Find out here.
Find out here.
A Canadian academic was puzzled:
I recently looked at the c.v. of a distinguished professor of medicine and saw that he had authored (most usually had co-authored) about 800 articles in peer-reviewed journals, an average of nearly 30 per year over his career. His publication rate has accelerated over the years, reaching 40 articles per year in the past decade. How can a scientist author and publish 40 articles in a year? Year after year? In my fields (Science and Technology Studies, Philosophy, Sociology), five peer-reviewed articles in a year is a lot, and most researchers would be happy to write one truly good article each year.
Rather than conclude the obvious — these guys are fucking geniuses — and go back to his low-paid slow-lane job, Sergio Sismondo decided to investigate.
Turns out they’re not writing the articles!
…[D]rug companies and their agents produce a significant percentage of the manuscripts on major current drugs. These manuscripts are then “authored” by academic researchers, whose contribution ranges from having supplied some of the patients for a clinical trial, to editing the manuscript, to simply signing off on the final draft. The companies then submit these manuscripts to medical journals, where they fare quite well and are published. The published articles contribute to accepted scientific opinions, but the circumstances of their production remain largely invisible. When the articles are useful, the marketing departments of the drug companies involved will buy thousands of reprints, which sales representatives (reps) can give to physicians. I call this whole process the “ghost management” of pharmaceutical research and publication.
[Ghost authors] are unlikely to make major contributions to the analysis or writing of an article. They are shown well-crafted manuscripts that have been reviewed by many scientists, writers, and marketers. They are not given access to the data. They are asked their views on very specific points. They are given short deadlines. Thus, authors of industry manuscripts are largely sidelined from the process of analyzing, writing, and publishing research.
About half of what you read about the drug you’re thinking of taking was written by a public relations firm.
[I]t appears that roughly 40 per cent of medical journal articles on major in-patent drugs are parts of individual publication plans on the drugs… [P]harmaceutical companies have complete control over roughly half of all clinical trial data…
A philosopher, Sismundo grapples with the ethics of simulacral science:
The pharmaceutical industry … has developed a [new] form of plagiarism, involving only willing participants. Moreover, it has created new reasons for concern: the hiding of interests that drive research and publication and the possible harm to patients that this may create. When sales reps bring reprints of articles to the offices of physicians, prescribing nurses, hospital staff in charge of formularies, and other drug gatekeepers, those articles may look like independent confirmation of the reps’ pitches. Plagiarizing [ghost authors] lend their good names to the pitches.
On the up side, there’s the rich abundance of scientific output with which, as modern consumers, we are blessed:
Another much-discussed issue in the ethics of publishing is over-publication. We are buried in masses of literature, making it difficult to find what is valuable. Publication hides as much as it reveals. Every year, library budgets increase at well above the overall rate of inflation. This is caused in part by publishers increasing the prices of journals, and in part by the increasing number of journals. The ghost management of pharmaceutical research and publication plays a role within the medical sciences, as industry planners calculate how many new articles bearing key messages they need to affect perceptions and sway those who prescribe drugs.
… medical school professors conspiring to place fake articles praising their products in respectable journals, the reporter stumbles on one John Buse. Buse, a professor at the University of North Carolina, is remarkably candid about things.
Buse said in a Nov. 28, 2006, deposition that working with drugmakers over a long period of time can change the way doctors think about clinical problems.
“It’s sort of like Stockholm Syndrome,” Buse said in the deposition, referring to a psychological phenomenon in which kidnap victims begin to sympathize with their captors.
“I’m not saying that the pharmaceutical industry captures me,” Buse said. “But to the extent that the relationship has something above and beyond medicine, science, you know, it could cloud one’s judgment.”
Buse added that many researchers develop emotional attachments to drugs they’ve discovered or studied extensively.
“There’s this natural tendency for people to fall in love with your drug: it’s like your child,” Buse said. “So you have a hard time accepting criticism.”
So there are at least two motives behind the outrageous conflict of interest scandal in America’s medical schools:
1.) A passionate affair with your drug which makes you desperate to protect it and show it in its best light — a desire its manufacturer abets.
2.) Raw greed.
… at Harvard. There are plenty of nuances in COI, and the piece touches on some of them.
Comments from a Harvard med student:
“This isn’t about a few bad apples,” says David C. Tian, a first-year medical student who joined the AMSA protesters early this year in their quest to revamp the school’s conflict of interest policies. “This is a systemic issue that requires policy-making on the institutional level. Harvard Medical School should represent the practice of medicine as a whole.”
