It's times like these when I'm happy that I haven't published in too many Elsevier Journals during the course of my career. I say that because on Thursday, it was revealed that pharmaceutical company Merck, Sharp & Dohme paid Elsevier to produce a fake medical journal that, to any superficial examination, looked like a real medical journal but was in reality nothing more than advertising for Merck. As reported by The Scientist:
Merck paid an undisclosed sum to Elsevier to produce several volumes of a publication that had the look of a peer-reviewed medical journal, but contained only reprinted or summarized articles--most of which presented data favorable to Merck products--that appeared to act solely as marketing tools with no disclosure of company sponsorship.
"I've seen no shortage of creativity emanating from the marketing departments of drug companies," Peter Lurie, deputy director of the public health research group at the consumer advocacy nonprofit Public Citizen, said, after reviewing two issues of the publication obtained by The Scientist. "But even for someone as jaded as me, this is a new wrinkle."
The Australasian Journal of Bone and Joint Medicine, which was published by Exerpta Medica, a division of scientific publishing juggernaut Elsevier, is not indexed in the MEDLINE database, and has no website (not even a defunct one). The Scientist obtained two issues of the journal: Volume 2, Issues 1 and 2, both dated 2003. The issues contained little in the way of advertisements apart from ads for Fosamax, a Merck drug for osteoporosis, and Vioxx. (Click here and here to view PDFs of the two issues.)
This is wrong on so many levels that it's hard to know where to begin.
If there is one thing that science-based medicine requires to function properly, it's good science and well-designed clinical trials subjected to rigorous peer review. Moreover, that review has to be unbiased, and the journals publishing them cannot be tainted with undue influence of big pharma. A while back, I wrote about JAMA editor Catherine DeAngelis, her crusade against undisclosed conflicts of interest by the authors of journal articles, and, most importantly, her hypocrisy and heavy-handed attempt to slap down a researcher and educator who pointed out the failure of a JAMA author to disclose that he had been on the speakers' bureau for a pharmaceutical company whose drug he had been studying. What made this offense particularly egregious was that the study in question had a rather glaring methodological flaw that, when corrected for, revealed that nonpharmacological therapy was equal to that of the drug company's medication, which the author admitted when it was pointed out to him.
What does one do when the whole journal--articles and all--is nothing more than a glossy advertisement for a pharmaceutical company's products?
First off, if there's one thing most physicians and scientists know, it's that there are numerous "throwaway" journals out there. "Throwaway" journals tend to be defined as journals that are provided free of charge, have a lot of advertising (a high "advertising-to-text" ratio, as it is often described), and contain no original investigations. Other relevant characteristics include:
- Supported virtually entirely by advertising revenue.
- Ads tend to be placed within article pages interrupting the articles, rather than between articles, as is the case with most medical journals that accept ads
- Virtually the entire content is reviews of existing content of variable (and often dubious) quality.
- Parasitic. Throwaways often summarize peer-reviewed research from real journals.
- Questionable (at best) peer review.
- Throwaways tend to cater to an uninvolved and uncritical readership.
- No original work.
Throwaway journals are rarely or never cited in the medical literature and virtually never indexed in PubMed. They also tend to have names like, well, em>Australasian Journal of Bone and Joint Medicine. However, as advertisement-packed as throwaway journals tend to be, they are actually fairly widely read--indeed as much or more so than some peer-reviewed journals. The reason, most likely, is because they tend to publish short, easily digestible review articles, perfect for busy clinicians, particularly in private practice. Moreover, as reported in this JAMA article (ironically enough), despite their lesser scientific rigor, throwaway journals have many aspects that are appealing to clinicians:
The mean (SD) quality scores were highest for peer-reviewed articles (0.94 [0.09] for systematic reviews and 0.30 [0.19] for nonsystematic reviews) compared with throwaway journal articles (0.23 [0.03], F2,391=280.8, P .001). Throwaway journal articles used more tables (P=.02), figures (P=.01), photographs (P .001), color (P .001), and larger font sizes (P .001) compared with peer-reviewed articles. Readability scores were more often in the college or higher range for peer-reviewed journals compared with the throwaway journal articles (104 [77.0%] vs 156 [64.2%]; P=.01). Peer-reviewed article titles were judged less relevant to clinical practice than throwaway journal article titles (P .001).
In other words, throwaway journals tend to be to peer-reviewed journals a lot like USA Today is to The New York Times or The Wall Street Journal. However, in general, they are not blatantly written by pharmaceutical companies, as apparently was the case with the Merck journal. (Yes, I'm going to refer to it as that. After all, that's accurate.) Moreover, in general doctors are well aware of throwaway journals and that they aren't meant to be taken as seriously as real journals. (If they were, they wouldn't be delivered free to their offices, sometimes whether they want them or not, after all.) Rather, doctors tend use them as shortcuts for digesting information quickly or not to rad them at all. (There's a reason they're called "throwaway" journals.) They also realize that they are completely advertising-supported. In essence, any conflicts of interest are pretty well right out there in the form of numerous ads.
This effort by Merck took it far, far beyond the throwaway journal:
In response to several questions about the publication posed by The Scientist, an MSDA spokesperson wrote in an email: "MSDA understood that Elsevier envisaged the complimentary publication would draw on the vast resources of Elsevier, publishers of many leading peer-reviewed journals including Lancet, Bone, Joint Bone Spine and others, to deliver novel and timely full text articles and abstracts to physicians." Many of the articles appearing in the Australasian Journal of Bone and Joint Medicine were in fact reprints or summaries of studies that originally appeared in other Elsevier journals.
As if that excuses the deception. Of course, they must have been reprints of articles that appeared in other Elsevier journals! Otherwise, Elsevier wouldn't have had the rights to publish them! It's not necessarily the quality of the reprinted articles that's an issue. It's their packaging in a pseudojournal that's nothing more than an advertising vehicle for Merck without any disclosure that that's what the purpose of the journal was! Elsevier's got some 'splainin' to do, as they say:
"Elsevier acknowledges the concern that the journals in question didn't have the appropriate disclosures," the statement continued. "It is worth noting that project in question was produced 6 years ago and disclosure protocols have evolved since 2003. Elsevier's current disclosure policies meet the rigor and requirements of the current publishing environment."
