Articles

Ghostwriting As Marketing Tool

An article in the latest issue of PLOS Medicine, The Haunting of Medical Journals: How Ghostwriting Sold “HRT”, details the use of ghostwriting as a marketing tool for pharmaceutical companies. It is a chilling discussion of how at least one pharmaceutical company, Wyeth, used the peer-reviewed literature as a method of distributing marketing messages to physicians.

The author, Adriane J. Fugh-Berman, details a practice that cuts at the heart of science-based medicine – the exploitation and distortion of the literature. The medical profession needs to jealously guard the legitimacy and purity of the peer-review process and the medical scientific literature. I am never one to gratuitously bash “Big Pharma” – this is often used as a method of casually dismissing inconvenient scientific evidence. But at the same time, pharmaceutical companies are in the business of making money. While they are a carefully regulated industry, some in the industry seek ways to skirt around regulations that limit their ability to market their products.

While most physicians consider themselves savvy with respect to pharmaceutical marketing, the story told by Fugh-Berman is one of profound naivete. I guess it should not be a surprise that some academics were bamboozled by expert salespersons who spent a lot of time and effort, apparently, figuring out ways to deceive and manipulate them. But now that the story is out, naivete is no longer an excuse. Here is what happened:

The FDA regulates what pharmaceutical companies can say in their marketing. For example, they are restricted to promoting on-label indications. However, the FDA does not regulate the peer-reviewed literature, and so some pharmaceutical marketers felt that this was a good opportunity to distribute marketing messages outside of FDA control. The primary process was to ghostwrite review articles, commentaries, case series, as well as the occasional primary trial report – and then have “thought leader” physicians sign their name and “author” the article.

This was done under the guise of “editorial assistance,” and “authors” were given the opportunity to edit and make changes to the draft they eventually signed off on. But the entire process was under the careful control and scrutiny of marketers who closely guarded the marketing messages in the paper. These messages included playing up the benefits of a treatment (the paper focuses on hormone replacement therapy), downplaying side effects, criticizing competitors, and promoting off-label use. Review articles are a great place to do this, because there is a great deal of judgment that goes into what to emphasize, and exactly how to present the facts. It is possible to influence opinions in this way without lying, and unless someone was looking for systematic bias it might not be apparent.

Some authors did give significant push-back against this process, but they were “managed.”  The ghostwriters also helped to manage the peer-review process, suggesting responses to the editors and reviewers in order to defend core marketing messages.

All of this behavior is documented in 1500 documents revealed in litigation.

Conclusion

The author concludes:

Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.

I completely agree. Reading the description of the ghostwriting process detailed in this paper was beyond disturbing. It gives the image of a callous disregard for the scientific process and a view of physicians and the scientific literature as something to be manipulated.

It is not clear how extensive the practice of ghostwriting is. I have never personally encountered it myself, but this fact is not terribly enlightening. What is clear is that academic institutions and peer-reviewed journals need to take definitive measures to eliminate the practice of ghostwriting articles. The behavior needs to be simply not tolerated. It may also be necessary for the FDA to ban the practice, since it is used as a means to thwart FDA regulations of pharmaceutical marketing.

I do not begrudge the pharmaceutical industry the ability to fairly market their products. But there needs to be an absolute wall of separation between the scientific process and the marketing process, and that means keeping pharmaceutical company ghostwriters out of the scientific literature.

Posted in: Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine

Leave a Comment (32) ↓

32 thoughts on “Ghostwriting As Marketing Tool

  1. cervantes says:

    The medical profession needs to jealously guard the legitimacy and purity of the peer-review process and the medical scientific literature.

    Hah! Might as well guard the purity of Paris Hilton.

  2. “The primary process was to ghostwrite review articles, commentaries, case series, as well as the occasional primary trial report – and then have “thought leader” physicians sign their name and “author” the article.”

    “[T]he medical profession must take steps to ensure that prescribers renounce participation in ghostwriting… .”

