Just a reminder – and an update – of one of the biggest pharma scandals of the year. Background on this one here. Basically the company gave humongous money to the university, which duly manipulated data for the company’s benefit. In turn, the company duly advertised its product by touting the results it had paid for.

Whoring for pharma: Happening also at a university near you.

… is, if you ask UD, pretty much the formula for some of what goes on under what people at universities call Leadership Studies.

Florida International University, famous for an onfield football brawl, squalid sports teams, and an arrogant high-living president who, when he retired, had a whole campus named after him as an expression of gratitude for what he did with public funds, has put together a real winner of a leadership studies program. Said president – Mitch Maidique – is on the faculty, as is Fred Walumbwa, whose pearls of leadership wisdom (“Always be on the path to leadership…”) adorn the page announcing his appointment.

Walumbwa was only hired last year, and already he’s leading FIU in (about to be) retracted research papers. Five – in one journal, Leadership Quarterly. The editor writes:

In recent weeks serious allegations have been raised about the scientific value and contribution of a number of papers published in recent years in our discipline, five of which were articles published in LQ.

It’s not clear exactly what Walumbwa and his co-authors did wrong, though one would have to suspect they fudged data. Mushy fields like psychology (leadership studies’ sister city) are notorious for retractions – here’s looking at you, Diederik Stapel — and Marc Hauser — etc. — …

Hank Campbell headlines his post about Walumbwa this way:

When Something As Vague As A Leadership Journal Retracts You For Lack Of Data, You Are In Trouble

He goes on to say:

A journal that published papers on something called ‘ethical leadership’ wouldn’t seem to need any strong evidence basis, just a lot of surveys and weak observational claims with pretty words attached, so if it gets so many complaints it retracts five of your papers, you must really be out there.

… Walumbwa told RetractionWatch “We have data, we are working on that now.”

Oh. If you have data, why wasn’t it in the papers? And how did it get published in the first place?

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UD thanks David.

A spokesman for La Trobe University said the research was of community interest as many Australians used complementary medicines and that the research would allow consumers to make better decisions.

Yes, and because many Australians check their star charts every day in the newspaper, La Trobe will be taking fifteen million dollars from the Association of Australian Astrologers to research their claims. This will allow consumers to make better decisions.

And because many Australians believe crystals cure cancer, La Trobe University will be taking fifteen million dollars from the Australian Association of Crystal Manufacturers to research their claims. This will allow consumers to make better decisions.

La Trobe University encourages other businesses to approach it with research funding ideas.

… notorious GlaxoSmithKline enabler Professor Martin Keller, now tries its hand at legitimate research in the form of an article that actually cautions against polypharmacy.

[B]ecause no clinical trial of bipolar medications has ever tested more than two drugs in combination, prescribing three or four exceeds practices supported by the field.

“By definition that’s not evidence-based treatment,” [the article’s lead author] said.

No prior studies had looked at the total medication burden, rather than just that of pyschotropics. It’s important to do so, Weinstock said, because cardiometabolic diseases, in particular, are often concurrent with bipolar disorder. Among the 230 patients in the study, for example, about half had such medical problems.

… “[The] increased reliance on polypharmacy does not appear to be contributing to decreased rates of illness chronicity or functional impairment in [bipolar disorder].”

I guess Brown faculty can do market-depressant research now that Keller (he was a honcho) has retired.

Thomas Marciniak, the FDA review-team leader [of AstraZeneca’s new anticlotting drug, Brilinta] … wrote that [according to trial results] 12 patients reported their own deaths by telephone.

Perhaps not wishing to stir up too much excitement among consumers, AstraZeneca is remaining mum on the matter.

AstraZeneca declined to comment on the allegation about patients reporting their own deaths…

One question UD has is whether users of Brilinta are able to report their deaths only by telephone, or let’s say they prefer tweets or email, or old-fashioned face-to-face.

… … A wondrous land where professors of psychiatry hide their financial involvement in companies that promote new diagnostic techniques these same psychiatry professors have promoted in seemingly neutral scientific publications … You’ve just crossed over into … The conflict of interest twilight zone…

[The] fifth edition of the Diagnostic and Statistical Manual of Mental Disorders was …published by the American Psychiatric Association (APA) in May 2013… [O]ne of the main claimed innovations in the DSM-5 is that it promotes the use of ‘dimensional‘ or quantitative measures of symptoms... [Why] is the DSM promoting symptom scales? Or more to the point, why is it suddenly promoting them now, given that dimensional measures have been used in psychiatry for 60 years? This is where it gets interesting.

The head of the [American Psychiatric Association’s] DSM-5 task force, David Kupfer, stands accused of failing to disclose a conflict of interest which – arguably – means that he has a financial stake in the concept of dimensional assessment.