The Elsevier spokesperson said the company wasn't aware of how many copies of the Australasian Journal of Bone and Joint Medicine were produced or how the publication was distributed in Australia, but noted that "the common practice for sponsored journals is that doctors receive them complimentary." The spokesperson added that Elsevier had no plans to look further into the matter.
So, in other words, we don't do it anymore; so it's not a big deal. Of course, Elsevier also publishes the vanity journal Medical Hypotheses, which will publish virtually any speculations authors want to publish with minimal peer review and has been a favorite of the anti-vaccine movement and other cranks. It also publishes the pseudoscientific journal Homeopathy (after all, homeopathy is quackery), a fair number of "integrative medicine" journals, and the quack journal Explore, which, as I described before, publishes Dean Radin's pseudoscientific articles on "distant healing" and food imbued with "intent." So you'll excuse me if I don't take Elsevier's hilarious "code of ethics" seriously:
Elsevier takes its duties of guardianship over the scholarly record very seriously. Our journal programs record "the minutes of science" and we recognize our responsibilities as the keeper of those "minutes" in all our policies, including the guidelines we have adopted to support editors, reviewers and authors in performing their ethical duties.
Except, apparently, when it comes to pharma-supported advertising efforts and the publication of quack journals.
Unfortunately, Merck and Elsevier couldn't do this alone. They needed help. Depressingly, they got it from the very people who should know enough to "just say no" to such blatant marketing ploys:
One of the members of Australasian Journal of Bone and Joint Medicine's "Honorary Editorial Board," Peter Brooks, a rheumatologist in Australia, said he didn't recall who asked him to serve on the board, but noted that he was on Merck's Asian Pacific and international advisory boards from the mid 1990s until about 2004, as well as the advisory boards of other pharmaceutical companies, including Pfizer and Amgen. "You get involved in a whole bunch of things at this level," Brooks said, adding that he had put his name on "a few advertorials" for pharmaceutical companies about 10 years ago.
So Dr. Brooks' excuse seems to be carelessness. The answer, of course, is for physicians to refuse to "get involved in a whole bunch of things at this level." He also claims ignorance, namely that he didn't know that the journal was nothing more than an advertising ploy for big pharma. That, I suppose, is possible, but surely he actually looked at the journal on whose editorial board he had agreed to serve. Surely he must have wondered when, after being on the editorial board, he wasn't ever actually asked to do anything, such as review a submission--or even solicit a review article. Apparently he did not, even though serving on a real editorial board is generally a large amount of work. Not having any work to do on an editorial board should have been a huge red flag that tipped him that this journal wasn't a "real" journal. So should the fact that it was listed as an "Honorary Editorial Board." (I wonder if he put that on his CV.) Moreover, one wonders what he did when he ultimately found out. Apparently nothing, other than to deny that it was a marketing journal. Never mind that there were review articles and even an article labeled as a "meta-analysis" that only listed one or two references. Usually reviews list numerous references that were used as the source material for the review; even more importantly, you can't do a "meta-analysis" on one or two studies. Such articles should have been even more obvious red flags.
Doctors like Dr. Brooks are every bit as guilty as Merck and Elsevier for deceptive pharma marketing like this. We physicians are supposed to represent the best interests of our patients, and, as far as I'm concerned, to defend science-based medicine. Our credibility depends upon it. Being accomplices to those using deceptive marketing practices such as this not only undermines our credibility and betrays our patients, but it provides an opening for purveyors of unscientific medicine and outright quackery to paint us as hopelessly corrupt. Pharmaceutical companies have ample resources for advertising their wares. We shouldn't be so willing to give them such cheap access to our credibility and respect as physicians.
ADDENDUM: More commentary at blog.bioethics.net, and by Janet Stemwedel.
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Well, that shoots their credibility right in the head. Despicable.
How long will it be till we see this being touted on an AltMed website as yet more conspiracy theory proof (and therefore that homeoquackery cures all ills)?
Maybe they should add to the Lancet "from the publisher of Homeopathy, Explore and Australasian Journal of Bone and Joint Medicine" to indicate the full quality of their publications.
We all know the fallout will merely be the firing of a few individuals from each company.
It's so absurd. Corporations whined and moaned for years to be treated as an individual in the eyes of the court, but as soon as they pull stunts like this they are the first people to claim they are all separate individuals within the corporation and should be treated as such. If Merck is an individual when they are being sued, then they are an individual when they pay off a publishing group to publish a fake medical journal. In other words, Merck should be fired.
Heh, and not too long ago, some troll was claiming you're a Merck shill. Definitely going to shove this article down the next troll to make that claim's throat.
No, no, no. I'm sure we'll be hearing from Jake again about how this post is merely a ploy by Orac in response to Jake cleverly calling him out on his obvious ties to Merck.
That's how it works with these conspiracy clowns. All roads lead to Rome.
Jake got the conspiracy right, just not the actor. Orac is a known PFITZER shill, when he's pro Merck, that's just general courtesy between sharks.
As a Ph.D. in a clinical department, I wrote several articles for throwaway journals. Naturally, they highlighted the research of my M.D. big-shot coauthor, but they were NOT thinly disguised advertisements for drug.
This "Merck journal" revelation besmirches the reputation of throwaway journals! How low can you go? Apparently there is medical literature lower than the throwaway journal.
Unrelated, but equally horrific. Oprah is going to help Jenny McCarthy launch a talk show.
This is not new, a lot of time ago they it do not only this class of companies but all those who exist on the stock market, it(he,she) is not understandable that a big company comes to these levels, but in this world where the corruption and the blackmail this one to the orden del dÃa already we do not know that more we can wait,
Bad pharmaceutical giant! No thiamin mononitrate!
The percieved and apparent problems of for profit, private journal publication companies is why PLoS was started, yes?
If med researchers and other scientists want the best possible arena for peer-review, then they need to open-source their results into moderated internet forums, (run under the auspices of their various associations, perhaps, to give them credibility and a source of funding).
