By the book

Some say that data produced by clinical trials comprise the most powerful marketing tools available to a pharmaceutical company.

If this is true, with a bright spotlight being pointed at pharma's promotional practices, and notably from both within and outside the industry, the judicious dissemination and delivery of key data-led messages has become critically important for today's multiplicity of global audiences.

With the intensification seen in recent years in the levels of scrutiny of industry-sponsored publications and the keen obligations upon pharmaceutical companies to be transparent in revealing their experimental results, no company can afford to overlook the value of a sensitive and carefully considered publication planning strategy.

A measured, intelligent programme needs, now more than ever, to ensure that key research reports and scientific papers are presented to and published within shrewdly selected journals providing maximum visibility and steadfast authority.

The latter point is particularly pertinent given today's watchful environment. The value of a strong evidence dossier which physicians can trust, and be seen to trust, and upon which they can base clinical judgement has become patent.

There are some prickly issues in this area, however, and pharma's challenge has been heightened in recent years as controversy has made keen watchwords out of `transparency', `vigour' and `credibility' in communicating research-led messages to an increasingly diverse array of decision makers. Authoritative, citable evidence is a cornerstone in growing brand value, and scientific publication opportunities today are akin to career advancement interviews; it's essential to prepare well and get it right first time, as there is no going back if an opportunity is missed or squandered.

Conflict of interest

The process by which scientific data is proffered by pharma companies for publication in esteemed biomedical journals has come under fire. Controversy has flared up fuelled by suggestions and perceptions of `misleading' practices, specifically procuring the paid services of professional `ghost' writers, and submitting what is deemed to be unbalanced or incomplete information.

Pharma companies are of course imbued with a plethora of benefits for achieving publication of data in prestigious journals. Consequently, insinuations that companies have been brazen in their attempts to persuade prescribers of the magnitude of new results has led the editors of several high-profile journals to protest that the industry was acting disingenuously, plagued by bad practice.

This seemed to climax, in the UK, in 2004/2005 when the government's Health Select Committee undertook a public enquiry into the potential undue influence of the pharma industry over prescribers, notably through its sales and marketing operations.

The problem with journals is that they are a great tool for marketing, editor of The Lancet, Dr Richard Horton, told the government. Citing the conflict that he felt exists between pharma companies and the big medical journals, Dr Horton unveiled evidence of specific incidences where he claimed firms had attempted directly to interfere with the supposedly impartial peer-review processes, thereby inappropriately trying to buy their way into The Lancet.

The Lancet has been offered substantial sums of money in exchange for publishing certain research studies, he noted. The mechanism of this intended exchange is commonly through the explicit promise by the company of a large order of commercial reprints in return - the invoice for such activities can exceed many hundreds of thousands of Euros for key papers.

During the peer review of new data for one COX-2 inhibitor, Dr Horton reported how a company had threatened to pull the reprint order on the basis of a leak that some reviewers had criticised the submission. He also described a separate incident whereby he had found `hidden' notes written from a supposed independent and impartial author to a pharma company requesting marketing approval for the paper. When the writers and paying company were challenged over this, the paper was dropped entirely, and never resubmitted.

Without greater scrutiny... the health of our population will continue to be put at risk by biased, over-interpreted and misreported research findings, he said during the enquiry. Dr Horton is known for his steadfast and sharp opinions on what he considers to be weak spots in the relationship between pharmaceutical developers and biomedical journals.

Full disclosure by pharma

The examples Dr Horton cites are of unusually clumsy practice, but the lessons learnt from such occurrences are key. Without clear strategic direction and a keen fervency in the pre-submission scrutiny of clinical information, the entire publication planning process can become ineffective or, at worst, even counterproductive.

Common practice is of course for pharma firms to procure the professional editorial services of a support company specialising in helping to attain the appropriate standards of writing expected by the editors of medical journals.

However, particular groups of people, including several editors of the most prestigious journals, have voiced their concern that parts of this process are secretive, biased and untrustworthy.

Some people would say that professional writing of scientific papers, particularly if paid for by the pharmaceutical industry, is, as a matter of principle, immoral, wrong and should never happen, notes Peter Hunter Johnston, managing director of PeerView Europe, a company specialising in publication strategies for pharmaceutical and biotechnology firms.

