Great Analysis - As Always -

of the Solution to Our Economic Crisis

(Keynes wins, Samuelson rules...)

From the NYT:

"So what we have here isn’t really a lack of a workable analytical framework. The disaster we’re facing is the result of the refusal of economists, both in and out of the corridors of power, to go with the perfectly good framework we already had."

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.

A crisis of spiraling tuition

Colleges must volunteer

— or be forced —

to address rising cost

[Does any of this sound familiar? The Morrill Hall Gang at the University of Minnesota needs to look in the mirror. We should not be spending $80 million on the so-called renovation of Northrop Auditorium.]

From the Boston Globe:

By Derrick Z. Jackson Globe Columnist / August 31, 2010

In a speech to the Urban League in July, President Obama bemoaned the nation’s drop from first in the world to 12th in measures of college completion. This situation is “economically indefensible’’ and “morally inexcusable,’’ he said, and “all of us are going to have to roll up our sleeves to change it.’’

Graduation rates aside, the most morally inexcusable aspect of college is the unbridled cost of getting in. It is clear who should be first to roll up their sleeves: college presidents. Obama should declare their tuitions and fees a state of emergency and call a national summit to hold these institutions accountable.

Since 1990, according to the Chronicle of Higher Education, the price of tuition, fees, room, and board at private and public four-year colleges has risen between three and four and a half times the increase in average family income.

For most families, it is impossible to put away enough money to prepare for such a burden. Last week, a Fidelity Investments survey found that 67 percent of parents have begun saving for college, compared with 58 percent in 2007. But the savings is only expected to cover 16 percent of college costs.

Even in the worst economic times since the Great Depression, universities behave with no conscience.

College presidents have plenty of excuses. To hear many tell it, rising tuition is like a Cold War arms race, in which each school must build fancy new structures...

No one has called them on their excuses.

The reasons are complex, but the outcome is simple. Soon, not only the so-called “best’’ colleges but also state schools will be beyond the reach of the middle class.

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GOP Chairman [sic] Sutton (left)
and Deputy Chair [sic] Broadkorb (far right)
at State Fair

Suppose the DFL did something like this with a large cardboard cutout of Mr. Emmer?

The GOP continues to disgrace itself in the Minnesota gubernatorial election campaign. The cardboard cutout demonstrates the juvenile, frat boy, approach of these two supposed adults. Karl Rove and Curly Howard would be very proud of these boys.

But I guess if you have a loser like Emmer for a candidate this is about the best you can do. Mr. Emmer is against the minimum wage because it is socialist. He also sponsored legislation to make complying with Federal laws optional for those sovereign individuals who do not believe these laws to be constitutional.

I can't wait until November when these clowns are off stage and we can get on with fixing the problems of our state, problems caused by our do-nothing GOP governor Pawlenty.

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Will the University of Minnesota

Destroy the Minnesota Apple Orchard Business?

An outstanding explanation by an orchardist with no dog in the fight. It is very important that the University of Minnesota management read and understand these points. Destroying Minnesota businesses because of greed is inexcusable...

From the website of Hoch Orchard:

SweeTango is the newest apple released from the University of Minnesota’s Horticultural Research Center. This apple is a cross between Zestar and Honeycrisp and is really a good tasting apple. It has the tartness of the Zestar and is even more dense and crisp than Honeycrisp. The flavor is richer than either of its parents.

The good news is we have planted 1000 of these trees. Which is the maximum that I am allowed to plant because the University sold the rights of the apple to a marketing group and they control who grows the trees and how many.

The bad news is most of the SweeTango that will be sold in Minnesota grocery stores will have been grown everywhere but Minnesota!

The local apple stands will be selling the Minnesota Grown SweeTango, but the grocery stores will get SweeTango grown in other regions. The last I heard there were only three Minnesota orchards out of the roughly fifty orchards that are allowed to grow SweeTango in wholesale volumes.

[NBT = Next Best Thing, Marketing Group controlling sales and production of Sweet Tango]

Minnesotans can only eat so many apples. Every SweeTango that NBT brings into Minnesota grocery stores displaces another Minnesota grown apple. As production of the NBT SweeTango increases it will displace a growing portion of the Honeycrisp and Zestar demand in the wholesale market.

Pepin Heights has put together a very restrictive marketing program that excludes Minnesota apple growers from the wholesale SweeTango market. While this may be a very good plan for NBT it could result in a drastically shrinking market share for the other Minnesota based wholesale orchards.

The Minnesota wholesale apple industry could be devastated by an apple developed by our own university.

There is no need for them to exclude the Minnesota wholesale apple orchards from the SweeTango market. We have to convince Pepin Heights Orchard and the University of Minnesota to remove the restrictions from the Minnesota apple growers.

Most of the SweeTango apples are produced on large-scale orchards around the country. Only a few of them are being grown right here in the state that developed them. The vast majority of SweeTango apples are grown hundreds or thousands of miles away and shipped here to compete with our local farmers. NBT is bringing apples into Minnesota and is trying to start what they hope will be a nation wide craze for SweeTango. We hope they won’t put the last few Minnesota wholesale orchards in the state out of business in the process. The orchards large enough to compete with NBT are not allowed to grow more than 1000 trees of SweeTango, and to top it off, they are not allowed to cooperatively pack the apples they grow.

NBT is doing a dance around the Minnesota orchards with an apple developed by the University if Minnesota! It really is a Sweet Tango! It’s just not very sweet for the Minnesota wholesale orchards that are trying to compete with NBT.

Why is this info on the Hoch Orchard Web site?

