Themes and reflections

Some themes in my recent work include:

1. Reinterpreting the interface between commerce and science in clinical trials.

2. “Attribution and disclosure bias” as a specific but overlooked form of bias in academic literature.

3. The critical, but overlooked, importance of reader’s perceptions in respect of attribution, disclosure, transparency and labeling.

4. Disclosures as a basis for unwarranted claims of legitimacy and transparency, while actually providing an apparatus for concealment and obfuscation.

5. Coordinated spin of content and attribution in contemporary marketing – this is more important than crude ghostwriting and guest authorship.

6. The critical importance of advocacy – i.e. subtle professional endorsement – in contemporary pharmaceutical marketing.

7. The “disposable author” – the idea that academics who work on industry projects are not necessarily “guest authors”, but that they are contingent and readily replaceable.

8. Defining ghostwriting. Far too many ethicists have inadvertently adopted industry’s disclosure-based definition, unaware that it has been vigorously marketed to them over the past decade.

9. The importance of “corporate display”. The attribution of industry-financed literature is carefully regulated, not to hide companies as “ghost” metaphors suggest, but rather to promote them.

10. The problem of “ethics marketing” – i.e. the application of drug marketing techniques, by the marketers, to ethics.

11. Cultural assimilation and merger, whereby the distinction between commerce and science gradually ceases to be apparent or even matter. This is industry’s greatest threat to academic medical science, constituting a greater threat than ghostly manipulation – although the two problems overlap.

12. Guidelines – I have analyzed the ICMJE Recommendations and industry’s “Good Publication Practice” guidelines in detail.

13. The moral culpability of medicine’s journals, editorial community and editorial policies for the commercial debasement of academic medical research and its published literature.

14. A preference for systematic analysis of publications as the preferred conceptual and methodological approach to publication ethics. This field of ethics has been held back by its predilection for metaphor-based thinking.

15. Solutions – I support the “sequestration thesis” – i.e. the complete separation of the commercial development of drugs by companies from their clinical evaluation, which should be done by independent academics – but in its absence, I propose a variety of solutions. Perhaps most notably I argue for the replacement of small-print “disclosure” with prominent commercial notification  and labelling, or by segregation of this literature into separate commercial journals or sections, such that it is perceived by readers from the outset to be commercial in character.

Some more detail, and some other reflections, not all of them serious, follow alphabetically:

Advocacy

In pharmaceutical marketing, “advocacy” means using respected doctors and academics to endorse your product, your research and your company. Advocacy is probably the single most important practice in the marketing of drugs to prescribing doctors, Advocates are assiduously recruited, groomed, evaluated, catalogued, developed, deployed and spoiled by companies, who grovel, fawn and flatter to enlist and retain their services – although if they don’t deliver the goods, they will be discarded. Some of these academic recruits are classed by companies as “rising stars”, whose careers will be assisted by the opportunities and connections industry patronage brings them. Others are already “key opinion leaders” or KOLs. They love the way the companies show them respect.

Professional academic medicine embraces advocacy and thrives on it, as do its journals. Both are responsible alongside the marketers for the cult of advocacy.

And now there is a new form of advocacy emerging. Some journal editors have unwittingly become KOLs for the publications/marketing trade. They have been courted and used as opinion leaders in the trade’s efforts to convince the world its practices are ethical.

Attribution

Attribution is an act of structured communication telling the reader who did the work placed before them. Attribution is about much more than authorship. The number of authors and their sequence, contributor listings, acknowledgements, the title, disclosures and labeling all contribute to the overall attribution of an article.

The terms “attribution” and “credit” overlap, but attribution is more neutral, and more centred on the mechanics of communication. Good attribution ensures that all aspects of finance, planning, composition and function are communicated to readers in a balanced way. Good attribution takes account of what readers perceive, and ensures that the true provenance of an article is faithfully represented, such that what is most essential is brought to readers’ attention with the greatest prominence.

Attribution is subverted by spin. This may involve authorship, author ordering, vagary, euphemism, omission, weak labeling and small print. During the development of some industry literature, stakeholders in industry and medicine work together, often with the acquiescence of journals and the assistance of editorial guidelines, to misattribute journal articles, aggrandizing the role of academic authors and underplaying that of companies. Everyone benefits – except readers and patients.

It used to be thought that marketing worked in journal literature though ghostwriting and guest authorship. That is true, but crude ghosting and guesting are a special case. The more general case is one of coordinated spinning of content on the one hand, and attribution on the other.

Attribution needs an overhaul. It needs an overhaul by journals, and also by indexing systems, notably the National Library of Medicine. The CREDIT initiative is a good step in the right direction, but has yet to take into consideration commercial roles, the problem of balance and conspicuity, and marketing spin.

