July 10th, 2009
The Etiology of COI

Arnold Relman, in the New York Review of Books:

Nearly a half-century ago, Stanford economics professor Kenneth Arrow, later a Nobel laureate, convincingly argued that medical care cannot conform to market laws because patients are not ordinary consumers and doctors are not ordinary vendors. He said that sick or injured patients must rely on physicians in ways fundamentally different from the price-driven relation between buyers and sellers in an ordinary market. This argument implied that, contrary to the assumptions of antitrust law, market competition among physicians cannot be expected to lower medical prices. And since physicians influence decisions to use medical services far more than patients do, the volume and types of services provided to patients—and hence total health costs—need to be controlled by forces other than the market, such as professional standards and government regulation. But Arrow’s argument was largely ignored in the rush to exploit health care for commercial purposes that ensued after the passage of Medicare and Medicaid in 1965.

When the organizations that set professional standards — the whorish American Psychiatric Association, for instance — are themselves market law conformists, what hope for change? That organization, speaking of excess volume and types of services, is even now revising the profession’s diagnostic manual to medicalize more and more non-medical human behaviors. There’s money in it.

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

Update: Recall Marcia Angell in the New York Review of Books:

Since there are no objective tests for mental illness and the boundaries between normal and abnormal are often uncertain, psychiatry is a particularly fertile field for creating new diagnoses or broadening old ones. Diagnostic criteria are pretty much the exclusive province of the current edition of the Diagnostic and Statistical Manual of Mental Disorders, which is the product of a panel of psychiatrists, most of whom, as I mentioned earlier, had financial ties to the pharmaceutical industry. [Christopher] Lane, a research professor of literature at Northwestern University, traces the evolution of the DSM from its modest beginnings in 1952 as a small, spiral-bound handbook (DSM-I) to its current 943-page incarnation (the revised version of DSM-IV) as the undisputed “bible” of psychiatry—the standard reference for courts, prisons, schools, insurance companies, emergency rooms, doctors’ offices, and medical facilities of all kinds.

Given its importance, you might think that the DSM represents the authoritative distillation of a large body of scientific evidence. But Lane, using unpublished records from the archives of the American Psychiatric Association and interviews with the principals, shows that it is instead the product of a complex of academic politics, personal ambition, ideology, and, perhaps most important, the influence of the pharmaceutical industry. What the DSM lacks is evidence. Lane quotes one contributor to the DSM-III task force:

There was very little systematic research, and much of the research that existed was really a hodgepodge—scattered, inconsistent, and ambiguous. I think the majority of us recognized that the amount of good, solid science upon which we were making our decisions was pretty modest.

Lane uses shyness as his case study of disease-mongering in psychiatry. Shyness as a psychiatric illness made its debut as “social phobia” in DSM-III in 1980, but was said to be rare. By 1994, when DSM-IV was published, it had become “social anxiety disorder,” now said to be extremely common. According to Lane, GlaxoSmithKline, hoping to boost sales for its antidepressant, Paxil, decided to promote social anxiety disorder as “a severe medical condition.” In 1999, the company received FDA approval to market the drug for social anxiety disorder. It launched an extensive media campaign to do it, including posters in bus shelters across the country showing forlorn individuals and the words “Imagine being allergic to people…,” and sales soared. Barry Brand, Paxil’s product director, was quoted as saying, “Every marketer’s dream is to find an unidentified or unknown market and develop it. That’s what we were able to do with social anxiety disorder.”

Some of the biggest blockbusters are psychoactive drugs. The theory that psychiatric conditions stem from a biochemical imbalance is used as a justification for their widespread use, even though the theory has yet to be proved. Children are particularly vulnerable targets. What parents dare say “No” when a physician says their difficult child is sick and recommends drug treatment? We are now in the midst of an apparent epidemic of bipolar disease in children (which seems to be replacing attention-deficit hyperactivity disorder as the most publicized condition in childhood), with a forty-fold increase in the diagnosis between 1994 and 2003.[18] These children are often treated with multiple drugs off-label, many of which, whatever their other properties, are sedating, and nearly all of which have potentially serious side effects.

July 9th, 2009
Calling All Patriots!