You may wonder why I am posting this information on my website. We grow organic apples that are sold in member-owned food coops. We don’t compete with the other Minnesota apple orchards and we don’t compete with the NBT SweeTango apples. We don’t really have ‘a dog in the fight’ so to speak. What does bother me is that our great University of Minnesota has made a mistake in its release of SweeTango, and may inadvertently play a role in destroying the Minnesota wholesale apple industry. I am strong supporter of sustainable agriculture and local food production. This business model for SweeTango will put family owned Minnesota wholesale apple orchards competing against some of the biggest and most progressive apple production companies in North America. This model brings their apples into our backyard! It doesn’t take an economist to figure out who is going to come out on top. This marketing model throws a bone to the smallest Minnesota apple growers, while cutting the wholesale growers (who produce the majority of Minnesota’s apples) completely out of the SweeTango market. It is pretty obvious this great new apple will drastically reduce local demand for its parents Honeycrisp and Zestar. Those two older releases from the University are what pay the bills for most Minnesota apple growers.

What about over production and quality?

On the other side of the coin, I am not against the University releasing this as a managed variety. Controlling production and setting quality standards are great ideas, and the Minnesota apple growers should certainly be required to adhere to this. We all pay an annual royalty for the right to grow SweeTango. These royalties help fund the successful marketing program.

This managed apple model would be fine if the Minnesota growers would be allowed to grow as many SweeTango as they need to compete in the Minnesota market place; and be allowed to pool the crop and cooperatively pack the apples. NBT could continue to control sales in 49 other states and Canada while allowing local wholesale apple growers to compete in the Minnesota market. Removing the volume restriction will allow Minnesota apple growers to compete on a level playing field here in Minnesota.

What have other Fruit Breeding Programs done?

After the U of Minnesota announced its release of SweeTango as a managed variety, Washington State announced that apple varieties it is about to release will be available to all Washington growers. Cornell University also announced that it is going to release its new varieties in a modified management model where New York apple growers get first option to grow their releases. It is just my opinion, but I do not think it was a coincidence that the other two major US apple breeding programs made this announcement after the U of Mn came out with its controversial model.

How can you help?

If you want to buy Minnesota Grown SweeTango in your local grocery store then I suggest you push the University to make this apple available to all Minnesota apple growers without a quantity limitation. Tell your produce manager that you want Minnesota Grown SweeTango. If they won’t carry them, tell them you will shop somewhere else. Then start a blog, push your politicians, call the University, send a letter to the governor, or do what ever is in your power to pressure the University and Pepin Heights to correct the situation.

What happens if this Model isn’t changed?

If local demand for Honeycrisp and Zestar falls off because of increasing demand for SweeTango, local wholesale growers will either have to reduce the amount of fruit they sell in Minnesota, or find a new variety to compete with SweeTango. Won’t that be something if Minnesota wholesale apple growers get together to market a new variety to compete with a variety developed with Minnesota tax dollars? I think the first option is the more realistic scenario. The result could be fewer Minnesota apple growers, fewer apples grown in Minnesota, and one more nail in the coffin for local family farms.

Administrative Bloat? At the University of Minnesota?
Could It Be?

From Critical Mass:

The admins are the enemy...

August 25, 2010, 8:12 am

George Mason law professor Todd Zywicki is a strong critic of the higher ed status quo, and has some skin in the game when it comes to rethinking governance models–several years ago he ran for the Dartmouth board of trustees as a dark horse alumni petition candidate, and he won.

The election was much discussed in the higher ed press, and was an important part of a larger power struggle at Dartmouth about who should have a say in how the college is run, and whether entrenched inside interests should carry the day. So he’s a governance reformer, if you will, with an eye to returning our colleges and universities to a form that compels them to focus on their educational missions and their obligation to serve not themselves–but the public good.

A new study has just come out about the mammoth administrative bloat that we’ve seen in higher ed in recent years. It points out, among other things, that from 1993 to 2007, hiring and spending on university admins increased at twice the rate of hiring and spending on faculty. Zywicki notes that this fact has major implications for how we think about higher ed reform, and for how we assign responsibility for the problems we are seeing now:

Many observers believe that the problem with higher education is that universities are basically run by its employees–the faculty–and that the faculty’s interests are not aligned with those of the students who they serve. But what [Jay] Greene’s report hints at is a larger trend at work–more and more universities are run by their bureaucrats, not the faculty, and the incentives of bureaucrats are even more poorly aligned with student interests than the faculty. University organization is so screwy these days, that even though faculty incentives are so poor, governance would probably be improved (at least in the short run) by empowering the faculty against administrators.

That’s a serious claim–the faculty have, as he notes, tended to be the focal point of much of the criticism that has been leveled against colleges and universities for their failure to fulfill their education missions as well as for their failure to maintain the system of peer review with integrity. I’m still thinking that latter is on the faculty–but the former is certainly more complicated.

Zywicki offers some thoughts on where all the money for the bloat came from, and speculates about how we might go about getting unbloated:

Jay focuses on the role of government subsidies in feeding the bloat of academic bureaucracy. That seems plausible to me. The other factor that strikes me as perhaps relevant is that during most of that period university endowments grew at record rates. This essentially gave university presidents and their minions a huge slush fund to play with without actually having to raise new funds from alumni. This created a growth in agency costs for senior university administrators. Finally, this allowed universities to continue giving raises to faculty while expanding the bureaucracy even more. Thus, the growth in bureaucratic spending was not coming out of a zero-sum pot, so that faculty were not monitoring the growth in the bureaucracy as much.

Finally, I suspect this might also reflect the developing model of university president as CEO. As university presidents have come to be more like CEO’s of universities, their entourages have grown as well. Universities have come to take the look of a top-heavy bloated corporation like General Motors, with Vice-Presidents layered one atop the other. In a world of lax budget constraints owing to flush endowments, it is easier to fritter away resources on unproductive bureaucrats and internal empire-building.

The acid test, of course, will be whether the financial downturn will lead to the scaling back of these bureaucratic empires. Ironically, it appears that one of the Obama Administration’s priorities is to funnel more money into higher education–which will reinforce exactly the sorts of pressures that Greene highlights. Higher education almost perfectly converts subsidies (whether direct or aid to students) into higher prices. With no real reason to expect that those subsidies will be used to promote better substantive outputs instead of internal agency costs.

