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An article in the New York Times covers a surprising fact unearthed in a class-action lawsuit against pharmaceutical company Wyeth:  they hired a PR company to write articles supporting their drugs, tacked on doctors' names as authors, and submitted them to journals:

The ghostwritten papers were typically review articles, in which an author weighs a large body of medical research and offers a bottom-line judgment about how to treat a particular ailment. The articles appeared in 18 medical journals, including The American Journal of Obstetrics and Gynecology and The International Journal of Cardiology.

The articles did not disclose Wyeth’s role in initiating and paying for the work. Elsevier, the publisher of some of the journals, said it was disturbed by the allegations of ghostwriting and would investigate.

 

The chosen authors were doctors, picked for their credibility and solicited to put their names on mostly completed work.  One example in the article shows how brazen the process is:  the PR company, DesignWrite, handed a draft of an article to a professor of Obstetrics and Gynecology.  She sent back an email with one correction.  Later, the article appeared with the professor's name as the primary author.  And the ghost-writers?

The acknowledgments thanked several medical writers for their "editorial assistance," not disclosing that those writers worked for DesignWrite, which charged Wyeth $25,000 to generate the article.

Wyeth argues that this sort of "editorial assistance" is common in the field.  Maybe, but it certainly isn't common in academia.  This is as surprising to an academic like me as it is to laypeople---and in many fields it would be considered blatant academic misconduct.

Different academic disciplines have widely different standards of publication.  Many fields don't have the concept of a review article, which leads to some confusion when a biologist says "I can't go out this weekend, I'm writing a review."  We differ on the relative importance of journal articles versus conference papers, and on the free online access of papers versus pay access.  In some fields, like mathematics, it is common for preprints to be widely disseminated.  In some fields, peer review is weaker.
 
But one of the biggest differences is that most of academia is not adversarial.  We don't have a bunch of outsiders with an interest in leaning the academic consensus a certain way, or who will use a bag of tricks to promote or suppress papers.  It does happen now and then in my field, information security:  I was once on a paper that was held from publication under threat of a lawsuit.  We broke a security system that was designed and marketed by the threatening party.  When that happened, our university was completely unprepared, because we simply aren't used to that kind of industry kibitzing.  My brush with the courts made me ever grateful that I'm not in a field where laypeople try to distort your work, like evolutionary biology, or stem-cell research, or pretty much any medical research involving commercial therapies.
 
For this reason, it's pretty obvious to most academics that this sort of practice is unethical.  Indeed, it's something we never encounter.  Nobody's going to write a paper for you, nobody's going to game the system by forging a consensus to help their company.  If it is a common practice in medicine, it's still shocking to the rest of us.

And to the rest of us, the fix is pretty obvious:  a journal must mandate that anyone who contributes text or data to a paper be listed as an author.  Customarily the author is listed with affiliation, and if the authors' work is supported by external support that is explicitly stated (people who fund research usually want acknowledgement, so they can brag that their funding has advanced the state of the art.)

Then when the authors sign the copyright transfer form, it has a clause that says, "to the best of my knowledge, the authors are the sole contributors of written text and new research results in this paper, and their funding to perform this writing and research has been explicitly acknowledged."  If such a simple rule cannot be enforced right away, then it only shows a severe need for reform.

Originally posted to Caj on Wed Aug 05, 2009 at 09:23 AM PDT.

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Comment Preferences

  •  Tip Jar (29+ / 0-)

    Linking to a news article is journalism in the same sense that putting a Big Mac on a paper plate is cooking.

    by Caj on Wed Aug 05, 2009 at 09:23:44 AM PDT

  •  Research ethics (8+ / 0-)

    is predicated upon funding.  Researchers are dependent on not only Federal funding but private sector funding if their labs are to remain afloat.

    Why?  Federal grants don't cover what's termed "overhead" - that means stuff that the university or other institution being funding should provide as day-to-day expenses including lighting, office furniture, office supplies, computers, office staff, etc.  Universities are cutting back on providing these essentials, so if a researcher needs a new computer (not for scientific purposes, just for checking email, writing grants, writing papers, etc.) the researcher generally has to shell out the money personally or get a private sector grant.

    Generally, these foundations don't influence results or publications.  However, when a researcher is dependent on a company like Wyeth for their day-to-day support and are unlikely to withdraw their name from an article and risk funding.

    We need more broad-based funding for medical and scientific research that frees researchers from being beholden to corporate sponsors.