It all started with a paper in the journal Archives of General Psychiatry (now JAMA Psychiatry) called Development of a computerized adaptive test for depression. The first author was statistician Robert. D. Gibbons of the University of Chicago (a veteran of psychiatric statistics). The last (senior) author was David Kupfer.

The Gibbons et al paper presents a software program to help rate the severity of depression, an ‘adaptive’ questionnaire. Whereas a normal questionnaire is just a fixed list of items, the new system chooses which questions to ask next based on your responses to previous ones (drawing questions from a bank of items adapted from existing depression scales). The authors say this provides precise measurement of depression across the full continuum of severity.

… He (and Gibbons and colleagues) seem to be preparing to sell their computerized adaptive test (CAT). They have incorporated a company, Psychiatric Assessment Inc. (PAI).

This raises the disturbing notion that Kupfer, in his capacity as computerized dimensional product seller, could benefit financially from his prior championing of dimensional assessment in his capacity as DSM-5 head.

Or, as UD’s blogpal Allen Frances puts it, more succinctly:

While using his DSM 5 pulpit to strongly promote the value of dimensional diagnosis, the DSM 5 Chair (and several associates also working on DSM 5) were secretly forming a company that would profit from the development of commercially available dimensional instruments. And unaccountably, he failed to disclose this most obvious of conflicts of interest while simultaneously lauding the DSM 5 conflict of interest policy.

Or, as UD‘s blogpal Bernard Carroll puts it, more colorfully:

Peddle unproven psychiatric screening scales backed up by black box statistics (a distressing specialty of Dr. Gibbons); publish a glowing report in JAMA Psychiatry, which you have infiltrated (Ellen Frank and Robert Gibbons are on the editorial board); get your corporate people inside the DSM-5 process (David Kupfer, Robert Gibbons, Paul Pilkonis); slant the DSM-5 process to endorse, however weakly, the kind of products you intend to market; start a corporation without telling anybody and establish a website with advance marketing that touts your new academic publication in JAMA Psychiatry while highlighting Dr. Kupfer’s key role in DSM-5; loudly proclaim … the advent of population-wide screening but before doing any serious field trials or acknowledging that most positive screens will be false positives. This is the usual dodgy hand waving of wannabe entrepreneurs, whose vision is obscured by dollar signs. Oh, and did I mention regulatory capture of NIMH for over $11 million in funding while not producing a product worth a tinker’s damn?

The only thing this group seems to have failed to do is get Virginia’s Governor Bob McDonnell in on it.

… is the familiar three-step featured at American medical schools like Emory University.

Emory University has mainly been known as the forcing ground of conflict of interest giants like Charles Nemeroff. Yet while plenty of other American med schools feature COI gone wild, Emory couples COI with high-profile, frequent retraction of fraudulent articles.

How high-profile? Chair of the department of medicine.

How does he manage to have produced (so far) six retracted papers?

Well, as lab honcho, he puts his name on stuff that goes out whether he’s had anything much to do with what’s been written.

This is known as guest writing or courtesy authorship (discussion of the practice here) and it accounts for the fact that when you look at any random med school jerk’s cv it’s going to say he’s published eight hundred articles. Everybody’s sticking their name on everybody else’s paper. It takes a village.

So step one is courtesy authorship. Step two, because you’re too important to notice conniving actual-author underlings, is retraction.

Step three is your amazing retirement party, where without irony people say things like “What is important is not just the quantity of Dr. [Wayne] Alexander’s work, but the quality.”

… and you’ll find our old friend, Harvard University’s Joseph Biederman. Go here for prior posts about this man.

… in and that’s the kicker, ain’t it? I mean, lots of people are on them; but do the little buggers actually work?

The New York Review of Books (scroll down) has for awhile been the go-to place for essays by writers who question the utility of antidepressants for many (not all – some people do benefit from some antidepressants) of the people prescribed them; but obviously, as The Guardian‘s headline suggests, the subject – as vast stretches of Europe and America chomp down on them – is very much out there.

If the very question as posed seems to you outrageous, impossible, obscene, consider for a moment the way antidepressants are made. Not that you really want to know. It’s like the thing about how sausages are made. Better not to go there.

But let’s go. Let’s ask why Louisiana’s attorney general is suing Pfizer, maker of Zoloft. For $987 million. Or so.

Attorney General Buddy Caldwell claims Zoloft is barely more effective at treating depression than a placebo, but Pfizer has persuaded doctors and consumers otherwise…

Long before Zoloft was approved by the FDA, Pfizer knew it had “serious issues with efficacy” because in early Zoloft trials, the placebo group actually had better results, the state claims.

“These early trials showed that ‘placebo still seems to be the most effective group’ and that “there is still no striking evidence of beneficial drug effect with placebo often being the superior treatment,'” the complaint states.

