… have gathered a good number of faculty at the University of Minnesota to request a review of Markingson’s case. The Regents will at least look at the letter Elliott and others have written to them. Maybe the Regents will act on it. This blog will follow the story.

University of Minnesota counsel Mark Rotenberg will meet with the Board of Regents to discuss a letter requesting an independent investigation into events surrounding Dan Markingson’s 2004 suicide.

Eight U of M bioethicists sent the letter last week detailing potential ethical lapses that may have led to Markingson taking his own life while enrolled in a clinical study at the college. Several more faculty members have since sent a subsequent letter to the Regents supporting the call for an investigation.

The story is complicated and long, but essentially involves a claim that University of Minnesota researchers, eager to enroll subjects in an experiment, enrolled Markingson, even though he was reportedly in no mental shape to give informed consent.

Long article by Carl Elliott about the Markingson case here.

…. sentiment.

Unfortunately, the horse has been out of the barn on this campus for many years.

A Nashville paper writes a long, thoughtful piece on the corruption of American medical education and practice.

The reporter interviewed – or tried to interview – some highly paid pharma shills. One of them, a professor at Meharry, said

he would need to check with the school’s communications department before commenting, but did not respond by press time.

Poor man can’t open his mouth without permission — either from his university, or from Eli Lilly.

A Duke University medical student is distressed at the tacky thing his expensive, classy Duke education begins to resemble. Why are so many of his well-compensated professors so greedy that they go out and shill for drug companies?

It’s really not very becoming. The American Medical Student Association gave Duke a D last year on its report card on conflicted med schools. This year, Bart Simpson-like, Duke med has pulled itself up to a C.

From Dirty to Cheesy. It’s a start.

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COMMUNIST!

“It’s nonsense,” [one paid medical speaker said of calls for stricter oversight of conflicts]. “The notion that somehow this is going to influence us, because we’re getting dinner from a drug company, this is communist, nanny government at its most extreme.”

Next thing you know they’ll be regulating for-profit education!

Yeah. Well. This blog’s tag line up there says UD wants to change things. But you’ll never change this thing. These guys are too smart.

And, you know, they run the universities, their boards, and their endowments.

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UD thanks Ralph for the link.

… how medical school professors become corrupted.

Universities could easily clean up the [conflict of interest] problem, simply by banning or capping industry payments to faculty members, but that is unlikely to happen. Not just because academic physicians would object, but also because many high-level university administrators have lucrative corporate relationships of their own. (For instance, the president of the University of Michigan sits on the Board of Directors of Johnson & Johnson, while the president of Brown University sat on the boards of Pfizer and Goldman Sachs.) As universities have come to look more like businesses, competing for funding and prestige in a consumer marketplace, industry relationships have become a lucrative perk of many university jobs.

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UD thanks Bill for the link.

It’s a remarkable new model whose time has come. Have physicians pay for their own education.

After all, homeless people have to pay back the government loans they take out in order to attend for-profit universities. Now some people are saying it’s time for doctors to pay for their Continuing Medical Education courses.

The way it goes now is like this: The doctor gets an invitation from a drug company to have dinner, paid for by the company, at the Palm Restaurant. At the Palm, the doctor joins a table of happy people who drink wine and eat steak and listen to a salesperson from the drug company talk about an expensive new pill. At the end of the meal, deeply satisfied with the dinner and very grateful to the drug company, the doctor decides he’ll start prescribing the new pill tomorrow.

His night at the Palm has earned him four CME credits.

“[D]octors often pay little or nothing for the instruction because many of the companies that offer it are partly funded by makers of drugs and medical devices,” explains the Boston Globe in an article about a Harvard professor who’s starting a CME company without big pharma money.

Critics say the reliance on industry funding allows drug and device companies to influence what is taught, potentially misleading physicians about the best treatments for patients and pushing up spending on prescription drugs. They note that many other professionals pay for their own continuing education.

In yet another sign of what Marcia Angell describes as “the widespread corruption of the medical profession by industry money,” a Columbia University study reveals that

Twenty-five out of 32 highly paid consultants to medical device companies in 2007, or their publishers, failed to reveal the financial connections in journal articles the following year…

Researchers followed the disclosure activities of a group of MDs and PhDs who were paid a million dollars or more by orthopedic device companies in 2007. Most of these people failed to disclose their financial conflicts of interest in the journals that published their articles.