Attribution is a major theme in my published work. The writings of David Resnick, Drummond Rennie and colleagues at JAMA, Richard Smith, and Nicholas Fotion in the 1980s and 90s are some notable precursors to my own.

Attribution and disclosure bias

I have recently argued that attribution and disclosure distortion and spin, which maybe both unconscious and deliberate, should be considered an important form of bias in its own right. See also “design bias”.

Authorship

Authorship is a preoccupation of editors and ethicists. In fact they should be more concerned with attribution (qv). But inevitably, a lot of my work has addressed issues of authorship. For instance:

1. Companies themselves have an authorial role in trials and the articles that report them. They are corporate authors, and because this is not adequately attributed, whether on the author byline or in the title of the article or some other form of prominent labeling, they are corporate ghost authors.

2. Many academics recruited into industry projects are disposable authors (qv).

3. I argue that writers who compose or modify substantial passages of text should be coauthors, or not used at all. Otherwise they are ghosts.

Blame

Who is to blame for the excesses of pharmaceutical marketing in science and academic medicine? Sometimes people like to say it’s all pharma’s fault, but no. The marketing and commercial publications agencies, publishing companies, journals, editors, certain editorial societies, and droves of doctors are just as responsible. They are all in it together.

My work falls into the category of criticism which emphasizes broad, cultural culpability rather than focusing on pharma alone. Carl Elliott, Trudo Lemmens and David Healy are among the many writers who have taken a similar perspective.

Cash disbursements

In my Empirical Investigations, I used data from Propublica’s “Dollars for Docs” resource to map cash disbursements to academic authors of industry publications. I found that authors were not paid directly for being authors, but the majority of them were mired in cash relationships with pharma, often involving many companies.

Cash disbursements are not merely a sign of potential inducement. They are also a marker for relationships which may influence prescribing behavior in other ways; and at a more strategic level, they help characterize the overall “footprint” of pharma within medical culture. In my investigations, I found a very broad footprint consisting mainly of modest payments, with higher payments to a smaller number of doctors and very high payments, principally for “research”, to a small, privileged minority.

Congress

In Nicholas Pileggi’s script for the movie Casino, Robert De Niro’s character “Ace” Rothstein describes Las Vegas:

This is the end result of all the bright lights and the comped trips, of all the champagne and free hotel suites, and all the  broads and all the booze. It’s all been arranged just for us to get your money.

Many major medical society congresses throb with pharma activity. Corporations with drugs to sell in that area of medicine have enormous glitzy booths in the industry exhibition hall. They are allowed to put on “satellite symposia” around the main programme to market their drugs. They finance numerous presentations of their clinical trials data within the main programme,  either as spoken presentations or posters. In some cases they help fund the meeting. Thousands of doctors are flown in by the companies and accompanied by their sales reps. The companies also pay for lavish hotels and lavish food. Reps and doctors drink together in the five-star hotel bars, and the reps pick up the bills. The companies fund daily tourist excursions for the doctors – congresses are usually in famous old cities. Grand gala dinners are held in the evenings, with top KOLs speaking as mille feu is consumed round flower-bedecked tables. I sat next to a psychiatrist at one such feast, in New York, where shiny leaders of the field explained why the company’s antipsychotic was the one to use. But it was the third gala I had been to at that congress alone and the competitors had used their own KOLs, sometimes even the same KOLs, to say it all before for their own brand. All I really remember of that particular evening now was the enormity of the diamond on the finger of the thirty-something psychiatrist beside me, who was married to a “rising star” cardiologist, just beginning to give this very sort of talk himself, she said proudly. The gem glinted in the spotlights from the dais. It really was – almost – as big as the Ritz.

The congresses are also important places for companies to meet. The marketing and medical affairs departments from the corporate HQ may be represented in strength, and will meet with colleagues from individual countries to  plan strategy. Sometimes they hold sales force meetings too, since so many reps show up. Companies may also hold “advisory boards” where they consult with their top academic KOLs, most of whom will have been flown there from their home countries. The really top KOLs are sometimes accommodated in the most exclusive of all the hotels, as are the most senior company executives, where there they can hobnob together like Olympian gods.

Meanwhile, at the congress itself, the keynote speakers and top members of the medical society running it sometimes have larger, fancier identification badges that set them apart. They carry themselves grandly. As some congresses I have been to, there are sections of building and corridor where only those with these special top-status badges can go. The culture of hierarchy, privilege and authority is stamped on the congress and its attendees through both plumage and geography. Needless to say, the grand eminences of the societies with their grand badges and segregated spaces are often top industry KOLs, the “friends” (qv) of many companies and well used to industry patronage.

