… hit close to home for UD last year, with one of her colleagues in the econ dept (here’s the post about him) (and here’s the original article about the conflict of interest) failing to note that a paper of his offering “a strong argument for shrinking the role of the Federal Housing Administration in insuring mortgages… was at least partially underwritten by the private mortgage insurance giant Genworth Financial Inc., which stands to benefit from a pull back in the market by FHA.”

Turns out this sort of thing is all in a day’s work for a lot of economists, who, like some scientific researchers at universities (led in the enterprise, until recently, by Charles Nemeroff and Joseph Biederman), don’t see why it’s anyone’s effing business which corporation or interest group pays for (and maybe ghostwrites) their research.

The American Economic Association has now adopted a few COI rules.

… lead the headlines at Brown University, where two inexplicable things are happening. Keller remains on the faculty, and a masturbation “spree” is afoot. Ahand?

Keller, as readers of this blog know, is one of the three official biggest baddest boys of academic medicine (along with Joseph Biederman and Charles Nemeroff). All men have undergone titanic struggles with conflict of interest regs, and in the process drawn plenty of attention to their schools, as well as to the quality of their research.

The latest effort to draw attention to the Keller scandal involves the non-profit Healthy Skepticism, which has written a letter to Brown asking its assistance in getting an apparently ghostwritten Paxil article by Keller retracted. Brown has been sitting on its hands.

Which you can’t say about the people involved in what reporter Lucy Feldman describes as “College Hill’s inexplicable months-long masturbation spree.”

In recent years, psychologists have reported a raft of findings on race biases, brain imaging and even extrasensory perception that have not stood up to scrutiny.

… In a survey of more than 2,000 American psychologists scheduled to be published this year, Leslie John of Harvard Business School and two colleagues found that 70 percent had acknowledged, anonymously, to cutting some corners in reporting data. About a third said they had reported an unexpected finding as predicted from the start, and about 1 percent admitted to falsifying data.

The ruler of this universe seems to be ex-Harvard psychology professor Marc Hauser (scroll down), and his long slow downfall is certainly instructive; but really where is the American Psychological Association? UD gathers the APA is the official organization here… UD fears the APA has, at the very least, co-dependency and enabling issues.

A far more healthy research model is the open rollicking naughtiness of the American Psychiatric Association, with its Schatzbergs and Nemeroffs and Biedermans and all. The first APA is getting all weepy and neurotic; the second hums happily along.

UD‘s friend Paul Thacker is now a contributor to Forbes, and his first article shifts our attention from the recent University of Miami football scandal to the ongoing University of Miami Charles Nemeroff scandal.

Nemeroff – arguably America’s most conflict-of-interest-compromised professor – left Emory University under a vast black misconduct cloud, and was immediately, enthusiastically, hired by Donna Shalala at the University of Miami.

Thacker wants to know why. “Why would [UM] … snatch up a physician with such a history?” Why would they ask him to be part of a proposed new ethics center?

Indeed, UM seems to have perceived Nemeroff, with his years of COI problems, as an ethical model. Almost on the same day Shalala announced new rigorous COI standards for faculty, she announced the hiring of Nemeroff. An astounded former faculty member wrote to her:

[H]is seeming lack of integrity in simultaneously accepting “consulting fees” from the very company (Glaxo) whose products were the basis of an NIH grant on which he was the [Primary Investigator] is absolutely outrageous… [H]ow can one reconcile [your recent statements about new ethics policies] with the immediately prior hiring of so questionable an individual to such a prominent position? Does the university not perceive that this may be seen as the worst sort of hypocrisy?

Of course Shalala now has far more dire ethical – and criminal – preoccupations… Still, it isn’t hard to see her bizarre handling of Nemeroff as a kind of precursor.

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Scathing local coverage begins. Paul’s piece only came out about an hour ago.

Look. If you can’t make that campus attractive to people (UD has seen its palm-lined splendor), you’re not much of a president. Shalala did accomplish this.

Her problem is that she did it indiscriminately. She just looked at anything that might tart up the place and went there: football, Nemeroff:

The former secretary of health and human services raised some eyebrows when Miami hired Charles Nemeroff, a star researcher who left a previous job at Emory during a conflict-of-interest scandal, to lead the medical school’s psychiatry program.

Shalala swung wild and wide. And struck out.

