Scientific publishing giant Elsevier put out a total of six publications between 2000 and 2005 that were sponsored by unnamed pharmaceutical companies and looked like peer reviewed medical journals, but did not disclose sponsorship, the company has admitted.
Elsevier is conducting an "internal review" of its publishing practices after allegations came to light that the company produced a pharmaceutical company-funded publication in the early 2000s without disclosing that the "journal" was corporate sponsored.
The allegations involve the
Australasian Journal of Bone and Joint Medicine, a publication paid for by pharmaceutical company Merck that amounted to a compendium of reprinted scientific articles and one-source reviews, most of which presented data favorable to Merck's products.
The Scientist obtained two 2003 issues of the journal -- which bore the imprint of Elsevier's Excerpta Medica -- neither of which carried a statement obviating Merck's sponsorship of the publication.
An Elsevier spokesperson told
The Scientist in an email that a total of six titles in a "series of sponsored article publications" were put out by their Australia office and bore the Excerpta Medica imprint from 2000 to 2005. These titles were: the
Australasian Journal of General Practice, the
Australasian Journal of Neurology, the
Australasian Journal of Cardiology, the
Australasian Journal of Clinical Pharmacy, the
Australasian Journal of Cardiovascular Medicine, and the
Australasian Journal of Bone & Joint [Medicine]. Elsevier declined to provide the names of the sponsors of these titles, according to the company spokesperson.
"It has recently come to my attention that from 2000 to 2005, our Australia office published a series of sponsored article compilation publications, on behalf of pharmaceutical clients, that were made to look like journals and lacked the proper disclosures," said Michael Hansen, CEO of Elsevier's Health Sciences Division, in a
statement issued by the company. "This was an unacceptable practice, and we regret that it took place."
When confronted with the questionable publishing practices surrounding the
Australasian Journal of Bone and Joint Medicine last week, Elsevier indicated that it had no plans of looking into the matter further, but that decision has apparently been reversed.
"We are currently conducting an internal review but believe this was an isolated practice from a past period in time," Hansen continued in the Elsevier statement. "It does not reflect the way we operate today. The individuals involved in the project have long since left the company. I have affirmed our business practices as they relate to what defines a journal and the proper use of disclosure language with our employees to ensure this does not happen again."
"I understand this issue has troubled our communities of authors, editors, customers and employees," Hansen added in the statement. "But I can assure all that the integrity of Elsevier's publications and business practices remains intact."
Correction (May 7): The headline and original version of this story incorrectly indicated that Elsevier had produced seven titles in their "series of sponsored article publications" when in fact the publisher produced only six. The Scientist
regrets the error.
Related stories:Merck published fake journal
[30th April 2009]Elsevier expands biopharma base
[11th March 2008]Merck's fall from grace
[May 2006]
[Comment posted 2009-05-31 09:38:55]
LINK
I missed in my skimming of this story on your site that Elsevier had initially refused to acknowledged that this was sponsored content. This was made clearer (to me) in the OTM story.
- Knowlengr
[Comment posted 2009-05-23 08:29:39]
[Comment posted 2009-05-21 19:08:06]
[Comment posted 2009-05-20 09:20:17]
Thanks!
Alison McCook
Deputy Editor
[Comment posted 2009-05-20 00:06:45]
The corruption of the pharmaceutical industry on the whole, and of course the FDA which is probably second in corruption only to the NCI, the collusion between those 3 and the stooge doctors and researchers(?) they trot out when necessary to lie through their teeth for the requisite coin of the realm, simply breeds such things as fake journals, faked research data, results that keep the negatives hidden or not even mentioned, and suppresses authentic research and results so as to keep the "big 3" as omnipotent...and the people dying and uniformed.
Too bad one can't "Digg" The Scientist though as this sort of information needs a broader audience.
So I'm not surprised at the fake journals or any faked research...just par for the course and standard operating procedure for the big 3 and their stooges.
[Comment posted 2009-05-19 14:42:34]
LINK
[Comment posted 2009-05-19 14:26:37]
Elsevier is keeping the guilty companies protected so they are still involved and should not claim to be "dirt free" now.
I do not care if there are legal risks, it is no excuse for withholding the information.
This is blatant hypocrisy.
[Comment posted 2009-05-11 19:02:24]
"Obviating" means to make something unnecessary, not, as may have been intended, to make something obvious.
[Comment posted 2009-05-11 08:41:49]
We are building a platform that can be used just for this purpose. Check us out on LINK or follow our blog on LINK
Barak
[Comment posted 2009-05-10 22:24:20]
Quote:
There are petabytes of research data being produced in laboratories around the world, but the best web search tools available can?t help us make sense of it. Why? Because more stands between basic research and meaningful discovery than the problem of search.