Continuing Medical Education, a great American tradition described here, is under attack by the government, and by universities.

Daniel Carlat’s on the case; he’s reproduced on his blog an ad — no, not an ad! A call to arms! — running in medical journals and magazines that alerts fellow Americans to the chilling effect of efforts to transform CME from free vacations paid for by drug firms that want you to prescribe their pills and use their devices, to evidence-based, serious seminars run by independent scientists. (Here’s another description of the ad.)

If CME junkets, which after all make everyone happy — the doctor who gets a free vacation, the salesperson who gets a captive audience — are undermined, the very foundations of this nation will begin to tremble.

July 7th, 2009
Doctors for Sail.

The Daily Telegraph, Australia.

A drug company is offering doctors who prescribe its medicines a 10-day Mediterranean cruise in a move that could breach a code of conduct.

And taxpayers will help subsidise the cruise – described as “the perfect mix of education and relaxation” – because doctors are being told they can claim it as a professional development program.

The cruise raises questions about drug company ethics and the Australian Medical Association and the peak pharmaceutical industry group have warned the offer could lead to the perception of a conflict of interest for doctors who take it up.

Sigma, a generic drug manufacturer and the third-biggest pharmaceutical company in the country, wants to take general practitioners on a luxury cruise visiting Italy, Malta, Corsica and Monte Carlo in October…

July 7th, 2009
“The UIHC began a review of its conflict-of-interest policy in January, because of growing national attention on several reports of conflicts of interest at other universities, including a case at Stanford involving a researcher who lied about the amount of money he received from companies.”

Yes, word’s getting around. This is from the University of Iowa.

July 5th, 2009
A good summary of the medical school conflict of interest story so far…

…from Science Magazine. Excerpts:

The end result [of Senator Charles Grassley’s investigation and proposed legislation] is expected to vastly expand the information that faculty — both basic and clinical — must report to their institutions and to NIH. And it will likely ask for more details on how institutions follow up on conflicts.

… The issue exploded in the media a year ago thanks to Grassley, the ranking member of the Senate Finance Committee. The 75-year-old Midwesterner, a longtime fraud buster, started out investigating defense contracts. In recent years, Grassley, citing his committee’s oversight of Medicare and Medicaid, began probing conflicts of interest involving the approval of drugs such as Paxil and Vioxx.

In 2007, these probes led Grassley’s investigators to conflicts of interest at biomedical research institutions. Using a strategy that had worked well in an inquiry by the House of Representatives, they asked both companies and institutions about payments to a faculty member and looked for discrepancies. Grassley says they got leads from media reports and “whistleblowers” such as critical faculty members.

Grassley’s team made its first big splash with a front-page story in The New York Times last June. They alleged that three Harvard child psychiatrists had failed to report hundreds of thousands of dollars in income they received over several years from drug companies. Other psychiatrists and surgeons have since been accused of hiding similar payments, and some have been disciplined…

… No rule is universally obeyed, of course, and scientists could still hide their income. Many of those Grassley has probed allegedly were not following existing rules. The remedy for that, many observers say, is a public database of payments reported by companies — such as one that would be created by the bill introduced by Grassley and Senator Herbert Kohl (D–WI), potentially by October 2011. University officials could use the database to audit their faculty members, say AAMC and AAU, which support the bill…

July 3rd, 2009
“The conflict of interest arose because the company acquires grants for research and then outsources some of the money to laboratories like the one at MU.”

A professor runs a research unit of some sort that gets grants.

At some point it occurs to the professor that he or she could start a business and steer grants the business gets to the university research unit.

This is classic conflict of interest, and there’s a case of it now at the University of Missouri.

An internal audit of MU’s Research Animal Diagnostic Laboratory, known as RADIL, prompted the lab’s director, Lela Riley, to step down because of a conflict of interest.

According to a statement issued by the university, a conflict of interest arose because Riley was both the head of the research lab and the head of a “private venture company” called Impact Bio Labs LLC. The company and the lab do business together, and MU felt that management changes were necessary to absolve the conflict.

Make that resolve the conflict. Conflicts don’t need absolution.