And, as Angell points out, the journals get money from the companies too, in the form of advertisements, so they’re not about to actually enforce their disclosure policy…

Everybody’s getting paid, see. Professors at medical schools are getting paid. Journals are getting paid.

Some in this group might be getting paid twice, as it were. Ghostwriters, possibly hired by the same companies paying their consultancy fees, could be writing their articles for them…

Quelle postmodern! Simulacral research (ghost-written, guest-written), simulacral disclosure, simulacral journals…

… UD needs to discuss DSMBs. (The link takes you to an Emory University page informing medical researchers there about Data and Safety Monitoring Boards.)

UD thought she’d covered most of the ways in which some pharmaceutical companies interfere with, compromise, and control university clinical trials and their results. Turns out there’s more. There’s the corruption of DSMBs.

These are supposed to be independent boards (though they’re appointed by the person doing the trial, which already seems odd) which oversee trials as they’re going on, so as to detect problems that might emerge in the midst of a study. The idea is to protect research subjects and, if necessary, call a halt to things if they’re beginning to look dicey.

An editorial in this month’s New England Journal of Medicine (I got the link via the indispensable Alliance for Human Research Protection) notes that the independence of DSMBs is routinely compromised by drug manufacturers who get advance information about a trial going poorly, let’s say, and decide to call it off — to “unblind” the data — before any shit hits the fan. In more than one documented case, write the NEJM editors:

… a commercial entity decided to unblind aspects of trial data rather than let the DSMBs exercise their important and appropriate responsibilities both to the trial participants and to the wider community.

… These and other episodes have undermined public confidence in the ability of trials to operate independently of the sponsor. The current way that DSMBs are constituted and report has resulted in a loss of faith. First, many commercial entities, as illustrated by the above-mentioned examples, have not given the DSMB the independence such a panel requires. Second, outside parties view the DSMB as serving the trial sponsor rather than the selfless volunteers who put themselves at risk to advance our medical knowledge…

… writing an Inside Higher Education post. Title: LEMONIZING THE UNIVERSITY.

No, not demonizing. Lemonizing. Should be up in a few minutes.

…Ooh. Just checked. It’s up.

Donald Light, a professor of health policy, has given a paper at this year’s meeting of the American Sociological Association, in which he estimates that “85% of new drugs offer few if any new benefits while having the potential to cause serious harm due to toxicity or misuse.”

Reasonable people know that this is likely to be true, though chances are their romance with a particular anti-depressant or an ADHD thing for their kid is still ongoing.

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And how do you keep the love alive despite side effects and enormous cost?

In a beautifully written and very sad opinion piece in the New York Times, Allen Frances pleads with his psychiatry colleagues not to introduce a new category into the next edition of the profession’s influential diagnostic manual:

Suppose your spouse or child died two weeks ago and now you feel sad, take less interest and pleasure in things, have little appetite or energy, can’t sleep well and don’t feel like going to work. In the proposal for the D.S.M. 5, your condition would be diagnosed as a major depressive disorder.

[This represents] a wholesale medicalization of normal emotion, and it would result in the overdiagnosis and overtreatment of people who would do just fine if left alone to grieve with family and friends…

But here’s the real beauty of it:

Because almost everyone recovers from grief, given time and support, this treatment would undoubtedly have the highest placebo response rate in medical history. After recovering while taking a useless pill, people would assume it was the drug that made them better and would be reluctant to stop taking it. Consequently, many normal grievers would stay on a useless medication for the long haul, even though it would likely cause them more harm than good.

Of course if pharmaceutical companies relied only upon this sort of stupidity on our parts, they wouldn’t be the successful enterprises they are. As Light’s paper demonstrates, an entire apparatus of disorder definition, control of the scientific literature, compensation for professors willing to promote new drugs, constant fear-mongering advertising, off-label use, regulator swamping, etc., etc., presses these pills upon us.

Those universities and medical school professors who continue to do their bit to fuck us up should stop.

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UPDATE: The Telegraph discusses the article.

UD has just printed out a copy of Light’s article and is reading it now.