More generally, I think that for some time academic reformers have focused on issues like tenure and other elements of faculty governance in thinking about reforming higher ed. But this growth of administrative bloat is a whole new issue and one that might prove more difficult.

“Might prove more difficult” is an understatement. It’s already demonstrably true that at many schools feeling a pinch, it’s not administrative salaries or positions that are being cut, but faculty ones. I’m reminded of Jonathan Rauch’s devastating book about how, once you create a special-interest bureaucracy, you can never get rid of it, Government’s End.

___

Sadly, many of the statements made above are very applicable here at the University of Minnesota.

+++

Children's Hospital Wars

in Minneapolis/St. Paul?

Gary Schwitzer Comments

wbgleason Children's Hospital plans to cut up to 250 jobs http://bit.ly/cYMfRb First casualties of local children's hospital wars... #UMN

I've tweeted on the matter, but Gary Schwitzer has done it right:

Where was the hospital competition/expansion angle in story of hospital job cuts?

This week, the Twin Cities' two major newspapers reported - in varying but incomplete ways - an announcement from Children's Hospitals and Clinics of Minnesota that it planned to cut up to 250 jobs by mid November.

The Pioneer Press beat its larger crosstown competitor, the Star Tribune, by at least doing some original reporting on the story.

The story also never commented on the hospital's expensive expansion, arguably the clearest manifestation of its competition with Fairview University medical center, which has also built a new children's facility (pictured at left in a photo taken last summer). We've written about this before, and how the Twin Cities may lead the nation in the number of different, separately-operated, competing children's hospitals it now has.

But the limited Pioneer Press story nonetheless still showed up the state's #1 newspaper, the Star Tribune, which only managed to rewrite and republish an Associated Press story, which ran only 123 words and was put in a little corner of page B4 in the Metro section.

Wow.

Local citizens deserve much more scrutiny of the local hospital industry than that.

I've posted before on this appalling situation:

Children as Pawns in the Latest Expensive Healthcare Competition Involving the University of Minnesota

University of Minnesota President to

Join Humphrey Institute

Will Study

"Transformative Public Leadership"

[The people want to know: how much will he be paid for more transformational verbigeration...]

From On Campus:

After his presidency ends at the end of June 2011, University of Minnesota President Robert Bruininks will join the faculty of the U’s Humphrey Institute of Public Affairs, university officials announced today.

[Terms of employment? Salary?]

Bruininks will be affiliated with the Center for Integrative Leadership, an interdisciplinary center run by the Humphrey Institute and the Carlson School of Management. His work will focus on “transformative public leadership” [tpl] and “human capital and economic development.”

[Is tpl a new theoretical discipline, Mr. Bruininks? And what is your background in economics, exactly? I hope what you know about the topic was not learned from your CFO...]

It was unclear just what that means or exactly how it fits into his past professional life,

[It doesn't... He's, ah, an educational psychologist.]

but the press release states:

… he also has a strong foundation in education policy issues. The Humphrey Institute is the perfect home for the next phase of his career.

Bruininks was once the dean and professor at the U’s College of Education and Human Development.

Transformational Leadership?

...we're in the midst of transformative change en route to becoming one of the top three public research universities in the world. [sic] President Bruininks Dec 7, 2009 (web site)

And how's that going, Mr. President? We're supposed to be there in four years, how is it looking?

One opinion:

"As for commitment to quality education at an affordable cost? Meaningless drivel. The administration has flatly failed on its promises of excellence and affordability." Daily (13 Oct 2009)

For more comments on transformational verbigeration, please see my Strib blog piece: Transformational Verbigeration at the U.

Medical Device Launch Pad?

Whoops! - The Gang That Couldn't Shoot Straight

Is At It Again?

From MedCity News:

Not so fast, says U of M tech transfer chief

Forget “One Life to Live” or “As the World Turns.” If you want a real soap opera, look no farther than the University of Minnesota.

One week after MedCity News first reported that University Enterprise Laboratories (UEL) and the school’s medical device fellowship program were close to a deal to establish MDC Launch Pad, an incubator for companies created by the fellows, the university’s top tech transfer official is opposing the project.

In an interview with MedCity News, Jay Schrankler, director of the Office for Technology Commercialization (OTC) said he supports the overall concept of Launch Pad but doesn’t think it should be limited to the just one program at the university. Schrankler, who said he was not consulted on the project, said he’s meeting with UEL chair Paul Knapp next week to press his case.

Schrankler downplayed MDC Launch Pad as a very preliminary idea. UEL documents, which contained specific details on Launch Pad’s structure and financing, seem to indicate otherwise.

The latest dispute comes just a few weeks after Rep. Tim Mahoney (D-St. Paul), the chair of the House Biosciences Committee, threatened to privatize OTC if the school didn’t make enough progress in commercializing technologies. That prompted university vice president of research Tim Mulcahy to angrily dare legislators to fund technologies the school passes on.

What we’re witnessing is a good old fashioned turf battle. Schrankler won’t say it outright but I’m sure he’s not particularly happy that he didn’t know anything about Launch Pad. He does, after all, oversee tech transfer so one would naturally assume he would be in the loop. Heck, Schrankler even works out of the UEL building!

In truth, the UEL dust up reflects tension between OTC and the school’s Medical Device Center (MDC). Founded in 2008, the facility, located on the top floor of Shepherd Labs on SE Union Street in Minneapolis, was meant to serve as a hub for faculty, students, and companies to translate high-concept research into real companies and technologies.

MDC also launched the Innovation Fellowship Program to “produce the next generation of medical device entrepreneurs, innovators and leaders.” Ideally, the fellows, graduate students around the country with backgrounds in medicine, engineering and biosciences, would create companies from their work in the program.

However, OTC was heading towards a different direction. Schrankler and Doug Johnson, head of the Venture Center, responsible for spinning out start-ups, say the university should look beyond the region’s traditional focus on mechanical medical devices.