Under Shalala’s leadership, UM is changing the face not only of American university sports. It’s also contributing to important changes in the way scientific research is conducted in the United States.

It was to Shalala’s UM that Charles Nemeroff repaired after his problems at Emory. As the Chronicle puts it:

… Thomas R. Insel, who was helping to lead the [government’s conflict of interest] review, was also helping a tainted researcher, Charles B. Nemeroff, land a new job at the University of Miami.

Dr. Nemeroff, while chairman of the psychiatry department at Emory University, was one of several high-profile doctors found to have given speeches or written articles in medical journals extolling drugs or products made by companies that had paid them money or stock benefits that they did not report to their universities. Emory agreed to make Dr. Nemeroff ineligible for NIH grant money for two years. But after moving to Miami with the assistance of Dr. Insel, the director of the NIH’s National Institute of Mental Health, Dr. Nemeroff was receiving NIH money before the two-year ban expired.

Addressing the NIH’s advisory board after Dr. Insel’s assistance to Dr. Nemeroff was revealed, Dr. Collins said he would delay the process of putting the rules in place to consider additional changes. In particular, he said the rules may need to be changed to ensure that any penalties or sanctions against a researcher remain in effect if the researcher moves to another institution.

Smart move on Nemeroff’s part, by the way, to jump to the University of Miami. They’ll never give him any trouble. You can’t go any lower than UM.

How did things come to this, Donna Shalala? What have you done to deserve this? Maybe it’s that $1.2 million salary.

This Dead Spin blogger is only the first of many writers who in the next few days will turn their attention to the woman who has presided over all of the amazing events at the University of Miami – hiring Charles Nemeroff, fielding the most violent university football team ever, enabling Nevin Shapiro for years… Miami, in UD‘s opinion, is just a scummy school, and Shalala has let it get that way. She should go.

A reader writes, in response to Jonathan Leo’s essay about ghostwriting (go here for a link to the original essay):

Oh dear. That article is not very well researched, is it? They mention the European Medical Writers Association (EMWA) as sanctioning the practice of thanking writers for “editorial assistance”. I take it they haven’t actually read EMWA’s guidelines on the subject, since they have totally misrepresented EMWA’s position, and also fail to cite EMWA’s guidelines in their references list.

Here’s what the EMWA guidelines actually say about “editorial assistance”:

“Vague acknowledgements of the medical writer’s role, such as ‘providing editorial assistance’ should be avoided as they are open to a wide variety of interpretations.”

Anyone who wants to read EMWA’s guidelines can find them here:
http://www.emwa.org/Mum/EMWAguidelines.pdf

Leo et al also use a rather idiosyncratic definition of ghostwriting. Most people would consider a ghostwriter to be someone who is not acknowledged, not someone whose role is transparently declared. Whether medical writers should be listed as authors is a legitimate matter for debate, but the debate is not helped by writing such an emotive and badly researched article.

(Conflict of interest declaration: I was one of the authors of EMWA’s guidelines)

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Jonathan Leo responds:

Scientific Papers with Unnamed Authors = Ghostwriting

We are happy that Adam has responded to our article as it gives us a chance to clarify a couple of issues, and to highlight one of the major points in our essay. Namely, that some groups in academic medicine are trying to find ways to allow the presence of unnamed authors to be involved with scientific papers – a practice which most people would call “ghostwriting.”

In his posting Adam says that we misrepresented the EMWA stance on the appropriateness of thanking editorial assistants and he cites the EMWA guidelines. However, when we mentioned the idea that the EMWA condones the practice of mentioning editorial assistants as a way around ghostwriting we did not have the 2005 EMWA guidelines in mind, but instead had Adam’s 2007 editorial in mind where he does sanction this practice. We should have been clearer in our essay about this. We did assume that when he wrote his editorial that he was speaking in behalf of the EMWA. If he was not, then we apologize.

