land near them. Dust, noise, VOCs from the asphalt plant, conveyors transporting rock overhead, and heavy equipment traffic - they cannot co-exist. The take-home message is that the University has to acquire new land in the area. As Dr. Al Levine, Dean of CFANS put it; it is like taking buildings down on campus and making no alternative arrangements for the faculty who were housed in them.
Professor Linn said that the Regents' letter indicates the plans will go forward even though most faculty members on the St. Paul campus oppose them. Dr. Braun reported that the gravel mining has been postponed because of the economic situation (an 80% decline in the demand for gravel), which buys them time to explore alternatives, such as mining on the east side and not disrupting the agricultural land.
Professor Vaughan asked if the Regents made the decision without consulting the faculty. Essentially they did, Professor Baker said. The Board was led to believe there would be additional discussions about what would serve the research needs of the faculty, but those discussions have not taken place.
Professor Linn said that from the time the process started and all along, they have said that what is going on there is not acceptable. There will be mining and a new community; the key issue is the lack of responsibility for agricultural research that has been there for 50 years. They are not looking at the importance of how to replace that land—the focus has been on the mining and the new community.
Dr. Braun reported that it was in March 2010 that agricultural researchers were informed about the plans for UMore Park. Many had no idea anything was being planned, even though UMore Park had been in the works for years.
The implication is that Vice President Mulcahy talked about the cost of relocating the NMR machines because of the light rail trains, which involved a cost in time and expense, including the effect on graduate students. One would have thought they would have had similar relocation costs as part of the UMore Park project, but apparently they did not, which reflects a misunderstanding of the research enterprise.
The argument was that things cannot go on like they have been, Professor Cleary said. What does that mean? That the value of the land and gravel outweighs the value of the research? Professor Orf said that, per Professor Baker, some of this research has a history and it would take 15 years to get back to the same point. Will NSF provide funding for another 15 years? That is not likely. Professor Cleary said he could not understand the negative views about the agricultural research being done on the UMore Park land.
These are merely excerpts. There is even more horrible stuff available where that came from.
Part II. Follow the Money
My fellow University of Minnesota alumnus, Michael McNabb comments on the situation:
Recent discussions have confirmed concerns about the UMore Park development. The gravel pit will be located on land that has been used for agricultural research that has produced hundreds of millions of dollars for the economy of Minnesota. See the remarks of the professors from the College of Food, Agricultural & Natural Resources Sciences at the April 25, 2011 meeting of the faculty research committee at More On MoreU Park.
In July 2010 the Regents dismissed the concerns expressed by CFANS faculty members about the decision (already made) to transform UMore Park. At that time the Regents were under the impression that the gravel pit would generate $3 million to $10 million in revenue per year. That projection by senior administrators was wildly unrealistic. See Section 1 of University Inc. Part II.
See UMore Park Craziness for a partial list of the numerous consultants who have received part of the $9.3 million (and counting) that the administration has spent planning the development of UMore Park. Note that there is not a single consultant from the fields of agriculture or veterinary medicine. (The Vet School has an entire farm at UMorePark.) It appears that the senior administrators and the Regents made the decision on UMore Park without consulting either the professors who were engaged in research on the land or any agricultural economists!
The decision of the administration on UMore Park fails to recognize the essential value of agricultural research for a land grant university:
“CFANS is a college devoted to solution-driven science; we use critical and innovative thinking plus all the tools of the arts and sciences to make our planet a productive, friendly, and sustainable environment--to solve everyday problems. We study the health of the land and the health of the living.”
See the message from the Dean on the University of Minnesota web site.
Added Later: Response from Chris Coughlan-Smith:
Hi, Professor Gleason. I can assure there is no effort to suppress discussion on this community. We have a policy in place on the approval of discussions, filtering commercial and promotional items to the correct area and deleting only profane and offensive material.
An error appears to have been made over the weekend and our policy has been reiterated with all who moderate the discussions.
I've personally approved Mr. McNabb's comments in the past and will continue to do so. I wish one of you would have asked someone in this office for a clarification. Thank you.
