In the days before television and other devices, some satirists used the comic strip for their commentaries – none more effectively than Walt Kelly who drew Pogo. Pogo possum and Kelly’s other anthropomorphized denizens of the Okefenokee Swamp delighted us with political satire and commentary on the human condition for a quarter century. There was only one character, Pup Dog, who remained on all fours as a playful puppy and only said "wurf." But there was a period, where he said, "Poltergeists make up the principal type of spontaneous material manifestation" – a nonsense Tautology that translates to "ghosts are ghosts."
To be honest, these short term clinical trials don’t really need much writing by anyone at all. Some simple tables would do just fine: a list of the primary and secondary outcome variable defined before the study started with their results; the subjects’ demographics and drop-out rates; some comparative tables of adverse events; and a special table for severe adverse events. Write a few sentences at the end summarizing the conclusions. How their assertion that "In fact, the contributions and expertise of medical writers working with authors is associated with more complete reporting of the results of clinical trials and higher quality content" fits into that is unclear [and highly unlikely]. The notion of the hired-on ghostwriters and the hired-on KOLs working hand in hand to produce a value-added article is a fabulist scenario. Neither has seen the data or run the numbers, so the whole picture they’re painting in their response to Matheson is a fantasy. We have a few opened windows into the ghostwriting process via subpoenaed internal emails and documents from various lawsuits. The general pattern is for the ghostwriter to get some kind of summary document from the Sponsor to turn into a first draft. After it’s tweaked by the Sponsor, it’s cleared for the "authors" to take a look at – hardly the royal road to "higher quality content."
"ISMPP’s long-standing position is that “ghostwriting” – defined by Laine and Mulrow in 2005 as individuals who wrote the paper but are not acknowledged’ – is an unacceptable practice…"
"ISMPP fully supports the role of professional medical writers and the complete and transparent disclosure of their involvement in medical publications and the source of their funding."
"… My analysis shows, however, that modest transparency and small print disclosure, while better than nothing, paradoxically provides an apparatus for subtle misattribution, concealment and spin. My article discusses this as a cultural problem within medicine for which many stakeholders are responsible. It is important not to lay the blame at industry’s door alone. As Stretton rightly points out, it is journals that make authorship rules, and decide how disclosures should be presented to their readers. Table 2 of my article provides some useful suggestions to the editorial community."
"More importantly, however, while I applaud Stretton’s and Weigel’s commitment to transparency, I remind them that the publications trade remains unacceptably secretive. Numerous articles are produced for journal publication every year, scientific platforms and publications plans are developed, academics are recruited to participate as authors, trade writers draft manuscripts, and substantial payments pass from corporations to agencies, but little of this activity is in the public domain. Indeed, the process has been characterized as ‘ghost management’. Commercial secrecy has no place in an open scholarly discourse…"
This affirmation of continued commercial secrecy on these aspects of medical journal literature – made directly to the medical community itself, in a leading medical journal – will be of broad ethical and policy concern. The joint statement ends by claiming the trade has been “working towards” transparency and disclosure for 15 years. There is clearly a long road yet to travel…
I wonder how much of the government’s high carb low fat food pyramid was ghostwritten by the processed food industry. Anything less than “all” would surprise me:
http://jamanetwork.com/journals/jama/fullarticle/2564564
Let’s all remember what “settled science” this all was at one time and how much Atkins was ridiculed.
The harm this did to American health greatly eclipses that of any pharma-KOL scam except possibly the opioid epidemic. (Lower number of victims, but greater devastation).
Dr. O’Brien – Your point is well taken. But I see similar comments – here and elsewhere – “this is a general problem, not specific to psychiatry (or to medicine).” That is worth noting, but also has a whiff of excuse about it. If a general problem occurs in our domaine, we need to fix it.
I agree about the food pyramid – and that’s just for starters: even a low carb diet, selected from most super market shelves, is not very good for us. I love Michael Polan’s characterization of most processed foods as “food-like substances.”
I didn’t mean it to carry that implication, and I wish we were bucking the trend. Psychiatry is probably a bit worse than more physical sciences, in fact, because the concepts are operational, and I am increasingly convinced many academics don’t even know that that means. I’ve read articles from supposedly highly respected psychiatric academics and KOLs who clearly don’t get concepts such as reliability vs. validity, and illness vs. disease.
Many thanks for these very interesting (and funny) reflections on the debate in the BMJ. Just a couple of points:
1. This joint statement by the trade associations really is pretty unique, and because it is made in response to a list of requests, it must be viewed as ducking them. In fact I suspected when making these requests that the ghostwriting companies might find them hard to meet, because they are (a) culturally inured to secrecy and (b) bound by contractual confidentiality to their Big Pharma clients. I wondered if they would admit to their own contractual obligations, or at least express an aspiration to greater openness on these critical issues, but of course they did neither. The whole exchange revealed in an unprecedented manner just how opaque the entire trade publications is, despite its claims to “transparency”. And the goal of it all is to make money by getting drugs into patients. So this exchange was important, both to ethics scholarship and I hope, for policy if ever lawmakers look at this .
2. Most writers have PhDs and are very smart, and need to be smart to write or edit this kind of scientific/commercial text, but the key point about them is that they are a marker for the publications machine, which involves (a) specialist agencies – which are experts in scientific marketing, not just writing – and (b) various personnel within the corporations. An enormous effort is put into planning and developing these publications. I personally think we need to think in terms of corporate authorship both of publications and trials.The challenge for journals is how to attribute these articles so that readers immediately get that they’re company productions. Right now journals are grossly failing in their responsibility to do this.
3. One of the key themes of my BMJ piece is how this trade sector, whose primary expertise, to reiterate, is in marketing, have been retasking exactly the same set of techniques they use to sell drugs to justify their own publications practices to an increasingly skeptical public. The attempt to redefine ghostwriting is an example of this “ethics marketing” and has drawn upon similar techniques to those used in “disease mongering”. It has, unfortunately, been very successful. It is almost second nature for us to think that ghostwriting is to do with disclosure not authorship, but this is in fact a heavily promoted, and initially plausible narrative. It’s only when we think in terms of the likes of Study 329 that we see it’s a nonsense. But anyway, the important point is that ethics is not safe or unsullied. It is commercially important, and commercially targeted, which means that ethicists, editors and policymakers really need to check their assumptions..
Thanks again for a fascinating commentary!
There is a very interesting parallel between this and legislation being written by lobbyists…an intersection of laziness and log-rolling… there are no conflicts of interest anymore, only synergies, as Jack Grubman once noted…