“Nonetheless Pfizer chose to go forward in attempting FDA approval.”

The attorney general claims that to do this, Pfizer published only information that pertained to Zoloft efficacy, and suppressed conflicting studies.

Pfizer then engaged in a “ghostwriting program to misleadingly enhance Zoloft’s credibility,” the lawsuit states. [Note: Most American med schools have no policies at all on the practice of ghostwriting among their professors.]

… Louisiana claims that despite numerous studies that show that Zoloft is “no more effective than a sugar pill at treating depression,” Pfizer’s ad campaign included a large sales force that visited healthcare professionals on a routine basis, took them out to luxurious diners and events during which salespeople promoted Zoloft.

Laissez les bons temps roulez! And as for those sad sacks – let ’em eat expensive sugar pills.

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One more note: Pfizer will settle. A thousand million dollars is nothing to Pfizer. Cost of doing business.

Professors Robert Dworkin (University of Rochester) and Dennis Turk (University of Washington) are feeling no pain!

Read their hilarious emails about how they’re making tens of thousands of dollars off of pharma – which wants to listen in on American professors conversing about new developments along the Oxycontin line (We Americans ♥♥ LOVE♥♥ our Oxycontin. Just look at any town in West Virginia. Eli Lilly’s got us eating out of its hand!).

’20k [to attend a meeting] is small change, and they can justify it easily if they want to be at the table,’ Dworkin wrote to Turk in July 2003, after an Eli Lilly representative bridled at the price.

Dworkin’s absolutely right. Once you’ve got a national (soon to be international!) epidemic going, you’re talking real money. Dworkin knows Lilly routinely pays billions in fines every year for illegal this and that, and it really don’t make no never mind since when your profits are zillions you can laugh at billions. So this Lilly asshole has the gall to bridle at paying twenty thou to sit in a room for twenty minutes? UD finds it amazing the Dworkin/Turk gang isn’t demanding twenty million per meeting.

Possibly Dworkin and Turk are low-balling because they’re professors and not businesspeople and there’s a learning curve for them. This might be helpful for context:

[There’s a new rule,] unveiled by the S.E.C. … requiring companies to disclose the ratio of the C.E.O.’s pay to that of the median worker. The idea is that, once the disparity is made public, companies will be less likely to award outsized pay packages… [Yet C.E.O. compensation continues, and almost certainly will continue, to rise.] Sunlight is supposed to be the best disinfectant. But there’s something naïve about the new S.E.C. rule, which presumes that full disclosure will embarrass companies enough to restrain executive pay. As [one expert] told me, “People who can ask to be paid a hundred million dollars are beyond embarrassment.”

If Dworkin and Turk find themselves at all hesitant, they can tape this article to their refrigerators and reread it just before talking price with Lilly.

… have been announced.

UD‘s favorite:

Probability prize

Bert Tolkamp, Marie Haskell, Fritha Langford, David Roberts, and Colin Morgan, for making two related discoveries: First, that the longer a cow has been lying down, the more likely that cow will soon stand up; and Second, that once a cow stands up, you cannot easily predict how soon that cow will lie down again.

Reference: “Are Cows More Likely to Lie Down the Longer They Stand?” Bert J. Tolkamp, Marie J. Haskell, Fritha M. Langford, David J. Roberts, Colin A. Morgan, Applied Animal Behaviour Science, vol. 124, nos. 1-2, 2010, pp. 1–10.

Mr UD liked this one:

Psychology:

Laurent Bègue, Brad Bushman, Oulmann Zerhouni, Baptiste Subra, and Medhi Ourabah, for confirming, by experiment, that people who think they are drunk also think they are attractive.

Reference: “‘Beauty Is in the Eye of the Beer Holder’: People Who Think They Are Drunk Also Think They Are Attractive,” Laurent Bègue, Brad J. Bushman, Oulmann Zerhouni, Baptiste Subra, Medhi Ourabah, British Journal of Psychology, epub May 15, 2012.

… where the former chief of transplant surgery is on trial for attempted manslaughter.

He also faces three charges of causing bodily injury resulting in death for transplanting livers to unsuitable patients, who subsequently died.

This guy – absurdly not named because of German laws, but so precisely identified in all the articles that everyone must know who he is – has apparently killed quite extensively, in a variety of directions: If the allegations are true, he has killed inappropriate recipients who (one assumes) bribed him to push them up the waiting list; he has also killed non-bribers patiently and legitimately waiting their turn for a liver.

Because this is part of a wider scandal involving medical abuse of the transplant system in Germany, Germans are now refusing – in droves – to donate their organs. As I say, sickening.

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Update: All the yummy details.