    "Right wing freak machine" General Wes Clark

    by Tracker on Wed Aug 05, 2009 at 09:34:05 AM PDT

    •  I don't think so. (3+ / 0-)
      Recommended by:
      Angie in WA State, ER Doc, yaque

      I have received several federal grants for my research, and our budget always included a line item for computers and other office equipment.  

      Indeed, the layout of the budget was entirely up to us, while the funding agency dictated only the total amount; as long as the budget was sane, it was fine.  There is no restriction upon federal grants that force us to seek private-sector funding.

      As for electricity etc, that is also drawn from all grants, government and private, by the university extracting a fixed percentage of "indirect costs."  Typically, about a third of any grant budget is reserved for the university to soak into its general fund and use as needed for maintaining buildings, paying TAs et cetera.

      •  I should also add... (2+ / 0-)
        Recommended by:
        ER Doc, yaque

        That when the university takes its indirect costs from our grants, a small slice is returned to us as an "infrastructure fund" managed by the university.
             
        Basically this gives you a tiny general-purpose budget that accumulates very gradually as you bring in funding.  The idea is to give each researcher a budget cushion that can be used to, say, fund a student in hard times.

        Now, I've never seen a researcher barred from using grant money to get a computer for writing grants and papers.  But even if there was such a weird restriction on equipment purchases, I could still technically buy what I needed out of my infrastructure fund.

        After all, the fund is so tiny that it seems to have no other uses.  Funding a student in hard times requires tens of thousands of dollars a year.

        •  Perhaps at your university the slice is returned (2+ / 0-)
          Recommended by:
          Creosote, Egalitare

          At others, indirects are not funneled back to faculty for funding students, etc. And some universities are much pickier about what they allow to be charged to federal grants, in fear of an audit.

          "Right wing freak machine" General Wes Clark

          by Tracker on Wed Aug 05, 2009 at 10:42:35 AM PDT

          [ Parent ]

          •  Despite all this, (1+ / 0-)
            Recommended by:
            ER Doc

            I have never once seen a researcher unable to use a federal grant for what you term "overhead."
             
            I have colleagues with grant money from NSF, NIH, DoD (DARPA, Army, Air Force,) and DoE.  I've seen some strict but obvious rules governing the use of federal money.  But I have never seen a PI disallowed from buying an office or lab PC from the equipment budget, and then using that machine to write papers or grants or emails.  I have never seen a PI unable to buy office supplies if needed for the project.
               
            I, for example, have only ever received federal money.  I have had no problems running my lab and purchasing what I need.  Never have I required private-sector funding to fill any deficiency in my grant money.

  •  Routinely common (9+ / 0-)

    And Sen Grassley's panel has been digging into this for awhile. JAMA has been leading calls to ban this practice - an effort they spearheaded about 2 years ago. Elsevier has been highly critical and their submissions process requires authors to submit statements regarding authorship for precisely this reason.

    The American Medical Writers Association has been very critical of this practice and are working with JAMA to enact industry ethics standards with respect to ghostwriting of journal articles.

    Now, all that said, academic integrity is not necessarily imperiled by this practice. This isn't "academic publishing" per se. Medical journals occupy various roles in the medical field and in physician education.

    Pharmaceutical companies and medical equipment firms usually have large numbers of MDs working on staff and they do write papers and they have to adhere to the peer-review model and conduct honest research. When they have been caught skewing data, the punishments have been extraordinarily severe.

    Often, physician or researcher may wish to publish a paper but not have the resources or time to do this, or a company would like to release its own research, and ghostwriters prepare a paper. If this paper is reviewed by a "big name" in the field, it has a better chance of being published as so this particular trick is commonly seen.

    It's wrong and should be stopped, and there's consensus on that.

    Every day's another chance to stick it to The Man. - dls.

    by The Raven on Wed Aug 05, 2009 at 09:40:01 AM PDT

    •  Big Pharm has many sins in their closet (4+ / 0-)
      Recommended by:
      Creosote, The Raven, Norbrook, Egalitare

      The whole practice of drug reps has been corrupt since its inception where doctors are offered perks, meals, trips and other incentives to prescribe the newest wonder drug before it is out from under patent.

      Now some years ago, Big Pharm came out with a white paper detailing ethical interaction between the reps and docs but it was only advisory. While some of the worst abuses were curtailed, many were not.

      One of the more amazing stories I have about drug reps and their sponsored meals, frequently at upscale restaurants, is the example of the former receptionist who continued to attend these dinners even after the industry had supposedly adopted a standard of meals had to come with educational content (i.e syllabus and roll call).