Another article about this conflict explained it this way:

In 2005, Riley and seven RADIL faculty members formed a private venture company known as Impact Bio Labs LLC. As a private company, Impact Bio Labs has been able to secure federal grant funding for private companies and unavailable to public universities.

Again, the idea is to steer grant money that the university can’t get directly to the university because, as owner of the private business, you now control the grant and can move it around. And you’re gonna move it around to your lab, of course. Conflict of interest means you’ve really got things sewn up. You’ve got them coming and going.

July 1st, 2009
Madoff? Don’t know the name.

From the Canadian Jewish News:

… In his keynote address [at a Yeshiva event in Montreal recently], [Richard] Joel, who has been YU president since 2003, made an appeal for greater financial support from Montrealers, as well as for them to send more of their children to YU.

He said the university spends about $2.5 to $3 million a year educating those Montrealers, but receives only about $750,000 to $850,000 in revenue in any given year from Montreal.

“The economy is awful, and we are operating in a major deficit,” he added.

Joel did not refer to the $14.5 million YU has said it lost in the fraud allegedly perpetrated by Bernard Madoff, who was a member of its board of trustees…

June 30th, 2009
“Industry financial relationships do not benefit the educational missions of medical institutions in ways that offset the risks created.”

UD takes this typically dull sentence from a book written by committee and full of dull sentences.

Unfortunately, the book is extremely important, making the case, as it does, that conflict of interest in academic and non-academic medicine is an immense national scandal.

This being University Diaries, UD pays attention only to that small part of the scandal that involves universities with medical schools. But there’s so much more, and this book covers it all. Dully.

Conflict of Interest in Medical Research, Education, and Practice (note titillating title), published by National Academies Press, may be bought, downloaded, skimmed online … mainlined via hypodermic… what I mean is, there are many, many ways to read this book. Is what I’m trying to get across.

An option that doesn’t exist is reading its important and even dramatic material in a way that doesn’t make you bitter about how old you’re getting. (Though this might just be me.)

June 30th, 2009
Gotta Give ‘Em Points for Chutzpah.

The University of Florida medical school can’t even find and retain forms it’s been sent to complete on conflict of interest.

Because of this pathetic failure, the American Medical Student Association gave the school an F grade on its widely publicized national measurement of how well universities are handling conflict of interest in their med schools. The university had to plead with AMSA to change its grade to in progress,which AMSA graciously allowed.

And now a blowhard UF dean, interviewed by the student newspaper, comes out with this:

[AMSA] is the least knowledgeable [in conflicts of interest policies],” Flynn said, referring to the fact that AMSA is an organization made up of medical students. “[No offense to them, but] they’re not even in the profession yet. We’re doing this because we feel it’s the right thing to do, not because of them.”

Yes, the wee babes of AMSA! We big boys who’ve been at the conflict of interest game for decades know how it’s played. These innocents, these hyper-moral fools, these fanatics, waltz in with their little questionnaires and think we have to notice! No offense, but they don’t know shit. We threw their presumptuous little form in the trash the minute we saw it… Now it turns out people actually pay attention to the fuckers…. We had four secretaries scrounging through garbage to find the thing! But no go. We’ve had to kiss up to the assholes…

June 29th, 2009
Madoff’s University.

As we await Madoff’s sentencing today, we revisit unapologetically ill-run Yeshiva University.

[Many institutions connected to Madoff] not only need to more formally organize their investing and giving along more official corporate governance lines — Yeshiva University in particular has been cited for this type of needed reform. [T]hey may need to address their own unwitting complicity in the dissipation of the assets of Mr. Madoff’s victims.

Madoff, recall, was Yeshiva’s treasurer, Ezra Merkin an influential trustee. There’s been no public reckoning with this history on that campus, and conflict of interest remains the all-male board of trustees’ middle name.

Sure, Yeshiva lost money through Madoff. It also made plenty of money – for itself, and for its trustees. Yeshiva has said nothing by way of acknowledgement of the depth of its misdeeds.

