“The U of M has sued Weiss to recover its own costs.”

How do you get to this point?

How, in one of America’s more enlightened, compassionate states, do you get to the point where that state’s university sues the grieving mother of a son who killed himself while enrolled in one of that university’s drug trials? That mother, Mary Weiss, did everything humanly possible to try to get a son she knew was too mentally fragile to have given consent to be dosed with a new antipsychotic (they’re almost never really new; they’re slightly fussed with so that manufacturers can charge more) taken out of that trial. But the big money from AstraZeneca was there in the psychiatry department at the University of Minnesota, and the amazingly positive results they needed for their next advertising campaign needed to be delivered, and Weiss’s son would have to play his part.

If Pirandello were writing this tragedy, he’d have titled it Six Characters in Search of Psychotics.

Or … Take the name from a recently released documentary: The Hunting Ground.

Mothers, lock up your children. Pharma’s sniffing around.

The lawsuit that the University of Minnesota initiated against Weiss was about bullying her into dropping her legal efforts against the university. The bullying worked.

What didn’t work was UM’s effort to pretend nothing sordid happened here. More than a few pharma-subsidized university trials are sordid, since there’s big money at stake, as well as pressure to produce the results all that money’s paying for. Things might not be quite as blatantly sordid as Star Scientific and Novartis and Joseph Biederman … The cynical determination to overdiagnose and overmedicate every person in America might not be quite as thunderingly obvious… But, as at the University of Minnesota, the deal was pretty clear to anyone able to see.

Now that the Minnesota state auditor has discovered what anyone able to see could see, that university has a big, big problem.

With grim determination, over many years, UD’s blogpal Carl Elliott…

… has kept after his employer, the University of Minnesota, in the matter of Dan Markingson and research ethics. Elliott and others have long argued that Markingson was too mentally fragile to have given informed consent to take part in a UM clinical drug trial, and that his suicide during the trial might not have happened had he not been “coerced …into participating … and then exploited…”

The university has been singularly and stupidly determined to deny that anything at all is amiss in any of its research protocols, and Carl has been subject to pressure and ridicule on that campus. Finally, however, something like victory might be in sight:

University of Minnesota President Eric Kaler told faculty leaders Friday that the university will change the way it treats human test subjects.

Last week, a review of the university’s human research practices criticized the school — and, in particular, its psychiatry department — for not doing enough to protect vulnerable adults in its research.

One doesn’t want to get too excited, though. As Carl points out:

The danger lies not just in the particular circumstances that led to Dan’s death, but in a system of clinical research that has been thoroughly co-opted by market forces, so that many studies have become little more than covert instruments for promoting drugs. The study in which Dan died starkly illustrates the hazards of market-driven research and the inadequacy of our current oversight system to detect them.

The Onion shares reassuring results on …

antidepressants.

The man running the show at Wisconsin’s universities.

SCOTT WALKER DODGES QUESTION ON
WHETHER HE BELIEVES IN EVOLUTION.

Sometimes, you need a lot of patience to reform institutions.

Whether it’s the FDA, so “deeply captured, drawn [so] firmly into the orbit of the pharmaceutical industry that it’s supposed to regulate,” that it routinely fails to inform “scientists, doctors, and the public” about research fraud; or whether it’s the research trials at the University of Minnesota, where the scandal of Dan Markingson’s 2004 death slowly, slowly begins to have real consequences for that institution.

A leading state lawmaker has asked Senate leadership to postpone selection of University of Minnesota regents until next month’s state review of the university’s drug-trial program.

Senate Higher Education Committee chair Terri Bonoff confirmed Friday she has asked Majority Leader Tom Bakk to delay the process in light of a letter from former Gov. Arne Carlson that was critical of the university.

In his letter, delivered Thursday, Carlson expressed concern over the university’s handling of patients in clinical drug research trials, as well as regents’ oversight.

Carlson said the program has a history of deaths, injuries and conflicts of interest. He described the selection of the 11-member Board of Regents as “little more than a political beauty contest.”

A key concern in the letter is the 2004 suicide of drug trial participant Dan Markingson.

