‘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.

Taking a STAP Back.

A paper claiming to have found a simple way to turn mature cells back into stem cells (via a process called STAP) has now been disavowed by one of its co-authors. Almost from the moment it was published, questions were raised about the exact nature of the cells used, about duplication of images, about plagiarism, and about reproducibility.

It will almost certainly be retracted.

Emily Dickinson on …

Zohydro and pay to play.


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

After great pain, a formal meeting comes –
Sales reps sit ceremonious, all ears –
While Dworkin and Turk
Collect their money and get to work.

The closed conversation goes round –
FDA-crown’d –
Of Oxy, Roxy — Of a drug pandemic
Regardless grown –
And now Zohydro, thrown –

In the mix.
Each and every soul gets a fix –
Pain or no pain — land of addicts, ho! –
First – Chill – then Stupor – then the letting go –

Yo!Hypno —

— a new super-opiate that also goes under the name of Zohydro — is the hypnomaniac’s little helper, the sort of thing Michael Jackson’s personal physician, who scoffed at anything weaker than Propofol, would have taken a second look at.

Even an FDA panel thought introducing Yo!Hypno to an already-mass-sleepwalking (to the point of falling over and dying) America was a bad idea; but somehow it got overruled, and soon all of America will be Hillbilly Heroin Heaven.

An NPR reporter asks a pain guy about to make, er, a killing on this thing about conflict of interest. “If the drug manufacturers are sitting in a room with FDA officials talking about pain drugs and they’re there because they spent twenty or thirty thousand dollars to be in the room, and [opponents] aren’t allowed in that room at the same time, does that raise any concerns for you that that could be a conflict of interest?”

Answer: Zzzzzz… wha’?….

“The Japanese sales arm of Swiss pharmaceutical giant Novartis contributed around ¥570 million to Kyoto Prefectural University of Medicine and Jikei University School of Medicine that conducted the clinical studies from 2002. A Novartis Pharma employee, who has since left the company, participated in the studies.”

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.

Junk Research and Arrant Knaves…

… 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?

—————-
UD thanks David.

La Trouble

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.

Brown University, Famous in Medical Circles for…

… 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.

A drug that allows people to report their own deaths by telephone is bound to be a blockbuster.

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.

You’re moving into another dimensionality…

… … 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.

Courtesy Authorship, Retraction, Courtesy Kiss-Off…

… 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.”

Scratch an International Medical Scandal…

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

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