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ANOTHER UPDATE: Citing current examples of global pharma corruption is shooting fish in a barrel, but to give Light’s paper some immediate context:

… [The Department of Justice] is … interested in corrupt payments that may have influenced the reliability or integrity of data in clinical trials performed outside the US. A recent report by the Department of Health and Human Services found 80 per cent of marketing applications for drugs approved by the Food and Drug Administration in the US had relied on at least one foreign trial.

“Companies may find themselves facing critical legal issues if approval of products rested on the results of studies the DoJ deems corrupt,” Arnold & Porter said in an advisory letter to clients last month.

… [L]ast November, Lanny Breuer, head of the DoJ’s criminal division, announced that investigators would be focusing on international corruption in the pharmaceuticals industry for “years”.

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SUPERNOVA: Light’s paper is exploding all over the web. , blogs, people are talking about it.

UD‘s often had occasion to feature hucksters on American medical school faculties, researchers whose work is farcically compromised by their massive financial interests in – and often active advertising of – the compounds they’re studying.

She’s particularly intrigued when members in excellent standing of the country’s highest mandarinate are exposed.

David Sinclair, of Harvard medical school, has already embarrassed himself and Harvard with his excited endorsement of longevity supplements. University Diaries covered the scandal here. Here he is using patented huckster language (A MIRACLE!) during an interview with the New York Times.

Now Sinclair’s corporate colleague, Christoph Westphal, on the Board of Fellows of Harvard Medical School, has also gotten into trouble over the same miraculous longevity compound (the compound seems likely to shorten both Sinclair’s and Westphal’s life via stress). Although an employee of Glaxo, which has rights to the compound, Westphal’s been selling it (or a close relative) via the website of a nonprofit he runs (How can it be a nonprofit if… ?).

Pharmalot explains (UD thanks Barney for the link):

Two years ago, Glaxo ponied up $720 million to buy Sirtris Pharmaceuticals, which is famous for trying to develop medicines based on a chemical in red wine known as resveratrol. This generated intense interest because it may have an effect on aging … The science has since been questioned, but meanwhile, two key Sirtris execs assumed important roles within Glaxo’s hiearchy – Michelle Dipp became senior vp of Glaxo’s Center of Excellence for External Drug Discovery and Christoph Westphal now heads SR One, a venture capital unit.

As it turns out, this dynamic duo had joined a non-profit called the Healthy Lifespan Institute to sell resveratrol supplements online …

… Glaxo didn’t know about the online sales. A Glaxo spokeswoman writes us: “Until today, Glaxo was not aware that the Health Lifespan Institute was selling a resveratrol formulation on the Internet.” And so, the drugmaker has “instructed” Dipp and Westphal to “cease their association with this activity.” Consequently, the pair will also resign from the non-profit board…

The spokeswoman adds that the formulation of resveratrol sold by the non-profit is not identical to the one Glaxo has been testing, an effort to reassure investors that its research was not being undermined by two of its own executives…

The Wall Street Journal covers the story here; here’s the New York Times.

You’ve got a Harvard med school faculty member and a Board Fellow of Harvard med. This is seriously hoitsy toitsy stuff. But these guys are so hungry for money — even though when they sold their business to Glaxo awhile back they made zillions — that they’re beginning to be a problem. Harvard, you know, is a university.

A New York Times article describes the way senators fund vanity institutes with money from corporations which have an interest in legislation over which particular senators have influence.

“The simple fact is these things should not be named after people when they are in office.” said Norman J. Ornstein, an expert in campaign finance at the American Enterprise Institute in Washington, a conservative-leaning research group. “We all know what is going on here: the donors are trying to influence the lawmakers.”

The New York Times seems determined to keep writing about the scandal of university presidents serving on multiple corporate boards. Good.

The piece has a headline and a sub-headline.

The Academic-Industrial Complex

A Fear That Academics are Distracted Directors

Some analysts worry that academics are possibly imperiling or compromising the independence of their universities when they venture onto boards. Others question whether scholars have the time — and financial sophistication — needed to police the country’s biggest corporations while simultaneously juggling the demands of running a large university.

Why do the presidents do it?

Moolah.

Bigtime.

The attractions are clear for the president: lucrative extra pay and useful networking, among other reasons. For a dozen hours or so each month for each board served, in addition to preparation time, and their wise advice, they can receive hundreds of thousands of dollars a year.