    So these “thought leader prescribers” are who, exactly? Presumably they publish, because that would be how they are thought leaders. But would they be researchers? I would think that researchers would want to publish their own stuff. Is it that the pressure to publish large volumes is so high that any little bit of help in producing a published article is gratefully received?

  3. Dr Benway says:

    It is possible to influence opinions in this way without lying, and unless someone was looking for systematic bias it might not be apparent.

    Yep.

    A political consensus emerges among groups and individuals haggling with each other over shared values and preferred leaders.

    A scientific consensus, in contrast, is an aggregation of relatively independent voices.

    Pack of wolves verses herd of cats.

    All triers of fact in civil societies –scientists, judges, and journalists– depend upon a culture supportive of their independence and security.

    Absolute independence is impossible, but relative independence appears sufficient to allow reasonable progress within science.

    Because we assume relative independence among researchers working in different labs, conspiracies are potentially a serious threat to our collective understanding of what is true.

    Taking money from a major pharmaceutical company doesn’t concern me so much as what might happen to a particular scientist if he loses a funding stream. So long as there are multiple alternative sources of funding available, I would expect honor to trump greed most of the time.

    This Wyeth case sounds like a great window into the world of stealth marketing. I’ll have to read more about it.

  4. JMB says:

    Is it that the pressure to publish large volumes is so high that any little bit of help in producing a published article is gratefully received?

    I haven’t been in academic medicine for quite some time, but I doubt the rules of academia have changed. I would answer “yes”. It used to be called “publish or perish!” Frankly, it is hard to be a practicing doctor, a teacher, and an author of grants and scientific papers. Universities should use a different criteria for granting tenure for the academic trying to fulfill three duties, as opposed to the academic only fulfilling two duties. University tenure committees share a fraction of blame for the publish or perish environment.

    Thought leaders were those physicians giving well attended talks at large international conventions.

    It was also more than a little bit of help. Thought leaders were also given honorariums from a company for giving small talks at small meetings at fancy resorts organized by the company. It paid almost as well as being an expert witness.

    I used to snicker at the idea that a particular thought leader was being paid to give a talk on digital methods at a meeting in a small resort in the Alps when he didn’t know the difference between a bit and a byte. I was also amazed as a med student when I found an article published by the attending (professor) physician extolling the virtues of a particular drug for treatment of a rare condition, that the attending didn’t even remember writing! I got out of academic medicine because I was told my research in computer aided diagnosis wouldn’t attract any industry money to the department (didn’t use any expensive drugs or equipment, what marketing department would pay any attention?) I believe the directive was, “It’s interesting work, but it doesn’t bring money into the department. So, don’t let it interfere with the work they pay us to do.”

    It got really bad when nonacademic physicians in private practice who wrote lots of prescriptions for a company’s drug were invited to give some of those small talks at industry organized meetings usually entitled, “Clinical experience with (substitute name of drug)”. These guys were profit centers, not thought leaders.

    However, many ethics rules and laws have reformed many of those past practices. We are still left with a dubious body of literature that shapes current standards of care. If there is a strong economic incentive for any procedure or treatment, then the scientific literature really has to be read with “two strikes against it” skepticism.

  5. Todd W. says:

    In theory, the FDA could take action against companies engaged in ghostwriting. IIRC, they can already take action against companies that engage in marketing trumped up as an educational seminar at a medical conference.

    Ghostwriting is marketing, plain and simple. If companies engage in such, then they should face the same types of penalties for other inappropriate, misleading or outright fraudulent marketing, from fines to removal of approval of the product.

  6. Xplodyncow says:

    Unfortunately, the practice is more widespread than you think. I’d never heard of ghostwriting until I took an ethics workshop in medical writing this past spring. Scary stuff.

    In fact, I heard of an incident where a reviewer spotted a ghostwritten article during the peer-review process — he or she had previously been asked to slap his or her name on a paper a med ed company had written. Although the reviewer declined, someone else had obviously accepted.

