From UD‘s friend Bill at The Periodic Table — a link to an editorial in the Minnesota Star-Tribune excoriating the University of Minnesota for ineptitude and indifference in regard to conflict of interest among its professors.

How is it possible to assess a conflict of interest, much less manage it, if [university] officials don’t know how much money is involved?

Grassley’s letter about COI to the university was “embarrassing,” writes the Strib.

Things at UM are going to get worse before they get better. UD thinks they should start stockpiling anti-embarrassment pills.

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Oh. The quotation in my headline, taken from the Strib editorial, is from Arthur Caplan, the country’s best-known medical ethicist.

These are quotations from a BBC special on the next edition (it will come out in 2012) of the psychiatric DSM.

The catch-all mental disorder category NOT OTHERWISE SPECIFIED — which will apparently be abundantly featured in the forthcoming edition — allows UD (and you too) to anticipate lifelong toxic drug treatment for something or other.

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“The relationship between the pharmaceutical industry and the American Psychiatric Association” is at the heart of Diagnostic and Statistical Manual.

“Each edition doubles the number of diagnoses.”

“A seemingly small change in adding diagnostic criteria can create a whole other population to prescribe a medication for… Most of the categories have a not-otherwise-specified diagnosis…. A person is exhibiting some mood symptoms but those symptoms are not that severe. When you have that kind of (NOS) prescription, you are inadvertently pathologizing what could be a normal part of [life].”

“If you create a criteria, and people appear to meet the criteria… well, many kids appear to have the criteria for bipolar pediatric disorder… This leads to treatment with a group of medicines that are among the most toxic in medicine…. Children of one, two, three, are put on these drugs…”

“There are barely short-term studies, let along long-term studies, on childhood bipolar disorder.”

“The majority of DSM panel members have financial ties to the industry. In the panels on mood disorders and schizophrenia, one hundred percent do… These are THE categories for which drugs are the standard treatment.”

“Psychiatry is undergoing a crisis of credibility… Senator Grassley has asked the APA leadership for their financial records…”

“The APA must develop more rigorous COI policies… Unrestricted research grants, for instance, are currently excluded in their COI policy…”

“The DSM decisions are worth $25 billion to the drug industry.”

“This whole business of sub-clinical disorders… will interest the drug industry enormously…”

“This could cause the rates of mental disorder to sky-rocket. … The pharmaceutical industry will be thrilled with broader, more open descriptions of disorders…”

Now UD, let’s calm you down.

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UD thanks Daniel Carlat.

… of the Senate hearing on Continuing Medical Education. It should be starting about now…

Oh. Here it is!

Senator Kohl, specs low on nose, summarizes the problem — “Crux of today’s hearing… Do they instead market the industry’s latest products? Greater transparency, stronger firewalls, need to be considered… I’m disappointed that the AMA has not yet updated their ethical guidelines on this… “

Martinez: “Accounts of ethical lapses on the part of some doctors and pharmaceutical companies are troubling… Sometimes the line between promotion and education can be blurred… ”

Franken: “How are patients affected by COI? … Unlimited and far from impartial interactions between industry and providers… This often has a negative influence on outcomes… Drives up prices to patients… Medical schools are over-reliant on industry funds… CME is another example of the same thing… ”

HHS/Inspector General guy: A little stiff, nervous. “An honest tale speaks best being plainly told – Shakespeare.” As opposed to glitzy biased CME tales. Wants full prohibition of industry support of CME. Wants firewalls – money yes, but independent grant organizations to disperse the money. Or doctors can pay for their own education. This might make for higher quality if they’re doing the paying. Growing concern about the quality of CME — shift cost to physicians.

Steven Nissen: “CME has grown into an enormous industry with extraordinary influence on the practice of medicine… CME has become an insidious vehicle for the aggressive promotion of drugs and devices. This now dominates the education of physicians. Marketing cleverly disguised as education…. With a wink and a nod the communication company selects speakers they know will please the industry. I can almost always guess who the speakers will be… Who is guarding the integrity of the process? I’ve written to the CME certifying agency with many complaints about bias – my letters were never even acknowledged.”

Next speaker: “It is impossible to find any aspect of medicine in which industry does not have significant control… Industry funding creates bias… Need to be free of industry influence… Stronger measures are required… Current situation unacceptable.”