The school, they argued, should focus on cutting edge biomedical technologies with blockbuster potential like Doris Taylor’s work in stem cell therapies and regenerative medicine or a breakthrough drug that can keep patients suffering from catastrophic blood loss alive long enough to reach a hospital.

The university has launched a major campus wide initiative to boost its efforts to commercialize promising drugs developed by programs like Masonic Cancer Center, medical school, and the Institute for Therapeutics Discovery & Development at the College of Pharmacy

Take a look at the start-ups the university has spun off in recent years and you won’t see a whole lot of medical devices.

Schrankler himself admits things could be better between OTC and MDC.

“I will say this, we got off to a bit of a rocky start,” he said. However, the relationship has greatly improved in recent weeks, Schrankler said.

John Alexander, president of TC Angels, has been advising many of the medical device fellows. He praises their work and loves the idea of the MDC Launch Pad. In fact, the university should emulate the program for other technologies, he said.

Asked about how the relationship between OTC and MDC, Alexander replied diplomatically: “They are trying.”

But then he added: “I wish I understood what [OTC] is thinking sometimes.”

More on Dan Markingson Case

at the University of Minnesota

from Hooked: Ethics, Medicine & Pharma

Dr. Howard Brody writes:

Back in April I blogged about the tragic case of Dan Markingson and the so-far-futile efforts of his mother, Mary Weiss, to get justice from the University of Minnesota:
http://brodyhooked.blogspot.com/2010/04/u-minnesota-evading-responsibility-for.html

Carl Elliott's book (mentioned in the last post) contains a brief synopsis of this case; but he goes into more detail in an article in the current Mother Jones, "Making a Killing." (To access, go to the Mother Jones current issue website, http://motherjones.com/toc/2010/09, and look for the title "Making a Killing." Click on that and you'll get a screen that will allow you to register for free access.)

In "Making a Killing," Carl not only describes the sad case but also puts it in the context of the pressure placed on universities today to compete for grant dollars with commercial research entities, all funded by a drug industry that is looking for marketing, not science. As Carl summarizes:

"If these experts [who have reviewed the study in which Dan Markingson was enrolled, and have declared it to be scientifically next to worthless] are right, then then the study in which Dan Markingson committed suicide was not simply a matter of inadequate informed consent, or financial conflicts of interest, or even failure to monitor a subject's care. The ethical breach was built into the study from the start. It is one thing to ask people to take risks for science, or the common good, or to help other people. It is another thing entirely to ask them to risk their lives for the marketing goal of [the sponsoring drug copmpany] AstraZeneca."

Carl throws a couple of other scary passages at us. When Ms. Weiss attempted to sue the University and its psychiatrists (a suit that was dismissed based more or less on a variant of sovereign immunity), her attorneys deposed the director of the U's Institutional Review Board (IRB) or research subjects ethical review committee, Moira Keane. The attorney asked what she thought was a routine question--didn't the IRB have the responsibility to protect human research subjects?--before proceeding to the issues under dispute. But Ms. Keane refused to admit that the IRB had any such responsibility. The attorney thought she had misunderstood (after all, the U-MN website says the purpose of the IRB is to "protect the rights and welfare of human research subjects") but Ms. Keane stood firm. In the end, all she would admit was that it was the role of the IRB to make sure that research investigators at the U had a plan to protect human research subjects. As Dr. Elliott then notes, this is as good as saying that the IRB at U-MN doesn't do a thing--since it was precisely to protect human subjects from the dangers of an overzealous investigator that IRBs were first created.

The next scary quote relates to how you can end up with a study like CAFE (the study in which Markingson was enrolled), which is basically jiggered from the start not to answer any legitimate scientific question, but to provide the drug company with marketing spin to sell their drug, and which can more or less be guaranteed to produce the answers that the company wants. In HOOKED and previously on this blog, I have described in detail some of the tricks used by study designers to rig outcomes. But the march of progress continues, and as journal editors, however belatedly, start to catch on to these little games, the goal posts move. Summarizing a 2006 study of research on atypical antipsychotics, Carl notes, "Much of this manipulation came from biased statistical analyses and rigged trial designs of such complexity that outside reviewers were unable to spot them."

The CAFE study, for those interested, appeared as: McEvoy JP, Lieberman JA, Perkins DO, et al. Efficacy and tolerability of olanzapine, quetiapine, and risperidone in the treatment of early psychosis: a randomized, double-blind 52-week comparison. American Journal of Psychiatry 164:1050-60, 2007.

Some comments on this article:

Bernard Carroll: Past chairman FDA Psychopharmacologic Drugs Advisory Committee. Past chairman, department of psychiatry Duke University Medical Center.

This so called CAFE study in which the young man died seems to fit the description of what I have labeled experimercials - pretend clinical trials designed by marketers rather than by clinical research professionals.

And why, pray, are the CATIE investigators lending their names to this undistinguished and indefensible study? CATIE broke new ground by calling into question the efficacy/safety claims for second generation antipsychotic drugs pushed by the corporations.

The lead CATIE investigator, Jeffrey Lieberman, chair of psychiatry at Columbia University has some explaining to do. But then, this is the same Jeffrey Lieberman who wrote to the Wall Street Journal back in 2006 defending the indefensible Charles Nemeroff.

It looks to me like the operative principle here is just money - and that it matters not to a Jeffrey Lieberman whether the money is from NIMH for CATIE or from AstraZeneca for CAFE.

John Nardo:

This is truly an absurd story: made surreal by the design of the study in the first place; with criminal negligence in the responses to Ms. Weiss; but approaches the macabre when it gets to the deposition of Moira Keane. It's a little hard to follow why this suit was dismissed ["a suit that was dismissed based more or less on a variant of sovereign immunity"]. How does being in a "study" immunize people from malpractice or wrongful death?

Seroquel^® Expose

at

University of Minnesota

From Shearlings Got Plowed:

First, a sincere hat tip to Dr. Adriane Fugh-Berman at PharmedOut.org, and to The Insider at PharmaGossip, for reminding me about this.