If science really is what scientists claim it is, then the logic, coherence and rationality of the review is what matters, not the credentials of the reviewer, yes? no? maybe?
I doubt anyone at Merck will be terminated over this issue. Maybe at Elsevier.
Strictly from the point of view of Merck (and I don't work there, but being in the pharmaceutical industry in product development and marketing, I have seen this stuff), it's marketing. They are trying something to get the word out to the physician market, trying to stand above the noise.
Even though I wonder how Elsevier was convinced to do this, but let me guess-huge dollars. I know we all want to think that science and medicine is some pristine industry, untouched by money, but let's get over it. It's not. Elsevier needs to pay it's editor, paper manufacturers, staff, building, whatever. It wasn't selling off one of it's journals, it created an advertising piece. I'll admit, I'm not getting why this is so unethical, dastardly, or evil.
But again, unless Merck violated some law, they're doing their marketing job. Believe it or not, if Merck developed and launched some new drug that cured male pattern baldness, CVD, erectile dysfunction, and beer drinking (because we all know that Big Pharma just focuses on male health issues), no one will beat a pathway to their door unless they advertised it to the physicians. (Just so you know, I find advertising to patients to be obnoxious and unethical.)
I find a lot of marketing practices in the medical products industry to be suspect. This one doesn't bother me too much.
The bigger issue would be whether Merck did anything outside of product labeling (but that's an FDA issue). Oh, and if they paid for it, and didn't place various FDA-mandated disclosures while allowing their sales reps to distribute it, then I'd have a serious problem with it. Orac states that it does not say anything about Merck on these fake journals, so if that's true, then I would modify my concern level from "not a problem" to "wtf were they thinking?"
That's a good suggestion, actually. In this day and age there's no reason raw data from most studies shouldn't be made publicly available in various formats (even if only CSV.) It could be scrutinized and re-analyzed in follow-ups. There might also be patterns in the data the original researchers did not notice.
Revision to my previous comments. Other than a couple of articles on some future research, I don't see where this violates any regulatory issue. The only ads were for Merck products. Those ads met the standards of product labeling. A more thorough examination might tell me that there are some off-label claims being made, which would be worrisome.
It's fascinating what one has to resort to to maintain those big profits. Maybe those direct-to-consumer ads aren't producing the goodies.
I agree wholeheartedly with the commenter's remark "I find advertising to patients to be obnoxious and unethical." It's no wonder physicians are losing their patience with with patients (yes, I did mean to write that) who come in insisting on getting the medicine they saw on TV.
One of my coworkers has a 6 year old son who told his pediatrician, "TV said I should ask you if Cialis is right for me."
Some 30 years ago, I read (in an otherwise useless book by NYT 'science' reporters Broad and Wade) that there were 8000 medical journals. No doubt more now.
So, Orac, how does a professional decide which ones to follow?
I find a lot of marketing practices in the medical products industry to be suspect. This one doesn't bother me too much.
Many marketing practices in the medical products industry create the appearance of a conflict of interest. You are right to be bothered about such practices.
A fake academic journal creates the appearance of a conflict of interest. It is designed to look like legitimate peer reviewed research published by a nominally independent publisher (Elsevier) who in fact is being paid to publish research in this journal which supports the products of the particular medical products company that is paying Elsevier to do it. Thus there is a conflict between Elsevier's ostensible role as a leading publisher of peer-reviewed scientific research and their actual role of being paid to produce advertisements for a particular company. And it was ethically wrong for Merck to suborn Elsevier's conflict of interest.
We have properly rebuked Elsevier in the past for what they have published in journals like Homeopathy and Chaos, Solitons, and Fractals. Those two journals represent breakdowns in the peer review process, but they at least paid lip service to the idea of a peer reviewed journal (I'm assuming here that Homeopathy has something at least formally resembling peer review, however bogus it may be). This case goes beyond that--Elsevier cannot even pretend that this is a peer-reviewed journal in which the peer review process broke down.
It's one thing to create a throwaway journal that is clearly identified as such and kept at arm's length from any academic journals published by the same company. It's another thing to create a throwaway journal that is specifically designed to look like another of the many academic journals published by the same company. The arm's length relationship between marketing and scientific publishing is key: without it, we scientists cannot trust the scientific publishing.
If only Big Homeo, Big Woo-Woo, Big Anti-Vax et al were willing to expose their own fraudsters. Then again, that would completely and utterly annihilate them.
Big Evil Pharma Big Evil Pharma Big Evil Pharma !!!!
Human nature is a bitch to override though...
Cheers ;)
Michael Simpson -- "legal" and "right" aren't the same thing. I'm sure you're right that there are no regulatory issues with this. But I sure as heck have ethical issues with it.
In all fairness, I don't have a huge problem with the concept behind this journal. People have different learning preferences. Maybe, as the author says, some clinicians really need "short, easily digestible review articles, perfect for busy clinicians, particularly in private practice." There's nothing wrong with that -- less-rigorous methodology doesn't necessarily eqaute to total uselessness in clinical practice. Clinicians as a whole, I believe, see through shams when presented, and if this journal is in fact a sham it will be regarded in such light and thrown away when opened instead of after it's read.
It's this simple -- when you need proven research, JAMA or other rigorous journals are the right choice. When you need to supplment rigorous data with easier-to-read information in your short time slots, sources like this journal are the place.
Maybe a better solution is all the journals need to provide information that's easier to read. ;-)
In all fairness, I don't have a huge problem with the concept behind this journal. People have different learning preferences. Maybe, as the author says, some clinicians really need "short, easily digestible review articles, perfect for busy clinicians, particularly in private practice." There's nothing wrong with that -- less-rigorous methodology doesn't necessarily eqaute to total uselessness in clinical practice. Clinicians as a whole, I believe, see through shams when presented, and if this journal is in fact a sham it will be regarded in such light and thrown away when opened instead of after it's read.
It's this simple -- when you need proven research, JAMA or other rigorous journals are the right choice. When you need to supplment rigorous data with easier-to-read information in your short time slots, sources like this journal are the place.
Maybe a better solution is all the journals need to provide information that's easier to read. ;-)
You obviously haven't been paying attention.
