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Feature Reporting of research

Ghosts in the machine

BMJ 2011; 343 doi: https://doi.org/10.1136/bmj.d7860 (Published 06 December 2011) Cite this as: BMJ 2011;343:d7860
  1. Rachel Hendrick, doctoral researcher, University of Edinburgh and BMJ, Edinburgh, UK
  1. rachelhendrick{at}gmail.com

Ghostwriting in medical publishing on behalf of big drug companies has a long history, finds Rachel Hendrick, and oversight of the practice has its problems

The medical writing industry is the subject of much heated debate. Some consider medical writers to be skilled communicators of knowledge; others argue that they are merely marketing puppets working at the behest of drug company masters.

Industry documents released during litigation show that some drug companies have hired medical writers to anonymously develop articles that portray their product favourably and have then paid academic physicians or scientists to be named as authors. This practice has been termed “ghostwriting.”

Lisa Bero, professor of health policy and clinical pharmacy at the University of California explains: “The main problem with ghostwriting is that you don’t know who is accountable for the research reported in the article. Knowing who will stand up for the integrity of the data is critical to trusting a scientific publication.”

Others suggest that the employment of professional medical writers gives the drug industry greater control over what is written about its products. “Ghostwriting is pernicious because it takes marketing and disguises it as science,” says Paul Thacker, a former investigator for Charles Grassley (senior US senator for Iowa) who researches medical conflicts of interest. “This completely undermines the foundation of science, meaning that any attempt at understanding is skewed in a marketing direction.”

Examples of ghostwriting include GlaxoSmithKline (GSK), then known as SmithKline Beecham, who employed a medical writing agency to produce articles promoting their drug paroxetine (UK brand name Seroxat; US brand name Paxil), a selective serotonin reuptake inhibitor antidepressant drug, in a publication programme named Case Study Publications for Peer Review (or, aptly, CASPPER, for short).1

Company documents show that medical writers were hired to assist in preparing material that highlighted the benefits of paroxetine, and to respond to “unbalanced information from competitors.” The articles they produced were intended to “benefit the sales force by expanding the database of published data to support PAXIL [Seroxat],” and were “authored” by physicians identified by SmithKline Beecham.1

This is an extreme form of ghostwriting, but any unacknowledged involvement of a sponsor on a manuscript is a matter of concern because of the potential influence on the content and the conclusions reached by readers.

Those involved in medical communications have responded to criticism by forming organisations and developing qualifications that aim to promote ethical practice. How successful these efforts are is open to debate, and many remain concerned about the independence of those hired by the drug industry to write up their trials.

Alastair Matheson, an academic and an independent consultant with extensive industry experience, explains the ineffectiveness of current guidelines. “Everyone is publicly against ghostwriting, but the key thing is, industry organisations and a few watchdogs define it in the wrong way. They say that ghostwriting only occurs if the writer is not acknowledged. Using that definition, they can generate a piece, put an acknowledgement in the footnotes, and say it is not ghostwritten, which is either a lie or disingenuous, because the piece was still conceived and developed primarily by commercial interests.”

Some point out that the highly cited industry documents quoted above are now some years old. However, Carl Elliot, professor in the Center for Bioethics and the departments of pediatrics and philosophy at the University of Minnesota, says, “The problem with deciding whether industry has changed is that it takes many years for court documents to be unsealed. So we will not know for certain for years [whether ghostwriting is still occurring now]. When industry says, ‘everything is different now,’ I would ask them to show you the proof rather than asking critics to prove that things have not changed.”

Medical writers argue that they fill a needs gap: not all researchers are able to write well, or are simply too busy to put in the time necessary to produce publications.2

Adam Jacobs, founder of medical writing company Dianthus Medical Communications, says that employing medical writers is a more efficient use of resources. “Many clinical investigators are highly paid people who may not write very efficiently, and it is daft for them to spend their valuable time writing papers if someone else can do it more efficiently,” he says.

However, it is not necessarily the integrity of the medical writers that is the cause for concern. “Medical writers are hired to write and they usually do it well,” Bero says. “It is the motives of the industries that hire them that need to be questioned.”