Ruth J. Simmons, the president of Brown University and the first African-American woman to lead an Ivy League university, sat on the Goldman Sachs board until she stepped down this year. In 2009, she earned $323,539 from her Goldman directorship, including stock grants and options, as calculated by Goldman, and left the board with stock worth at the time around $4.3 million. This is in addition to her salary from Brown, $576,000 this year.

[Shirley Ann] Jackson earned $1.38 million from her directorships, comprising both cash and stock. That’s in addition to $1.6 million from her day job, including bonuses and other benefits.

Plus you learn new things! One president who was on Merck’s board says: “It was one long seminar in the sciences and molecular biology.”

Great. But if you were taking a seminar, why did Merck pay you? Why didn’t you pay Merck?

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Why do the corporations do it?

Universities are among the few institutions trusted by the public …and companies believe they can associate themselves with this quality by installing an academic on the board.

“Corporations think this is a way of enhancing their prestige and legitimacy, especially in the case of Ivy League presidents,” he says. “I suspect that’s the principal motivation. It’s probably not for their business sense.”

John Gillespie, who has written a book on corporate boards, “Money for Nothing,” says academics are often selected for another reason — because they are less likely to rock the boat than directors from the business world.

Academics may be trained to ask tough questions in their own fields, but when confronted with tricky business issues far above their level of expertise they “often become as meek as church mice,” he says.

Right. They’re learning things. They’re taking one long multi-million-dollar seminar.

One expert on corporate boards does not mince words about one of this blog’s favorite board-sitters, Brown’s Ruth Simmons.

… Goldman Sachs was hurt having Dr. Simmons as a director because she lacks financial expertise and was focused more than she should have been on other things like the firm’s philanthropy… “That seat could have been held by someone who understood derivatives.”

But she was learning!

As for the exceptionally greedy Jackson of Rennselaer:

“[I]t is just physically impossible to do the work necessary to be a good director” on so many boards. The Corporate Library estimates that board members must invest 240 hours a year, including meetings and preparation, to do the work properly. But it can become a full-time job if the company runs into trouble.

Charles M. Elson, a corporate governance specialist at the University of Delaware, is highly critical of university presidents who serve on several boards, although he is reluctant to single out particular directors or companies. “If you see a university president on multiple boards, that’s a problem,” he says. “There is no way you can do the job. Someone has got short shrift.”

As academics serve on a greater number of boards, there is also an increased chance of reputational risk if a company runs into difficulties.

“Woe to the university president who would sit on BP’s board,” says Richard P. Chait, a professor at the Harvard Graduate School of Education.

Erroll B. Davis Jr., chancellor of the University System of Georgia, was on the BP board for 12 years, though he stepped down in April, just days before the Deepwater Horizon rig exploded, causing the massive oil spill in the Gulf of Mexico. His retirement, however, wasn’t enough to protect him from being named, along with other directors, in a small number of lawsuits filed against BP over the disaster.

Plus… He’s only a business professor at Harvard, but… Bill George! Here’s looking at you!

And don’t forget Ruth Simmons. She’s left the Goldman board, but she’ll probably be named in various lawsuits against it.

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I think Phyllis Wise, who has compromised herself and her university by sitting on Nike’s board, puts the matter best:

“Many years ago, academicians tended to be dreamers,” she says. “We assumed somebody else would figure out where the money was going to come from. That notion is no longer the case.”

I mean, I think Wise intends to refer here to the money that comes to the university. But UD prefers to read her statement differently.

Those poor silly old dreamers! They never got rich.

That notion is no longer the case.

… this book.

Or, I mean, they should. Their university, after all, was dumb or corrupt enough to make Bernard Madoff, and his comrade in crime, Ezra Merkin, trustees of the school. The Markopolos book will help Yeshiva’s students understand how Madoff was able to turn their university into a laughingstock. It will help them understand how to avoid having that happen to their university in the future.

Unfortunately, far from dealing openly and honestly with its embroilment in Madoff, Yeshiva airbrushed him and Merkin from its history, hoping, I suppose, that no one would notice the positions of trust and authority these men held at that school for years.

It’s a shameful story, as Yeshiva alumni with integrity, like Andrew Sole, know.

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Here are many UD posts about Yeshiva University and Bernard Madoff.