Adam’s 2007 Editorial

The story behind his editorial starts back in 2006 when Charles Nemeroff and his colleagues published a paper in the journal Neuropsychopharmacology. Their review article concluded that a useful treatment for depression was a vagus nerve stimulator manufactured by Cybertronics. The journal Science discussed charges that the article in question was ghostwritten because one of the main authors of the paper, Sally Laden, was not mentioned in the byline. Laden was also paid by Cybertronics. Adam’s subsequent editorial was very critical of the Science article and took the same dismissive tone with Science that he has taken with our paper. He has also taken this dismissive tone in the comments section of the BMJ and PLoS Medicine. In his editorial he never argued about the facts behind the Vagus nerve paper, Laden’s role, or who her employer was. The major point of his editorial was that the paper should not be labeled as ghostwritten because Sally Laden was mentioned in the acknowledgement section, and this is why we mentioned the EMWA. In his defense of Laden’s role he says:

“In fact, Ms Laden’s role, and the fact that the authors maintained final control over the content, were reported in the Acknowledgements section in these words [3]: ‘We thank Sally Laden for editorial support in developing early drafts of this manuscript. We maintained complete control over the direction and content of the paper. Preparation of this report was supported by an unrestricted grant from Cyberonics, Inc.’”

And just last year in a discussion about the most famous ghostwritten paper of all time, Study 329, Adam again used the “editorial assistance excuse.” In his words, “It’s also not accurate to describe this as a ghostwritten article, as I see that Sally Laden was acknowledged in the published version.” Yet, in this article, Laden was simply acknowledged for her editorial assistance. Our take is that Sally Laden should have been listed in the author byline of both the Nemeroff paper and Study 329. This is not really a very profound, or earth-shattering idea, nor do we think it solves the major problems in medicine with undeclared conflicts of interest. It just seems to be simple common sense.

EMWA Guidelines

We are glad that Adam has brought up the guidelines and we are happy to address those here. At one point in the EMWA guidelines they say, “The involvement of medical writers and their source of funding should be acknowledged. Identifying the writer, either as an author or contributor or in the acknowledgements section.” To us this seems to suggest that EMWA believes that mentioning editorial assistance in the acknowledgment section is considered acceptable. Later in the document, they do say, “Vague acknowledgements of the medical writer’s role, such as ‘providing editorial assistance’ should be avoided as they are open to a wide variety of interpretations” but it is important to point out that the EWMA is still trying to find a way to have unnamed authors on papers. Instead of using the term “editorial assistance” they are simply proposing another term. In their words: “We suggest wording such as ‘We thank Dr Jane Doe who provided medical writing services on behalf of XYZ Pharmaceuticals Ltd’.” However simply changing the term of “editorial assistance” to “medical writer” is just another way to keep deserving authors off the byline.

The acknowledgement section is traditionally seen as a spot to mention people who don’t rise to the level of “author” – for instance, colleagues who looked at the paper and made comments, a grammar guru who tweaked the composition, or Mom and Dad who provided the necessary motivation. The EWMA seems to be doing their best to figure out a way to include deserving authors in the acknowledgement section – something we have previously referred to as “an academic sleight of hand.” It is not that we are against the term “editorial assistance,” it is that we are against leaving a deserving author out of the byline. Keeping them in the acknowledgement section but calling them something else is just a way to sanction ghostwriting. What we should have said in our paper is that simply mentioning authors in the acknowledgement section as editorial assistants or medical writers or any other term is not a solution.

Legitimizing Ghosts

At the end of Adam’s posting he says that whether medical writers should be listed as authors is a legitimate debate, but why should this be considered a legitimate debate? If academic medicine allows papers to have unnamed authors, as Adam is saying, then they are sanction ghostwriting. Shouldn’t the ICJME just require that writers of papers be listed as authors? We did point out that we think ICJME has a loophole that can allow ghostwriting, but we don’t think their intention is to condone the use of unnamed authors, and we don’t think they are debating whether this should be allowed.

The Twilight Zone

This is a very weird discussion. It seems to us that we are the ones calling for increased recognition for a group of very bright and skillful people. Rather than be hidden in the shadows we think that their skills and intelligence should be given the credit they deserve by rising to the level of authors. Medical writers do provide a very valuable service and there is no reason they should not be used but why not list them as authors? Sally Laden is surely one of the brightest and most prolific people in the scientific literature yet a pub med search would not reveal this. Yet, for our efforts, this group’s spokesperson attacks us on the basis that his group is not deserving of this credit. Welcome to the world of academic medicine. Adam has taken on the task of attacking anyone in the medical literature who suggests that writers should be called authors. But he seems to be leading his organization down a path that we are not sure his constituency wants to follow. If he is not careful his organization is going to become the EMGWA -The European Medical Ghost Writers Association.