Indeed, the goal of life should not be so see what one can "get away with" but to make and meet real commitments with real people.
Just because it's legal doesn't make it right.
@ Calli
Sorry, but I don't see the ethical problem. How do you expect physicians to know of new products, their indications, their contraindications. By Qi waves floating through the ether? Merck has a legal right to market its products. To call them unethical for this is no different than the anti-vaccination nutjobs calling Merck unethical for marketing MMRII, or Gardasi, or Recombivax. Please tell me what's unethical about this? Are they lying? Are they not providing product labeling? What is it that they're doing?
Tell me one physician that has the time to read every journal article about every new drug out there. There has to be a method that allows them to read about new indications that might help their patients. Merck and Sanofi are trying to develop new vaccines that will reduce the number of vaccinations, that improve the immune response. How is that information going to get to them? Through blogs? They have to advertise them, sometimes aggressively.
There are over 100,000 medical products companies in the United States, probably quadruple that number in the world. Some of these companies make incredibly useful products. How do you expect them to get the information to the doctor?
I headed product development for cardiovascular devices for a Big Pharma company. Our sales reps trained more interventional cardiologists on new techniques than did Professors of Medicine at medical schools. I stood in full leads in a interventional lab in Palm Springs, explaining to a new attending how to thread a new specialized guidewire to a distal lesion, which he was then able to treat with angioplasty instead of sending the patient to surgery. This wasn't done with any peer-review article, this was done with a white paper written by a renowned cardiologist who was remunerated by an honorarium. The patient lived, the technique worked, the guidewire was able to reach distal lesions that, in the past, could not be reached by standard PTCA techniques, and everyone was happy. Was that unethical? How about me, a Big Pharma shill, standing in that lab training the doc?
I have a problem with Elsevier selling out, but they sold out long ago, so I'm not sure this makes them any worse than they were 2 weeks ago.
@ Joe
Says who? You? Please, what's your qualifications to make such a statement? Are you a physician? An ethical philosopher? An attorney? An FDA officer? Please, just tell me what skills/experience/position makes you better able to determine what's legal and what's "right" (legal being very objective, and "right" meaning whatever anyone wants it to mean)?
Merck did what is necessary to market its products to a challenging set of customers. Given the response here, I guess they're better off making TV commercials, because those commercials seem to be less annoying to all of you.
You have a malformed HTML tag here:
They also tend to have names like, well, em>Australasian Journal of Bone and Joint Medicine.
Mike Simpson wrote:
I think this is rather letting Elsevier off the hook. It may be relevant - and probably explains why Elsevier is getting such a kicking on the blogs over the vanity journal business - that Elsevier's name is frequently mentioned (to be diplomatic) in connection with blocking access to journal back issues, with high pricing of academic journals, and with an aggressive "bundling" policy:
"Your library can have these journals you actually want at a swingeing-ish but barely affordable price, but ONLY if you take these other ones of ours too in a "bundle" offer - but the others (that you don't want) are really cheap so you get them almost free, aren't we nice?"
As to journal pricing from academic publishers like Elsevier, it is not so much the paying of the staff and the production costs (which are presumably fairly similar for most publishing outfits) as the making of a whopping profit. I have heard figures like "40% of cost price is profit" bandied about for Elsevier journals, and most librarians will tell you that an Elsevier journal subscription costs an academic library far more than a subscription to a comparable journal run by a learned society and published by a different publisher.
I suppose you could call this "aggressive marketing and returning lots of values to Elsevier shareholders". But suffice to say the company is, er, not terribly highly regarded amongst academics, academic librarians, funders of research etc. etc. etc. Indeed, some of the Open Access lot refer to Elsevier as the "Evil Empire".
Oh man... I really want to swear at Merck and Elsevier right now. Are you allowed to swear here? This is bad on a number of levels:
1) Doctors could be influenced unduly, leading to bad prescription habits and more death/nasty side effects/other unpleasant stuff for patients.
2) The reputation of respectable journals will be tarnished. As I understand, the Lancet is one of the most respected journals in medicine. Will its reputation come through this unscathed?
3) Homoeopaths and antivaxers will, and probably already have, capitalise on this as evidence that real medicine is no good.
LOL. Do you think its association with Elsevier will damage its reputation more than the Wakefield fiasco?
:P
Thanks for posting this. I'm really not surprised, though. I used to work for a giant software company, and our team would have meetings where marketing would tell us what they were doing to sell the project. I think a little piece of me died every time I went to one of those. Marketing's concept of "ethics" tends to be a little wider than that of most individuals.
My favorite was when the company would seek out young girls who were considered "alpha girls", ie, middle school social butterflies with lots of influence with other preteen divas, and pay their parents to host a sleepover with our product as the theme.
Ooooh. Or about the time when we flew in a bunch of bloggers covering our product and put them up in a nice hotel and gave them a free tour and previews. Nah, we're not bribing you to give us good reviews. Not us!
These are little examples compared to yours, but yeah. Not at all surprised over that one. The sad thing is, it makes other throwaway journals, and even Elsevier's other publications look bad, too. It takes a bit of a leap of faith to assume that this is the only publication that Elsevier has published that has had..err...undue outside influence.
Oh, and sadly, in my experience, they almost never fire anyone who actually makes the decision to do these kind of things.
This seems to be problem with Elsevier, especially since they bundle these rags into subscription packages for libraries. See this case for example; "The Case of M. S. El Naschie"
@ Michael Simpson:
Hey, I work for Big Pharma (not Merck) too--and we would have fired the dumbass marketing exec responsible for this fiasco.
Reason #1: Every Big Pharma is downsizing right about now, especially support staff. They are looking for any excuse to can people at every level including VPs, and this is as good a reason as any.
Reason #2: The dumbass made the company look bad. If you are Marketing, your whole entire job is to make the company look good. It's not like you're Clinical and your data management contractor made a PR mess for you by accident or something; it's not like you're Toxicology and you can reasonably plead that "it worked just fine in monkeys." They are Marketing, fer crying out loud, they are supposed to have half a clue about how the public generally feels about our untrustworthiness and sneaky behaviors, and have a vague idea of how to fix it.