Many scientists today work in relative isolation, left to follow blind alleys and duplicate existing research. Data are balkanized ? trapped behind firewalls, locked up by contracts or lost in databases that can?t be accessed or integrated. Materials are hard to get ? universities are overwhelmed with transfer requests that ought to be routine, while grant cycles pass and windows of opportunity close. It?s not uncommon for research sponsors to invest hundreds of millions of dollars in critically important efforts like drug discovery, only to see them fail.
The consequences in many cases are no less than tragic. The time it takes to go from identifying a gene to developing a drug currently stands at 17 years ? forever, for people suffering from disease.
...
[Comment posted 2009-05-10 04:48:07]
For all practical purposes, a journal that merely looks like it is a "peer-reviewed" is not different from one that has real peer review, but of a very poor quality. I say this because there are scores of journals published by professional or scientific societies, and in-house journals published by institutions, laboratories, etc., all of which are virtually "captive journals". There is a plethora of such journals in India. They are all nominally peer-reviewed, but the review is often a complete farce. The reviewers may not have expertise in the field of study to which the paper pertains: for instance a person whose [nominal] speciality is nuclear physics, may review a paper on biochemistry. (This also happens routinely in performance assessments for purposes of career advancement: the reviewer would usually be the Head of the laboratory or institution, a titular superior to the person being assessed.) Also, if a conscientious reviewer rejects a paper from a high-profile lab, the journal will black-mark him and send him no more papers to review. At the same time the journal will ensure that the paper gets published somehow or other. Further, in certain fields of study, only a handful of specialists would be available, and they would all be close associates -- and you get the "dog don't eat dog" phenomenon. Besides, most scientists who occupy high positions in India are political appointees, and appallingly ignorant even in basic science (e.g. high school level chemistry): but they are the ones doing most of the "peer review" both for scientific publications and personnel assessment.
[Comment posted 2009-05-08 12:20:15]
If I were to rate the corruptive tactics performed by big pharmaceutical companies during my intimate experience with them , the frequent and intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others possibly tops the list.
A list of corruptive tactics by the pharmaceutical industry that sponsors such trials. By this atrophy of the scientific method absent of authenticity that has been known to occur, harm and damage is possibly done to the health of the public.
Most would agree that the science of research should be sound and as aseptic as possible- completely free of deliberate and reckless interference.
However, it appears, money and increased profits can be a catalyst for disregard for human health with the clinical trial process that is largely unregulated.
This is particularly a factor on post-marketing studies of various pharmaceutical companies, as some pharmaceutical corporations seem to be deliberately conducting nothing less than seeding trials- with about a 50 percent tax credit for these trial sponsors.
Trials that are in fact pointless and void of scientific benefit.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of drugs and devices to benefit mankind.
Then, in 1980, the Bayh-Dole Act, Public Law 96-517,was created, which allowed for such places with their researchers to profit off of their discoveries that were performed for pharmaceutical companies and others in the past.
Furthermore, such academic institutions were coerced to license patented inventions to those pharmaceutical companies that will then commercialize these discoveries paid for in large part by the taxpayers who funded this research to a degree.
This resulted in the creation of for-profit research trial sites without any academic affiliation that are called Contract Research Organizations.
CROS utilize primarily community patient care clinics whose staff are absent of any research training compared with the former researchers that existed decades ago.
Because of this structure, the clinical trial investigators of these pharmaceutical sponsored trials are likely novice compared with academic researchers.
This, of course, happens with intent by the sponsor who can and does control all aspects of the clinical trial protocol at the site locations of a clinical trial that the pharmaceutical company structures and even gives the trial the title they want for their marketing purposes.
These quite numerous CROS are in fact for- profit, with some CROs making billions of dollars a year, and this market continues to grow.
The trials conducted at such places again are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their particular drug chosen to be studied.
Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for this drug of theirs to be studied in this manner.
This coercion is done by various methods of deception in subtle and tacit methods.
As a result, research in this protocol of the sponsor ensures favorable results of the sponsor?s medication that is involved in the clinical trial they clearly own.
These activities are again believed to be absent of true or applied regulation to any degree, and therefore have the autonomy to create whatever they want to benefit the pharmaceutical sponsor.
There likely is a collusive relationship between the sites, the CRO, and the sponsor, as this whole system is planned beforehand by the pharmaceutical sponsor of their clinical trial to again be utilized to increase the market share of the drug studied that they promote.
Guest authorship has been known to be aggressively recruited by sponsors by paying a known opinion leader to sign off on the completed clinical trial.
Furthermore, the pharmaceutical sponsor recruits investigators to be used for this function of what ultimately is a fabricated clinical trial protocol.
The trial manuscript and protocol design is prepared by those employed by the drug company sponsor upon specific direction of this sponsor on how this should be prepared.