… “Starting with our third year, our teachers are doctors who are interacting with industry on a daily basis in ways that the Medical School currently doesn’t standardize or set standards for,” Tian told The Crimson last fall.
… just … I dunno… conflict of EVERYTHING! — inspiration will always be Harvard’s last president, Larry Summers, who earned, I dunno, something in the mid hundreds of thousands for being Harvard’s president, but who got FIVE MILLION DOLLARS AT THE SAME TIME for whatever the fuck he did for some hedge fund ONE DAY A WEEK.
Even UD‘s recent acquisition of Hummer is unlikely to yield such results. (She’s already fielding emails from Hummer Club presidents about this that and the other. Who knew there were Hummer Clubs?)
But anyway, what with Senator Grassley making a fuss about it, lots of universities are trying to cough up new and improved COI language. (Language only, of course. The relationship of university administrators to faculty COI is much like the relationship of the NCAA to university sports programs.)
And then there are places like the University of Oregon, which doesn’t seem to have any COI policies at all. A significant segment of UO’s faculty is undergoing attachment issues as UO threatens to take away cherished freedoms…
This article takes a pretty intelligent look at COI at UO. The comments after the article are also worth a read.
It’s how you manage conflict of interest.
You know.
University administrators are always telling us that it’s not a matter of avoiding conflict of interest but managing conflict of interest.
So here’s how you manage it if you’re chief of spinal surgery at UCLA. You take out your little conflict of interest form, and where it says Do you have a conflict? you say No.
[Senator Charles Grassley says that] Jeffrey Wang, chief of spine surgery at UCLA … didn’t inform the school of $459,500 Wang was paid from 2004 to 2007…. Companies that made payments such as consulting and speaking fees to Wang included medical-device makers Medtronic and FzioMed and the DePuy unit of Johnson & Johnson. Grassley says Wang “consistently checked no” on UCLA disclosure forms when asked whether he had received income of $500 or more from companies funding his clinical research.
Fellow UCLA professors of the spine! Show some backbone! Follow your chief!
Lie.
In a move Harvard University should consider in connection with Joseph Biederman, Washington University has rid itself of a professor so deeply compromised in his research ethics as to do terrible damage to the school’s reputation as long as he remains on the faculty.
… [F]our former colleagues [accuse Kuklo of] falsifying research on a bone-growth product made by Medtronic that was used on severely injured soldiers. He was also accused of forging the other doctors’ signatures when he submitted a research report to a medical journal last year.
The Army, which investigated the matter, issued a report rebuking him. It took no further disciplinary action, Army officials said, because Dr. Kuklo is now retired from the military. But Walter Reed notified Washington University of its findings five months ago.
The Journal of Bone and Joint Surgery, a British publication, retracted Dr. Kuklo’s article in March after receiving a report of the investigation from the Army. But the episode largely escaped public notice until last week.
This week, a Republican senator, Charles E. Grassley of Iowa, sent letters seeking more information about Dr. Kuklo from Walter Reed, Washington University, two medical journals and Medtronic.
Dr. Kuklo has been a consultant to Medtronic…
Kuklo’s silence in the face of all of this has been as total as the silence of the pretend soldiers he enlisted in his study. He won’t talk to anyone. UD guesses he refused to talk to Washington University too, and that this persuaded the university of his guilt – or at least so pissed it off that it booted him out.
… correcting UD‘s misunderstanding of the nature of the University of Texas Medical Branch at Galveston:
First, disclosure: I am on the verge of graduating from UTMB with a Ph.D in ethics & medical humanities, so my affiliation most assuredly colors my views.
Second, some of my academic work involves COIs in research and medicine.
But I do think it is important to understand a bit more of the local context re UTMB. UTMB is indeed part of the UT system, but to assert that it shares in the Adzillatron and what that represents is something of an error or at least an oversimplification. Some knowledge of Texas politics is required in order to explain why. UTMB may “share” in the Adzillatron, but its share is pitiful compared to the two flagship institutions, UT-Austin, and Texas A&M. These two are both extremely wealthy institutions, with literally every other UT scrabbling for scraps. UTMB itself is near the bottom of this heap, since their very charter declares that the mission of the school is expressly to provide indigent care.
There is a perception that the regents have grown tired of this mission, such that the funds allocated to UTMB to provide indigent care have consistently crept lower. The regents very nearly ended the school’s clinical operations “due” to damage caused by Hurricane Ike. Only a well-positioned and powerful representative in the Texas Capitol prevented this from occurring.
