The Government’s “independent” adviser on mass tranquiliser addiction has received research funding from a drug company which manufacturers two commonly prescribed tranquilisers.
Professor John Strang, head of the National Addiction Centre at King’s College London, and author of a government report on the prescription of potent psychiatric sedatives, did not declare he received the money from the pharmaceutical firm …
… and since he’s a feisty fellow, ever ready to defend his position, UD sees a promising future for him.
He’s entirely unfazed that the editors of America’s three major medical journals found a recent study he published (it argues that the FDA’s product reviews stifle the medical device industry) scientifically shoddy and rife with conflict of interest. A congressional committee report summarizes:
“After reviewing the paper, the editors of the three premier peer-reviewed medical journals concluded that the study would not be fit for publication in a peer-reviewed journal.” Dr. [Gregory] Curfman concluded that “it is not really a study at all.” Dr. [Rita] Redberg found “several serious methodological issues with the Makower report that render its findings scientifically invalid.” Dr. [Howard] Bauchner determined that “[g]iven the extent of these limitations, the inferences and conclusions that can reliably drawn from this report are limited.” Finally, all three editors identified significant conflict of interest concerns with the report.
The objections to the study were similar to reactions by Dr. Jeffrey Shuren, director of the Center for Devices & Radiological Health, who lambasted the study when it was released in December. Shuren told MassDevice that the study was “horrible.”
“That’s well below the quality level of a good study,” Shuren told us at the time. He pointed out that lower response rates would magnify the opinions of people unhappy with the process. He added that a sufficient response rate would have been 35 to 40 percent. “We want to have good data.”
The Minnesota Star Tribune provides more conflict of interest details:
Dr. Curfman writes that he was surprised Makower did not disclose his financial ties to the device industry since they “clearly constitute a significant conflict of interest.” Further, he states, “this isn’t a study as all. This is an opinion piece that is dressed up to look like a research study.” The authors had a specific agenda from the outset, he continues, and “they conducted their work in a biased manner.” The CHI report “advocates a potentially dangerous position — that regulation stifles innovation, he says, and “do a serious disservice to medicine and the health of the public.”
Now on to Dr. Redberg, who says there are “serious methodological issues” with Makower’s report, claiming a selection bias among the companies that responded to his inquiry. She goes on to claim the authors, funders and survey respondents may have a conflict of interest because their “livelihood depends on fast approval of medical devices.”
She also quibbles with the report’s conclusion that FDA regs are driving med-tech companies abroad. This argument is flawed, Redberg writes, because approving unsafe devices “actually hurts the economy by allowing limited health care dollars to be spent on expensive devices that do not help patients” [which leads] to higher health care costs that may result in economic difficulties and possible bankruptcies of small businesses.
Stanford is a hotbed of professor-entrepreneurs for whom fast approval is of course the name of the game. Note to Congress: Shut up and get out of the way. Note to Stanford: Terrific research program you’ve got going there.
UD‘s colleagues Anthony Yezer and Robert Van Order appear to be small players in the very large, competitive game of corporate funded and controlled research results (even corporate controlled faculty) in the contemporary American and European university.
**********************************************
Lately, some of the bigger players seem to be jostling each other out of the way for the right to pleasure the financial sector. BABY, TELL ME WHAT YOU WANT ME TO SAY AND HOW TO SAY IT. WRITE IT YOURSELF IF YOU WANT AND I’LL SIGN IT. LIE BACK AND NIBBLE MY INTELLECTUAL NEUTRALITY.
Harvard’s bipolar babe, Joseph Biederman, pitched his research center to Johnson and Johnson by writing to them that it would “move forward the commercial goals of J.& J.”
Most of these chicks deny. Biederman burbles happily away and Harvard can’t get enough of it…
Sure, when he gets really out there they sanction him … But he’s still a big girl on campus… And always will be!
So here you’ve got this latest article in the New York Times about how a German bank gave a couple of universities there a lot of money and
the bank was allowed a say in the hiring of … two professors. It was also given the right to have bank employees designated as adjunct professors, allowed to grade student work. Appropriate topics for research and research strategy would be decided by a steering committee made up of two academics and two bank employees, with the managing director, a bank employee, casting the deciding vote in the event of a tie.
Deutsche Bank was given the right to review any research produced by members of the Quantitative Products Laboratory 60 days before it was published and could withhold permission for publication for as long as two years. The agreement even specified that the laboratory would be located “in close proximity to the Deutsche Bank” headquarters in Berlin.
Finally, the whole agreement was to be secret…
At last my heart’s an open door; and my secret love’s no secret anymore!
… this book. It shows a child’s hand grabbing a massive number of pills. [Scroll down to read some of the book.]
Your Child Does Not Have Bipolar Disorder is a richly deserved attack on one of Harvard University’s most prominent professors, Joseph Biederman, a man whose financially self-interested insistence on this serious diagnosis continues to damage and stigmatize millions of young children.