This Mother Jones article should be read -- cover to cover -- by anyone familiar with the sordid history of the "atypical" antipsychotics (paging Salmon!) -- as much of the narrative likely applies to the studies legacy Schering-Plough used to clear New Merck's Saphris^® (asenapine). In my estimation, Carl Elliott has a Pulitzer-worthy Seroquel^® piece, here -- do go read it all:

. . . .On the surface, the study appeared benign. Its purpose was to compare the effectiveness of three “atypical” antipsychotic drugs, each of which had already been approved by the fda: Seroquel (quetiapine), Zyprexa (olanzapine), and Risperdal (risperidone). The study was designed and funded by AstraZeneca, the manufacturer of Seroquel, and it called for 400 subjects experiencing their first psychotic episode to take one of the three drugs for a year. AstraZeneca called it the “CAFE” study, which stood for “Comparison of Atypicals in First Episode.” The management of the CAFE study had been outsourced to Quintiles, a contract research organization, which was conducting it at 26 different sites. . . .

Yet the CAFE study was not without risks. It barred subjects from being taken off their assigned drug; it didn’t allow them to be switched to another drug if their assigned drug was not working; and it restricted the number of additional drugs subjects could be given to manage side effects and symptoms such as depression, anxiety, or agitation. Like many clinical trials, the study was also randomized and double-blinded: Subjects were assigned a drug randomly by a computer, and neither the subjects nor the researchers knew which drug it was. These restrictions meant that subjects in the CAFE study had fewer therapeutic options than they would have had outside the study.

In fact, the CAFE study also contained a serious oversight that, if corrected, would have prevented patients like Dan from being enrolled. Like other patients with schizophrenia, patients experiencing their first psychotic episode are at higher risk of killing themselves or other people. For this reason, most studies of antipsychotic drugs specifically bar researchers from recruiting patients at risk of violence or suicide, for fear that they might kill themselves or someone else during the study. Conveniently, however, the CAFE study only prohibited patients at risk of suicide, not homicide. This meant that Dan — who had threatened to slit his mother’s throat, but had not threatened to harm himself — was a legitimate target for recruitment. . . .

You. Must. Read. It. All.

It is this sort of study-design -- coupled with the schemes in a few states (like New Jersey, and Minnesota, apparently), in which no actual court or judge is involved, before an otherwise presumptively-competent adult is forcibly-held in a psychiatric ward, and then effectively forced onto very powerful medications -- that leads to these more-than-occasionally atrocious outcomes. Outcomes that defy Hippocrates' oath -- outcomes for which (in a reformed system) the treating health care professional must ultimately held responsible, if we are see meaningful changes.

[UPDATED: Apparently, Natasha Singer of The New York Times had written to recommend the above article -- on Friday night, as well. I missed hers -- but it is also a worthy read.]

+++

A Clinical Trial

A Suicide

And Patient Safety

From Pharmalot:

What happens when a university is bound up in the outcome of an industry clinical trial? What does it say when university researchers are actively recruiting patients for a trial while also accepting consulting or speaking fees from the same drugmaker sponsoring the study? Is the research furthering commercial needs more so than scientific needs? And how are patients protected in such situations?

These are among the questions explored in a sobering piece in Mother Jones magazine by University of Minnesota bioethicist Carl Elliott. He focuses on the sorry plight of Mary Weiss, who lost her 26-year-old son, Dan, while he was enrolled - over her strenuous objections - in a trial at the University of Minnesota (yes, the same school) to compare AstraZeneca’s Seroquel antipsychotic with rival brands.

The circumstances in which Dan was placed in the study go to the heart of the matter. Back in 2003, he suddenly exhibited increasingly troubling behavior and threatened his mother before he was briefly committed involuntarily to a mental institution. Later, he was transferred to a halfway house before being released. But along the way, he was enrolled in the trial by a University of Minnesota psychiatry professor, who was also doing work for AstraZeneca, as was another researcher in the department.

Yet just before that occurred, this same physician indicated in a court petition that Dan was dangerous and mentally incapable of consenting to taking antipsychotics. As his mother wondered: How could her son suddenly be capable of consenting to a participation in a research study while he was in a state mental institution? Elliott goes on to explain the university researchers were under pressure to bolster enrollment in the trial, which was run by Quintiles, the contract research company.

As Elliott notes, the study contained a loophole. “Like other patients with schizophrenia, patients experiencing their first psychotic episode are at higher risk of killing themselves or other people. For this reason, most studies of antipsychotic drugs specifically bar researchers from recruiting patients at risk of violence or suicide, for fear that they might kill themselves or someone else during the study,” he writes. “Conveniently, however, the study only prohibited patients at risk of suicide, not homocide. This meant that Dan - who had threatened to slit his mother’s throat, but had not threatened to harm himself - was a legitimate target for recruitment."

The tale goes on to recount previous ethical lapses at the university, the interlocking interests among academic researchers and drugmakers, and oversight issues raised by the growing number of for-profit institutional review boards. At the end of the day, studies are supposed yield info to improve medical conditions - a Machiavellian prospect, perhaps, for those who say shareholder interests predominate.

But as Elliott posits after combing through product-liability litigation: “The documents…suggest that pharmaceutical companies are designing, analyzing, and publishing trials primarily as a way of positioning their drugs in the marketplace. This raises a question unconsidered in any current code of research ethics. How much risk to human subjects is justified in a study whose principal aim is to generate commercially attractive messages?”

+++

The Farce That is Faculty Governance

in the Academic Health Center

at the University of MInnesota

Continues

[The implementation of a conflict of interest policy at the University of Minnesota has had a long and checkered history. (In the Nixonian sense) Over the summer a policy was put into effect without adequate faculty consultation - this after three years of foot dragging by the medical school administration. Possibly they were in a hurry to do damage control because they learned of the upcoming piece by Carl Elliot - Making a Killing?]