The medical program coordinator of a particular sponsored trial is an actual employee of the sponsoring drug company.
This person also may act as the publisher, manuscript version reviewer, and the clinical trial director who works with the drug company?s hired CRO editors whose objectives are to benefit the sponsor.
Typical and ultimate cost of the final manuscript of the trial to the sponsor created by the hired CRO and the recruited ghostwriters exceeds 1000 dollars per page, some have said.
Merck engages in this behavior, which shocked many, as they were always viewed as an ethical pharmaceutical company that always placed patients over profits.
Apparently, this is no longer the case. There are other well known and large pharmaceutical corporations that consider this plan of action standard operating procedures to ensure growth of their drugs.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known again as ghostwriters.
These people are usually not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers.
One does not need research training or certification in order to perform this function. Rarely do clinical trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the pharmaceutical sponsor.
Also, these hired mystery writers are known to make about 100 grand a year performing this deception full time.
This activity removes accountability and authenticity of the fabricated clinical trial even further.
The corruptive act is finally completed by the sponsor hiring again a known thought leader as an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked or required by the hired author, others have said.
To have the trial published, the sponsor has been known to pay an obscure journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example.
Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry.
So benefits of pharmaceuticals that are studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks as a result of this process.
The purchased reprints of the fabricated clinical trial are then bought by the sponsor of the study from the medical journal they hired to publish this trial.
The reprints are eventually distributed to the sponsor?s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation that has happened with such a trial that benefits the drug they promote for their employer.
As a bonus, the sponsor may agree to pay the chosen medical journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns, as stated previously.
If so, our health care treatment options with drugs that are claimed to have benefits that are absent have now become unreliable in large part due to such corruptive situations.
Not to mention the absence of objectivity that has been intentionally eliminated with trials produced in this way.
More now than ever, meds are removed from the market or are given black box warnings due to the damaging effects of drugs approved by the FDA. We as citizens need to dig deep and ask why this is happening.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method.
More importantly, research should be conducted in a way that the sponsor cannot in any way interfere in such ways described in this article, which would require independent clinical trial sites with no involvement from the maker of the drug studied in a clinical trial.
And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters.
Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course.
We can no longer be dependent on others for our optimal health.
Knowledge is power, and is also possibly a lifesaver.
?Ethics and Science need to shake hands.? ??. Richard Cabot
Dan Abshear
Author?s note: What has been written was based upon information and belief.
Published on: www.brainblogger.com
[Comment posted 2009-05-08 12:13:39]
We do know a lot more about our minds today. We are becoming better and better at finding weaknesses and manipulating minds of publishers, researchers, doctors and consumers of medicine. We need to use that same knowledge to create new systems which would minimise the distortion field affecting the knowledge of medicine today.
[Comment posted 2009-05-08 11:00:36]
[Comment posted 2009-05-08 11:00:26]
A week later I was informed that someone had agreed to ?play by the rules?. It also became apparent that there was a pharmaceutical underwriter and that this was standard practice. Whether or not they intended to make the combined pieces ?look like a journal? is irrelevant. It was certainly not going to be made clear that this was marketing run amok.
As an aside, a then post doctoral fellow who I had invited to collaborate periodically notes the value of the lesson learned and the pitfall avoided. And so we accumulate experience.
jg
grabo040@umn.edu
[Comment posted 2009-05-08 07:13:49]
[Comment posted 2009-05-08 03:39:23]
It is worrying that a renowned publisher as Elsevier is involved in this.
But this affair is less surprising if you know that Excerpta Medica is a MECC, a strategical medical communications agency, partnering with their clients in the pharmaceutical and biotech industries to educate and write papers. ?In the past the pharmaceutical company Wyeth has hired the MECC Excerpta/Medica to produce several scientific papers on the dangers of obesity and on obesity treatment as part of their marketing strategy for Fen-Phen. Mundy documents that Wyeth paid between $15,000 to $20,000 for Excerpta to prepare each article, of which $1,500 would go to the ?named author? as an honorarium.? (cited from a PLOS article)
Although both condemnable, I find this ?shaping of articles? in truly peer reviewed journals far more dangerous than the publishing of an evident throwaway. Because it won?t be recognized as such by doctors, who might decide to prescribe medication on basis of wrong or incomplete information.
For citations and more information see LINK">my blogpost here
[Comment posted 2009-05-08 03:20:01]
* Australasian journal of asthma
* Australasian journal of dentistry
* Australasian journal of depression
* Australasian journal of gastroenterology
* Australasian journal of hospital pharmacy
* Australasian journal of infectious diseases
* Australasian journal of musculoskeletal medicine
* Australasian journal of obstetrics & gynaecology
* Australasian journal of paediatrics
* Australasian journal of pain management
* Australasian journal of psychiatry
* Australasian journal of respiratory medicine
* Australasian journal of sexual health
Like the admitted-fake Australasian journal of bone & joint medicine, these titles can be found in WorldCat but not in Ulrich's, Pubmed or Elsevier's own Science Direct.