The book’s author, Stuart Kaplan, a professor at Penn State, also has a blog on which he worries, in a day-to-day way, about the psychiatric profession maintaining Buy-Bipolar Biederman’s regime. He notes that although the diagnosis is gradually (thanks to books like Kaplan’s, and to Biederman’s having been sanctioned for taking and not disclosing drug money) being discredited, the editors of the latest, in-progress DSMV are still saying things like this:
… ‘[C]lassic’ adult [bipolar disorder] clearly does present in pre-pubertal children as well as in adolescents, although it may be rare in the younger age group. Unambiguous agreement about this fact weighed heavily in the Work Group’s deliberations.
Kaplan goes to town on this:
The use of the wording “unambiguous agreement about this fact” is a coercive rhetorical device that has held sway for more than 15 years in the pediatric bipolar scientific literature. Instead of providing evidence, the Work Group attempts to persuade the reader that everyone who is smart and important knows this to be true. In truth the assertion is unfounded and has no place in sophisticated scientific discussions of bipolar disorder in children. The clause “although it may be rare in the younger age group” suggests some hesitation on the part of the Work Group in endorsing the existence of Bipolar Disorder in pre-pubertal children.
That the committee accepted as fact that bipolar disorder exists in children raises the issue of the use of the word fact in psychiatry as contrasted with its use in other sciences and in everyday conversation. The use of word “fact” in scientific papers in psychiatry is highly unusual. The use of the word in this context by the DSM-V Work Group is jarring to regular readers of the scholarly literature in psychiatry. In this scientific literature, papers end with conclusions preceded by discussions that are expected to point out the limitations of the scientific work. Conclusions are usually modest, tentative and limited. The word fact is almost never used.
Are there “facts” in psychiatry comparable to the physical constant of the speed of light in physics, the periodic table in chemistry, the function of the adrenal gland in biology, or the boiling point of water on the earth at sea level in everyday life? There may be some (e.g., need for an adequate environment for infants and children for psychological growth and development) but most so called facts in psychiatry are brief stand-ins or proxies for many inferences and theories that shift and change abruptly. For example, the diagnosis of bipolar disorder in adults is based to some degree on the diagnosis of Manic Depressive Insanity first developed by Kraepelin. The veracity of his observations and theories about psychosis are part of the brew of the current diagnosis of Bipolar Disorder. The diagnosis is based to limited degree on Kraepelin’s theories and a large number of other hypotheses many of which are disputable. Fact as the acceptance of some immutable truth does not enter into the discussion.
When the DSM-V Work Group refers to the unambiguous fact that the disorder exists in prepubertal children, does the Work Group have any specific age range in mind? Preschoolers? Children ages 10 years to 12 years? Children ages 6 years to 12 years? Each of these age groups has been the subject of controversy related to bipolar disorder in children, but they are lumped together without any discrimination between them. Similarly, the use of the word “rare” by the DSM-V Work Group remains inexplicably undefined. The expression “rare” has a specific meaning in medicine, referring to a prevalence of 1 or less cases per 1500. Is this what the DSM-V Work Group means? There is a startling lack of precision in the discussion of the existence of pediatric bipolar disorder in childhood by the DSM- V Work Group. Many people, myself included, believe it is closer to the truth to assume, until proven otherwise, that this prepubertal “disorder” does not exist at all.
The misdiagnosis monster lives: the stake must still be driven in to the heart of the beast.
Beast? Why the strong language?
Because the diagnosis is doing terrible things to children; and because the only people benefiting seem to be the people who sell all those pills under the child’s hand on the book’s cover.
The bipolar monster was loosed because American university professors, in cooperation with drug companies, created it. Indeed the problem that confronts us now, as Kaplan says, is how to kill it.
… secretly industry-sponsored research papers in the field of medicine to secretly industry-sponsored research papers in the field of economics!
Two of UD‘s colleagues recently released a report which makes “a strong argument for shrinking the role of the Federal Housing Administration in insuring mortgages. But nowhere is it disclosed that the paper 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.”
WHOOOOPS. One of the authors “said he didn’t realize he had failed to note Genworth’s underwriting of the paper in the credits.” Such a small thing… easy to overlook… they’re just the people paying for the work.
And here’s a funny thing for a professor to say about his research: “They are using up our time, so they make a [financial] contribution to the university.”
“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.
*************************************
Many more details here, including the shameful non-involvement of some authors of the study, and the undisclosed pharma affiliation of others.
Response to the Disciplinary Committee
Say Biederman, Wilens, and Spencer:
“Ah hell, we just do what we can, sir.
You can’t avoid sleaze
When you’ve got our disease:
The absence of all moral sensors.”
*******************************
(UD thanks B. for the link.)
*******************************
Update:
“You could have made more nice statements about the drug.’’
More on the culture of academic psychiatry in the United States.
********************************
Lest we forget.
… Biederman is a leading proponent of the off-label use of antipsychotic drugs to treat bipolar illness in children. His work is widely seen as contributing to an explosive growth in such prescriptions, and much of his support came from companies that benefited from his research.
Stanford University’s Eugene Carragee gets it said with beautiful concision.
And with authority: He’s the editor of The Spine Journal, and, as Paul Thacker notes, Carragee has devoted an entire issue of his journal to the appalling ongoing story of Infuse. (This New York Times article, which appeared minutes ago, provides background.)