      In this lady's case, she was a receptionist for a couple of years for one of the older docs in town who passed away. At this time, she began driving a delivery truck as her next career move. Now with the doc dead and the dinners now including heavy duty discussions of topics like drug interactions or the microbiology involved in the drug's being processed by the body, she continued to show up for steak and lobster dinners every month like clockwork. So much for the educational value of these dinners  

    •  Call me naive, (0+ / 0-)

      ...but I don't see why anyone has to be working with anyone to enact standards.

      The simple solution is for a journal to mandate that all contributors are listed as authors, and this does not require an glacial drift toward universal reform.  It requires the editorial staff to agree to a simple no-brainer requirement for submission.

      Meanwihle, if a physician wants to publish but lacks the resources or time, they can co-author with people.  Then there is no ethical quandry.  Here the issue is not co-writing, but concealment of authorship.

      •  Yep, you're naive (0+ / 0-)

        Just kidding. Once you're working in this business, you see that there are endless variations on the process of creating a paper for journal release. There's no one set pattern for how this happens.

        So ethics need to be defined that offer general guidance to all persons involved in the process.

        Every day's another chance to stick it to The Man. - dls.

        by The Raven on Wed Aug 05, 2009 at 10:57:26 AM PDT

        [ Parent ]

        •  asdf (1+ / 0-)
          Recommended by:
          The Raven

          Just kidding. Once you're working in this business, you see that there are endless variations on the process of creating a paper for journal release.  There's no one set pattern for how this happens.

          But there is a set pattern for the journal's submission rules and peer review mechanism.  
           
          If the editorial staff of a specific journal wants to stop this practice for their own journal, they can do so with the addition of a simple submission requirement.  

          I can see one complication:  sometimes an author seeks to be removed from a paper, for various professional reasons.  This must still be allowed, in such a way as can't be abused by a tricksy ghostwriter.

          •  Well... exactly (0+ / 0-)

            What you describe is extremely common. And journal submission guidelines already specify rules for authors. Problem is, journals cannot investigate the actual authorship of papers and have to trust those making the submission. That's why AMWA et al have to be at the table on this matter.

            Every day's another chance to stick it to The Man. - dls.

            by The Raven on Wed Aug 05, 2009 at 11:38:04 AM PDT

            [ Parent ]

            •  Trusting the submitters (0+ / 0-)

              Surely we must trust that the submitters are not lying about authorship, just as we must trust that they are not fudging data or committing plagiarism.  Much of this cannot be caught in the peer review process, for plain logistical reasons.  
               
              That still doesn't prevent a journal's editorial board from mandating a submission rule regarding disclosure of authorship, and doing so right away.  They do not need to wait for a bunch of people to come to a table and discuss general ethical guidelines.

              Nor do I see how input from professional societies can make it any easier for me, as an editor or program chair, to investigate academic misconduct in my journal or at my conference, or why they need to be at my table at all.

              •  Look (0+ / 0-)

                The authors submission guidelines require the person submitting the paper to be truthful. We know that they aren't.

                The problems we're discussing here aren't stemming from the physician researcher in the field who is submitting the results of his or her research. The normal academic path is working fine and the standard guidelines in place at Journals do the job at this level.

                Ethics guidelines are needed for the organizations who routinely dodge the rules, we're talking freelance medical writers, pharma and med, certain labs, medical communications firms, PR firms, etc.

                Every day's another chance to stick it to The Man. - dls.

                by The Raven on Wed Aug 05, 2009 at 12:35:01 PM PDT

                [ Parent ]

                •  I don't think so. (1+ / 0-)
                  Recommended by:
                  The Raven

                  I mean, I certainly agree that ethical guidelines are needed for organizations.
                   
                  However, the problem we're discussing here requires the complicity of an academic.  This gives us the power to stop ghostwriting within our own sphere of influence, without waiting indefinitely for pharmaceutical companies to submit to ethical guidelines.  At least one of us must sign on to let it happen, and we can make that an explicit act of professional misconduct that risks an academic's career.
                     
                  I disagree that submission guidelines already require the authors to be truthful about author disclosure.  They do not.  The professor in the article technically acknowledged the "editorial assistance" of the writers, and while we regard this as clearly unethical, the professor is not committing an explicitly forbidden act of academic misconduct.  If investigated, it will not likely get her disciplined.  

                  The problems we're discussing here aren't stemming from the physician researcher in the field who is submitting the results of his or her research. The normal academic path is working fine and the standard guidelines in place at Journals do the job at this level.