    Both the International Committee of Medical Journal Editors (ICMJE) and the American Medical Writers Association (AMWA) offer some guidelines:

    Uniform Requirements for Manuscripts (URM)
    http://www.icmje.org/ethical_1author.html

    AMWA Ethics FAQs
    http://www.amwa.org/default.asp?id=466

  7. I feel the need to assume the relative lack of comments is either due to the fact that many have been left speechless by this (especially if you read the whole linked article), or that most feel little need to comment because we assume there will be no dissenting viewpoints.

    I’d really like to hear some of the resident hard core libertarian commenters (you know who you are) take on this and hear why they still think an unregulated drug industry would be a better idea than what we have now.

  8. wales says:

    just type “ghostwriting” into the PLOS Medicine search tool, several articles have tackled this topic back to 2007, all disturbing.

  9. red rabbit says:

    Sadly, this is still prominent. Even more sadly, there is a culture outside the major learning centres, which I thought defunct years ago, of industry funding for CME, of industry courting physicians, and of offering ghostwriting gigs.

    CME- continuing medical education. Seminars and training courses, a requirement for maintaining a medical license in most jurisdictions.

    As public funding declines and hospitals and doctors feel the pinch, I fear this can only get worse. It’s of utmost importance that my patients trust me, and I myself want to be able to trust that my judgement is free of industry taint. Ugh.

  10. Ray Greek MD says:

    This is really not new. In “Science in the Private Interest: Has the Lure of Profits Corrupted Biomedical Research?” (Rowan & Littlefield Publishers 2003) Sheldon Krimsky discussed this in chapter 7. As i recall this was also in the news several years earlier. I am not saying the PLOS Medicine article is unwarranted just that this has been known for at least 20 years IMO. Note that in all that time not much has been done to stop it.

  11. KevinK says:

    Disclaimer: my ox is being gored here. I’m a member of the American Medical Writer’s Association, and I earn my living writing about science and medicine.

    I agree that “ghostwriting” carries with it negative connotations, and that the process described in the PLoS article details what cannot be described as anything other than an unacceptably heavy influence of marketing into medicine.

    Professional medical writers adhere to a canon of ethics; some of the practices described in the PLoS article are far outside the acceptable standards.

    However, I don’t think the baby should be thrown out with the bath water. There is a role for professional writers in both the marketing of products and in the reporting of clinical trial results either in peer-review publications or at scientific convocations.

    Consistency and clarity are the hallmarks of good communications. Sadly, the vast majority of physicians and other researchers I’ve dealt with over the past 20 years offer little to none of that in their writing.

    Would you rather have an abstract of a potentially ground-breaking clinical trial be rejected because the researcher in charge can’t write subject-verb-object? Would you rather that an almost-right word be used in the place of the right word to describe the trial outcomes? Lightning for lightning bug, as it were? Accurate, clear, and compelling reporting is the job for a professional writer working in close cooperation with the owner of the data.

    Professional medical writers who are hired as independent contractors outside of the employ of the pharma company also help keep things “real”.

    True story here: I was hired by one of the BIIIIIIIG pharma companies to re-work a slide deck that was to be used by their medical science liaisons. The original draft, written in-house, contained out-and-out misrepresentation of data (in the black-is-white sense). My job quickly turned into one of telling the pharma company that misrepresenting their data in this way would get them not just laughed at, but sued.

    So, there’s a continuum. I think we can all agree that a line was crossed in the Wyeth case. But I’m not sure that the solution being offered is the correct one, let alone even possible. There’s a lot of writing to be done; my plate is almost always full and my colleagues also report no let-up in the need for their services.

    I have meetings, but will return, because I’m sure there will be those with questions and criticisms of me and my profession, which I’ll be happy to address. Just don’t start questioning my professional ethics, or assume that I’m a “whore” or a “shill” and we’ll get along fine…m-kay?

