A philosopher’s take on Big Pharma marketing

You may not expect to find an ivory tower academic whose erudite specialty is philosophy hanging out at drug marketing conferences, but that’s where you would have found Dr. Sergio Sismondo a few years ago. The professor of philosophy at my old stomping ground, Queen’s University in Kingston, Ontario, turned up at the annual meeting of the International Society of Medical Planning Professionals, one of two large organizations representing medical communications firms.

A medical communications firm is a business that sells services to pharmaceutical and other companies for “managing” the publication and placement of scientific research papers for maximal marketing impact, often  running a full publicity campaign to help sell the drug being “studied”. This is an alarmingly widespread practice in which drug companies essentially decide what your physician will end up reading in medical journals. 

For example, Dr. Sismondo describes the practice like this*:

“Roughly 40% of the sizeable medical research and literature on recently approved drugs is ‘ghost managed’ by the pharmaceutical industry and its agents.

“Research is performed and articles are written by companies, although apparently independent academics serve as authors on the publications.

“Similarly, the industry hires academic scientists – termed Key Opinion Leaders – to serve as its speakers and to deliver its continuing medical education courses.

“In the ghost management of knowledge, and its dissemination through key opinion leaders, we see the pharmaceutical industry attempting to hide or disguise the interests behind its research and education.”

He added that major medical journals commonly reject 90% of more of all scientific research papers submitted for publication, while several top medical communications companies claim an 80% success rate with the industry-funded manuscripts they submit to journal editors.

So imagine that you’re a pharmaceutical company who’s keen on getting a favourable study about your drug published in a big name medical journal. You may well be tempted to bypass that ploddingly old-fashioned scientific research tradition in favour of funding your own studies, cherry-picking the most favourable results of those studies for publication (what’s known as selective outcome reporting), convincing willing academics and physicians to fraudulently lend their names as the study authors, and then hiring a medical communications company to “ghost manage” the whole process for you.

And that’s pretty well what most savvy Big Pharma marketing departments  do.  For example, Dr. Sismondo offers this chilling illustration of how it works (or, if you’re a patient, how it doesn’t work):

Research has shown that pharmaceutical companies systematically failed to publish negative studies on their SSRIs, the Prozac generation of antidepressant drugs.

“Of 74 clinical trials, 38 produced positive results and 36 did not: 94 per cent of the positive studies were published, but only 23 per cent of the negative ones were published, and two-thirds of those were spun to make them look more positive.

“Physicians reading the scientific literature got a biased view of the benefits of SSRIs. This helps to explain the huge number of antidepressant prescriptions, in spite of the fact that, according to a meta-analysis in JAMA in January 2010,  for 70 per cent of people taking SSRIs, the drug did not bring more benefits than a placebo.

“Compared to placebo, however, SSRI antidepressants can result in serious adverse drug reactions.”

Physician Dr. Howard Brody is the Director of  the University of Texas Institute for the Medical Humanities, and holds a PhD in philosophy; he’s also the author of the intriguing book called Hooked: Ethics, the Medical Profession and the Pharmaceutical Industry. The self-described “pharmascold” has written about Dr. Sismondo’s work, and adds his own unique perspective on this industry practice of ‘ghost management':

“Many pharmapologists accuse pharmascolds like me of creating a straw man argument when we talk about ‘conflict of interest.’

“They claim that, after all, we are here dealing with scientists doing science. All human beings have various biases and prejudices that influence how they think and act.

“But the norms and methods of science are designed to transcend those personal quirks and assure that the outcome is valid and objective.

“The point I take away from Dr. Sismondo’s discussion is that whatever the rest of us may think about conflicts of interest and science, when one reads the internal documents of the drug industry and attends industry conferences, it’s quite clear that ‘interest’ describes exactly the way the industry thinks and behaves.

The drug industry believes that they’ve bought and paid for the science and the scientists, and therefore they can expect the scientists to dance to their tune and the science to translate directly into sales and profits.”