                  Again, I disagree.  The individual physician researcher is the keystone in this problem, because it requires the physician's consent for this external deception to take place.

                  Beyond this phenomenon, we find that the individual researcher can also be a target if he or she publishes inconvenient results.  Overall I'd say that our existing system of publication and peer review was not designed to deal with a well-funded external adversary, and our processes need to be hardened in a few ways to deal with it.

  •  Americans are easy to fool (4+ / 0-)
    Recommended by:
    greeseyparrot, Clio2, Norbrook, Egalitare

    We hear the word choice and somehow assume that it means, preserve the insurance predators. American education and culture are seriously deficient. As an old but still working doctor, I’ve seen the bad effects of converting Blue Cross and other insurance companies into for profit entities. I spend about 8% of my working time on getting permission for necessary drugs and treatments- don’t tell me that you don’t want rationing. We have rationing for most Americans now, for the benefit of the executives and shareholders of insurance companies. I’m not against intelligent and open rationing, I’m against stupid, shortsighted and concealed rationing, which is what we have today. Read Michael Hiltzik, who tells it like it is- http://www.latimes.com/...  

    The insurance companies manipulate public opinion, jerk Congress around by the nose and distort the public sphere by 1. Seducing doctors and other health practitioners with lunches, gifts, etc medical schools are short of cash, so they turn over medical education to the drug reps- big mistake. 2. Misleading ad aimed at consumers which are illegal in all developed countries except the US and New Zealand and creating bogus medical articles such as the one you found. Doctors who allow their names to be put on such articles should be shunned by their colleagues, but many MDs are caught up in a mindless round of rapid fire patient visits, worry about various bogeymen and just don’t take their profession seriously.

    When the brown shirts scream that they won't accept government healthcare and government sponsored euthanasia, and other lies, we’d better stand up and speak or we’ll never get out from under these manipulators.

    •  Mergers are also to blame (1+ / 0-)
      Recommended by:
      ER Doc

      as well as the Balanced Budget Act of 1998 (I think) which expanded hospital administrators' control over what constitutes disruptive behavior and what is an appropriate punishment for offending an administrator. To add insult to injury, many administrators find the threat of reporting a doc to the Data Bank sufficient to cow the most hardy soul.

      http://www.medicalaw.net/...
      scroll down to peer review
      or visit the Semmelweis Society's site

  •  Outrageous. (1+ / 0-)
    Recommended by:
    Ralphdog

    I hope JAMA and NEJM do a little research themselves, figure out which articles were infected by this vile practice, and publicly withdraw them.

    If you don't stand for something, you'll stand for anything.

    by Keith Pickering on Wed Aug 05, 2009 at 09:54:04 AM PDT

  •  It's impossible to exaggerate how vile this is. (8+ / 0-)

    We as physicians depend upon peer-reviewed, (supposedly) intellectually honest professional journals. They are the main source for up-to-date yet professionally vetted scientific information on medical care.

    There have always been doubts about the impartiality of journals that depend on BigPharma for advertising dollars. There is worrisome evidence for significant publishing bias in favor of articles demonstrating "positive results", that is, showing that one of BigPharma's products is effective for its intended therapeutic goals, over articles proving them to be ineffective.

    So now we learn that BigPharma has been using trusted expert physicians as sock puppets?

    This is so odious, it's difficult for me to contain my rage.

    And the physicians involved? Contempt is too weak for the feelings I have. They have shamed us all with this despicable conduct.

    I personally prescribed estrogen replacement for years, in part based on supposedly solid evidence of its efficacy and relative safety. To my knowledge so far two of my patients who received ERT have developed breast cancer. I understand they may have contracted this even without ERT, but it's now abundantly clear that it is a significant risk factor, and that BigPharma systematically toiled to conceal that risk. I can't express how devastating this is to me personally; the scientific basis of my clinical judgment was corrupted by BigPharma's greedy minions, with profound consequences for my innocent patients.

    This is beyond shameful.

  •  Where this has been common (1+ / 0-)
    Recommended by:
    greeseyparrot

    A fair bit of this has been seen in articles, on a variety of "sciency" topics, for newspapers, regular magazines (not scientific journals), etc.  Of course, it's bad enough there; where the average lay reader is thinking "well, this Dr. Soandso from Esteemed University says it, it must be true". Certainly not cool at all if it is spilling over into what would be presumed to be peer reveiwed academic journals. In such cases it is less to the point to be pissed at Wyeth, it's the doctors who whored themselves out that deserve major condemnation.

    tweetivism.comA cool tool to tweet your Congressmembers with Health Care Reform messages.

    by Catte Nappe on Wed Aug 05, 2009 at 10:30:34 AM PDT

  •  It used to be that (3+ / 0-)

    Pharma, usually Big, but not always, paid a good chunk of the cost of a lot, maybe most, of these studies.