Jack Rusley, med student, AMSA: He’s wearing his white doctor suit! “Medical research must serve the public and not physician lifestyles… Why do students care so much about these issues? … Not yet tinged with the streak of cynicism… My computer’s shutting down… Sorry… I’ll continue speaking off the cuff… Med students used to be docile in regard to authority… Not anymore… After pressure from Senator Grassley, the press, and students, Harvard has reviewed its COI policy and now has a passing grade on the AMSA scorecard.”

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Question session. Martinez, a lawyer, is shocked because continuing ed in the law is not sponsored by any industry. No money involved.

The bias was so terrible at a recent CME session Nissen wandered into that “I had to walk out.”

Another speaker: “Physicians are accruing the education capital here — They should pay for it themselves.”

Franken asks about the accreditation organization for CME. Nissen: “I can assure you that a considerable amount of CME … is marketing. It is not restricted in any way. It is highly biased. We therefore need a new system of certification. We need this organization to go away altogether. There’s no will to police this.”

[I’m sure I’m getting some names wrong, etc. Will correct later. This is live-blogging.]

Franken: “Is there anything good to say about CME, besides better hotels and shrimp?”

Nissen: “There are a few good CMEs. But most are subtly or not so subtly organized to get people to buy a product.”

Another speaker: “CME hugely drives high costs in health care in this country. We spend ninety billion dollars a year more than we should be spending. This machine for getting doctors to prescribe the most expensive medications is one of the big reasons for the problem…. It drives me crazy to hear all this talk that we can’t afford health care reform! We can. We need to make these changes.”

Enough. The second panel’s here. They’re the pro-COI guys. I’ll let one of their fans live-blog that.

Alas, poor ghost!

Pity me not, but lend thy serious hearing
To what I shall unfold.

Speak; I am bound to hear.

So art thou to choler, when thou shalt hear.

What?

I am big pharma’s mouthpiece,
A paid tool of some drug’s maker,
A walking shadow, a money’d player
That smiles and signs his name upon a page.

I was forbid to tell the secrets of my counting-house,
But now good Grassley has them out. List, list, O, list!

O God!

…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…

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.

… just … I dunno… conflict of EVERYTHING! — inspiration will always be Harvard’s last president, Larry Summers, who earned, I dunno, something in the mid hundreds of thousands for being Harvard’s president, but who got FIVE MILLION DOLLARS AT THE SAME TIME for whatever the fuck he did for some hedge fund ONE DAY A WEEK.

Even UD‘s recent acquisition of Hummer is unlikely to yield such results. (She’s already fielding emails from Hummer Club presidents about this that and the other. Who knew there were Hummer Clubs?)

But anyway, what with Senator Grassley making a fuss about it, lots of universities are trying to cough up new and improved COI language. (Language only, of course. The relationship of university administrators to faculty COI is much like the relationship of the NCAA to university sports programs.)

And then there are places like the University of Oregon, which doesn’t seem to have any COI policies at all. A significant segment of UO’s faculty is undergoing attachment issues as UO threatens to take away cherished freedoms…

This article takes a pretty intelligent look at COI at UO. The comments after the article are also worth a read.

It’s how you manage conflict of interest. 

You know. 

University administrators are always telling us that it’s not a matter of avoiding conflict of interest but managing conflict of interest.  

So here’s how you manage it if you’re chief of spinal surgery at UCLA.  You take out your little conflict of interest form, and where it says Do you have a conflict? you say No.

[Senator Charles Grassley says that] Jeffrey Wang, chief of spine surgery at UCLA … didn’t inform the school of $459,500 Wang was paid from 2004 to 2007….  Companies that made payments such as consulting and speaking fees to Wang included medical-device makers Medtronic and FzioMed and the DePuy unit of Johnson & Johnson. Grassley says Wang “consistently checked no” on UCLA disclosure forms when asked whether he had received income of $500 or more from companies funding his clinical research.

Fellow UCLA professors of the spine! Show some backbone! Follow your chief!

Lie.

In a move Harvard University should consider in connection with Joseph Biederman, Washington University has rid itself of a professor so deeply compromised in his research ethics as to do terrible damage to the school’s reputation as long as he remains on the faculty.

… [F]our former colleagues [accuse Kuklo of] falsifying research on a bone-growth product made by Medtronic that was used on severely injured soldiers. He was also accused of forging the other doctors’ signatures when he submitted a research report to a medical journal last year.

The Army, which investigated the matter, issued a report rebuking him. It took no further disciplinary action, Army officials said, because Dr. Kuklo is now retired from the military. But Walter Reed notified Washington University of its findings five months ago.