Historically, professional writers have not been acknowledged on publications and I think that the International Society for Medical Publication Professionals (ISMPP) will view that as wrong, and take the position that any professional writer working on a paper should
be acknowledged by name.

Pharma is requested to be full in its disclosure of trial results with all references and acknowledgements, but it has taken time to restore credibility in the process, a challenge which is not yet fully overcome. It is naturally to be expected that the journal editors will seek to verify all submissions beyond any doubt. This is the fabric of their role, and without diligence credibility can be brought into question not only of the pharma company and study author, but also of the journal and of the science itself.

At one point, the accusations that pharma firms were in essence `hiding' things were so rife that the situation brought to life a phrase attributed to Irish-born Arthur Wellesley, a leading and political figure of the 1800s, who famously said: Publish and be damned.

Full disclosure by editors

There is of course another side to this issue, which has not had nearly as much exposure by the press or debate among key members of government and the public. What should be disclosed by the editors?

The relationship between pharma companies and medical journals is not a perfect tessellation. Each relies on the other, directly or indirectly, for two purposes, which may often be found at odds with each other. The pharma company wishes to inform the medical community of particular advances it has made in medicine, and/or perhaps new achievements regarding established products, with credibility, independence and authority.

Conversely, the medical journal wishes to publish groundbreaking trial data, as it further establishes the title in the minds of stakeholders as credible, cutting-edge and authoritative. This is simple; any problems arise over the issue of funding.

In his book, The Trouble with Medical Journals, former editor of the British Medical Journal Dr Richard Smith claims that the `buying power' of pharma companies is so great that medical journals are able to be influenced, and to an unacceptable degree.

The promise of reprints and advertising, in supposed return for publication of new data, drives this mechanism inappropriately, he says.

These high-brow medical journals are also primarily commercial ventures that benefit from the publication of major trials... and reprints are very expensive items, notes Liz Shanahan, managing director of Sant? Communications, a GlobalHealth PR partner.

Medical journal editors claim that the industry is compromised because of a need to hit profit targets. I cannot imagine that editors, who are responsible for both the editorial content and productivity of their journals, are not then also compromised.

She continues: I don't think journals are overly influenced by pharma, but they are compromised by their commercial relationship. The pharma industry has made great strides to respond to criticisms of its approach to trial publication. In my view, the publications should now follow suit.

Regarding the public debate over the alleged sullying by ghost writers of the fundamental practice of publishing scientific findings, Dr Nick Ashley, director of medical education at Wells Healthcare, a privately-owned communications agency, says: It was a bit of a surprise I think, as there was the perception that papers were being written 100 per cent by the named authors. These days, however, the top journals insist on the writer actually being totally responsible for the publication and I think that's correct.

He adds: I think the credibility of the process is once again intact. Reviewers take it very seriously. They understand the responsibilities they have in the verification process. It is obviously an honour system and you'll find that people participating in it are usually senior, well respected figures. It's in everybody's interest to have exacting standards.

Universal standards

A raft of clear guidance is available for stakeholders in creating and implementing publication strategies; typically the pharmaceutical developer and trial sponsor, the authors and also in many cases a specialist communications agency, which will strive for clarity, transparency and robust ethics throughout the process.

The ICMJE publishes the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (see www.icmje.org) which provide advice for both key parties, pharmaceutical companies and journals, on how trial data should be submitted, reviewed and published (see box, right, for advice on naming authors).

Additionally, an international working group publishes the Good Publication Practice guidelines for pharmaceutical companies (see www.gpp-guidelines.org), which again seek to ensure that experimental data is published wholly and in a responsible and ethical manner.

Positive sentiments

Given the level of scrutiny into the medical publications process on an international basis, as well as within individual Member States, in recent years, it would take only a relatively mild improvement in the situation for companies to feel comfortable again in their publishing plans.

However, from the select number of client and service companies PM Europe interviewed for this article, the general concensus is that the interrogation spotlight has done its job, highlighted where both pharma and journals should be clearer on their expectations and commitment, and now both parties are starting to recover their confidence in the process and each other.

If pharma companies wish to make absolutely sure that their approaches to journals, whether for hard copy or in online format, are appropriate and stand the best chance of success, the advice is to bring a specialist onboard and heed their counsel.