Reason #3: Are they honestly hiring such idiots that their Research staff can't get published in a high impact journal? I have met some of the Merck chemists, and they are not morons. I think their Marketing department is not taking advantage of/sufficiently promoting their legit research publications (I count 3 Nature, 1 Science, 5 PNAS, 7 JBC in the past year), although I forbear to comment on why that might be. If they are handed such plum assignments--brag about how brilliant our researchers are!--and they screw around with this nonsense, then they deserve a pink slip.
I think you're being more than a little disingenuous when you compare this to CMEs. Now, frankly, I don't know how to make up for the lack of adequate biochem and biophysics in medical school that is really needed to administer modern medicine, and I often feel like we should simply approach the problem as if we expected toddlers to self-medicate. But you know as well as I do that making up a faux journal is not a damn bit of help and does an awful lot to make us look stupid--plus, it's besides the point entirely.
Ethical disclosure: My employer does indeed make many products that compete with Merck's, although I don't personally work in the small molecules dept. I still think their Marketing department is staffed by idiots. But to be fair, I think ours is probably staffed by idiots too. I haven't met a Marketing department I liked, really.
Merck did what is necessary to market its products to a challenging set of customers.
On the contrary, most of us seem to think that this step was not "necessary". Merck could have put together something that was clearly meant to be a throwaway journal. That's what throwaway journals are for. Merck did not have to make their throwaway journal look like an academic journal.
Remember, in the scientific research business it is necessary to avoid the appearance of a conflict of interest. This is different from the for-profit sector, where "ethical behavior" is legally equated with "whatever makes a profit for the company without violating the law". Elsevier, as a scientific publisher, is held to the higher standard because scientific publishing is their business. Publishing a throwaway journal disguised as a legitimate academic journal put Elsevier in a conflict of interest situation: they are simultaneously a journal publisher and an advertising agency.
Nor do I let Merck completely off the hook here. IANAL, but if somebody purchased a subscription to the fake journal because he reasonably believed it to be a real journal, Merck could be liable as an accomplice to Elsevier's fraudulent inducement. In general, paying somebody to perform an illegal act on your behalf is itself illegal.
This is something new? I loved it when Jim Carrey was on Larry King Live and opened the journal "Pediatrics" and there was a big ad for the Rototec vaccine. This has been going on for years. I am glad the public is losing trust in medicine. It is just totally disgusting. Modern medicine is only good for a few things like surgery and acute care.
When it comes to infectious disease etc they don't know anything. The whole scientific establishment just follows orders from drug companies and crooked public health officials. I tested this hypothesis, I asked a doctor recently some questions, of course he had no answers, I totally embarrassed him at a wedding recently.
I asked him what were the scientific experiments that proved HIV was a fatal disease that justified AZT's release in 1987. He had no clue. I asked for the papers that proved HPV and Hepatitis C cause disease (more microbes that fail all of Kochs Postulates), he had no clue.
This is what is wrong with todays medicine, Doctors and many scientists just follow orders from Drug companies and crooked public health officials and they don't read scientific papers.
Suddenly, cooler! Dozens of him!
Prepare for some fine wharggbl.
And when you open an entertainment magazine, you just might find an ad for a Jim Carrey movie. What's your point? That businesses advertise?
Cooler, the doctor at the wedding recognized you as "that guy" we all have in our families that people try to avoid direct eye contact with at gatherings. We just sort of nod and say "ok" and "uh-huh" until we get an opening and break off the conversation so we can "go say hello to dear Aunt So-and-so". It's just not a good idea to enter into a debate with a crazy person like you at a wedding.
Congratulations though on taking advantage of a captive and unprepared audience that clearly wasn't going to argue with you. I'm sure your whole family is proud to be related to you and cannot wait to invite you to the next reunion.
Ababa,
You've never been to a wedding, you probably spend your day ad adult peep shows, masturbating in private booths, of course you could answer the questions the doctor couldn't, if you're not touching yourself now.
LOL@ Joseph C
So your saying peer reviewed journals should have the same standards as MTV and entertainment weekly?
No, I'm asking you what exactly your point is. For someone who claims to read so many journal articles, the presence of advertisements should not be news.
The point is it is a disgusting conflict of interest. I read my papers from google scholar.
Google Scholar is a journal?
Well, its a search engine that provides studies from Journals. Unlike Pediatrics, they were no ads when I searched.
You're still getting your information from those same journals that greedily accept ad revenue so that they can make payroll, pay the rent, keep the lights on, etc.
Right... so.. for once there actually was a big pharma shill.
So cooler, you get all your education and information from Google? Good thing no one ever lies on the Internet or anything!
You know I type vaccine in Google and it pulls up the CDC website. According to your line of "thinking" (I use that word very loosely) everything it says is accurate.
Oh noes, we have ourselves a conundrum! Is teh Google right or does it tell us lies?
Ababa,
Are you retarded? Google Scholar only searches through peer reviewed papers. Man you are dumb.
Man Ababa is so stupid, he doesn't know the difference between Google and Google scholar! I'm still laughing my ass off!
cooler called me dumb, so I guess that means I'm smart since he gets everything else all twisty-turny.
Aww shucks, thanks cooler!
Does this surprise anyone? Pharmaceutical companies exist to make money. If they could sell Formaldehyde covered aspirin, they would do it in heartbeat.
To sell drugs, you gotta sell ideas (and fear) about disease. To sell ideas (and fear), you gotta get published in journals.
95% of published papers are unread garbage, though. To get tenure, to get a job, you gotta publish something, anything. It's not surprising that Merck or these other Pharma whores game the system every now and then, by finding some college professor to write some dreck.
You got dolts like Orac as self-appointed guardians of a corrupt system. No wonder Americans are scientifically illiterate.
According to Dr. Starfield at Johns-Hopkins, doctors and hospitals kill 225,000 patients each year thru incompetence, hospital infections and adverse drug reactions. Merck just plays the game real well.
Karri, is that the ever increasing number? How many people would die if there were no doctors, vaccines, medications, ventilators, and other medical interventions?