So what assurance have we that they are not all fake?
[Comment posted 2009-05-08 02:53:27]
[Comment posted 2009-05-07 20:33:07]
Is it any wonder that serious debilitating or fatal diseases that impact huge numbers -- hundreds of millions -- of human beings around the world --e.g., malaria -- remain without truly effective treatments or vaccines, while Viagra, dermal fillers, etc. are making big bucks for their manufacturers and the cost of plain-vanilla medical care in the USA is going through the roof?
Physicians, heal (heel?) yourselves!
[Comment posted 2009-05-07 19:37:44]
The journal was fake, not the articles. And it was a fake journal not a faked journal.
Merck and Elsevier didn't make anything up. They just selected Merck-friendly articles already out there (which I assume Elsevier already had, or acquired, copyright to), and slapped them together under a brand new title.
There is no real need to name and shame the authors published in these titles, nor quetsion any research based upon them. Presumeably all the articles had gone through a legitimate peer-review process elsewhere when they were first published.
Pharmaco-sponsored publications as of themselves aren't automatically an abomination (just a little questionable) - this format can be used to get more information out to doctors.
The major foul-up appears to be that Merck's involvement wasn't declared, the journal was misrepresented as some kind of independent publication (and moreover, were doctors charged for what is essentially Merck marketing material?).
[Comment posted 2009-05-07 16:41:46]
Why should this be a relief? Given that it was an international company (Merck was German originally, but now mostly USA based, I believe) paying for this and an international company (Elsevier's headquarters are in The Netherlands) publishing these I would say that culpability lies equally in the Northern hemisphere.
The companies that did this should be the ones responsible, not the region where it happened.
[Comment posted 2009-05-07 15:44:07]
As an oncologist I am frequently astonished by the reporting of phase III trials in "high impact" journals. Many of these trials are strongly biased on their design to show that the "new" product should become the newer standard. This assures for journals high revenues from reprints at least. I am convinced that the ?elseviergate? is just the tip of the iceberg.
[Comment posted 2009-05-07 15:17:10]
We also see El$evier's true colors too! There is a "word" for doing something only for money...
The entire academic community should call them to the carpet on this!
[Comment posted 2009-05-07 14:11:17]
It is correct that the response of the scientific community is limited to the factual instance(whch we worship ever so much being scientific and all that) and not bother about an introspective analysis where all it occurs and for what reasons.
Perhaps we all know that corruption always starts at the top. Where do we pin the primary blame, Merck or Elsevier? That is a sociological query and not a a scientific one.
[Comment posted 2009-05-07 14:09:43]
[Comment posted 2009-05-07 13:38:53]
In medicolegal liability litigation, the detection of any attempt to modify the facts is almost always associated with a total loss of confidence in the honesty of the perpetrators. I realize that a huge pharmaceutical organization like Merck may be too compartmentalized for even such obvious breaches of scientific ethics as the one we now have before us to be readily apparent at the highest administrative levels, but, unfortunately, the presumption of general culpability weighs heavily when such a breach is detected, just as it does, or should do, in tort litigation.
[Comment posted 2009-05-07 13:20:37]
We need to stop this by asking all the publishers and editors of Journals to raise their standards by checking if the Journal actually exists along with a list of the Editorial Board including a letter with signatures to validate the Journal. In the case of manuscripts, Editors should request to authors to provide along with manuscripts, copies (preferably notarized and in PDF format) of all the original data obtained from the research with signatures from all the authors confirming that the experiments, data and all the content of the manuscripts are genuine and that they have read it and approve its publication. Reviewers should get this copy in order to review the manuscripts before comments are submitted to editors.
I am just wondering how many fake articles with fake data are published out there. The fact that many high quality Journals are recalling published papers with fake data shows that this problem is growing and must be stopped.
[Comment posted 2009-05-07 13:20:30]
Here's another question: What scientists have cited research in the journals in laying the groundwork for their published research?
[Comment posted 2009-05-07 13:17:05]
Isn't this for us - the consumers of Elsevier's products - to decide?
To retain their integrity, surely they need to -
- name and shame the person/s responsible for this scam
- name the companies involved and the fees involved
- donate the money that Elsevier was paid for these journal to charity
- out the authors who knew these were fake journals, and apologise publically to those authors who did not.
- out the editors who knew these were fake journals, and apologise publically to those editors who did not.
- identify the articles in Medline that cited papers from these fake journals and include links to information about this scam so that readers can be fully informed.
[Comment posted 2009-05-07 13:08:48]
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