It is sometimes said the true top people in medicine, the real brains and pioneers, rarely involve themselves in all this ermined vulgarity. I don’t know how true that is – in fact, I rather fear it is true in part only – but it is a pleasing notion, and it calls to mind a passing moment in, I think, the late 1990s, at a congress I attended in Barcelona.

At least, I think it was Barcelona. I went to so many congresses back then that they tend to merge in the memory. I am pretty sure, though, that it was a transplantation medicine congress, or else a liver disease congress. Needless to say, every drug company that made an anti-rejection drug was there, and had flown in doctors, with each country’s cohort attended by its own coterie of sales reps and local executives. The KOLs were on parade too, although it has to be said that the liver and transplant KOLs were a bit different to those in some other branches of medicine, in that I found them to be more like everyday people. I saw them quite often, and remember bunking out of swanky Chicago dinners with them to grab a deli in the Loop, and having real conversations about nothing to do with medicine.

I must also defend the pharma companies who work in this branch of medicine, because their antirejection drugs really are life-savers. So too are many liver disease drugs, notably the new antivirals that have emerged during the past decade or so. This, so to speak, is good pharma (qv) – or at least, it would be were it not for the immorally high prices of many of these drugs. One might conjecture that congresses are worse when the drugs are for modest risk management, when there is a plurality of me-too products, and where there is a blockbuster market to fight for. Here in liver disease and transplantation things are a little different, because the drugs work, and top doctors and manufacturers  work closely together to refine their use. And yet for all this, marketing is still important, and still runs by the standard playbook. Companies with competing products duke it out to build their markets, to prove their drugs the best, and to get the KOLs on their side.

Which brings me back to my anecdote. That day in Barcelona, I was with a group of four or five marketing company and Medical Affairs executives in one of the main congress halls when they all suddenly fell quiet and looked on as someone walked by. I followed their gaze, but could see nothing but an unassuming, bespectacled man, somewhere in his sixties by the look of him, wearing a tweed Jacket, or perhaps it was a comfortable suit of the kind one might wear around the hospital, and carrying an old briefcase with a strap over his shoulder, making his way unconcernedly along without a hint of grandeur in his carriage. No KOL he, maybe a broadsheet journalist, I thought, or some everyman doctor, not one of the power-dressed elite.

I was still trying to understand why my marketing colleagues had gone quiet at the sight of him, when I noticed a strange, collective glint in their eyes. At that moment it made me think of adolescent boys gazing on an unattainable beauty; but afterwards I thought of dogs –  domestic dogs ruefully eyeing something delicious they know they cannot have, but also dogs eyeing some quarry together, with the mentality of a pack. And I found myself thinking that while regular doctors came to these congresses to learn a few things and perhaps have a bit of a junket, and while KOLs and society heads came sometimes for serious science, sometimes to parade their robes, we were there for red meat, there for the sale – not of the drug, but the idea, or for the reps, perhaps, that late-drink-in-the-hotel-bar bonding moment, the thought that would impel these people when we flew them home to make the buy. That was what got our juices flowing.

“Who is that chap?” I asked my colleagues, as they watched the man with the comfortable jacket and old shoulder-bag walking by.

“It’s Calne,” said one of them curtly.

“Eh? What, Roy Calne, you mean? Oh golly, you’re right, so it is.”

I recognized him now, from photographs in newspapers and the odd TV interview. It was that rare thing, a true great of modern medicine, the surgeon Professor Sir Roy Calne, a pioneer of liver transplantation, one of the few doctors whose name was known outside medicine.

“Well, what’s the problem with him?” I said. Looking at my colleagues’ faces, my first thought was that he must have been flown in, scooped so to speak, to the advantage of its drug, by a competitor. “Who’s he with?” I asked.

But no. The real problem was altogether worse.

“He’s with no one,” said another. “He flew in on EasyJet. You know – the budget carrier. Bought his own ticket. And if he’s staying anywhere in Barcelona – well, it’s not going to be five-star, I can tell you that.”

How they knew about the hotels I cannot say, but I remember the fleeting oddity of it all, the momentary sense that we were looking at something that should not be, a violation of the natural order. It was a peculiar feeling altogether, tinged for an instant perhaps with some kind of remote, passing embarrassment, or reflectiveness, about the difference between what medicine meant to Calne, and what it meant to us. But by then he had disappeared amid the criss-crossing suits, and no sooner had the sight of this unsettling, unassuming, unrivalled untouchable been taken from our eyes than the normal rhythms and salivations of congress life returned.