The Journal of Bone and Joint Surgery, a British publication, retracted Dr. Kuklo’s article in March after receiving a report of the investigation from the Army. But the episode largely escaped public notice until last week.

This week, a Republican senator, Charles E. Grassley of Iowa, sent letters seeking more information about Dr. Kuklo from Walter Reed, Washington University, two medical journals and Medtronic.

Dr. Kuklo has been a consultant to Medtronic…

Kuklo’s silence in the face of all of this has been as total as the silence of the pretend soldiers he enlisted in his study. He won’t talk to anyone. UD guesses he refused to talk to Washington University too, and that this persuaded the university of his guilt – or at least so pissed it off that it booted him out.

Her critics become more and more shrill as Karen Wagner’s deception generates outrage; yet Wagner, like the university that employs her, remains absolutely silent.

The University of Texas has issued a few We don’t know shit but uh when we get a chance we’ll look into it statements in response to Senator Charles Grassley’s repeated letters to it about the vice-chair of the psychiatry department’s way-lucrative, hidden conflicts of interest, and of course the campus can’t be happy that Grassley  just reported her to the Health and Human Services inspector general.

In his latest letter, the Iowa Republican says that the amount Wagner didn’t report may be as high as $230,000. The university’s counsel told the Dallas Morning News last week that it has been investigating Wagner for two weeks -– though it got the first letter on the issue eight months ago.

But hey.  If you were an office of sponsored research guy, and you had a choice between going to a football game and staring at a big ol’ Adzillatron, and shuffling through disclosure papers from Wagner in which she makes a fool of you to the tune of hundreds of thousands of dollars, what would you do?

That Texas Adzillatron — the world’s largest — has UD thinking.  What if, during major athletic contests, with the whole nation watching, the university were to pause the stream of ads for a few moments and flash the names of its professors who’ve lied about outside income?  You know – list their names, departments, and the amount of money they didn’t tell anybody about over, say, the last ten years.  Also any sanctions imposed.  If UT takes disclosure seriously, this would be real disclosure.   It would also embarrass Wagner and others, thereby discouraging fellow professors of psychiatry from following their path.

… we’re getting our education in academic medicine.

Thanks to Senator Grassley, the weird science of some university-sponsored research reveals itself, and even UD, who’s been around, finds it head-spinning.

Here, for instance, is a professor at Washington University defending his colleague, Timothy Kuklo, charged with falsification of data, forgery of documents, and other stuff:

… The inquiry also found that Kuklo falsely claimed other Army doctors helped write the study. … [A colleague said, in defense of Kuklo, that] it’s not uncommon for a researcher to sign other authors’ names to a study after getting verbal consent. It is a practice that is done, for example, when other authors are abroad and do not have easy access to fax machines.

Since Kuklo has so far refused to respond to anyone – in the press or the military – about any of this, we can’t know whether he got the four faxless horsemen’s verbal consent… Or what that consent was for. We do know that sticking lots of names on articles – names of people who have absolutely nothing to do with the project – represents one of many curious folkways of UD‘s fellow professors in med schools around the country. No doubt it’s a short jump from rounding up friends who have nothing to do with your work and pretending that they helped you with it, to just going ahead and putting their names down… forging their names… on the cover page of your study… without permission:

… [Kuklo] falsely claimed had a 92 percent success rate in healing shattered legs of wounded soldiers injured in Iraq, and Medtronic [his client, and maker of the device at the heart of the study] has supported his research, the Times reported.

Kuklo’s study was retracted in March after [the] paper’s publisher, The Journal of Bone and Joint Surgery, received notification from Walter Reed questioning the validity of the report’s conclusions.

“It was further disclosed that much of the paper was essentially false,” the retraction read.

Additionally, four doctors listed as co-authors on the report said they had not seen the manuscript prior to publication, and their signatures were forged on the article before its submission…

But wait! They were detained abroad, bereft of faxes …

It’s not only the weird ways of research we’re learning about. It’s the yet weirder ways in which other researchers defend the research.

Chuck Grassley is sticking around as the ranking Republican on the Senate Finance Committee, one of the centers of power in the health reform debate.

… Grassley and Max Baucus, who chairs the committee, had lunch at the White House today with Barack Obama and Joe Biden. They spent most of the meal talking about health reform, the Des Moines Register reports.

… The prospect [that Grassley might leave Finance] apparently had some pharma lobbyists pretty excited, given Grassley’s scrutiny of the industry.