He also shares Dr. Sismondo’s conviction that the industry knows that if it wants to sell drugs using science, it has to go to great lengths to disguise this ‘interest.’

That’s why drug companies value their paid KOLs (Key Opinion Leaders) and the entire ‘ghost management’ process – precisely because other doctors can easily be made to believe that what they get from these sources is disinterested science, and not industry interest.

The reality of these paid KOLs (or “thought leaders”) is fascinating. ** (See also: “Is Your Doctor a Thought Leader?”)

Essentially, these are physicians or university academics who are seduced by drug or medical device companies to help shill their products.  Medical communications conference attendees even spend time discussing how to best manage their stable of physician-scientist KOLs.

One KOL, for example, is Dr. Michael Thase. He told his conference audience how difficult it had been for him while serving as an expert witness in a court case when the attorney for the opposing side hit him with documents describing the drug company’s “individual management plan” for him.  Thus, he said, it’s problematic when drug companies talk about “managing” the KOLs on their payroll. His presentation apparently led to a long discussion of semantics in which phrases such as “opinion leader engagement” were tossed about. Dr. Sismondo noted that there was a lot of debate on what to call this behaviour, but no one apparently suggested actually changing the behaviour itself.

(By the way, Dr. Thase knows more than most what it’s like to be on the take from Big Pharma: according to his Integrity in Science conflict of interest disclosures, this University of Pittsburgh psychiatrist has disclosed receiving cash payments from what looks like a Who’s Who of drug companies including Bristol-Myers Squibb, Forest Pharmaceuticals, Glaxo-Wellcome Inc./Cerenex Pharmaceuticals, Eli Lilly, Merck, Organon, Pharmacia & Upjohn, WyethAyerst, Parke-Davis Pharmaceuticals, SmithKline Beecham, Solvay Pharmaceuticals, Cephalon, Cyberonics, GlaxoSmithKline, Novartis, Organon, Pfizer, and Wyeth. One might, in fact, wonder if there exists a drug company that Dr. Thase has not yet agreed to take money from?)

Dr. Brody adds that there is much talk at these medical communications meeting about the topic of ethics.

“But it’s not the sort of ethics I learned about in philosophy grad school, but rather a corporate-compliance model of ethics: just tell us what the rules are and then leave us alone to get about our business.

“The possibility that ‘ethics’ means that this business should not be conducted at all was not, apparently, an acceptable answer.”

Dr. Sismondo describes the most intriguing presentations at the medical communications meeting he attended. These were from the actual real-life editors of the medical journals who publish these industry-funded research papers. This was their message to the anonymous medical writers who create the journal articles that other people will attach their names to:

  • We are shocked, shocked that you people would ever turn to underhanded things such as ghostwriting.
  • We really want you to send us your papers to publish (and just look at the impact factor numbers showing that my journal is the best one in which to place your articles!)

Medical journal editors, it is widely presumed, will further admit candidly that with all the dreck they have to read that is spewed forth by academic physicians who have no writing skills whatsoever, it’s often a great relief to turn to an article written by a commercial medical writer who actually knows how to put sentences together.

Here’s how Dr. Sismondo summarized the current state of affairs:

“In the ghost management of medical research by pharmaceutical companies, we have a novel model of science.

“This is corporate science, done by many hidden workers, performed for marketing purposes, and drawing its authority from traditional academic science.

“The high commercial stakes mean that all the parties connected with this new science can find reasons or be induced to participate, support, and steadily normalize it.”

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See also:

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* Sergio Sismondo. Corporate Disguises in Medical Science: Dodging the Interest Repertoire. Bulletin of Science, Technology & Society December 2011 31: 482-492, December 15, 2011 doi:10.1177/0270467611422838

** KOL = Key Opinion Leaders:  A KOL (aka “thought leader”) is a well-known medical specialist, highly regarded by peers, who can influence other physicians, and who has experience with the drug/device/product. Thus the KOL is defined by being able to act as a mediator between companies and physicians. In practice, the term is only applied to specialists who are already financially enmeshed in relationships with pharmaceutical companies, not to fully independent specialists who merely have the potential to mediate.