Corporate display

Some ethics scholars have emphasized how industry operates “behind the scenes” to control the information doctors see, and there is some truth in this. But the whole truth is more nuanced. Companies do not seek to be hidden entirely. Instead, they seek to be seen in the right way, to be perceived as the august supporters and colleagues of the academic medical profession, deeply respectful and deeply respected.

The attribution of most industry-financed journal literature therefore involves carefully crafted “corporate display” – the measured, regulated projection of the company as a trustworthy partner, endorsed just as the drug is by the KOLs who front the author byline, and the prestige of the journal.

Corporate science

This term has been bandied about for years to refer to big, bad science done by corporations for their own benefit. “Corporate science” was defined on the ever-trustworthy Urban Dictionary back in 2005 by user Omega Death as “See bullshit. It’s made-up nonsense, concocted by so-called ‘scientists’ and ‘experts’….” That same year, Philip Mirowski and Robert Van Horn used the phrase in Social Studies of Science to refer to industry science per se, as it had become mutated in the era of neoliberalism and corporatization. Theirs is a good paper and I think makes best use of the term. I published an article on “corporate science” in BioSocieties in 2008, using the term to refer to  a particular “mode” of science where research and discourse is organized to generate profit, with what counts for truth and knowledge assembled to that purpose. In 2009 Sergio Sismondo used the term more narrowly still, simply to refer to medical research subordinated to pharmaceutical marketing. By 2013, even Ralph Nader was writing about “corporate science” in the Huffington Post.

I like the phrase because it sounds creepy, but I don’t know exactly what it means and encompasses.

Cultural corruption, cultural  transformation, cultural merger

In my article in Medical Writing, I note that:

What Lessig would term “institutional corruption” occurs when commercial drives … deflect the scientific, clinical and publishing domains from their traditional goals. Because commercial forces reach across many institutions and discourses, however, “cultural corruption” is to be preferred to “institutional corruption”, although the latter term remains valid within individual institutions and discourses. Yet the term “corruption” does not capture the full range and subtlety of change wrought within science and medicine…. Perhaps the most troubling trend is best characterised not so much as a deflection, deception or corruption of traditional academic discourse but rather a gradual merger between the domains of commerce and medical science, generating a hybrid research culture…

The greatest threat industry presents to academic science and medicine is not external, ghostly manipulation, important though that is. The greatest threat is creeping cultural merger, such that the distinction between what is noncommercial academic science and what is commerce is no longer apparent, or even considered important. I discuss this in my recent Hastings Centre piece on “The Disposable Author.”

Disclosure

Editorial and marketing speak for a series of holes tied together with small print, vagary and euphemism.

A disclosure that nobody reads, because it is in fine print or vaguely worded, is a great place to put inconvenient facts, while claiming how ethical you are. This is a problem medicine’s journal editors have failed to grasp – but to marketers, the “disregarded disclosure” is a staple of the trade.

QV transparency.

Design bias

Subtly fixing the details of a clinical trial’s design to favour one comparator. This is the stock-in-trade of commercial trials. You can read about it in my Trials paper and the references therein.

The detailed work in this area gas been done by Peter Gotzsche, Joel Lexchin, Kay Dickersin, Lisa Bero, Vance Berger, Vinay Prasad and many others. Berger and Prasad have proposed the term “hard wired bias” for fixes of this kind. I prefer “design bias” but what is more important is that the trials community should give this form of bias a specific name – as far as I am aware, Berger and Prasad were the first to make this point.

See also Attribution and disclosure bias – a second species of bias which I think requires proper academic recognition.

Discourse

See my 2008 BioSocieties paper. Discourse is crafted by corporations with the same care and precision as knowledge and opinion. It is important to draw a distinction between discourse content, and discourse structure – both are crafted, moulded and manufactured by commerce.

Disposable author

A disposable author is one who is recruited into a project for their name, and whose  contribution is a contingent detail, such that an equivalent contribution could, and would, have been made by someone else had a different author been selected. Disposable authors are not the same as guest authors, since the disposable author’s contribution may be substantial. Another party, typically a pharmaceutical company, is the primary instigator and true lead author of the party, but disposable authors are positioned as if they were the leaders for purposes of endorsement. Disposable authorship and its corollary, corporate ghost authorship, are common vices in marketing-driven publication.

I tried a number of phrases for this concept. Others have presumably thought along the same lines, so do let me know and I’ll update this. I thought of disposable author, selling author, throwaway author, name author, junk author, contingent author and so on. It was Adriane Fugh-Berman who nudged me toward this particular phrase when she read it in draft.