  12. Bogeymama says:

    I thought this was widely known? Just about every journal supplement, CME leaftlet is ghost-written. It’s not hard to find docs to sign off on it, they are chosen based on their prescribing habits / preferences and whether or not they’re considered “thought-leaders”. Although things have really tightened up in Canada in the past several years, they used to involve sunny trips to the Carribean for the initial planning sessions. Case studies are usually “composite” patients that are dreamed up to steer the reader in the direction of how best to choose / use the company’s drug. Every CME I read now I read with a very careful eye. If it spends too much time slamming the competition then I toss it.

  13. pmoran says:

    This kind of thing is a severe blow for those of us trying to sustain some faith in mainstream medical systems — “we do get it sorted out in the end.”

    What to do? Can the usual peer review and disclosure requirements cope with such shenanigans, now that everyone is aware of them?

  14. BillyJoe says:

    Kevin,

    “I’m sure there will be those with questions and criticisms of me and my profession, which I’ll be happy to address.”

    My criticism is that your post is actually off topic. ;)

    Helping researchers to write accurate reports about their research is just a little different from writing the whole damn thing and having the researcher simply sign his name at the bottom.

    Still, I think the medical schools should do their utmost to put you out of business.
    …by teaching medical students how to write their own reports! ;)

  15. “Both the International Committee of Medical Journal Editors (ICMJE) and the American Medical Writers Association (AMWA) offer some guidelines:”

    From a layperson’s, ethical guidelines are nothing unless there are negative consequences when they are ignored.

    Apparently it is profitable for companies to be engage in this process (or at least they think it is profitable), so they do it. It is individually profitable for some physicians to sign these papers. So they do it.

    If the larger group of physicians or medical professionals think this practice is counter productive they need to make it less profitable for the companies or the signing physicians.

    Is that being done?

  16. Dr Benway says:

    I don’t see how an independent third party could determine that a written work was 100% ghost written by a marketer verses simply polished by a professional writer.

    Rather than policing whether mommy did the homework, I think we have to fall back upon rational criticism of the claims made within the paper as our best defense against bullsh*t.

    The conspiracy bit is troubling, however. I’m still thinking about that problem.

  17. Dr Benway says:

    My last post is in moderation.

  18. TsuDhoNimh says:

    Steve –
    There is also the “build up hysteria in the popular press” and then offer a solution system I saw happen with toxoplasmosis in the 1970s. At that time we were not doing ToRCH testing (immunology had come a loooong way, baby) and suspected toxo got shipped to the CDC for testing.

    A flurry of articles showed up in various women’s magazines about the dangers of prenatal toxoplasmosis, with some crucial facts omitted (like giving the incidence, comparing its 1/4000 live births with congenital syphilis’s 1/250, stating the lack of a way to treat it, etc.) and all the gory details intact. All were printed as editorial content, not ads, and those with a byline all showed the same author, Elmer Fudd.

    It caused a number of OBs and our lab to have to do damage control. These articles were causing pregnant women and their relatives considerable stress over a rare complication that at the time had no treatment. My then FIL was sending me all these articles, because we had cats and he was a worrywort. It caused interns stress when we told them that we would ship samples to CDC if the pathologist approved and have the results back in a month or two.

    Just after the last of the flurry, our lab and all the other labs in the country got a 4-color glossy ad about the just-approved toxo test that ACME Industries was now offering for sale. One of the little blurbs cited text from one of the articles under the byline, “Noted science author, Elmer Fudd”.

    It wasn’t until later, when I learned about the printing industry, magazine publishing and lead times that I realized that the toxo articles were still in the publishing queue when all that marketing material aimed at the labs was being laid out and in production … ACME had hired the writer to create the awareness as part of their marketing campaign.

    We didn’t buy the test, nor did any other lab – spending $400 for something with a short shelf life when we did at most 3 a year was not cost effective and not likely to be accurate. It was not an easy test, very technique-dependent. We preferred to ship tests to a lab that did the test every week and had techs who stayed in practice.

  19. Chris says:

    TsuDhoNimh:

    A flurry of articles showed up in various women’s magazines about the dangers of prenatal toxoplasmosis, with some crucial facts omitted….and all the gory details intact. All were printed as editorial content, not ads, and those with a byline all showed the same author, Elmer Fudd.