Although it has been major law suits that have turned attention to ghostwriting, it is not a new phenomenon in medicine. Nicholas Rasmussen, professor of history at the University of New South Wales, has traced concerns about industry’s influence on research back to the early 20th century. “Reformers like JAMA editor George Simmons [were] outraged at drug firms ‘debauching our journals’,” Rasmussen says.

By the 1930s drug companies had grasped the role medical journals could play in marketing their products. Memos from this period show the relationship between the drug company Smith Kline French and Joseph Scarano, a rhinologist from Philadelphia. The company was involved in “outlining Scarano’s protocols in advance, preparing his illustrations, and submitting papers to journals for him (presumably after editing by the firm).”3

“Marketing and medical staff in companies like Smith Kline French learned how to design trials to meet commercial goals, and then to commission clinicians to conduct these firm initiated and sponsored studies. In some cases they seem also to have written up (or helped write) the resulting reports, as in Scarano’s case,” says Rasmussen.

The marketing drive found further impetus after the second world war, when new medicines, surgical procedures, and psychological treatments led to a rise in spending on biomedical research and healthcare. As the drug market became more competitive, companies began to hire medical writers as part of their marketing teams.

The thalidomide disaster in the 1960s, where the morning sickness drug was found to cause birth defects, heralded the start of drug regulation and companies turned to medical writers to compile the complex dossiers required by regulators.

It was in the 1980s that the medical writing industry really took off, as the commercialisation of research began in earnest. Partnerships between universities and industry were actively encouraged in the US, and a number of policies encouraged private companies to invest heavily in university research.4 Legislation persuaded researchers to patent publicly funded work and then to license it to private companies in return for royalties. By 2003, an estimated 60% of biomedical research in the US was funded by private companies.4 The UK witnessed a similar expansion with universities operating increasingly as businesses.

Marcia Angell, senior lecturer in social medicine at Harvard Medical School and former editor of the New England Journal of Medicine, says, “Academic medical centres have largely become arms of the pharmaceutical and device industries, and adopted their agendas,” and that commercial research needed marketing.5

The marketing was partly done via so called communications, such as journal articles, conference papers and posters, and patient education information. “Given the huge costs of bringing a new product to the market and the short patent protection, companies have to sell as much of the product as quickly as possible in order to finance the development of new products,” says one medical writer.

Drug companies began to outsource their communications strategies to cut overheads. Sensing the commercial potential, medical communication agencies began to emerge. Early examples include Scientific Therapeutics Information (established in 1985), Health Science Communications (established in 1987), and Fleishman-Hillard (established in 1988).

The sector has since boomed and medical writing has become an industry in its own right. Medical writers can now be found working in a variety of arenas: independent agencies, subsidiaries of advertising and public relations companies, contract research organisations, journal publishers, and as freelancers. They are employed to communicate clinical and scientific research and they work on a variety of materials, such as regulatory documents, marketing materials, and journal articles. It is hard to tell exactly how many agencies or professional medical writers there are as there is no formal registered database.

A number of organisations have been established to represent the industry and are keen to see medical writing become a respected profession (see box).

Although some organisations have developed codes of practice, they do not have to be followed and many medical writers are not even aware of their existence. Adam Jacobs and Cindy Hamilton conducted a survey on ghostwriting in 2008 that found only 58% of those questioned were aware of the 2003 Good Publication Practice guidelines developed by the International Society for Medical Publication Professionals (ISMPP), who are themselves funded by industry.6

Jacobs, who was president of the European Medical Writers Association in 2004, also acknowledges that although the organisation can encourage its more than 900 European members to abide by good practice, it has little control over the writers beyond its member base.

Some argue that self imposed standards miss the point entirely, as they fail to address the conflict between science and marketing that leads to biased literature.7

Indeed, despite its commitment to good publication practice, medical writing agencies affiliated with ISMPP have, in the past, been involved in ghostwriting publications for the pharmaceutial industry.