Drug narrative

Problem/solution narrative in which the drug overcomes an “unmet need”. Like a virus injecting DNA into a cell, marketing injects simplified narrative structures, with superficially compelling logic, into the heads of its victims, to help make the sale. Often the narrative has a “feel good” nature such that by adopting it, the prescriber feels he or she is acting in a noble, helpful, intelligent way; but also, the narrative might merely provide the logical excuse for a prescription decision that is heavily driven by emotional factors, such as liking for a particular Rep or a desire to maintain industry patronage.

There is perhaps herein something about the basic human susceptibility to narrative, in the interplay of logic and emotion, that proves commercially useful. See my 2008 BioSocieties piece.

Recently, the marketing trade has also indulged in “ethics narratives” using the same template to sell its rebranded definition of ghostwriting. See my 2016 BMJ piece.

Editor in Chief

The medical publications trade has tried to raise standards during the last decade, by introducing publication guidelines, although in my opinion these have brought industry publications only a few steps down the long road to rectitude. But how often are even these current, commercially friendly standards attained?

Pretty often, I should think, especially in the large and established marketing firms that specialize in developing journal publications. After all, the trade standards are no barrier to marketing whatsoever, and staple marketing practices like advocacy, ghostwriting and publication planning are all fully supported.

I have had experiences, though, when these self-regulatory trade standards were paid little more than lip service, and treated as a nuisance. According to current trade standards, for instance, academic authors are supposed to “direct” the writers who compose the text, although of course the planners who are the true masters already know what sort of article they want. In 2011, I  developed an extended outline for a scholarly review which some other ghost, god knows who, was actually going to write. The editorial executive in charge of the project, who was of a sardonic disposition, told me that the academic author had already been selected, and consulted for his views by phone. He was one of those “busy” KOLs whom everyone in the trade has heard of, none other in fact than “the ubiquitous X Y” as my colleague put it – I cannot share his real name – who “must be a millionaire by now”, adding: “we have to do these calls with authors for reasons of compliance but they are always a waste of time.”

Well, that’s an example of lip service. But sometimes, I suspect, trade standards are overlooked entirely, more through lackadaisical culture than any plan to deceive. Here is an example, one that also illustrates the accommodating attitude of some in the editorial profession to all these marketing shenanigans.

The last manuscript I ever ghostwrote was in 2010-11. It was a review article for a medical communications company, which had a contract with a major corporation to market a cancer drug then in clinical development.

My personal contribution to this review article included: 1. revising the original brief – the original argued that the “unmet need” for these dying patients was a different molecular mechanism for constraining tumor growth, which I thought ridiculous – their unmet need was not to die; 2. determining the article’s overall content and conclusions; 3. writing a fully referenced outline; 4. writing the first and second drafts in full, including the Abstract and all references; and 5. conceiving, researching and drawing up two extensive tables. The invited author, with whom I never corresponded and whom I knew little about, also spent considerable time developing the piece on the basis of my text. No doubt others in the medical communications company and pharma corporation made their mark on the project too.

When the piece finally appeared in print, I noticed that some of the “unmet need” nonsense had found its way back in. Footnotes acknowledged pharma funding and “editorial assistance” from the project manager at the medical communications company. My own contribution went unmentioned.  The fact that the article was created to promote a drug was not disclosed. The medical communications company was an established one with an up-to-date code of conduct, was full of bright people, and was a supporter of the ISMPP trade association, which has been the prime mover in developing trade standards. The article was published in 2012 in a journal owned by a commercial publishing house and a member of the Committee on Publication Ethics. Its sole named author was the journal’s Editor in Chief.

Evolution of the marketing sector – research and legal implications

Since 2004-5, the marketing sector and the pharma corporations have been working overtime to clean up their act, transform their language and reorder their internal procedures and organization.

The way ethicists think about pharma is largely based on documents and scandals from before this hiatus. Following  its reorganization, pharma is now in a much stronger public relations position, and is more insulated and fortified against potential future litigation. Some of my recent work touches on this problem — for instance, the rebranding of ghostwriting is part of the industry’s retrenchment, and has been expedited with great success.

Friends

To me and to most people the word “friend” means, well, a friend. But in the Mafia movie Donnie Brasco, a “friend of mine” means a “connected guy” being introduced to the crew, and a “friend of ours” means a “made guy” – part of the trusted team.

This usage of “friend” is similar to the way some of my drug company colleagues applied it to doctors and academic medical researchers. We would refer to opinion leaders who could be relied upon as “friends”. What this meant was that they were friends to the brand – and yet at one and the same time, the relationship was felt emotionally. Product commitment from the academic elicited true personal affection from the company executives. People down on the sales force had the same feelings about doctors who prescribed large quantities of drug.

