Medical writing: vigilance for ethics

As of the beginning of this year, the American Medical Writers Association (AMWA) has added its code of ethics to membership application and renewal materials. New and renewing members are asked to indicate that they have read and accepted the principles of the code. The goal is to increase awareness of ethical principles and, it is hoped, to contribute to maintenance of high ethical standards among medical writers.

AMWA, despite its name, is an organisation of medical writers from not only the United States but also around the world. Its members come from a variety of disciplines, including academic, pharmaceutical, marketing and regulatory.

The code of ethics itself is not new. It was first developed in 1973 and revised in 1989, 1994, and 2008. The 1994 revision came in response to a Food and Drug Administration (FDA) guideline that proposed severe restrictions on industry-sponsored medical writers. AMWA worked with the regulators to educate them on what medical communicators actually do and also strengthened the code of ethics by adding wording about “scientific rigour” and “fair balance.”

The code, intentionally brief, consists of a preamble that explains the role of AMWA in promoting excellence in medical communication, followed by eight principles to be applied in developing materials in the various media in which medical writers work. Among the principles are recognition and observance of applicable statutes and regulations; application of objectivity, scientific accuracy and rigour; maintenance of the highest professional standards, whether or not the materials they develop fall under the purview of any regulatory agency; and insistence on conditions that allow them to properly apply their own judgment and skills, with refusal to participate in assignments that require unethical or questionable practices. Additional principles include professional development, respect for the confidentiality of materials provided by clients, and expectation and acceptance of fair remuneration of and acknowledgment for their services.

AMWA will not enforce adherence to the code of ethics, and the organisation does not encourage individuals to become “ethics police.” Its goal is rather to increase awareness of ethical issues and principles.

Ethical issues are also addressed by AMWA’s sister organisation, the European Medical Writers Association (EMWA, www.emwa.org). EMWA includes on its website its own guidelines on the role of medical writers in developing peer-reviewed publications. The guidelines include the importance of respecting and acknowledging the role of medical writers in the development of scientific publications.

Ethics in publishing: Conflict of interest

By David Woods (dwoods@rxcomms.com)

A recent article in the Journal of the American Medical Association (JAMA) concluded that women who stopped taking their antidepressant drugs during pregnancy were at greater risk of relapsing into depression.

But several newspaper and television reports latched onto the fact that most of the JAMA article’s 13 co-authors are consultants to pharmaceutical companies that produce antidepressant medications.

This kind of relationship between key medical specialists and the pharma industry isn’t new. The industry funds a significant number of medical research projects, as well as continuing medical education conferences and scientific publications.

In fact, the JAMA article was funded by the National Institutes of Health with no support from industry. And, as the study’s designer and the analyst and interpreter of its data pointed out: “[It] clearly and strongly suggested that… women who choose to discontinue antidepressant medication during the course of their pregnancy have a substantially greater risk of relapsing into a depression episode compared with those who choose to remain on their medication.”

Moreover, media focus on the perceived conflict of interest among the study’s authors has a negative public health impact and does a disservice to women, who may be confused by the conflicting messages.

That said, there remains an issue of complete transparency and rigor on the part of medical journals. JAMA’s editor said that the journal wasn’t aware of the relationship between some of the authors and the pharmaceutical industry. But it should have been. The International Committee of Medical Journal Editors (ICMJE), of which JAMA is a member, is explicit in the matter, requiring that putative journal authors disclose all potential conflicts; and moreover, to state explicitly that they have no such conflicts.

ICMJE specifically states that “conflict of interest exists when an author… reviewer, or editor has personal or financial relationships that inappropriately influence (bias) his or her actions.”

When you as a potential author submit a manuscript, you’re responsible not only for disclosing all financial and personal relationships but also for stating explicitly whether potential conflicts do or do not exist. The World Association of Medical Editors (WAME) offers a further definition of conflict of interest: “some fact known to a participant in the publication process that if revealed later would make a reasonable reader feel misled or deceived (or an author, editor or reviewer feel defensive).”

And editors must apply stringency by what the ICMJE calls “declining to consider papers unless the authors can attest that they had full access to the data and control over the decision to publish.”

In all of the fuss over the JAMA article, the point was not that it was a matter of duplicity but of laxity. Authors need to be more open about their affiliations, and editors more rigorous in making such connections known to readers. But in the final analysis, patients need to be served by findings they can trust.

No commercial or financial interests supported or influenced the content or contentions of this editorial.