Yes, pharmaceutical companies make money. People who work actually like to get paid.
If you have any kind of medical emergency, remember to not call 911 --- because you know those folks in the ambulance are in it for the money, along with all those people who are in the hospital emergency department, and oh... heaven forbid that you actually get prescribed pain medications (which I did not take when I broke a bone, since I cannot tolerate narcotics, just plain ol' ibuprofen for me).
Chris, you sound like one of these CIA analysts back in 2003 who warned us of the menace of Iraq's weapons of mass destruction.
Of course, some medicines help us. Aspirin works, ER doctors and nurses are great. Yeah, broken bones HEAL over time. Yeah, opiates work as pain killers. Yeah, we have some kick-ass surgeons.
But, these segments of medicine have been overrun with mass hysteria, slick advertising, bullshit research, quest for money, quest for tenure, insurance bureacrats, turf wars, and NIH funding whores.
You must live in some dreamworld. That's not medicine as ACTUALLY practiced in 2009.
@Michael Simpson, who fails to understand the problem: If Merck and Elsevier had published the "Big Book of Why Merck Products Are Good!", and had the exact contents with lovely attributions showing which journal each article came from.. well, that would have been no problem at all.
Actually, since this is an Australian thing, the Trade Practices Act may have been contravened in relation to advertising rules. Hmm.. might need following up.
Karri, regarding your genocidal doctor worldview, http://tinyurl.com/c7bcen may be of interest.
You say: "Elsevier also publishes the vanity journal Medical Hypotheses, which will publish virtually any speculations authors want to publish with minimal peer review..."
Considering that you are writing an article on ethics, and I am editor of Medical Hypotheses, it seems important to point out that you have your wires-crossed about Medical Hypotheses and have a mistaken understanding of the nature of the journal.
Medical Hypotheses is explicitly (and proudly) an editorially reviewed journal, as almost all journals used to be during the golden age of science. I have written about the desirability that _some_ journals be editorially-reviewed in the BMJ:
http://medicalhypotheses.blogspot.com/2007/09/peer-usage-versus-peer-re…
Medical Hypotheses has a respectable Impact Factor (1.3) and pretty high download rates (about 45 000 downloads per month last I heard).
The journal's stance is supported by an exceptionally distinguished Editorial Advisory Board including Arvid Carlsson (Nobel Laureate), Roy Calne, Antonio Damasio and VS Ramachandran (look them up on Wikipedia).
In short, it is objectively demonstrable that Medical Hypotheses performs a significant role in medical science - and this fact serves to validate the editorial policy of the journal.
Then Mr. Charlton you should not have published this piece of crap:
http://www.ncbi.nlm.nih.gov/pubmed/15082108
The basic premise was false and idiotic and none of the authors were qualified on the subject.
Oh, and let's add to the fact that it was published more than a couple of years after thimerosal was removed from vaccines, and that the subsequent years have shown no effect in the levels of autism.
Really, now... seriously, we are to take you seriously?
Also, about that "Medical Hypothesis" paper, here is some information on one of its authors, "S.Bernard":
From: A bad day for antivaccinationists: Yet another study fails to support an association between vaccines and neurodevelopmental disorders.
http://www.alexa.com/siteinfo/whale.to+medical-hypotheses.com
Perhaps you've cleaned up your policies since the days your journal published articles by Mark and David Geier, Mark Blaxill, and other antivaccine loons of such astoundingly poor quality that I could not believe a reputable journal would allow such nonsense to see print. I will take a look.
Egad, I had to read the editor's name 15 times before I got the word, Charlatan, out of my head.
Hilarity or god's hand at work?
Orac, a quick look finds such gems as "The gluten syndrome: A neurological disease" and "Acidâbase balance and weight gain", although my favorite must be "An association between geomagnetic activity and dream bizarreness". Bizarre indeed.
Actually, it just occurred to me. How could I forget this "gem":
Geier M and D Geier (2005). The potential importance of steroids in the treatment of autistic spectrum disorders and other disorders involving mercury toxicity. Med Hypotheses 64, 946â954.
This is the "paper" that was the basis for Mark and David Geier's treating autistic children with powerful steroid-inhibiting drugs like Lupron in order to "improve the removal of mercury" with chelation therapy. Of course, they were smart enough not to mention in their article what they tell others, namely their claim that testosterone somehow "binds" mercury and makes it harder to chelate, hence the rationale for lowering testosterone. That's utter nonsense that even Medical Hypotheses might not publish. Truly, it was the pseudoscientific and speculative paper that launched dangerous quackery on autistic children, as so well documented by two excellent bloggers:
Autism & Lupron: Playing With Fire: Easy Stories & An Unexpected Twist
Significant Misrepresentations: Mark Geier, David Geier & the Evolution of the Lupron Protocol
Below Junk Science
Armchair science vs. real science
I truly hope that Dr. Charlton was not the editor of Medical Hypotheses when the Geier paper and the Blaxill paper were published. If so, I have some bones to pick with him.
In any case, reading Dr. Charlton's complaint again, I can't help but note that he refers to Medical Hypotheses as a "editorially reviewed journal, as almost all journals used to be during the golden age of science." In other words, he confirms my assertion that Medical Hypotheses is not peer-reviewed. Consequently, after taking a closer look, I fail to see what Dr. Charlton's complaint is--other than that I criticized the journal for very shoddy editorial standards that allowed pseudoscientific articles that fuel the anti-vaccine movement see print and make it in practice a "vanity" journal--or how I have misrepresented his journal.
Med. Hypotheses is a journal that routinely publishes speculation. This is not necessarily a bad thing, so long as people realize it should never be cited as evidence.
Some examples of autism speculation in Med. Hypotheses:
"Has enhanced folate status during pregnancy altered natural selection and possibly Autism prevalence? A closer look at a possible link." (Rogers, 2008).
"The association between tick-borne infections, Lyme borreliosis and autism spectrum disorders." (Bransfield et al., 2008)
"Autism and vitamin D." (Cannell, 2008)
"Play with online virtual pets as a method to improve mirror neuron and real world functioning in autistic children." (Altschuler, 2008)
It's easy to find these examples. Note that all these are from 2008.