Yes, the doctors who backed our brands were our friends. Except, that is, for doctors whose credibility among their academic peers was low, but who were too ready to please us. Now and then some of us referred to these people as “tarts” – not too disparagingly, more with a certain wry affection. We liked them for sure, but true “friends” they were not.

The “tarts” faced something of a Catch-22. Their low standing with other academics derived not merely from the fact that they were not the brightest, but because their colleagues considered them “tarts” too. Such people could scarcely be “key opinion leaders.” To the contrary, their names could prove a liability when top-level endorsement was required for a publication. Consequently, we sometimes used them to author the greasier publications which more self-respecting academics would not touch. All of which led the hapless “tarts” to acquire a yet-more-questionable reputation. And yet if they stuck it out, who knew what persistence might bring?

Back in the 1990s and early-to-mid 2000s there was one particular academic medical researcher – let me refer to him as “Doctor X” – whose real name was a standing joke among us. Many were the cheesy articles to which he gave his time and name. Blimey, we would joke, who can we get to author this piece of [insert Joe Pesci expletive-laden-rant of choice]? Ah, yes… Doctor X.

Gamely he ploughed on. He was still going when I moved away from publication planning in the late 2000s. Then just recently, to my surprise and delight I saw Doctor X proudly billed as the lead author of a couple of prestige industry trials published in one of the higher ranking North American journals, none other than – well, I’d better not mention its name, either.

“Isn’t that just grand,” I said to myself. “Doctor X is a friend at last.”

Foucault

I use the Foucaludian term dispositif a couple of times in my work.

Much though I like Foucault, dispositif only found its way into my work by accident. My first article in this area, on “Corporate science” with all its talk of product dogmas, drug narratives, a quasi-Kuhnian “mode” of science and the like, had more than enough fruity terminology in it already. I submitted it to Social Studies of Science, but they rejected it, and BioSocieties was my second choice. Nick Rose, the editor, was a keen Foucauldian and one of the peer reviewers suggested the stuff about dispositifs. I groaned, but put it in just to get the article published. So my first essay came out in a weaker form, in my second-choice journal, more than a year after I first wrote it.

But it’s still a good essay; and in the end,  I like the dispositif stuff.

Gendered division of ghosts and guests

The majority of ghostwriters are women. The majority of KOL authors, and especially  lead and corresponding authors, are men. Sad, but there it is. See my Empirical Investigations.

Ghost metaphors

Ghostwriting, ghost authorship, ghost marketing, ghost management. Ethicists like “ghost” metaphors. I have jumped on the bandwagon too, by using the phrases “corporate ghost” or “corporate ghost author” to describe the failure to identify companies themselves as authors of journal articles and the studies these report.

Personally, though, I don’t like ghost metaphors much, and have criticized their use in my essay on The Disposable Author in the Hastings Center Report.

The good thing about “ghost” metaphors is that they draw our attention to the powerful forces manipulating scholarly literature from behind the scenes. The bad things about them are that (a) they are hard to define; (b) they focus our attention on secret plotting, when in fact public collaboration is just as important; and most importantly (c) they imply that academic medicine is the victim of all this ghostly planning and writing, when in truth medicine and its journals are in on the sin.

Ghostwriting, definition

A major issue for ethicists, academic medical centres, journals. Don’t be hoodwinked by the industry definition. Do you think ghostwriting is all about disclosure? If you do, you are being played by the trade, which has used similar techniques to those used in disease mongering to change how people think. See my 2016 article in the BMJ.

Good pharma?

I always make a point in my published work of emphasizing that pharma does a lot of good. There are many great and life-saving drugs and much important research. Even research into “me too” drugs is often valuable. If you were going to have an ACE inhibitor, would you prefer the first one to reach the market, the thrice-daily captopril, or a once-daily me-too drug like ramipril? That’s a valid choice.

I don’t consider myself a pharmascold, at least not with respect to research and development. I have met too many serious scientists and seen too much good industry science for that. Indeed, most of the people I have met in pharma and even marketing have been very nice, dedicated people, good scientists who care about people. Many of the ethical failings of pharma arise from the encroachment of the cultural norms of business into science and medicine. This is not a Hollywood movie and pharma is not Darth Vader. The problem is much more difficult, and insidious, than that. I discuss this in my 2008 BioSocieties piece.

I don’t consider myself a pharmascold; but perhaps I should; perhaps I do; I guess I flip-flop. Because of course the bad is all real: the distortions, deceits and lies of the trialists and marketers, the fatuous and misleading research, the depraved direct-to-consumer advertising, the intellectual debasement of medicine and its journals, the corrupting political power and reach of the corporations, the shameful pricing of the drugs, the burden on economies, the dead and injured bodies in rich countries and poor… how can one not condemn? And yet knowing the people, and seeing some good science, my feelings are conflicted.