Minutes*

Faculty Consultative Committee
Thursday, August 12, 2010
1:00 - 3:00
238A Morrill Hall

Professor Campbell commented that the timing of the adoption of Appendix A was confusing.

Faculty in the Academic Health Center had received an email message that the Appendix had gone through the 30-day consultation period, but no one knew anything about it.

He said that the Appendix had not been brought to the Academic Health Center Faculty Consultative committee and that he did not know with whom there had been consultation.

Ms. Zentner said she had not been involved in the consultative process that took place in the AHC regarding the Appendix but understood that Dr. Cerra had met with the deans, who in turn were to have taken the Appendix to their schools for consultation. He then met with the deans again.

Professor Campbell said the process had been unsatisfactory.

It is not consultation if Dr. Cerra talked only to the deans, after which all the faculty receive an email saying the 30-day comment period had ended.

He said he did not blame Vice President Brown or Ms. Zentner but observed that only a small group in the Academic Health Center had seen the Appendix before it was put in place. That is not usually the way the University operates, he commented.

Vice President Brown agreed Professor Campbell's criticism was fair and pointed out that the document can be changed in the future as the need arises.

Professor Luepker noted that he is a faculty member in the Academic Health Center and had not seen Appendix A prior to its adoption; it appears the faculty were not consulted, he said.

Professor Curley said, apropos of Professor Campbell's comments, that it is a matter of concern if Academic Health Center faculty have not seen Appendix A. When the policy comes to the University Senate, will Appendix A be a part of it? Vice President Brown said they can be separated and that she did not want controversy about Appendix A to serve as a bar to adoption of the institutional policy as laid out in the main document.

But what happens when there is a direct disagreement about the application of a term or phrase in the policy, Professor Hancher asked? The policy will not be "policed," Vice President Brown said. If a question about COI arises, it will go to one of the COI committees, where there will be discussion and the issue worked out.

Of course this is business as usual at the University of Minnesota and only offers further proof of the inadequacy of faculty consultation. In the future, there will be a price paid by the administration. May they hang separately.

Ranking the Rankings

Not All University Rankings Systems

Are Equal

(Our provost is a big fan of the Shanghai rankings.)


Richard Kahlenberg writes in the Chronicle of Higher Education:

In recent days, U.S. News & World Report released its much-discussed rankings of U.S. colleges and universities, and the Shanghai Jiao Tong University declared its ranking of world universities. As my Innovations Blog colleague Richard Vedder noted recently, Forbes has its own rankings to compete with U.S. News, and Vedder (who helped Forbes come up with its methodology) argues that Forbes’s is better—that is, ranks higher.

My own favorite in the rankings game is The Washington Monthly, which today released the 2010 rankings of “What Can Colleges Do for the Country.” While other guides “help students and parents decide how to spend their tuition dollars wisely,” the Monthly says its goal is “to tell citizens and policy makers which colleges [are] spending their tax dollars wisely.” The Monthly ranks colleges and universities based on whether they promote social mobility; research, and service.

As I’ve noted elsewhere, one of the intriguing findings of the Monthly’s social mobility ranking is that public universities systems where affirmative action by race has been banned—California, Florida, Michigan, and Washington—do particularly well on the social mobility front, perhaps because they can’t use race in admissions and therefore rely strongly on socioeconomic status instead.

While it is fashionable to bemoan rankings of all kinds, many are now recognizing that rankings should not be fought but improved upon. Jamie Merisotis, president of the Lumina Foundation, told Wildavsky: “The reason rankings are popular is that they actually serve a purpose. ”Rankings, he says, “are basically reflecting the market’s desire for more information.”

In the future, one hopes the proliferation of rankings will move us closer to the goal of providing students—and citizens—with the right kids of information.

[Actually, I think that the rankings, collectively, already provide a lot of useful information. For example: graduation rates and debt at graduation.]

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White Coat, Black Hat

Adventures on the Dark Side of Medicine

by Carl Elliot of the University of Minnesota

Margaret Soltan Reviews the Book

From University Diaries:

“Medical journals still trust authors; patients still trust doctors; researchers trust subjects; and subjects trust researchers,” writes Carl Elliott in his new book, White Coat, Black Hat: Adventures on the Dark Side of Medicine. “Nobody wants to admit that the world has changed. Nobody is willing to concede that trust may no longer be warranted.”

Chapter by chapter, White Coat, Black Hat systematically considers the way the world has changed. And most of the change, Elliott argues, goes one way: Toward the corruption of each aspect of the drug delivery process by commercial interests.

“Discovery” of new medications may well involve the corporate creation of pseudo-disorders (“‘You are not shy; you have social anxiety disorder. You are not absentminded, dreamy, or fidgety; you have ADHD. You are not moody; you are bipolar.’ Each diagnosis comes with a prescription. The need for medication becomes part of your identity.”); testing can mean sloppy, industry-run exploitation of guinea pigs, poor and desperate people who present themselves as human subjects in one trial after another because they need the money; the publication of results can mean corporation-controlled ghostwriters whose “articles” are warmed-over advertising.

Then there’s the aggressive selling of meds to doctors by salespeople in the field, and by drug lobbyist/physicians at Continuing Medical Education junkets; there’s also the sophisticated advertising of the new pseudo-disorders:

Pharmaceutical companies have been joined by advertising companies, publishing companies, public relations firms, medical education agencies, and university CME offices, each with its own set of skills, services, and financial incentives.

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Elliott looks beyond outward evidence of corruption. He’s good on the deeper motivations underlying, for instance, academic physicians who sell out to pharma. It’s not just money that draws once-respectable researchers into corporate thralldom:

The real appeal of being a [Key Opinion Leader] is that of being acknowledged as important… It is a hunger for status that motivates many academic physicians to work for industry…

Pharmaceutical companies, David Healey tells Elliott, pick KOL’s “based on their psychology and things like that, to suit their needs. They pick the kind of people who would like to have on their CV that they have written eight hundred articles. When in fact they have written ten or twenty, and the other seven hundred and ninety have been written by medical writers.”