But it didn’t work out that way…

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LAMENT OF THE MED SCHOOL FACULTY

We thought with the end of Chuck Grassley
We could go back to acting all crassly.
But our passion for pharma’s
Run into bad karma:
The man is alive, and it’s ghastly.

It involves drug company payments to Karen Wagner, a psychiatrist at the University of Texas. Big payments, over many years, for her touting the benefits of various dangerous concoctions for the most vulnerable among us — children.

The Commission’s very hush-hush. Wagner never reported any of this money to her university. Well, once she reported she’d gotten six hundred dollars. That left multiple hundreds of thousands that she concealed.

The university thought it’d be a great idea to put Wagner on a committee reviewing other professors’ conflict of interest forms.

Wagner knows how to keep a secret:

In March 2006, Dr. Wagner was being deposed in a case on Paxil. During that deposition, Dr. Wagner was asked how much money she had taken from drug companies over the previous five years.

Her response? She said, and I quote, “I don’t know.” In fact, she testified that she couldn’t even estimate how much money she received from the drug companies.

The latest on the Wagner Commission:

An influential U.S. senator has reported a University of Texas researcher’s financial relationship with a drug company to the top investigator at the U.S. Department of Health and Human Services.

Iowa Sen. Chuck Grassley, the ranking member of the Senate Finance Committee, sent a letter to the University of Texas System in September raising concerns that child pharmacology researcher Karen Wagner had not properly disclosed her financial connections with drug companies. He reported her in a letter to the Health and Human Services Office of the Inspector General.

…is a plan to end industry influence over medical refresher courses. Presently, drug and device makers provide about half of the funding for such courses so that doctors can often take them for free. Even as they have acknowledged the need for other limits, many medical societies and schools have defended subsidies for education as necessary.

“As science progresses, it’s going to get harder and harder to get doctors to keep pace,” said Dr. Jack Lewin, chief executive of the American College of Cardiology. “I think industry has some responsibility toward education.”

By contrast, the American Psychiatric Association recently announced that it would phase out industry funding for medical refresher courses at its conventions.

The institute acknowledged that many doctors depend on industry funding for refresher medical courses but said that “the current system of funding is unacceptable and should not continue.” The report recommended that a different funding system be created within two years.

That would be the National Academy of Sciences Institute of Medicine, which has added its voice to the condemnation of widespread conflict of interest in America’s medical schools and in the practice of medicine generally. Its just-issued report on industry corruption of research and care is, says the New York Times, “scolding… damning… a stinging indictment.”

But as to the creation of that new funding system for continuing education courses about which Jack Lewin’s so worried… Let’s see… How do people usually fund their education?

Well, if they’re poor, you know, they get scholarships and take out loans and pay some out of pocket… They take part-time jobs while they’re in school…

Which is all well and good. But how in the world are they supposed to pay when their average salary is $300,000? This is what’s worrying Jack Lewin… It’s getting harder and harder for doctors to keep pace with new information, and how in hell are they going to afford these courses????

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Update: I’ve made this point many times on University Diaries. If you kids keep misbehaving…

Much of the IOM report echoes recommendations from the Association of American Medical Colleges, which also supports Grassley’s proposed database. But not all schools have followed that group’s advice. “We give a pretty clear warning,” says panel chair Bernard Lo, a bioethicist at the University of California, San Francisco. “If the [institutions] don’t get their act together, they’re really inviting the legislators to step in.

UD likes macho men.

She can’t help it. She was socialized into it by a sexist society and now it’s too late. Hope perhaps lies in future generations.

When pertinent, UD likes to point out on this blog instances of her attraction to academic rogues, rascals, rakes and randies, pre-impotence Hemingways swaggering the quad…

Today she likes the Harvard professor featured in this Crimson story, a med school guy going after Grassley and the other “quasi-religious” pharmascolds who worry about conflict of interest.

He argues that “physicians should be free to determine on their own if [an industry] gift is a bribe.”

How exactly would this work?

“This gift is a bribe. Great. I can use the money.”

No, no. And here’s where UD begins to pant a bit. “If people do bad things,” says her man, “shoot them.”

I also like how he describes the current turmoil over the issue: “Now there’s some skin in the game.” Meaning now doctors are getting pissed because the rules are changing and they’re losing money. Life’s a rugby match, baby, and Grassley’s pissing off the other side and he better look out!

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One editorial thing. The Crimson reporter notes that many other medical faculty believe “academic medicine has long suffered from ethical breeches.”

I think this would be trousers made with no leather products.