"Golden age of science"? That's right now. The rates of discovery and publication are highest right now. And it's not going to end anytime soon.
Since Medical Hypotheses is not taken seriously by the scientific community, why doesn't the editor change the policies and start having real peer review? If the editor thinks peer review is not different from editorial review (which is code for "anything goes," or "I decide,
he's living on another planet.
Medical Hypotheses has a respectable Impact Factor (1.3) and pretty high download rates (about 45 000 downloads per month last I heard).
In short, it is objectively demonstrable that Medical Hypotheses performs a significant role in medical science - and this fact serves to validate the editorial policy of the journal.
But then again the Journal of Complementary and Alternative Medicine has an impact factor of 1.526, because the quackery it publishes is highly cited by other quacks. The impact factor tells you nothing about journal quality.
Sorry folks, the second paragraph of my last post should also be set in italics....
Damn, I missed a cooler sighting, so he only came for some name calling it looks like. He still managed to drop a hilarious stupidity:
For your information, Google Scholar indexes Homeopathy and Medical Hypotheses; you can even find the above mentioned Geiger and Geiger article.
"Pharmaceutical companies have ample resources for advertising their wares."
Such as this website.
Jake, you're of course referring to your own website, which currently runs four adds for pharmaceutical companies?
Do you have a single fact to back that claim up, Jake?
(Sneak preview of the answer - no, he's just making it up out of whole cloth.)
I would not get too hung up on Medical Hypothesis.
Elsevier has proven to have questionable work ethics before. Some years ago, they had to retract 50 papers or so printed in their new journal Gene Expression Pattern, because those papers had been submitted to and accepted for publication in the journal Mechanisms of Development. The negotiations with Elsevier over this were very unpleasant, to say the least.
"...pretty high download rates (about 45 000 downloads per month last I heard). "
Hence the value to Elsevier--downloads=money.
Downloads are not a measure of value to medical science. Sorry. If the downloads are mostly to lay people (not medical or research professionals), it is a magazine.
One librarian asked me personally to avoid submitting to Elsevier journals. You guys are very expensive. I avoid submitting to Elsevier because I just don't like the journals.
AoA's newest advertiser is Dr. Andrew Moulden. The guy sells a DVD where he claims vaccine injury can be physiologically proven in court. Even John Best believes this guy is a fraud. That was after his initial excitement about Moulden's claims.
Mr. Charlton whines:
Apparently, Mr. Charlton thinks that the late 19th century and early 20th century were "The Golden Age of Science". How quaint.
However, Mr. Charlton neglects to mention that the reason editorial review was abandoned in favor of peer review was that the editors tended to be less well-informed and less objective than anonymous reviewers. Peer review is the current standard for scientific and medical journals.
It is delightful that Medical Hypotheses has become the last bastion for Victorian-era scientific standards, but that doesn't change its irrelevance to real scientific research.
If Mr. Charlton wants Medical Hypotheses to be anything more than a vanity publisher, he should consider a move into the 21st century.
Prometheus
@Catherina
"Orac, a quick look finds such gems as "The gluten syndrome: A neurological disease" and "Acidâbase balance and weight gain", although my favorite must be "An association between geomagnetic activity and dream bizarreness". Bizarre indeed."
I can't speak for the geomagnetic activity or the acid-base balance, but if one does a search on the neurological links to gluten and celiac disease on Pubmed, one would find that this article in Medical Hypotheses is not too far afield as to be considered "bizarre".
http://www.ncbi.nlm.nih.gov/pubmed/19018335?ordinalpos=4&itool=EntrezSy…
My point being that there is good and bad to be found everywhere. Medical Hypotheses, and others of its ilk, may not be considered to be "worth anything", but even trash has a valuable function--mainly to fertilize. As such, we do a disservice to discourse and to open-minded thinking if we fail to discuss and dispute any "bizarre" findings by just allowing editors or others to make these decisions for us.
While it is tiresome to keep doing battle with certain people convinced of certain findings of science,(ie., autism/vaccine links) it helps all of us to continue the discourse. Doing this makes sure that we haven't overlooked anything in our own haste to discount apparent "bizarre findings". Call it exercise if you will, but to avoid journals like Medical Hypotheses creates a condition where free thinking, discourse, and the ability to interpret and synthesize findings goes as limp as a muscle without exercise.
It is in the best interest of the scientific mind to read and reflect on not only that which one agrees with, but also to construct coherent arguments to dispute what seems "bizarre" on the face of it. Doing this can only help the progression of science and prevent the type of narcissistic group think that could destroy it.
Autodidactyl,
the paper you linked to is a review, not a research paper.
Dr. Charlton,
Thanks for writing. Don't let some of these neanderthals get you down, most of them aren't real scientists, just desperate morons who have learned an itsy-bitsy amounts of science foisted on them at college. They are mostly sheep, including the host.
Your journal is just fine, and keep on being provocative. This paper on AIDS was very good. I bet none of the bozos here address it on the merits.
Hmmm. I suppose that M.D., Ph.D., and those peer-reviewed papers and grants must mean I have only learned an "itsy-bitsy" amount of science. How much science do you know?
At least Karri restrained herself from calling us "sheeple." :-)
Such as this website.
I bet "Lee Silsby Compounding Chemist" are only in the game for free hugs and the occasional balloon ...
"This is wrong on so many levels that it's hard to know where to begin."
"This effort by Merck took it far, far beyond the throwaway journal."
You wonder why parents don't trust big pharma or the vaccines that these deceptive lying sneaky bastards manufacture?
http://scienceblogs.com/effectmeasure/2009/02/baxter_bird_flu_botch.php
Now to reward Baxter for their botched effort to "accidentally" infect millions of people with H5N1 Avian flu virus, the WHO is giving Baxter the exclusive rights to produce the new Swine flu vaccine?
http://www.chicagotribune.com/business/chi-baxter-swine-flu-27-apr27,0,…
???
I love that Hyotheses paper on aids Karri links. It's the finest example of circular reasoning ever seen.