    Just after the last of the flurry, our lab and all the other labs in the country got a 4-color glossy ad about the just-approved toxo test ….

    ACME had hired the writer to create the awareness as part of their marketing campaign.

    This almost fits nicely into the conversation on Dr. Hall’s experience with “O” Magazine, and further proves that women’s magazine articles are just to push products!

  20. KevinK says:

    @ Billy Joe:

    No, I’m quite sure that I’m addressing the topic at hand. That topic is a PLoS article detailing how a medical communications company over-reached in helping a pharma company over-reach in promoting its product through a wide range of written communications vehicles, including “ghostwritten” review articles.

    The solution offered, including by you — that all researchers/experts/thought leaders should be responsible for all of their own writing from blank page to published piece, with some sort of governmental oversight imposed to enforce such a restriction — is impractical at best, laughably naive at worst. It’s also a direct insult to the thousands of people who do their best to work in an already highly regulated, high-pressure, high-stakes environment to assist in providing clear and accurate assessments of research into important medical conditions. (And let’s be fair, solutions to trivial but potentially lucrative conditions as well.)

    I wonder, which medical school courses would you replace with writing skills classes? Immunology? Anatomy? Virology? Would you replace the weekly Grand Rounds lecture with a weekly grammar rounds class? Which would you rather have; a physician who knows how to do a lumbar puncture, or one who knows what a gerund is?

    It takes years to become competent at what I do. And trust me on this one, some very bright people never learn how to write well.

    I’ve worked with experts in a wide range of disciplines, and with medical researchers working on topics that literally range from head (alopecia) to toe (nail fungus) and everything in between. I’ve found you can divide these folks into two major categories: 1) those who can write well but don’t have the time; and 2) those who can’t write well but don’t have the time.

    I once spent several weeks in-house at a major pharma company working with their medical research team and their clinical trial investigators in putting together a series of abstracts for an International AIDS Conference. The abstracts as a package detailed the first effective use of combination therapy, representing a substantial improvement in patient welfare. The deadlines for such conferences are “hard” deadlines. Would you have the pharma company miss the deadline for some of the abstracts? Have some accepted and others rejected because they made no sense? Have the data misrepresented?

    What we do as a profession matters. Of course there is a continuum of skill, expertise, and (sadly) ethics. Just as there is a continuum of skill, expertise, and ethics in every profession. But one does not judge all financial advisers guilty of fraud because of Bernie Madoff.

    I will invite you to look at the American Medical Writer’s position on researchers working with medical writers appropriately: http://www.amwa.org/default.asp?id=308. As well as this article published in Chest on the subject (pdf). http://chestjournal.chestpubs.org/content/130/3/921.full.pdf.

    And now, back to my nearly full plate…

  21. kleenhed says:

    It’s information like this that makes laypeople wary of the medical industry in general. I have recently pointed a friend to this site to get him to reconsider his staunch anti-vax position. He’s a real conspiracy-minded individual. I can only hope he stays on those pages and doesn’t ever see this one, or he surely won’t ever trust anyone in the medical profession again!

    Also, JMB’s statement about getting out of academia because he “…was told my research in computer aided diagnosis wouldn’t attract any industry money to the department (didn’t use any expensive drugs or equipment, what marketing department would pay any attention?)”………???? That’s disappointing. How much great work doesn’t get pursued because there isn’t any money in it? (Don’t answer that, it was a rhetorical question).

    I think that sums up why some people (even smart ones!) still have a little faith in what you guys call woo or CAM. I think the sentiment is… maybe there is some value, but the studies haven’t been done because no one can make money off of it.

    Just my (untrained, unscientific) two cents.

  22. Xplodyncow says:

    KevinK said:

    The solution offered, including by you — that all researchers/experts/thought leaders should be responsible for all of their own writing from blank page to published piece, with some sort of governmental oversight imposed to enforce such a restriction — is impractical at best, laughably naive at worst.

    I’m new to the medical writing/editing profession. I agree there is definitely a need for intelligent, talented medical writers.