    Ghost writing the articles is taking it to an even more corrupt level.

    FWIW, I'm a former Wyeth employee.  I'm currently out of work and UI running out in 2 or 3 weeks.

    Calling torture enhanced interrogation techniques is like calling a skunk a rose. It really doesn't smell any better.

    by grada3784 on Wed Aug 05, 2009 at 10:37:16 AM PDT

    •  The funding is fine... (2+ / 0-)
      Recommended by:
      grada3784, Egalitare

      ...as long as it is disclosed, and we have some regulation that prevents the "file drawer problem" of multiple funded studies of which only several are published.
       
      Similarly, it's fine for a company employee to participate in the writing of an article, as long as the authorship and affiliation is disclosed---not as a footnote, but explicitly among the authors.

      It isn't even a bad for a company to fund a writing effort, as long as funding is explicitly disclosed in the publication.  Technically, the people who give you a research grant are already funding your writing, because publishing is considered part of your research effort, for which you are paid.  My budget usually includes an explicit line item for publication costs, which I could spend on editorial services.  Again, my funding is not money from some eeeeevil company, but from the US government.
         
      The problem with this ghost-writing is not the involvement of funding sources, but the concealment of such, the unethical attempt to fake a consensus of independent third parties.  

  •  Death by spreadsheet (0+ / 0-)

    The scary part is that people die.   Just five out of a thousand, or something like that, who had "increased risk of heart attack or stroke" due to taking the medicaion, or some other that other "fine print" language you always hear on the drug ads.  By the time the pharma buries the studies that didn't go so well, and "ghost writes" a few articles purportedly from a respected physician advising treatment with their blockbuster drug,  gives away a few millions of free samples at the doctor's office, and spends millions on advertising -- no one really notices that a few more people died this year.

  •  Hmmm. (0+ / 0-)

    Wyeth argues that this sort of "editorial assistance" is common in the field.

    And therefore what?

    Persecusion of Jews was common in the Nazi "field" in the 30s and 40s.  Did that make it ok?

    Only dead fish go with the flow.

    by dov12348 on Wed Aug 05, 2009 at 11:23:20 AM PDT

  •  Forged Kenyan birth certificate... (1+ / 0-)
    Recommended by:
    ybruti

    ...forged letters to Congress members....forged authorship on medical articles...audacious mendacity seems to be the be theme of the week.

    Things are seldom what they seem,
    Skim milk masquerades as cream.
    Highlows pass as patent leathers;
    Jackdaws strut in peacock's feathers.
    Storks turn out to be but logs;
    Bulls are but inflated frogs.  
    Gild the farthing if you will,
    Yet it is a farthing still.

  •  Isn't this a violation of medical ethics? (0+ / 0-)

    Aren't there standards among medical journals that one must disclose conflicts or interests? I wonder what extra perks the physician  "author" received--new equipment, a paid junket to a Wyeth conference?

    This practice is not uncommon. See Melody Petersen's book Our Daily Meds and Marcia Angell's The Truth About  Drug Companies and How They Deceive Us.

    Co-op + Public Option = Co-option. Call your Represenative, Senator, and the White House to Demand Public Option

    by SuburbanGrrrl on Wed Aug 05, 2009 at 09:34:08 PM PDT

  •  Repeat offender (0+ / 0-)

    This isn't the first time Elsevier has been caught palming off corporate-written marketing happytalk as "peer-reviewed research".  See, for example:

    http://www.cbc.ca/...

    If I were a medical practitioner or researcher, I'd be reluctant to believe anything I read in an Elsevier publication until it was verified by a real medical journal. You know, one written by doctors and researchers, not Marketing Dudes.

  •  yet another reason why pharmaceutical (0+ / 0-)

    research should be a fully public endeavor and not under the guidance of the "invisible hand" (that has an annoying tendency to smack down honesty).

  •  Doesn't It Make You Wonder (0+ / 0-)

    What about the peer reviewers?  Many times, you can suggest reviewers for your publications.  Could they have hired help there, too?  

    There's no point for democracy when ignorance is celebrated -- NOFX

    by Lupeyg2 on Thu Aug 06, 2009 at 04:41:55 AM PDT

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