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Rules of engagement

Academia, investigators, journals and the industry, where do we go from here? Will legislation and policies change the face of publication practice? We asked two leading figures to speak out about what the future could hold...
A boxerThe pharmaceutical industry has been under intense scrutiny and the subject of much adverse press regarding its interactions with healthcare professionals (HCPs) and the funding of undeclared professional writing support for manuscripts.

The controversy continues unabated, the flames being fanned with each new 'story', as evidenced by the flurry of media coverage of the recent Journal of the American Medical Association (JAMA) article on guest authorship and ghostwriting.

Self-regulation, government legislation and society guidelines have done much to ensure increased transparency of the industry-HCP relationship. Journal editors, publishers, publication practice guidelines and industry policy have taken great strides in acknowledging industry support when the results of clinical studies are published.

Within the pharma industry itself, a number of marketing teams have handed the publication planning reins and budget control entirely to their clinical colleagues. And the Food and Drug Adminstration (FDA) Amendments Act of 2007 now requires the results of applicable clinical trials for products subject to FDA regulation to be posted on www.clintrials.gov.

Despite these advancements, the academic community is still concerned about public perception of associations with the industry. All recognise the critical need for pharma and scientists to collaborate to ensure that healthcare advances continue to be made, but the risk of tarnished reputations is affecting HCPs.

The New York Times (April 15, 2008) described a small number of scientists who decided to stop accepting industry payments for speaking engagements or advisory board services. Some clinical investigators have turned down offers of writing support, despite the additional drain on their time. And a few academic bodies, such as the Association of American Medical Colleges (AAMC) and the US Institute of Medicine, are now drafting their own rules of engagement.

What does the future hold for publication planning - can more be done to assuage concerns about the objectivity of industry-supported publications? Where will the legislation, guidelines and policies end?

Transparency across the board
Ensuring full transparency of industry funding and provision of professional writing support to authors needs to continue, and it is likely that publishers will adopt clearer policies for how this should be acknowledged.

However, professional writing support also encompasses congress activities; congresses may be the first time an HCP learns about a new clinical trial given the lag time for publications to appear in the medical literature. Complete transparency would encompass wider acknowledgement of industry support for conference abstracts, posters and oral presentations.

The recently published CONSORT for abstracts, if widely adopted by conference organisers, requires that the source of funding be declared. And evolving academic guidelines might see 'acknowledgements slides' becoming more commonplace at the end of oral presentations.

Despite transparency of professional writing support, some journal editors view author drafting of an article as critical. Some editors consider that nuances of tone and message are set by the person who prepares the first draft, which may be 'subjective' if the first draft is prepared by a professional writer - despite author input and amendments, the authors become 'editors' of the article.

To continue to satisfy journal editors and academic institutions, professional writers will need to work even more closely with authors, perhaps requiring authors to fully prepare the discussion, such that their professional interpretation of the implication of the results and validity of the study cannot be misinterpreted as the alleged subjective views of a paid professional writer.

Several pharma companies have reduced or eliminated marketing team review of manuscripts. One school of thought is that this trend will continue and manuscripts might become governed by similar restrictions as those adopted for Continuing Medical Education (CME) in the US, with industry providing unrestricted grants to assist authors in developing publications, with no influence over content.

One would hope that increased transparency and proper scientific debate regarding content will be sufficient to avoid this scenario.

Industry scientists are academic experts in their own right. With intimate knowledge of the clinical trials and therapy area, they provide valuable insight and interpretation of scientific data generated in studies supported by the pharma industry.

The question should be whether industry scientists should feature more often as authors, alongside the clinical investigators, with journal editors being more accepting of this practice.

A common global commitment
Although legislation and guidelines are predominantly being driven out of the US, in practical terms these will affect publication planning activities across the globe. Most medical journals are global in reach and, therefore, changes in publication practice, whether voluntary or enforced, will likely affect all countries.

Industry, academia and journal editors need to work towards a common aim of full transparency to avoid enforced legislation that could drive a wedge into the relationship between industry and clinical investigators that is critical to future advances in medicine.

The Author
Angela Cairns
is SVP, medical & scientific services, KnowledgePoint360 Group. She can be contacted at angela.cairns@kp360group.com

 

The aim of publication planning is to optimise the accurate and consistent communication of data, analyses and educational perspectives. Working with authors and journals to plan primary publications, reviews and commentaries (and to present data at scientific meetings) has long been a key element of the pharma industry's activity. However, the very idea of planning and engaging in the development of peer-reviewed publications is now being questioned.

This challenge is driven in large part by mistrust of the commercial interests of bio-pharmaceutical companies. This mistrust has in turn led to increasing regulation and, in some cases, the reluctance of opinion leaders, authors and journals to work with the industry.

Sergio Sismondo typifies this view. He cites publication plans and quotes (out of context) from the websites of medical communication agencies to imply that publication planning allows commercial interests to influence both science and medical practice adversely.