From the abstract:
Basically, my hypothesis is better NOT because it has more science behind it, but because, if I'm right about it, we can treat the disease.
That's like saying he's dead with a bullet in his brain, but I think he died of a heart attack, because we can revive heart attack victims.
I love that Hypotheses paper on aids Karri links. It's the finest example of circular reasoning ever seen.
From the abstract:
Basically, my hypothesis is better NOT because it has more science behind it, but because, if I'm right about it, we can treat the disease.
That's like saying he's dead with a bullet in his brain, but I think he died of a heart attack, because we can revive heart attack victims.
Doh, sorry about that double submission, I fail commenting 101.
@Catherina
"Autodidactyl,
the paper you linked to is a review, not a research paper."
Your point being? I did not think such exacting specificity was required to make my point. The link offers a number of articles (and research papers)in the sidebar as well.
There may possibly be more where this came from.
Ben Goldacre's Post on this - he calls the fake journal a "fanzine"
http://www.badscience.net/2009/05/elsevier-get-into-fanzines/#more-1136
There are 6 of these
http://www.the-scientist.com/blog/display/55679/
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 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.
The marketing protocol for pharmaceutical clinical trials includes designing the clinical trial protocol and having the ability to oversee this trial. Also, they select targeted investigators and the clinical trial sites. The sponsor runs investigator meetings, as well as select and control contract research organizations (CROs). The sponsor also performs data assessment, as well as completes the clinical trial so it can be published in a journal chosen by the sponsor.
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 can 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 sponsorâs 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. The authorâs duty includes making noted cognitive contributions to a published clinical trial, as well as revising and drafting the 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 and also may act as the publisher, manuscript version reviewer, and the clinical trial director who works with the drug companyâs 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 sponsorâs 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.
Commercial sponsors of clinical studies have the potential to manipulate the structure, implementation, and assessment of the clinical trial results to further their monetary interests.
This, of course, is detrimental for patients because clinical trial results supposed to be based on the best information from clinical trials possibly may be restructured by others, and is done so with deliberate intent and reckless disregard. Pharmaceutical Marketing uses science this way as a host to infect it, and bastardize the scientific method.
Knowledge is power, and is also possibly a lifesaver.
âEthics and Science need to shake hands.â â¦â¦. Richard Cabot
Dan Abshear
Authorâs note: What has been written was based upon information and belief.
Published on: www.brainblogger.com
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 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.
The marketing protocol for pharmaceutical clinical trials includes designing the clinical trial protocol and having the ability to oversee this trial. Also, they select targeted investigators and the clinical trial sites. The sponsor runs investigator meetings, as well as select and control contract research organizations (CROs). The sponsor also performs data assessment, as well as completes the clinical trial so it can be published in a journal chosen by the sponsor.
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 can 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 sponsorâs 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. The authorâs duty includes making noted cognitive contributions to a published clinical trial, as well as revising and drafting the 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 and also may act as the publisher, manuscript version reviewer, and the clinical trial director who works with the drug companyâs 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 sponsorâs 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.
Commercial sponsors of clinical studies have the potential to manipulate the structure, implementation, and assessment of the clinical trial results to further their monetary interests.
This, of course, is detrimental for patients because clinical trial results supposed to be based on the best information from clinical trials possibly may be restructured by others, and is done so with deliberate intent and reckless disregard. Pharmaceutical Marketing uses science this way as a host to infect it, and bastardize the scientific method.
Knowledge is power, and is also possibly a lifesaver.
âEthics and Science need to shake hands.â â¦â¦. Richard Cabot
Dan Abshear
Authorâs note: What has been written was based upon information and belief.
Published on: www.brainblogger.com
More clueless spamming from Abshear.
A reminder folks: this is the guy who got the what the initials PDD are for, and kept repeating the same mistake over and over --- even after several folks corrected him!
While browsing the net, I found two more fake journals in Computer Science:
(1) International Journal of Computer Science and Information Security (http://sites.google.com/site/ijcsis/contact-ijcsis)
(2) International Journal of Computer and Network Security (http://www.ijcns.org/)
It's no wonder physicians are losing their patience with with patients (yes, I did mean to write that) who come in insisting on getting the medicine they saw on TV..
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.
Good...I would not get too hung up on Medical Hypothesis.
Elsevier has proven to have questionable work ethics before. Some years ago, they had to retract 50 papers or so printed in their new journal Gene Expression Pattern, because those papers had been submitted to and accepted for publication in the journal Mechanisms of Development. The negotiations with Elsevier over this were very unpleasant, to say the least.
Oh, and sadly, in my experience, they almost never fire anyone who actually makes the decision to do these kind of things.
Very good discussion drive us to analyze and prepares us for the next era. What i believe is we invented the computers, we make them to be perfect, and now we supposed to act like them. I also intend to work in multitasking way but feeling not comfortable because having side effects of it. I always feel uncomfortable while performing one job and knowing that the previous job is not completed and having the disturbance of it subconsciously. I believe that we must spend more time on making computers to have better AI, and make them the necessary jobs and left business development jobs to humans.
Pharma and bias? who would have figured. Fraudulent "journal" masquerading as a real peer-reviewd journal paid for by drug companies. Who would have figured?
what a joke and sad what corporations will stoop to for $$$$$$$
In other words, throwaway journals tend to be to peer-reviewed journals a lot like USA Today is to The New York Times or The Wall Street Journal. However, in general, they are not blatantly written by pharmaceutical companies, as apparently was the case with the Merck journal.
A very good article about how Big Pharma have evolved and their roots is outlined in 'Return To Nuremberg: Big Pharma Must Answer For Crimes Against Humanity'
http://foolscrow.wordpress.com/2010/07/27/return-to-nuremberg-big-pharm…
It makes very interesting reading.
Dr David Hill
Executive Director
World Innovation Foundation Charity
Bern, Switzerland
Dr. Hill, have you ever heard of Godwin's Law. Because you just invoked it.
You also win no points with that article that mentions Gary Null and Mathias Rath, especially when it says "Dr. Rath should be congratulated for his efforts and assisted in every way possible". More on Rath: The Doctor Will Sue You Now.