Paul wonders if this particular revelation of the ghostwriting, conflicts of interest and undisclosed payments behind the promotion and use of a destructive medical device might be “a critical turning point, when we see physicians finally break free from [the] corrupt influence of industry and begin to put patients first and money second.”
UD‘s primary interest is in the ways universities collude – through passivity or cynicism or ineptitude – in the activities of conflicted professors on their faculties.
And it’s not merely collusion. Often these people – easily identified by the 800 or so articles they claim on their cvs to have written (many of these publications are ghost- or guest-written) – are among the highest-profile, most celebrated faculty on campus.
Among the highest-paid, too. Keep that in mind when you read this, from the NYT article:
The median amount of Medtronic money received over time by researchers involved in some studies ranged from $12 million to $16 million, with most of that going to a few individuals…
“A consistent number of people involved with these studies got extraordinary sums,” [Carragee] said.
The surgical operation at play here is known as cash infusion.
… 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.
… Marcia Angell highlights the corruption of academic psychiatry:
Drug companies are particularly eager to win over faculty psychiatrists at prestigious academic medical centers. Called “key opinion leaders” (KOLs) by the industry, these are the people who through their writing and teaching influence how mental illness will be diagnosed and treated. They also publish much of the clinical research on drugs and, most importantly, largely determine the content of the DSM. In a sense, they are the best sales force the industry could have, and are worth every cent spent on them…
[T]here are no objective signs or tests for mental illness — no lab data or MRI findings -and the boundaries between normal and abnormal are often unclear. That makes it possible to expand diagnostic boundaries or even create new diagnoses, in ways that would be impossible, say, in a field like cardiology. And drug companies have every interest in inducing psychiatrists to do just that…
************************
************************
Also related. If you can read this article without wanting to vomit, you’re a better man than I am.
Once the medical establishment started buying into the idea of bipolar kids in the 1990s, the diagnosis gained unusual force. In 2000 the National Institute of Mental Health convened a roundtable of researchers in pediatric bipolar disorder and financially supported several controversial propositions, including the practice of asking bipolar adults to date the origins of their own disease. The creation of a new source of funding generated frenetic activity among university psychiatrists, and in a twinkling it created stakeholders in the diagnosis.
Whoops! Plus I own the company that makes the stuff!
Labrie’s take on this is great: “The one that is the first author has got the responsibility.”
It’s great because, you know, quite a few medical journal papers have like five to twenty authors, with only the first author (maybe – maybe a drug company got the whole thing ghostwritten) actually having any involvement in experimenting and writing and shit like that which you might associate with experimenting and writing…
So put quotations marks, in that last sentence, around each use of the word author and you begin to see Labrie’s point.
Some of those not-first writers, let’s speculate, had little to do with the article; their names were plastered on it like some cheesy face cream because people know who they are, and that adds prestige. Why in hell – since their only involvement is to be informed of when the article comes out and instruct their secretaries to add its title to their list of publications – should they bother listing conflicts of interest?
While experts contacted by Reuters Health say that none of the anti-aging creams available to consumers has been proven to work better than a simple moisturizer, some products still run well over $100.
One way to justify those exorbitant price tags is to tout “clinically proven” …
(Why isn’t Suze Orman talking to women about one hundred dollar moisturizers?)
Journals, concludes one editor, are “the marketing arm of the pharma industry.”
… the disgusting, injurious corruption of medical knowledge in America.
[T]he $310 billion pharmaceutical industry quietly buys … the contents of medical journals and, all too often, the trajectory of medical research itself.
[Continuing medical education courses are] pedagogic playdates [that] familiarize doctors with pharmaceutical companies’ patented products to the exclusion of cheaper and sometimes safer and more effective alternatives.
[A Canadian bioethicist says:] “Many psychiatric medications are little more than placebos, yet many clinicians have come to believe that SSRI [selective serotonin reuptake inhibitors, a newer class of antidepressants] drugs are magic, all through the suppression of negative studies.”
[Another observer calls much of the content of our medical journals] “little better than infomercials.”
[At least] 50 …Elsevier journals appear to be Big Pharma advertisements passed off as medical publications.
*****************************
UD thanks Adam for the link.
[M]edical societies and doctors with financial ties to Sanofi served as components of a coordinated public relations strategy to use FDA’s citizen petition process to prevent or delay generic alternatives to its blockbuster drug Lovenox from coming on the market… Every day that pharmaceutical companies successfully delay safe and effective generic alternatives to their brand name drugs by attempting to manipulate the citizen petition process is another day that Americans pay more for their drugs.
PharmaLive quotes a letter from the Senate Finance Committee to the FDA, asking that agency if it would please make an effort to find out whether people like Duke University professor Victor Tapson are in the pay of pharma (Sanofi seems to have given him almost $300,000) before taking into consideration their representations seemingly on behalf of the industry. (Tapson apparently did not disclose, in his representations, that Sanofi was paying him.)
Here’s a letter Tapson sent to the FDA under the non-generic gravitas of the Duke University name. (I found the letter via Paul Thacker at POGO.) I gather Duke is fine with being officially enlisted in efforts to restrict generic drugs in the United States.