One of these is US firm DesignWrite. The company’s CEO, Rosie Lynch, is on ISMPP’s board of trustees. Wyeth (now part of Pfizer) employed DesignWrite at the end of the 1990s to ghostwrite articles on its hormone replacement therapy drug, brand name Prempro. The company promised to provide “the bridge between marketing and clinical disciplines” and assured “that benefits of publication planning are achieved.”8 DesignWrite was paid $100 000 (£64 000; €75 000) to ghostwrite four articles on the Health and Osteoporosis, Progestin, and Estrogen (HOPE) trials of low dose Prempro.9

Another of ISMPP’s funders, Complete Healthcare Communications, was the medical writing company employed by SmithKline Beecham on their CASPPER programme.1

The medical writing industry appears to be striving for recognition as a profession, and in the US various courses have been established to this end. Johns Hopkins University, Emerson College, and Tufts University are among those offering masters degrees in medical and health communications.10 Similar courses are now slowly beginning to appear at higher education institutions in Europe. The University of Worcester in the UK started a postgraduate certificate in medical communications in October 2010, offering modules that teach students how to prepare regulatory documents, present posters, identify and work with key opinion leaders (influential physicians and academics), and plan publications.

It is unclear how much information these courses provide on ethical publication practice and the most explicit references accompany the courses at the University of Worcester and at Tufts University. The former’s handbook says that, “Students will be trained in the codes of practice applicable,” and the latter has an optional module on ethical issues in health communication, which covers the function of professional codes of conduct. However, that is not to say that the other courses do not tackle this important topic. The University of Innsbruck in Austria has recently redeveloped its masters in medical writing in conjunction with EMWA, and says that about 20% of the new course, to launch in 2012, will cover good publication and writing practice.

European Medical Writers Association (EMWA)

Established in 1989, members are encouraged to follow recognised authorship criteria and abide by good practice, and the organisation has developed its own guidelines. EMWA’s position statement asks medical writers to ensure that, “those listed as named authors have full control of the content of papers. The role of medical writers must be transparent, together with a statement about funding. Writers and authors must have access to relevant data while writing papers. Medical writers have professional responsibilities to ensure that the papers they write are scientifically valid and are written in accordance with generally accepted ethical standards.”11

International Society for Medical Publication Professionals (ISMPP)

Formed in 2005, ISMPP now has a membership of over 1000 from all areas of medical research publishing: drug and medical device companies, publishers, journal editors, and communications agencies. ISMPP’s stated mission is to “Advance the medical publication profession through education and advocacy; drive integrity, excellence, and transparency in medical publications; lead the establishment and adoption of medical publication standards and best practices.”12 It is funded by medical communication agencies, contract research organisations, and drug companies.

ISMPP has a code of ethics13 and was instrumental in putting together the Good Publication Practice 2 guidelines (GPP2),14 which grew out of the original 2003 Good Publication Practice guidelines (GPP). The original GPP guidelines were developed by individuals involved in publications in the drug industry, and aimed to “ensure that clinical trials sponsored by pharmaceutical companies are published in a responsible and ethical manner.”15

The updated GPP2 guidelines, published in the BMJ in 2009, take into account the various ethical codes of conduct already in existence, such as that produced by the International Committee of Medical Journal Editors (ICMJE), and offer guidance to individuals and organisations to enable them to “maintain ethical practices and comply with current requirements when they contribute to the communication of medical research sponsored by companies.”14

Healthcare Communications Association (HCA)

The HCA was founded in 2001, growing out of the “recognition that healthcare communications was [sic] playing an increasingly pivotal role in the strategic marketing plans being developed for pharmaceutical products.”16 The HCA caters for drug companies and agencies working in healthcare communications.

The 79 organisations involved in the HCA include medical communications agencies, drug companies, and public relations firms. As well as learning and development opportunities, membership offers contact with industry leaders, policy makers, and industry commentators. These contacts raise concerns about the organisation’s influence over policy. For example, a forum for members was held with the Association of the British Pharmaceutical Industry (ABPI) on 6 September 2011, and seminars were held in October 2010 with politicians and key industry figures.

Access to the HCA’s resources is restricted—they are available to members only—and the association has not produced any ethical code or guidance that is available to non-members.

Notes

Cite this as: BMJ 2011;343:d7860

Footnotes

  • All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

  • Provenance and peer review: Commissioned; not externally peer reviewed.

References

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