Why does industry want to attach itself to people associated with universities? “[B]ecause pharmaceutical companies are so widely distrusted by the public, they need academic physicians to front their research and give it a patina of legitimacy.”

Among university faculty, professors who sit on bioethics panels oversee, and usually approve, various trials. Originally independent, bioethicists, argues Elliott, now increasingly serve to legitimize many of pharma’s bastard offspring. “Since they are paid by the companies whose protocols they review, commercial [bioethics review boards] have a financial interest in keeping their clients happy.” He quotes Jonathan Imber calling bioethics “the public relations division of modern medicine.”

Indeed at universities, “Bioethicists teach ethics to college students … who generally do not suspect that the professors may be getting a paycheck from the very corporations they are discussing in class.”

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The concept of “university” itself has dulled to the point of vanishing, Elliott suggests, in America’s compromised medical schools. “[U]niversities … must compete in a marketplace dominated by the [drug] industry and its commercial spin-offs. If more academics think like businesspeople now, it is partly because the world in which drugs are tested, developed, and marketed is so completely ruled by business.”

The Barnum and Bailey ridiculousness of professors listing eight hundred publications on their cvs tells us that the ethos of big business has come crashing into our medical schools, elevating ringmasters like Charles Nemeroff and Joseph Biederman (both of whom Elliott discusses) to the top of the profession.

*************************************

Trust? Only an idiot would trust these clowns.

Unfortunately, as Donald Light details in his much-discussed recent paper about the drug industry having become a market in lemons, it turns out we are. Idiots. We must be. We’re still buying.

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Hooked: Ethics, Medicine and Pharma

Ethics Problems at the University of Minnesota

Updates and Commentary related to HOOKED: ETHICS, THE MEDICAL PROFESSION, AND THE PHARMACEUTICAL INDUSTRY, by Howard Brody, MD, PhD

New book of interest from Carl Elliot:

I have been privileged to receive an advance copy of Carl Elliott's White Coat, Black Hat: Adventures on the Dark Side of Medicine (Boston: Beacon Press, 2010, ISBN 978-0-8070-6142-8; $24.95 hardcover, 211 pp.). I have only just dipped into it, and may post more after I have read it all, but wanted to waste no time in getting the word out.

Carl, who has been mentioned in these parts previously, is an MD who then went on and got a PhD in philosophy and has taught bioethics at a number of world universities, currently at University of Minnesota. He's published his essays in such places as The New Yorker and The Atlantic Monthly, and I feared at first that this book would be merely a collection of those essays, but I see he's reworked the material for this book specifically.

Carl is concerned about the cast of characters that populates the "dark side of medicine" where business and market values seem to have taken over from any sort of professional commitment to the care and well-being of patients, with a special focus on Pharma.

His chapters deal, respectively, with

professional guinea pigs who volunteer for one research study after another;

the "ghosts" who actually write ghost-written articles;

drug reps; medical "key opinion leaders"; marketers;

and finally, a group that Carl has practically made a career of irritating, bioethicists like Carl and me who (unlike Carl and me) get seduced into signing on with corporate boards and taking corporate cash, assuming that the corporations actually want us to tell them what's ethical, and might listen if we tell them (while meanwhile we get to fly to their meetings first class and stay in five-star hotels).

The book is nicely illustrated with anecdotes and interviews, such as this nice quote from former drug rep Jordan Katz, about how the code of ethics introduced by PhRMA in 2002 actually made things worse: "The companies that tried to follow the guidelines lost a ton of market share, and the ones who didn't gained it. The bottom line is that if you don't pay off the doctors, you will not succeed in pharmaceuticals. Period."

I think it's a safe bet that readers who find this blog interesting will like this book.

Alliance For Human Research Protection

on

Carl Elliot's Making a Killing

Monday, 23 August 2010

The catalyst for Dr. Elliott's article was the tragic case of Dan Markingson, a 26-year old who committed suicide in May 2004, while prescribed Seroquel in the CAFE trial.

Kudos to Carl Elliott, MD, PhD, whose insightful article, "Making a Killing ," published in Mother Jones, is a searing indictment of the morally bankrupt prevailing culture in academia and government oversight agencies that has lent the veneer of legitimacy to dubious commercially-driven clinical trials that are designed to promote drug marketing goals--NOT to produce scientific knowledge for the benefit of society--as mandated by ethical standards, such as the Nuremberg Code.

The Nuremberg Code stipulates that an “experiment should be such as to yield fruitful results for the good of society,” and “the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.”

But, Dr. Elliott identifies a fundamental moral deviation from universal ethical codes governing clinical research: the assumption that medical research is being conducted to produce scientific knowledge is no longer valid.

Dr. Elliott's article focuses on AstraZeneca's CAFÉ study which was designed to promote the marketing of its antipsychotic drug, Seroquel. The study was sponsored by AstraZeneca and the University of North Carolina--it was conducted at 26 sites, involving 400 patients. Of these, all but 119 stopped taking the drug before the yearlong study was finished. Such trials lack a scientific raison d'etre. They are, by definition, immoral.

Indeed, when shown the published report of the CAFÉ study, Dr. Peter Tyrer, the editor of the British Journal of Psychiatry, Dr. Tyrer indicated:

“I would have major problems accepting a manuscript of that nature....“In scientific terms this study is of very little value.”

Internal AstraZeneca documents indicate that the CAFÉ study was designed to serve two purposes: a “regulatory” purpose and a “commercial” purpose. The regulatory purpose was to “produce data that will help us defend the Seroquel label.”

The commercial purpose was to “produce data that will enable us to generate commercially attractive and competitive messages in relation to diabetes and weight.”

So, Dr. Elliott cuts to the chase when he asks:

"... if a research study is not really aimed at producing genuine scientific knowledge at all...How much risk to human subjects is justified in a study whose principal aim is to “generate commercially attractive messages”?