Chris, group founder and owner
Image Credit: Wikimedia Commons
Recently I learned of yet another attempt to stifle criticism at the University of Minnesota. It is sad, indeed, that the administration and the alumni association are engaging in the tactics of censorship and intimidation.
I sincerely hope that the next president will not tolerate this kind of activity at our university.
From my friend and fellow alum, Michael McNabb:
The University of Minnesota Alumni Association has a LinkedIn web site for posts submitted by alumni. I have sent several single sentence posts with links to essays in The Periodic Table, such as:
See the attached My Activity section of the UMAA site.
On April 30 the UMAA site blocked the submission of a single sentence post [Administration seeks to stifle criticism of research] with links to these posts:
When I scrolled down to the end of the My Activity section I saw the following question:
Are you sure that you want to permanently remove, block and delete all contributions from this member?
Then I checked the main section of the UMAA site and saw that my previous posts had been deleted.
The mission statement of the Alumni Association states that it is "dedicated to connecting alumni, students and friends in lifelong support of the University of Minnesota and each other."
It appears that the Alumni Association considers the current administration and the University to be one and the same for it excludes any perspective that challenges a course of action undertaken by the administration. (It is far easier to exclude than to allow alumni to hear different perspectives and to engage in an exchange of ideas.)
A "guiding principle" of the Alumni Association is that it "represents the independent voice of the alumni." See the UMAA site above. By excluding different perspectives of alumni the Alumni Association acts as the representative of the administration to silence the independent voices of those alumni.
Image credit: Wikimedia commons
I have earlier written about this matter. See University of Minnesota General Counsel: Is Defamation Protected by Academic Freedom for some background.
Since that post there have been further reactions to the situation at Minnesota, including articles in the Chronicle of Higher Education, Inside Higher Education, and the Bioethics Forum at the Hastings Center.
The time for weary negligence in this matter has long passed.
Today a nationally respected professor of Law and Philosophy at the University of Chicago posted a strongly worded piece on his widely read blog, Leiter Reports: A Philosophy Blog.
The University of Minnesota Clinical Trials Fiasco and the Apparent Attempt to Silence Faculty Critics
A clinical trial of an antipsychotic medication at the University of Minnesota in 2003 resulted in the death of a patient; bioethicist Carl Elliott at Minnesota investigated, concluding that the patient should not have been enrolled, and that the clinical trial itself was run by doctors with financial ties to the drug manufacturer sponsoring the clinical trial, and that many such trials are really aimed at marketing the drug, not testing its safety:
Professor Elliott and others appealed to the University's Board of Trustees to investigate. Now the University's General Counsel is trying to stop faculty from pursuing this matter! This latest development--a quite brazen attack on the core of academic freedom.
This blog also offers a useful timeline of the recent events :November 23, 2010. Eight professors and bioethicists submit a letter to the Regents requesting an independent investigation into the death of Dan Markingson while he was participating in a clinical trial at the University. See Faculty Letter at http://ptable.blogspot.com/2010/12/university-of-minnesota-faculty-letter.html#links.December 10, 2010. General Counsel Mark Rotenberg meets with the Regents regarding the request. See U of M Attorney at http://ptable.blogspot.com/2010/12/dan-markingsons-suicide-u-of-m-attorney.html#links.February 7, 2011. Regents deny request for independent investigation. See Regents Play Innocent at http://ptable.blogspot.com/2011/02/regents-play-innocent-regents-are.html#links.February 24, 2011. General Counsel Rotenberg submits to the FCC [the faculty council] the following question: What is the faculty's collective role in addressing factually incorrect attacks on particular U faculty research activities? FCC refers the question to the AF & T Committee. See the February 24 report of the FCC at http://conservancy.umn.edu/bitstream/101836/1/11_02_24FCC.pdf.This is a case where the University President needs to exercise some real leadership, including, at a minimum, instructing the General Counsel to back off. This whole episode is also indicative of how important tenure is to protect faculty whose research adversely affects corporate interests.