Good pharma somehow needs to be rescued from bad commercial practices. I don’t see that happening unless neoliberal excess is supplanted by a more regulated form of capitalism, at least in the domain of human health. Possible, but unlikely. Still, I want my industry friends to think hard about what a truly ethical approach to clinical research, publications and marketing might look like.

Guidelines

David Healy’s wonderful book Pharmageddon has a chapter titled “Trussed in guidelines.” I wish I’d thought of that.

But if guidelines can be a dangerous thing in clinical medicine, they have serious pitfalls in publication ethics too. I have written two articles on the ICMJE Recommendations. I am also highly critical of the pharmaceutical publication trade’s so-called “Good Publications Practice” self-regulatory guidelines, known as GPP3. I know how hard their authors must have worked on them and they are good, smart people, but the bottom line is that publications following these guidelines would certainly not be good – except perhaps for marketing. I am happy to advise the GPP3 authors on how to improve them.

Integrity, scientific; misconduct, scientific

A system of concepts and practices designed to burn small-time crooks in the public square while letting corporations lie, rob and poison their way to riches.

See King Lear, Act IV, Scene 6:

“Plate sin with gold, and the strong lance of justice hurtless breaks; arm it in rags, a pygmy’s straw does pierce it.”

So-called “corporate integrity agreements” in the United States do no more than require corporations to be bad in a better way – for instance, by complying with the marketing-friendly ICMJE Recommendations.

Knowledge manufacture

This is something I looked at in my 2008 BioSocieties piece.

Kuhn, normal science, normative science, paradigm

Kuhn viewed the scientific paradigm as a necessary constraint on science, one that suppressed fundamental questions which might challenge the paradigm itself, but enabled detailed questions suggested by the paradigm to be investigated efficiently.

Commercial drug paradigms have important similarities and differences with paradigms as Kuhn understood them. I discuss this in my 2008 BioSocieties piece.

Mood Elevator

I found an old faded T-shirt in the back of a drawer. It had emblazoned on it “GET YOURSELF IN THE MOOD. RIDE THE MOOD ELEVATOR.”

It was given to me by a major drug corporation, back in the early 2000s when they were pushing their so-called “atypical antipsychotic” in bipolar disorder. But what exactly was the Mood Elevator?

Well, the company’s marketers had got hold of what appeared to be a converted flight simulator, and were taking it round the congresses. The idea was to “simulate” what bipolar was like. The contraption was about the size of a small ship container, hydraulic and programmed: you could see it rearing up and bucking about, somewhat on its own on the far side of the exhibiton hall, cordoned by ropes. But on closer inspection it wasn’t that great. I think perhaps it had been acquired from a fairground rather than Boeing or NASA, and had been got up to look “futuristic”.

Doctors were rounded up by young women in smart black business suits and ushered inside. We were seated inside in about 3 rows – the “flight capacity” was about 15 I think, but it was far from full. Then the lights dimmed and with a hydraulic whine and jerk the show began. Instead of a simulated flight on the windscreen at the front, they ran a cheesy movie in which we found ourselves inside the mind of a young middle class woman with bipolar disorder. Whoosh! and up we went, with accompanying dramatic music, to find ourselves looking out through her excited eyes as she flirted with a guy at a party… then crash… down we went into blue-lit, solitary despond… then whoosh! up we went again… “I’ve got a date with that gorgeous guy I met… at the laundromat…” she sighed…then crash! down we went into suicidal gloom. Finally we reached a happy equilibrium full of flowery feelings and a warm glow … how happy and relieved she was to have got treatment with the company’s product in time; how glad the sexual disease tests had checked out OK. She had been saved, saved, saved.

That was the end of the ride and we were turned out. We had “ridden the Mood Elevator.” I felt sick and wanted to chunder. But I got the T-shirt.

Paradigm, psychological aspects of

A “drug paradigm” is sustained by money. Once the drug comes off patent, or is superseded, or if it kills too many people and is found out, or when the company simply decides to spend its money elsewhere, the paradigm blows away like sand in the wind. This can be hard for the reps, the doctors, the marketers who sold their souls to the paradigm, and who sometimes were so committed they thought the scientific knowledge they were proselytising was eternal.

I remember the horror on a colleague’s face when it turned out the drug he was promoting was being pulled off the market because it killed people. It could not be true! He looked stunned, refused to believe it, and eventually, some two weeks later, began to grieve – for the drug, not its victims. I remember too how horrified another colleague was when Viagara came on the market. His whole working life had involved persuading doctors to teach men with performance anxiety to inject their penises with the company’s vasoactive drug. He refused to believe a pill could do the job. Never mind performance anxiety, the poor fellow looked like he had just had his schlong docked.