None of this is to offer any opinion on the events surrounding Dr. Wagner. But it is inaccurate to argue that because UTMB is part of the UT system, it shares equally in the Adzillatron culture. UTMB has historically lacked the funds to even fulfill its charter; wealthy donors and endowments do not generally come UTMB’s way.
UD is very grateful to the reader for this clarification.
Her critics become more and more shrill as Karen Wagner’s deception generates outrage; yet Wagner, like the university that employs her, remains absolutely silent.
The University of Texas has issued a few We don’t know shit but uh when we get a chance we’ll look into it statements in response to Senator Charles Grassley’s repeated letters to it about the vice-chair of the psychiatry department’s way-lucrative, hidden conflicts of interest, and of course the campus can’t be happy that Grassley just reported her to the Health and Human Services inspector general.
In his latest letter, the Iowa Republican says that the amount Wagner didn’t report may be as high as $230,000. The university’s counsel told the Dallas Morning News last week that it has been investigating Wagner for two weeks -– though it got the first letter on the issue eight months ago.
But hey. If you were an office of sponsored research guy, and you had a choice between going to a football game and staring at a big ol’ Adzillatron, and shuffling through disclosure papers from Wagner in which she makes a fool of you to the tune of hundreds of thousands of dollars, what would you do?
That Texas Adzillatron — the world’s largest — has UD thinking. What if, during major athletic contests, with the whole nation watching, the university were to pause the stream of ads for a few moments and flash the names of its professors who’ve lied about outside income? You know – list their names, departments, and the amount of money they didn’t tell anybody about over, say, the last ten years. Also any sanctions imposed. If UT takes disclosure seriously, this would be real disclosure. It would also embarrass Wagner and others, thereby discouraging fellow professors of psychiatry from following their path.
You figure universities are primarily dumping grounds for politicians, their friends, and their families. You figure that because that’s the way it’s always been.
And then things suddenly change on you, and your life becomes unbearable.
The top academic official at North Carolina State University stepped down Thursday, saying controversy over his hiring of the state’s former first lady has become “unbearable.”
Provost Larry Nielsen created a new faculty position and used it to hire Mary Easley, wife of former Democratic Gov. Mike Easley, who left office in January after two terms.
The 31,000-student school hired Mary Easley in 2005 to oversee a lecture series and teach three courses. Last summer, a new compensation agreement expanded her role and boosted her salary to $850,000 over a five-year contract. [88% raise.]
The News & Observer of Raleigh has raised questions about why Nielsen was hired as provost even though he was not among an initial pool of candidates.
He served as interim provost during the search, and school officials named him to the post permanently in June 2005, shortly before the university announced Easley’s hiring. The newspaper said Nielsen worked closely with Easley ally McQueen Campbell, who chaired the university trustees’ personnel committee.
… N.C. State is the largest campus of North Carolina’s 16 public universities.
Last summer, Nielsen defended Easley’s increased salary by saying she had new duties, working at the Center for Public Safety Leadership and Strategic Legal Partnership. Before joining the university, she had taught law at North Carolina Central University in Durham.
University of North Carolina system leaders launched a review of the deal but later approved her salary while saying a portion of the pay would come from private funds.
Nielsen said the personal stress had become unbearable and he understands that some people will interpret his resignation as an indication the allegations are valid…
For background on Easley, who, unlike the fragile provost, will tough it out for the sake of the money, go here.
… we’re getting our education in academic medicine.
Thanks to Senator Grassley, the weird science of some university-sponsored research reveals itself, and even UD, who’s been around, finds it head-spinning.
Here, for instance, is a professor at Washington University defending his colleague, Timothy Kuklo, charged with falsification of data, forgery of documents, and other stuff:
… The inquiry also found that Kuklo falsely claimed other Army doctors helped write the study. … [A colleague said, in defense of Kuklo, that] it’s not uncommon for a researcher to sign other authors’ names to a study after getting verbal consent. It is a practice that is done, for example, when other authors are abroad and do not have easy access to fax machines.
Since Kuklo has so far refused to respond to anyone – in the press or the military – about any of this, we can’t know whether he got the four faxless horsemen’s verbal consent… Or what that consent was for. We do know that sticking lots of names on articles – names of people who have absolutely nothing to do with the project – represents one of many curious folkways of UD‘s fellow professors in med schools around the country. No doubt it’s a short jump from rounding up friends who have nothing to do with your work and pretending that they helped you with it, to just going ahead and putting their names down… forging their names… on the cover page of your study… without permission:
… [Kuklo] falsely claimed had a 92 percent success rate in healing shattered legs of wounded soldiers injured in Iraq, and Medtronic [his client, and maker of the device at the heart of the study] has supported his research, the Times reported.