Ian Hacking discusses the perennially expanding petals of the Diagnostic and Statistical Manual of Mental Illness. The latest revision of the DSM is now out, it’s published, it’s a done deal, so instead of people trying to change it or delegitimize it, you’ve got people reviewing it.

Like Hacking. Hacking’s philosophical, logic-based approach considers the DSM a bureaucratically useful fiction: We couldn’t have paid mental health treatment without it. But as “a representation of the nature or reality of the varieties of mental illness,” the DSM is a total failure. Its classificatory system assumes an object with a genealogy and a reasonably stable real-world character. Yet any given mental disorder lacks originary biomarkers as much as it lacks existential discreteness. Thus Hacking makes much of the DSM‘s recourse to the NOS (Not Otherwise Specified) category:

An entry [will] begin with a generic disorder, pass to various species and subspecies, and finally to NOS. Thus in DSM-IV, genus: ‘Schizophrenia and Other Psychotic Disorders’. Eight species: e.g. Schizophrenia. Five subspecies: e.g. Catatonic Type (295.20). After the first seven species with their subspecies, we come to the eighth: Psychotic Disorder, NOS (298.9). Some 32 generic disorders end with a species NOS, where patients are judged to fall under the generic heading but not under any of the specific headings… DSM-5 does its best to drop NOS, but often ends up with a mess. Thus we now have ‘Schizophrenia Spectrum and Other Psychotic Disorders’ with a structure pretty different from that of DSM-IV. There is now a species ‘Catatonia’, with two subspecies, ‘Catatonia Associated with Another Mental Disorder (Catatonia Specifier)’ (289.89), and ‘Catatonic Disorder due to Another Medical Condition’ (293.89). The generic entry ends with a noncoded ‘Unspecified Catatonia’. This applies when we cannot make out the underlying condition, or the ‘full criteria are not met’, or if we simply lack information. Then we read ‘coding note: Code first 781.89 … followed by 293.89 unspecified catatonia’, which sounds very much like NOS.

Everything sort of gutters into anything, in other words. “If,” says Hacking, “I started trying to explain the new categories under schizophrenia, I would get lost in the forest. Indeed, in reading these sections I felt unable to see the tree – schizophrenia – for all the branches that were on display.”

The DSM embodies a strange procedure whereby, as Rilke writes in his fifth Duino Elegy:

the pure too-little

is changed incomprehensibly -, altered

into that empty too-much.

A supremely ironic, supremely self-consuming artifact, then, the DSM elaborates a thing to extinction. The book turns out to be a seek and destroy mission; only billable codes are left standing. Hacking rightly describes this take on the DSM as “a far more radical criticism of it than [NIH director Thomas] Insel’s claim that the book lacks ‘validity’. I am saying it is founded on a wrong appreciation of the nature of things.”

With a full blank slate as background, as it were, research has been easy to corrupt. “[U]niversity research departments and learned journals are [often] funded by those who stand to profit – literally – from their presumed objectivity,” writes Will Self in his review of the DSM.

… Pinafore. In the fraud case of Professor Charles L. Bennett, it was, according to the FBI, his “brother and cousin” who improperly benefited (along with Bennett himself, of course) from his personal use of government funds. Northwestern University, on whose faculty he sat while distributing his NIH grant to himself and his brother and his cousin, should have seen that happening, and so has had to choke up “$2.93 million to settle claims of cancer research grant fraud.” The whistle-blower – a purchasing coordinator at NU’s med school – gets almost $500,000 of the proceeds.

Lucky South Carolina College of Pharmacy has pried Bennett free of Northwestern and successfully recruited him to its faculty. What a coup! The center he’ll be running is “is particularly focused on economic return on investment.” So is Bennett.

There’s a potentially very big story emerging out of the University of Louisville (one of the scummiest football factories this blog has covered, by the way), on whose faculty sits Mariusz Z. Ratajczak. Ratajczak has gotten a lot of attention, and a lot of money from the Catholic church, to pursue work on

heretofore unknown stem cells present in adult cells. These tiny cells, he claimed, could perform the same tasks as embryonic stem cells, including tissue regeneration and the miraculous capacity that embryonic stem cells have to mimic other types of cell tissue. Moreover, these VSEL cells, said Ratajczak, could be harvested from adult cells without harming human embryos or relying on them for cell material.

Ratajczak claims to have discovered these cells; but no other scientist has been able to find them, let alone test them in any way. Arthur Caplan writes that Ratajczak’s claim (that “he had found very tiny cells residing in adult cells that behaved just like embryos. Ratajczak said they could develop into all manner of other cells, thereby acting as natural repair kits, given the right conditions and genetic tweaking.”) “must be the product of wishful thinking, or at worst, fraud.”

More detail here.

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The University of Louisville hospital has more than its share of problems lately.

Oh, and I forgot all about Robert Felner.