In correspondence, Steve Fuller made an interesting point about Schumpeter and “creative destruction” when one drug paradigm displaces another, which you can find in my BioSocieties paper.

Perceptions of readers

That means how readers perceive things, not how readers are perceived. It is a critical consideration for effective attribution, labelling and disclosure. Largely overlooked by journal editors and ethicists – to the great advantage of marketing.

Product dogma

Fixed set of scientifically-based propositions about a product upon which is differentiation and marketing is based. Closely related is the idea of a “product canon”, the set of core published texts on which the dogma and all marketing is based. See my 2008 BioSocieties piece.

Reasoning diagram

Flowchart isolating and comparing the key components  of a reasoning pathway or narrative. I use reasoning diagrams to deconstruct the marketing trade’s definition of ghostwriting in my BMJ paper.

Tool kits

I have used the analogy of a “tool kit” to describe the options available to companies when spinning the content and attribution of articles, such that commercially functional content is communicated by trusted academics. Marketers themselves do not think about tool kits, of course, they just think about spin, or more commonly, of nothing more than their normal way of doing things – bias is often unconscious. But the “tool kit” analogy is useful in that it shows a range of options are available for shaping literature, that these are functional, that these are used to variable degrees or not at all, and that they may be used to tweak and modify as much as to create. Marketing is a combination of grand plans and tinkering, and the same tools work for both.

Transparency

The art of saying as little as possible as vaguely as possible and as inconspicuously as possible, then shouting as loudly as possible about how ethical you are.

Journals and marketers are masters of transparency.

Ghosts are not invisible. They are transparent.

Truth and truthfulness

In my opinion, pharma science and academic marketing are vindications not of relativism, but of realism: of the possibility of scientific truth, and the possibility and importance of scientific truthfulness. But pharma science also shows that these concepts are attended by great difficulty, because it is often difficult to know where the truth lies, because bias is often unconscious, and because just as in noncommercial science, people have presuppositions, and commit themselves to beliefs on the basis of sentiment – all of which shapes what is often taken for objective truth.

Still, bona fide truth is possible. Or at least, if there is a spirit of truthfulness, it is possible to get closer to the truth, the whole truth and nothing but the truth. It is true that imatinib keeps many people alive for years who would otherwise die. It is true that rofecoxib kills some people who would otherwise live. A relativist cannot argue with a dead body.

Or then again, perhaps they can. I think it was David Healy who observed that scientific marketers are the ultimate social constructionsists. Sometimes, pharmaceutical companies bury the dead in the data if they block the Blockbuster Express.

I discuss the problem of truthfulness in my 2008 BioSocieties paper.

Wittgenstein

Ludwig Wittgenstein was my great uncle, though he died many years before I was born. My dad kept a whole crate of his notebooks in the garage for years. Then one Saturday some bloke called David Bloor or some such name turned up at the door with a thug sidekick he referred to as “Collins”. They wanted the notebooks. My dad told them to “sod off”. They said they’d be back. Next day my dad got the notebooks out of the garage and made a great bonfire out of them. We wrapped potatoes in tin foil and chucked them in the flames. Just as we were eating the potatoes Bloor and “Collins” showed up again.

Moral of the story – it would be better to use Wittgenstein’s work to cook potatoes than let the likes of Bloor and Collins get their hands on it.

(P.S. Strangers to the field known as “Sociology of Scientific Knowledge” will have to excuse my penchant for arcane and pretentious badinage.)

Zoology

Zoology is the best field there is. I love animals. I started life as a zoologist but gave it up when everything went wrong with my PhD. It was, I suspect, a not uncommon story: absent advisor, department in transition, deserted lab, no academic colleagues, no techniques to learn, non-university town, crushing isolation. At last I scraped enough barely meaningful data together to get an apology for a PhD and went to live in London. I never heard from my advisor again. I was shattered, I felt science was finished for me, although if only I’d not been so cut off, I’d have known it wasn’t too late to survive. As it was, the need to earn a living drove me to get a job and I found myself a medical writer in an oily marketing company. All the other writers were wretched souls too, who for one reason or another had fallen out of science. Many ghostwriters really do have a ghostliness about them. They have been coshed by fate and sit with their heads down, haunted by dead dreams of how they hoped their lives would be. In the end they just moulder away.

I love Drosophila melanogaster and Araneus diademata. I love zoology. I cannot think of zoology without love and sadness; and so I don’t think about it much. I think instead that while I might be an exile, ethics, science studies, commercial and cultural studies are great fields too, where I can do something worthwhile for science and medicine, and against their poisoners.