Ethics in publishing: Authorship

While there is no universally agreed definition of authorship, several organisations, including the International Committee of Medical Journal Editors (ICMJE) and the World Association of Medical Editors (WAME), have taken a stab at defining what constitutes authorship.

ICMJE, for instance, recommends the following criteria:

• Authorship credit should be based upon substantial contributions to conception and design, or acquisition of data, or analysis and interpretation of data; drafting the article or revising it critically for important intellectual content; and direct responsibility for the final approval of the version to be published.

• When a large, multicentre group has conducted the work, the group should identify the individuals who accept direct responsibility for the manuscript. The ICMJE notes that acquisition of funding, collection of data, or general supervision of the research group, alone, does not justify authorship; on the other hand, everyone designated as an author should qualify for authorship, and all those who qualify should be listed. The order of authorship on the byline should be a joint decision of the co-authors, who should be prepared to explain the order in which authors are listed.

WAME urges that all journals should publish guidance about what constitutes authorship; but while the association suggests awareness of the ICMJE guidelines, it waspishly suggests that these are the subject of some controversy, represent the views of editors rather than authors, and are widely disregarded even by authors publishing in ICMJE journals.

Authorship, says WAME, implies a significant intellectual contribution to the work, some role in writing the manuscript, and reviewing the final draft of the manuscript – but authorship roles can vary.

Who will be an author, and in what sequence, should be determined by the participants early in the research process, to avoid disputes and misunderstandings which can delay or prevent publication of a manuscript. For all manuscripts, the corresponding author should be required to provide information on the specific contributions each author has made to the article.

While all authors are responsible for the quality, accuracy, and ethics of the work, one author must be identified who will respond if questions arise or more information is needed and who will take responsibility for the work as a whole.

You can see that there’s a measure of agreement here – some of it based on common sense, some on covering all bases, and some on enlightened self-interest. The main points to look for, though, are responsibility, rigour, and transparency.

Ethics in publishing: Plagiarism

Such ethical issues as truth, deception, confidentiality, paternalism, relativism, conflict of interest, and personal and social responsibility have an impact both on healthcare and on publishing. We’ll be examining some of these issues in future issues of HOC; but we’ll start here with deception, whose most obvious example is plagiarism.

Plagiarism has been a hot topic recently. Reporters have been fired from such august publications as the New York Times for fabricating stories. And in the UK, Ian McEwan was accused of using some brief wording in his best selling novel Atonement that was drawn too directly from another author’s romantic novel.

But plagiarism isn’t new. The Financial Times notes (and I’m quoting here with full attribution; not copying) that ‘Shakespeare… took a large number of his plots straight from a contemporary source, Holinshed’s Chronicles,’ and that ‘no less upright a figure than T.S. Eliot grandly declared that ‘immature poets imitate; mature poets steal.’’

Plagiarism is often hard to pin down since much published work can be a mixture of originality and half digested ideas vaguely plucked from memory. Nonetheless, it’s the imperative to compete or to ‘get there first’ that can sink writers and publications into an ethical swamp. According to the Freedom Forum Media Studies Center: ‘Seventy six per cent of [Americans] believe that journalists often or sometimes plagiarise material and 66% said that stories are often made up and passed off as real.’ Respondents to the survey blamed the rash of debacles on weak editing and pressure to beat the competition.

In medicine, if there’s a serious error, there’s a funeral and a lengthy lawsuit; in publishing, an error usually produces an apology and a retraction in four-point type buried in a subsequent issue of the publication.

In medical publishing, the issue is far more critical than in the general media. At the American Medical Publishers Association’s annual meeting a couple of years ago, The Economist’s then healthcare correspondent Shereen El Feki observed that publications can carry outlandish medical stories, stir up a furore with them, and then later countermand them. ‘Oops, sorry, we were wrong about [name the substance] being a cancer cure. At the same meeting, mathematician and author (Innumeracy) John Allen Paulos noted the tendency for writers in scientific publications to play fast and loose with numbers and statistics.

Publish or perish may be part of the problem, and peer review may be part of the solution. But not always. There can be selective underreporting of unfavourable results and overhyping of positive ones.

Plagiarism comes from the Latin for kidnapper. Rather than paying a ransom for it after your work is published, be vigilant as you write it. And don’t give your editors cause to suspect you of literary theft. Unlike Shakespeare’s editors, they can Google you if they think some part of your work may be less than pristinely original.

Google, by the way, apparently has some 10 million entries for plagiarism. The first one listed is plagiarism.org. One hopes they all meet ethical standards.