The flaw in this position is the baseline assumption that industry involvement is inherently corrupting and unethical. An alternative perspective sees industry as enabling research and providing support for timely and accurate publications, which would not otherwise meet even the timelines set by regulators.

It is also sometimes forgotten that bio-pharma has no interest in undermining the integrity of publications or journals, since this would only diminish its long-term ability to credibly communicate key data.

However, these concerns are deeply felt and have significant consequences for publication planning.

Tightening regulations
Industry is currently responding in varied, even polarised, ways. Some companies have a comprehensive, publicly available, publications policy and are completely restructuring their publication management into clinical, or medical affairs ñ even fire-walling this from commercial or marketing input. Other companies, though, have not yet made any significant changes to working practices or organisational structure, in relation to publications.

Developments in regulations and best practice are pointing a way forward for publication planning.

The 2007 FDA Amendment Act (FDAAA) required the registration of clinical trials and the public disclosure of results within 12 months of trial completion. Clinical trial registries are also having an impact in Europe by driving rapid and open access to trial results. The need to register studies before they start, as a stipulation for publication in a top-tier journal, is also now pretty well established and has a direct effect on publication planning.

Good Publication Practice (GPP) is also well established and if applied consistently will reduce confusion and mistrust.

Fundamentally, if professional editorial or medical writing support is acknowledged and the principles of GPP followed then charges of 'ghost writing' become completely inappropriate. In addition, the ICMJE requirements for authorship are clear, and if applied consistently there should be no uncertainty about who has contributed to a publication. Readers can then draw their own conclusions and test them against other peer-reviewed publications, colleagues, expert opinion, or any other information source, as they wish.

A recent JAMA article by DeAngelis and Fontanarosa proposed some very sensible recommendations along these lines - and some others which are unrealistic. Their recommendations to have all clinical trials prospectively registered, ensuring all authors fulfil the required criteria and full disclosure by all parties are already in hand and should represent best practice.

These developments and debates coincide with potential signs of a more adult relationship beginning to emerge with journals.

At the recent fourth annual meeting of the International Society of Medical Publishing Professionals (ISMPP), attended by industry executives, William L Lanier from the Mayo Clinic Proceedings stressed the mutual responsibilities of the two parties: We need each other, if we play along fair and square, don't let us kid you, we need you too and the product you provide.

He also said that as most therapeutic drug development is paid for by drug companies, the Mayo Clinic Proceedings would have a difficult, if not impossible, job reaching its goals of advancing clinical medicine without considering some drug company-sponsored manuscripts.

In short, the mutual reliance of journals and the pharmaceutical industry is unlikely to change in the short-to-medium term. The key will be forging an improved relationship built on transparency and trust.

Looking to the future
Over the next few years, the need to address mistrust and improve transparency - and the diminished control over publications that these imply - will lead to major changes. Specific developments may include:
- Stronger partnerships between industry, publishers and agencies, with publishers providing innovative vehicles and agencies providing expert guidance, resource and facilitation.
- Greater consideration given to publishing via clinical trial databases or pharma company websites, as well as peer-reviewed journals.
- Greater emphasis on driving outreach and amplification from primary publications. As industry plays a potentially smaller role in the production of primary publications, there will be greater focus on the interpretation of publications, and driving the debate around them into national clinical contexts. This will be especially important with the ongoing emergence of new markets, and the diversity this brings.
- Greater use of, and responsiveness to, e-publishing. This is a powerful tool for sharing information, but open access to the web for anyone who wants to express a view can dilute expert opinion and increase the risk of misinformation. There may be less direct industry influence, but a greater need to ensure expert analysis and opinion is heard and defended.
- The development of more specialist skills will ensure careful, consistent and appropriate management of publications within agreed guidelines and regulations. The ISMPP is considering accreditation for publication planners. This would be a positive move as publication planners will need to be leaders, providing direction, arbitration and excellent people management, along with a sound understanding of the science and the regulations.

One scenario is that authors and journals remain ambivalent about transparency in the form of open acknowledgement of industry support. In this case, authors may want greater distance and industry will have less input in the process of developing and delivering publications.

A healthier scenario is that full and open acknowledgement of industry support or involvement becomes widely accepted by all stakeholders. In this case bio-pharma companies could still play a key role in facilitating the management and development of publications.

Keeping an open debate
In either case, industry will need to get better at actively driving transparency and ensuring a balanced debate about new data. Ultimately, we need to respond to increasing regulations not with trepidation, but with conviction and confidence. We should view regulations and the challenge of transparency as an opportunity to build trust and truly differentiate our products.

Taken to its logical conclusion this means industry-sponsored publications and presentations that include a balance of different expert views, both for and against a given product, alongside a clearly-stated company perspective, and a debate about the role of the product involved.

Do we have the courage to fund this kind of evidence-based debate? It could certainly make a difference to perceptions of bias, and if our products are well designed, with a clear vision and strategy, and appropriately placed in clinical care, then they ought to stand up to this test.

The Author
Charlie Buckwell
is chief executive of Complete Medical Group. He can be contacted at charlie.buckwell@complete-grp.com.

2nd September 2008

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