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

Update: It’s also a good day to remember this letter, written last year to the president of Yeshiva from one of its law school graduates, Andrew Sole. Here are its closing paragraphs:

[H]arm has come to this distinguished University, both in financial loss and worse, in reputation. It is my view that the harm today is directly attributable to the failed performance of our trustees. As fiduciaries they lost sight of their primary mission, to safeguard the long-term interests of Yeshiva University. Whether their activities were merely negligent, or worse, that judgment is best left for others.

In my view it will take a generation to repair the damage inflicted upon Yeshiva. And that is very sad. But what would be even sadder, and which would also give grave concerns to Yeshiva’s many supporters, would be for the University to continue to allow the current Board of Trustees to serve as fiduciaries going forward.

The honorable course (and we have seen virtually no honorable behavior in American corporate boardrooms, nor in our public servants, in 2008) would be for the University’s President, and its legal counsel, Sullivan and Cromwell, to demand the immediate resignation of the entire Board of Trustees. The University’s counsel, government regulators, and law enforcement will conduct their proper investigations, but the proud students, graduates, and supporters of Yeshiva University should not have to wait that long for credible and therapeutic action to be taken by this University.

Yeshiva has the opportunity to begin the healing process today by installing new fiduciaries that are untainted by scandal and embarrassment. I hope you will take this letter to heart and I wish the University the best during these incredibly trying times.

Yeshiva responded to Sole with a form letter brush-off.

And all of those men, those hands-in-each-others’-pockets men, those Madoff and Merkin men, remain on the Yeshiva University board of trustees.

June 24th, 2009
A Business Blogger…

… reminds us of the two biggest Larry Summers scandals at Harvard.  The blogger reminds us of this because he doesn’t think Summers should be considered for head of the Federal Reserve.  He doubts Summers could even make it through a Senate confirmation.

…He … was criticized for shielding his protégé Andrei Shleifer from accusations of conflict of interest when Shleifer sought lucrative commercial deals for himself as he headed a government-sponsored Harvard team to advise Russia on privatization. The university paid $26.5 million to the U.S. government to settle a lawsuit that Shleifer’s activities violated its contract.

This controversy, too, would resurface in any hearings on Summers’ fitness for the Fed job. Coupled with his own dubious fees from various Wall Street firms who wildly overpaid him for “advice” while he was aiding candidate Obama, the Shleifer affair would raise questions about Summers’ judgment in these matters. …

Both of these sleazy tales have been extensively covered on University Diaries.

June 22nd, 2009
“Universities cracking down on student plagiarism need to pay closer attention to faculty.”

Mississippi State University bioethicist Barton Moffatt predicts doctors who allow their names to be put on ghostwritten articles may one day find themselves being fired over the practice, adding that many in academia now see the practice as plagiarism.

[Trudo] Lemmens [a professor of medical law at the University of Toronto] says he would fail any student who handed in a ghostwritten article, adding that universities cracking down on student plagiarism need to pay closer attention to faculty, as well.

“It is clearly false representation, which is academic misconduct. If we don’t do something about it (ghostwriting), it’s hard to tell the students it is wrong.”

You do begin to wonder… I mean, what are universities afraid of? The medical faculty will poison their sherry? You’ve got all these really highly paid professors, quite a number of whom do a raft of illegal, unethical, embarrassing things… The whole conflict of interest, ghost-writing, Continuing Medical Vacation shebang…

From the same article:

To test the integrity of a [corporate-ghosted] publication called The Open Information Science Journal, Cornell University student Philip Davis and Kent Anderson of the New England Journal of Medicine, submitted a fake manuscript – generated by a computer program to be purposely nonsensical – at the end of January. The “open information” journal offered to publish the article if the pair agreed to pay an $800 publishing fee. The editor later resigned.

June 22nd, 2009
They’re timing the report to coincide with USC’s …

… release of its report on  Reggie Bush.

Medical school professors at the University of Minnesota are just as eager to lose money on their personal promotion of pills and devices, and on the sale of their university affiliation for use on corporate-generated research papers, as the University of Southern California is to admit guilt in the Bush recruiting scandal.   

Thrilled at the prospect of losing football games, incurring financial and win-record penalties, and telling professors accustomed to $500,000 base salaries plus up to a million dollars a year in corporate supplements that they’ll have to make due on the $500,000, committees at both schools are working with brisk efficiency on sanctions and rule changes. 