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11 thoughts on “A philosopher’s take on Big Pharma marketing

  1. Ghost writing happens in most professions, even judges often rely on law clerks or winning attorneys to write the “opinion”, however the signature author must bear the responsibility for what she/he is claiming as their work.

    It is ridiculous that someone would put their license on the line to claim work they haven’t even read or are familiar with…happens – you are doing a great service exposing this.

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    • Thanks so much for your comment. The difference between judges and doctors who each use ghost writers might be that a third party (let’s say, a drug company) doesn’t stand to gain financially based on what a judge’s clerk writes. But both the doctor claiming to be a study’s author and Big Pharma make big money off their hired writers.

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  2. As expected from this blog, this is an excellent expose of BigPharma power over data dissemination.

    I support most of your points but I may take a different view in your description of publication bias. Your blog points an accusing finger at BigPharma for “selective outcome reporting,” which I do not doubt occurs just like you described; however, I am not certain this behavior is solely, or primarily, an outcome of BigPharma manipulation.

    For example, in an attempt “to evaluate the extent to which the medical literature may be misleading as a result of selective publication of randomized clinical trials (RCTs) with results showing a statistically significant treatment effect” K. Dickersin and associates [Clinical Trials 8:343-353 (1987)]] concluded that “non-publication (of negative results) was primarily a result of failure to write up and submit the trial results.”

    The authors go on to state that “Negative trials … may be submitted for publication less often or rejected more frequently because the authors or editors do not consider the findings worthy of publication.” As Michael J. Mahoney has written (Cognitive Therapy and Research, Vol. 1, No. 2, 1977, pp. 161-175) publications are “biased against manuscripts which reported results contrary to their theoretical perspective.”

    I believe the points brought out in this blog are valid and of grave concern, but so are the epistemologic constraints in the scientific community.

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    • Thanks Dr. H for your comments here. It seems that journal editors are less likely to engage in publication bias against negative outcomes of studies submitted. For example, Dickersin later wrote in JAMA: “We are unaware of any evidence that editors are more likely to publish studies with positive results”, which supports your observation that negative studies may indeed be submitted less frequently – as opposed to being submitted but rejected by journal editors (which seems to contradict Mahoney’s 1977 theory).

      But this still leaves us with the disturbing and well-documented prospect of industry-funded studies that deliberately cherry-pick trial results for submission so as to present their drugs in the most positive light in order to maximize sales (e.g. Danish study from Chan et al published in JAMA 2004 suggesting “50% of efficacy and 65% of harm outcomes per trial were incompletely reported in journals”).

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      • Carolyn, Gwendolyn B. Emerson and co-workers tested exactly the query you are posing. In a sense you are questioning if there is any validity to the claim that journal editors have a bias against negative outcomes studies. The investigators concluded that a “Positive-outcome bias was present during peer review. A fabricated manuscript with a positive outcome was more likely to be recommended for publication than was an otherwise identical no-difference manuscript.” (Arch Intern Med. 2010;170(21):1934-1939)

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          • Editors and those who perform peer review share epistemic values. Furthermore, my guess is that the way the term “medical journal editors” is used, specially when the concern is of “all the dreck they have to read,” it would be difficult to differentiate editors from members of the peer review faculty/staff.

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  3. Yes and no, Dr. H. Concerns about peer review have been increasing for years, as you know. Remember the 2010 open letter to major scientific journals from Drs. Robin Lovell-Badge, Austin Smith and 12 other stem cell researchers questioning the peer review process? They alleged that “a small scientific clique” was using peer review to block papers from other researchers, and that some reviewers are sending back negative comments, asking for unnecessary experiments to be carried out for spurious reasons, or intentionally hampering competitors’ work from being published in these high profile journals.

    Again, peer review isn’t the focus of this particular article on the influence of industry-funded medical ghost management – that other topic deserves its own airing!

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