Useless trustees make the world safe for things like conflicted researchers, and conflicted researchers can make the situation of participants in experiments unsafe. UM has managed to avoid a serious reckoning with what Markingson’s fate represents, but events are beginning to change that.

“His work is well supported. Dr. Bennett has been awarded more than $4.2 million in federal research grants.”

So okay he’s had to give a chunk of that back because he stole it. Fine. We at the University of South Carolina are still proud as punch! Charles Bennett’s a winner and Northwestern had him but NU had to pay “$2.93 million in July 2013 to settle claims that the University ignored a whistleblower’s concerns about Bennett,” and I guess all the hoo-haw didn’t sit too well with NU because Bennett had to scoot.

So he became a free agent and we got him! Score one for USC!!

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

Background on The Pride of USC here and here.

Coming: Pills to counteract the anxiety-provoking effects of your anti-anxiety medication.

ANXIETY MEDICATIONS ATIVAN, XANAX, AND VALIUM MAY INCREASE RISK OF ALZHEIMER’S DISEASE

“Prosecutors say the data were ascertained to have been altered in many cases. We cannot help but wonder why the medical doctors at the universities were unaware of what happened. Laboratories of those universities have so far received more than ¥1.1 billion in research funding from Novartis Pharma. The possibility is high that the back-scratching relations between universities, who are eager to obtain cash from businesses, and Novartis, out to exploit research results to promote its drug sales, may have formed a hotbed of wrongdoing.”

The Japanese have actually arrested someone in the Novartis scandal (background here). Color UD shocked. Color her shocked beyond recovery if the guy actually goes to jail for more than a day or two.

Novartis embedded one of its employees – made him a staff scientist – in five Japanese university laboratories. Five.

As a Novartis Pharma employee [Nobuo] Shirahashi took charge of analyzing data from clinical tests comparing Diovan and other blood pressure-lowing drugs at five Japanese universities … between 2002 and 2004.

How did that happen? How did a Diovan pusher get accepted – hired? – into five university labs in Japan and then take charge of clinical results?

That’s the ¥1.1 billion question, ain’t it?

“His sins trickled from his lips, one by one, trickled in shameful drops from his soul festering and oozing like a sore, a squalid stream of vice.”

A squalid stream of vice does nicely to describe the now-released details of Harvard’s Marc Hauser, one of a number of naughty psychologists whose misdeeds keep hitting the newspapers.

It’s rather heartbreaking to read this email exchange, revealing as it does what happens when a person of integrity blunders into the lab of a powerful, crooked scientist.

In 2007, a member of the laboratory wanted to recode an experiment involving rhesus monkey behavior, due to “inconsistencies” in the coding.

“I am getting a bit pissed here. There were no inconsistencies!” Hauser responded, explaining how an analysis was done.

Later that day, the person resigned from the lab. “It has been increasingly clear for a long time now that my interests have been diverging sharply from what the lab does, and it seems like an increasingly inappropriate and uncomfortable place for me,” the person wrote.

This of course is the way in which dirty labs get dirtier and dirtier. Legitimate people leave, and even schools as burnished as Harvard find themselves harboring high-profile fraud.

Scientific Fraud: A “Stapel” of Dutch Research.

Not that plenty of other social psychologists around the world don’t fudge their research results; but those working in the Netherlands currently dominate the field, with Jens Forster (German, but works in Amsterdam) the latest high-profile example.

SUCCESSOR TO DIEDERIK STAPEL REVEALED one newspaper puts it, recalling the notorious fraudster who earned a lengthy New York Times profile featuring a moody, gray sweater/frayed jeans, self-portrait. If Jens Forster, with his Art Garfunkel vibe, plays his cards right, he could score a Rolling Stone cover.

But he will have to play by the Stapel playbook. “I am in therapy every week. I hate myself,” Stapel tells the NYT guy. Self-hatred is good, very good, and Forster should definitely go with it, though he obviously shouldn’t use Stapel’s exact words. His larger self-description should, once again, cleave pretty closely to Stapel’s while avoiding obvious borrowing. Here’s Stapel.