Here’s an update on the work of the University of Minnesota conflict of interest committee:

 

After a year and a half of work, the University of Minnesota still does not have a new conflict of interest policy in place for its 450 faculty, 990 residents and 920 medical students.

… [S]ome are frustrated with the pace of the process, and say the university has missed an opportunity to draft a tough policy that protects patients.

Josh Lackner and two dozen others in the University of Minnesota medical community came up with 14 pages of recommendations to prevent conflict of interest at the U of M’s medical school last fall.

Lackner, a recent med school graduate, doesn’t see many of those suggestions in a draft document being used by med school leaders to create a new conflict of interest policy.

… Allan Coukel, director of the Pew Prescription Project, a Boston-based group that monitors conflict of interest policies at the nation’s medical schools, has followed the U’s effort to rewrite its policy. Coukel thought early on the U was headed in the right direction.

“It looks like at one stage they were considering policies that really would have put them in the first rank nationally,” Coukel said. “And now they’re circulating a document that we can say is a modest advance, but they’ve squandered a chance to be a national leader.”

… Some say it’s simply taken too long for the med school’s leadership to come up with a new document. At one point, the document was expected to be ready by April.

June 20th, 2009
You only get a peek.

Professors at the University of Wisconsin medical school are appalled at the voyeuristic ways of Charles Grassley.

Some of the orthopedic surgeons [who make enormous outside sums pushing medical devices] also were among the most vocal opponents to the university’s new disclosure requirements, referring to the more stringent disclosure requirements as voyeuristic.

In the past, they and other doctors who earned large sums working as consultants, speakers or from royalties could merely state that they received more than $20,000 without having to tell their patients or the university the actual amount.

It’s only appropriate that we not tell you the actual amount. Only a sicko would want to see the actual amount.

June 20th, 2009
A Few Sweet Nothings on the Conflict of Interest Front

… [I protest the] feigned or real naiveté on the part of [medical] professionals who claim they are above being influenced [by industry money and gifts]. Physicians owe their patients much more than naiveté. The degree to which policy rather than personal ethics is necessary to bring an end to obvious marketing schemes is a reproach to my profession.

… Almost two-thirds [of medical school department chairs] have a personal relationship with industry as consultant, board member, paid speaker or the like. It is not unusual to see papers in major medical journals where authors disclose relationships with many, many industrial organizations.

Is anyone reassured by all this disclosing? I am not. To the contrary, I look askance at the discloser and at the substance that is being put forth. I am not surprised when paper after paper documents that when the study of a drug or device is industry supported, the result is far more likely to be positive than when the study of the same drug or device is government supported.

… My queasiness peaks when I know that the “CEO” of a large state-supported academic health center is also on the board of a certain major pharmaceutical benefits manager — which just happens to be the pharmaceutical benefits manager for that state’s employee health plan.

… Very seldom, anymore, are the trials necessary for licensing drugs or devices carried out by the manufacturer. There is an industry devoted to providing that service, the Contract Research Organizations (CROs). I have long railed against this relationship as I consider it inherently conflictual. Science is the exercise of disproving any hypothesis. The CRO is contracted in the hopes it will prove the hypothesis that a particular drug or device is an important contribution. There is no joy in Mudville when the study is negative (see the discussion above about industry-supported vs. government-supported science of this nature). CROs can be very lucrative. Many academic health centers have their own CRO, and many others wish they did. Furthermore, many an “academic physician” is employed for “translational research,” which is a euphemism for recruiting patients into trials run by CROs…

Norton Hadler, ABC News.

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UD REVIEWED

Dr. Bernard Carroll, known as the "conscience of psychiatry," contributed to various blogs, including Margaret Soltan's University Diaries, for which he sometimes wrote limericks under the name Adam.
New York Times

George Washington University English professor Margaret Soltan writes a blog called University Diaries, in which she decries the Twilight Zone-ish state our holy land’s institutes of higher ed find themselves in these days.
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It’s [UD's] intellectual honesty that makes her blog required reading.
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There's always something delightful and thought intriguing to be found at Margaret Soltan's no-holds-barred, firebrand tinged blog about university life.
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