Kuklo’s study was retracted in March after [the] paper’s publisher, The Journal of Bone and Joint Surgery, received notification from Walter Reed questioning the validity of the report’s conclusions.
“It was further disclosed that much of the paper was essentially false,” the retraction read.
Additionally, four doctors listed as co-authors on the report said they had not seen the manuscript prior to publication, and their signatures were forged on the article before its submission…
But wait! They were detained abroad, bereft of faxes …
It’s not only the weird ways of research we’re learning about. It’s the yet weirder ways in which other researchers defend the research.
… are the latest schools housing professors charged with serious professional misconduct. Wash U’s faculty member faces falsification of data charges (details here, at The Periodic Table). Federal prosecutors (as I note in the post below) charge the Dartmouth professor with conflict of interest. He could go to jail.
I must say, psychiatry departments at American universities look almost as troubled as campus athletic departments. Both places often seem epicenters of greed, stupidity, and criminality.
Call UD old-fashioned, but she doesn’t immediately associate that set of values with universities as we’ve come to know them.
Federal prosecutors have filed conflict of interest charges against a VA hospital psychiatrist, alleging that he supervised contracts in which he had a financial interest.
Dr. William Weeks of Lyme, N.H., is accused of misconduct in five contracts between the White River Junction VA hospital and Dartmouth College. He acted as both a VA representative responsible for approving payments to Dartmouth and as Dartmouth’s principal investigator performing work on the contracts, prosecutors say.
If convicted of the misdemeanor charges, he faces a year in prison and fines of up to $100,000 for each charge. He also faces up to $1.3 million in penalties in an 11-count civil complaint.
In court papers filed Friday, Acting U.S. Attorney Paul Van de Graaf said Weeks sought $1.1 million in contracts from the VA for Dartmouth, and then did the work for significantly less by hiring fewer people and at lower rates. An estimated $567,000 was left over and deposited into an account at Dartmouth in Weeks’ name.
Weeks also is accused of participating in other contracts with the VA and Dartmouth while holding the dual positions…
Studies of cancer treatments were more likely to report improvements in overall survival when the investigators reported some kind of financial conflict of interest, researchers said.
Analysis of 124 oncology clinical trials showed that those with a conflict of interest — either direct industry funding or an author’s declarations of financial relationships — were more than twice as likely to find significantly improved patient survival, according to Reshma Jagsi, M.D., D.Phil., of the University of Michigan, and colleagues.
The finding emerged from an online report in Cancer covering conflicts of interest in more than 1,500 oncology studies in major journals during 2006.
Among 52 randomized, controlled trials with no conflict of interest, 14% found significantly better survival with the intervention relative to control, 72% found equivalent survival, and 6% significantly favored the control.
In 72 similar trials with a conflict of interest, 29% found in favor of the intervention, 61% showed no difference, and none reported better survival with the control (P=0.04 for trend relative to nonconflicted studies)….
It involves drug company payments to Karen Wagner, a psychiatrist at the University of Texas. Big payments, over many years, for her touting the benefits of various dangerous concoctions for the most vulnerable among us — children.
The Commission’s very hush-hush. Wagner never reported any of this money to her university. Well, once she reported she’d gotten six hundred dollars. That left multiple hundreds of thousands that she concealed.
The university thought it’d be a great idea to put Wagner on a committee reviewing other professors’ conflict of interest forms.
Wagner knows how to keep a secret:
In March 2006, Dr. Wagner was being deposed in a case on Paxil. During that deposition, Dr. Wagner was asked how much money she had taken from drug companies over the previous five years.
Her response? She said, and I quote, “I don’t know.” In fact, she testified that she couldn’t even estimate how much money she received from the drug companies.
The latest on the Wagner Commission:
An influential U.S. senator has reported a University of Texas researcher’s financial relationship with a drug company to the top investigator at the U.S. Department of Health and Human Services.
Iowa Sen. Chuck Grassley, the ranking member of the Senate Finance Committee, sent a letter to the University of Texas System in September raising concerns that child pharmacology researcher Karen Wagner had not properly disclosed her financial connections with drug companies. He reported her in a letter to the Health and Human Services Office of the Inspector General.