His lifelong obsession with elegance and order, he said, led him to concoct sexy results that journals found attractive. “It was a quest for aesthetics, for beauty — instead of the truth,” he said. He described his behavior as an addiction that drove him to carry out acts of increasingly daring fraud, like a junkie seeking a bigger and better high.

The addiction and junkie bit, and the noble quest for beauty bit, are both excellent and should be retained, though again with slightly different wording. Example:

I was, from a young age, more sensitive to the beauty of the world than other people; and as I became older, this sensitivity became – I don’t know – call it a hypersensitivity. To the point where I developed almost what you might call a dependency on beautiful results.

An Italian Psychology Professor Has Found the Holy Grail…

… and quit his job at the University of Udine to heal the world.

Davide Vannoni is making quite a killing (in more than one sense of the word) with his stem cell pasta.

Physicians at the hospital in Brescia were in the dark about the details of the treatment administered there; the report says they used to temporarily leave the lab because a Stamina Foundation biologist “had to add a secret ingredient to the stem cells” that supposedly helped the cells develop into neurons.

Ah! Un po’ aceto balstemico! Si, delizioso…

‘The term cosmeceuticals is not recognized by the U.S. Food and Drug Administration and thus not subject to its regulatory scope. What this means is that not one of these products are required to prove the validity of the science it preaches for it products. To date, none of these companies have published any significant data in the literature that proves their effectiveness. Furthermore, no stem cells could even survive long-term embedded in a cream, let alone be guaranteed to work on all individuals (your body would be more likely to reject foreign cells).’

One of UD‘s colleagues has joined the board of a company that “offers plant stem cell-based facial creams and beauty products.”

My colleague’s beauty product line “stimulates your own stem cells.”

Amazing.

Faint Heart Never Won Full Funding

If there’s one thing UD‘s learned from following the history of retracted papers – most of them, lately, hothothot stem cell papers – is that you don’t want to go half way. You don’t get to be “the principal investigator on grants totaling $57 million since 2000″ without going for it, attracting BIG attention onaccounta your amazing, but strikingly difficult to replicate, work on regenerating dying hearts.

UD has also learned that with the imprimatur of Harvard behind you (our old friend Joseph Biederman continues, in his curious research, to benefit from the association, as does the scientist at issue here, Piero Anversa, the scrambled letters of whose name, UD feels sure, add up to some great phrases, but she’s not up to the task right now), you can just keep rolling along and pulling it in (all those millions for Biederman and Anversa are of course your taxes). People have been making a fuss (a negative fuss) about Anversa’s work for more than ten years.

One Harvard researcher who has long been familiar with Anversa’s work said that many people at Harvard are not surprised by these developments. “If anything it’s surprising how long it’s taken for these questions to surface.”

It’s kind of a funny way to live, isn’t it? You watch a way-belaureled scientist do his questionable research year after year… Many of you watch…

O stempora! O mores!

You can’t keep these ambitious stem cell researchers down. Remember the Korean guy? They even did a stamp for him showing a person in a wheelchair gradually gaining the ability to walk because of the Korean guy’s amazing stem cell research.

That didn’t turn out well. I mean, once scientists tried reproducing his results.

Now there’s this Japanese stem cell person who also got amazing results due to the simple expediency of making up data and altering pictures.

‘”[A]ny academic that has the time to be a part-time drug salesman needs to have a talk with their department chair right away about how they’re spending their time,” said Eric Campbell, a professor of medicine at Harvard Medical School who studies the topic. “If doctors want to be drug salespersons, they should go to be drug salespersons.”’

One of the several sleazy self-dealings available to med school professors at universities as reputable as Tufts is flacking the drugs you’re researching.

But UD! you say. How – put aside the greed part of it – can the research results of someone not only flacking the product she’s researching, but receiving personal compensation from the company pushing the product – be ethical? How can the results of her experimentation be taken seriously by anyone? Doesn’t Tufts have standards?

No. Plenty of other schools do, but Tufts doesn’t.

When it comes to infamy, Tufts University is a well-established pro.

Next Page »

Latest UD posts at IHE

Archives

Categories