“Ghosted” medical school professors – researchers who allow themselves to be named as authors of studies which are in fact all, or in part, written by ghost-writing agencies in the pay of drug firms promoting certain pills and devices – are a dime a dozen.

But not all ghosted – or in various other ways pharma-compromised – professors are created equal. When they come from our most respected universities – Harvard, Duke, Penn, Stanford – they lift a merely scummy underhanded practice all the way up to a national disgrace.

Professors are themselves of course reluctant to talk about the practice. In his withering response to Brown University professor Peter Kramer’s recent effort to defend antidepressants, Felix Salmon notes that Kramer

…takes care not to even mention part two of [Marcia] Angell’s two-part [New York Review of Books] series, where she talks at length about how psychiatry has been captured by drug companies, who “are particularly eager to win over faculty psychiatrists at prestigious academic medical centers”. (After reading Angell’s second essay, you’ll certainly wonder why Kramer doesn’t disclose how much income he gets from pharmaceutical companies.)

One of these prestigious medical centers, and the president of its university, has just hit all the papers.

[It is alleged that] five psychiatrists allowed their names to be appended to a manuscript that was drafted by medical communications company Scientific Therapeutics Information, hired by SmithKline Beecham, now GlaxoSmithKline. The paper [reportedly] misrepresented information from a research study on the antidepressant drug Paxil.

The manuscript published in the American Journal of Psychiatry in 2001, and cited many times since, suggested that Paxil may be beneficial in the treatment of bipolar depression, without acknowledging the medical communication company’s contribution or the extent of GSK’s involvement.

If any of the claims are true, it’s a really icky case: The complainant, a University of Pennsylvania professor who, along with colleagues, was involved in the research and writing of the paper, even claims that “the ghostwriting firm, Scientific Therapeutics Information in Springfield, N.J., chose [one researcher] as the paper’s first author and that Glaxo then decided to replace him with [Charles] Nemeroff.” [Background on Nemeroff here.]

Eeny meeny miny mo, who’s the biggest pharma ho? Ghost company offers one candidate; pharma co. another… Meanwhile, where are the actual, like, professors of medicine who supposedly wrote this shit? Sitting on their asses, directing their secretaries to add another ghost-written article to their hundreds and hundreds of ghost-written or guest-written articles…

Since this scandal largely involves the University of Pennsylvania, one would expect at least a word or two from its president, Amy Gutmann – especially since she chairs President Obama’s bioethics commission. Rather than traveling to Washington and generalizing about good and evil in the world of science, Gutmann should stay home, release a statement about this situation, and investigate the troubling ethical matters in her own backyard.

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Many more details here, including the shameful non-involvement of some authors of the study, and the undisclosed pharma affiliation of others.

… who cannot seem to keep their names out of the papers.

Their universities continue to praise them to the skies — see here, here, and here — and yet the New York Times and various United States senators and various university colleagues are constantly writing in very negative terms about these guys, sending them angry letters, suggesting they’re corrupt and destructive…

Biederman, Nemeroff, and Zdeblick aren’t the only controversial high-profile medical school professors in America; but no other professors have been so enduringly under attack – for conflict of interest, for suppression of negative evidence, for personal greed – by the media, professional organizations, and Congress. All three men, for years and years and years, have been accused of serious misbehavior. Their names are always in the papers, and always for the wrong reasons.

Zdeblick is -for the umpteenth time – in today’s headlines.

When does a university decide that a prominent, grants-getting, journal-editing, mover-shaker on its faculty has become so compromised that he or she should go? Emory University let Nemeroff go, but the University of Miami immediately panted after him, and has worshipfully adored him ever since… I mean, you have to wonder: Do the leaders of these universities even know they have a problem?

And it’s adorable! To watch Tom and Charlie consort with one another year after year despite all the conflicts and penalties and sanctions and recusals and rules and everything!!!

[Charles Nemeroff] repeatedly contacted [Thomas] Insel for help with NIH grants, including attempts to renew and relocate his work at Emory.

Plus!

At Miami, [conflict of interest will be] handled by the medical school’s dean, Pascal J. Goldschmidt, who hired Dr. Nemeroff after conferring with Dr. Insel. The dean subsequently said that he understood the concern over Dr. Nemeroff’s track record, and that he would be “scrutinizing his activities” to be sure he reports all future income from outside companies.

Dr. Goldschmidt was found last month to have underreported his income from service on the boards of two outside companies.