The catalyst for Dr. Elliott's article was the tragic case of Dan Markingson, a 26-year old who committed suicide in May 2004, while prescribed Seroquel in the CAFE trial. AstraZeneca reported 18 "serious adverse events" in the trial, including an alleged homicide, five suicide attempts, of which two were successful suicides--both by patients taking Seroquel.

Dan was enrolled in the CAFÉ study at the University of Minnesota--while he was in the thows of a psychotic episode. In that mental state, he was, by definition mentally incapacitated--and therefore, incapable of giving informed consent. Within 6 months of being in the study, he committed suicide. Those involved in his enrollment were violating fundamental national and international ethical standards.

Documented evidence shows that Dan was enrolled in the trial under duress--threatened with involuntary commitment to a mental hospital. Furthermore, university psychiatrists kept him in the trial despite the vigorous opposition of his mother who expressed concern about his deteriorating mental condition and explosive rage. Mary Weiss' relentless effort to protect her son from the risks involved in the trial were ignored by senior university psychiatrists--Dr. Stephen Olson and Dr. Charles Schultz, chairman of psychiatry. She wrote numerous letters asking that Dan be released from the study, to no avail.

Ten days before he killed himself, his mother left a voice message for the CAFÉ study coordinator saying:

“Do we have to wait until he kills himself or someone else before anyone does anything?”

This case encapsulates the tragic consequences of a broken system which is not designed to detect the hazards for human subjects posed by market-driven research. Nor is the system designed to take steps to prevent predictable hazards. Indeed, the authorized academics and government officials charged with protecting human subjects from unjustifiable risks of harm and / or exploitation, whose responsibility is to ensure that clinical trialists adhere to federal regulations for the protection of human subjects, are violating their public mandate. Instead of protecting human subjects from exploitation, they shield the commercial and academic stakeholders.

Dr Olson and Dr. Schulz, who were handsomely paid by AstraZeneca, denied that Dan's condition deteriorated during the trial.

A public database maintained by the Minnesota pharmacy board indicates that "Olson received a total of $240,045 from the pharmaceutical industry between 2002 and 2008, with $149,344 coming from AstraZeneca. Dr. Charles Schulz, his co-investigator and department chair, received an even greater sum: more than $571,000 from the industry, with $112,020 coming from AstraZeneca." The University of Minnesota received $327,000 for the study from AstraZeneca. Clearly, these sums presented a conflict of interest.

Sharon Matson, an FDA investigator exonerated the University of Minnesota, finding no evidence of misconduct: “I did not find any evidence of misconduct, significant violation of the protocol, or regulations governing clinical investigators or IRBs...” She specifically dismissed the suggestion that Dan was mentally incompetent to consent to the study, writing that “there was nothing different about this subject than others enrolled to indicate that he couldn’t provide voluntary, informed consent.” In other words, FDA officials endorse the enrollment of psychotic patients in drug trials--even as such patients are incapable of making sound judgments.

As Dr. Elliott explains, "the study in which Dan Markingson committed suicide was not simply a matter of inadequate informed consent, or financial conflicts of interest, or even failure to monitor a subject’s care. The ethical breach was built into the study from the start. It is one thing to ask people to take risks for science, or the common good, or to help other people. It is another thing entirely to ask them to risk their lives for the marketing goals of AstraZeneca."

Dr. Elliott notes that documents unsealed in related civil suits suggest an alarming pattern of deception. Internal correspondence reveals company officials discussing how to hide or spin potentially damaging studies. “Thus far, we have buried trials 15, 31, 56,” wrote a publications manager in 1999.

“The larger issue is how do we face the outside world when they begin to criticize us for suppressing data.”

Indeed, in 2010, AstraZeneca became the fourth pharmaceutical giant in the last three years to admit to federal charges of illegal marketing of antipsychotic drugs. The company has paid $520 million to settle federal investigation over the illegal marketing claims made about Seroquel.

It faces more than 25,000 civil lawsuits filed on behalf of patients contending that the company did not disclose the drug’s risks.

But what about the culpability of the academics who conducted such commercially-motivated exercises?

The principle investigator of the CAFÉ study was Jeffrey Lieberman MD, chairman of psychiatry, Columbia University (then at Chapel Hill, North Carolina).

How much did AstraZeneca pay him to provide the appearance of legitimacy to this commercially driven exercise whose goal was "to produce data to generate commercially attractive and competitive messages?"

In 2005, Dr. Lieberman rhapsodized to physicians at the World Congress of Biological Psychiatry about the CAFÉ study findings and the value of second generation antipsychotics. He recommended that they explore "even higher doses" on their patients.

"CAFÉ is the first study of this size to compare multiple second generation antipsychotic drugs in first-episode patients. This study provides important new information on the comparative efficacy and safety of these medications that will guide clinicians in their care of these patients. These data underscore the importance of appropriate dosing for agents such as quetiapine [Seroquel] in first-episode psychosis. In individuals with chronic schizophrenia, clinicians should fully explore even higher doses of medications, including quetiapine."

Our own observation is that commercially-driven clinical trials such as the CAFÉ study, foster about as much genuine scientific information as prostitution fosters family values!

Dr. Elliott, who is a Professor at the Center for Bioethics at the University of Minnesota Medical School; and a Professor in the Department of Pediatrics as well in the Department of Philosophy, writes:

"Of all the ways in which Mary Weiss has been damaged by the University of Minnesota, there is one episode that still brings a sting of shame to my face. When the lawsuit over Dan’s death was dismissed, the university filed a legal action against Mary, demanding that she pay the university $57,000 to cover its legal expenses. Gale Pearson, one of Mary’s attorneys, says that while such suits are technically permissible, she had never seen one filed in her previous 14 years of legal practice. The university agreed to drop the lawsuit against Mary only when she agreed not to appeal the judge’s decision.

“Maybe they want to chill anyone who might think of challenging the university, even if her child had died,” Pearson said. “It gave me a sick feeling.”

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