    But is there a need for ghostwriters in medicine?

  23. Scott says:

    KevinK,

    As I read it, the solution being offered is that those who write significant parts of the manuscript should be listed as authors. Banning ghostwriting doesn’t mean that the scientist must write every word; it just means that it must be clearly documented who did.

  24. JMB says:

    @kleenhed

    I abandoned academia, not SBM. I had a greedy chairman, not all department chairmen were so greedy. The majority of the scientific medical literature will still withstand the test of time. Even most of the articles published in my old academic department will withstand the test of time, in spite of the pressures. Profit incentive and publish or perish syndrome are just confounders in the assessment of the scientific literature. SBM does require constant self criticism in order to improve. Advancement of science is aided by the constant debates about scientific validity. CAM has not advanced by self criticism or debates of scientific validity.

  25. windriven says:

    @Karlwithakay

    Libertarian lawless. Libertarianism anarchy.

    Libertarianism depends heavily on the rule of law. No libertarian would argue in favor of deceit as a valid marketing tool.

    Libertarians believe in broad freedom to conduct their lives and pursue their economic interests. Libertarians also believe that all freedoms come with deep and inescapable responsibilities. There is nothing in libertarianism that condones licentiousness.

  26. windriven says:

    @Karlwithakay

    My post failed to show opposing greater than and less than symbols. My point was that libertarianism is not anarchy or lawlessness.

  27. Calli Arcale says:

    FYI: the greater-than/less-than symbols (also called angle brackets) don’t show because of their use in HTML — they are special characters, and this blog permits us to use some HTML, so angle-brackets are tricky. One solution is to use these representations (to make them display, I’ve inserted spaces):

    >
    & g t ;

    <
    & l t ;

    See also:
    http://www.utexas.edu/learn/html/spchar.html

  28. windriven says:

    @CalliArcale

    Thank you for the instructions and the link. This happened to me once before and, having the attention span of a three year old, I got distracted before searching out the correct syntax. Now I’ve no excuse.

  29. weing says:

    I think the take home message should be “caveat lector”. This is just pharmaceutical marketing. I believe it actually goes much deeper than just this. Take any medical journal, NEJM, JAMA, etc. and you have to wade through advertisements of pharmaceuticals to get to the articles. Don’t tell me that this does not affect the editorial decisions of which articles get published, without giving evidence that the authors and editors are immune to marketing.

    Heck. If a note pad or pen with a drug name is able to influence my prescribing habits, how much more can millions of dollars in advertising revenue do? What’s good for the goose is also good for the gander. I propose that all pharmaceutical and medical device advertising be banned from all medical journals. The journals can get just as good revenue from cigarette, gun, alcohol, cosmetic, video game manufacturers, and others.

    Short of that stick, with caveat lector.

  30. windriven says:

    @weing

    Caveat lector given lector latet?

    I will argue day in and day out for the right of commercial interests to flog their products in most any venue. But with rights come responsibilities and here the responsibility is to the law. Pharmaceutical companies must stick to the indications and dosages approved by FDA. Suborning others to evade these legal constraints is arguably criminal behavior and should be prosecuted vigorously. Further, those who hire themselves out in the furtherance of these schemes should be disciplined by their professional organizations.

    Prostitution is illegal in most jurisdictions.

  31. windriven, I think it’s a little difficult to define prostitution. (If it’s just the exchange of sex for money, take a look at some old marriage contracts. I saw one from the 70s that was very explicit: I will buy you a house worth x and furniture worth y and in exchange you will bear and raise my children. I suspect that many continue to be written this way.) Instead, most jurisdictions penalize soliciting and “living off the avails,” or pimping.

  32. windriven says:

    @Alison Cummins

    “I will buy you a house worth x and furniture worth y and in exchange you will bear and raise my children.”

    Wow, that’s so romantic it brings tears to my eyes! But there should be an escalator clause in the event that more than two children are born; maybe z worth of SUV?

    I guess at a minimum the pharmas could be cited for soliciting ;-)

Comments are closed.