Ethics in publishing: 2 – Authorship

by David Woods

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.

Next in the series: conflicts of interest

How to make the best use of graphics: Part 2 – line graphs

by Ruth B Murray

Line graphs are an extremely useful way of showing changes and trends, especially over time. The following pointers are helpful when considering the use of line graphs:

• Use when graphing a continuous variable by a continuous variable. A common example is a time series. In a graph of a time series, time should run horizontally.
• Display a maximum of three dependent variables (as lines) on any one graph. Otherwise the graph can become crowded and difficult to read.
• Use a different line style for each variable, even if the lines are also
  distinguished by colour. This facilitates black-and-white printing and photocopying.
• Where multiple lines overlap such that they are difficult to distinguish, consider using more than one graph to display the data, or perhaps a grouped bar graph.
• Consider using a vertical bar graph for time series where the series is short and the message relates to comparison of individual quantities (e.g. yearly results) rather than to changes.
• Where there is a visible seasonal component in a time series then at least two years' data should be graphed, or the seasonal component of the variation may be mistaken for a trend.
• Equal intervals (of time, for example) should be equally spaced.
• Where there is a discontinuity in the data do not join the points across the discontinuity, and explain this in the caption.
  

Profile: Madhusree Singh, health economist

By David Woods

Madhus, as she prefers to be called, is a global outcomes fellow at a major pharmaceutical company. Responding to questions in the precise and mellifluous tone characteristic of those who grew up and were educated in India, she describes her work in outcomes research. It’s mainly in health service, she says, and disease related and product related.

What prompted her to get into this field? It was a conscious choice, she says. After completing her residency in internal medicine, she wanted to use her medical skills but to diversify into an area that, as a mother of one child and with another expected in February, she could combine professional with family life. She wanted what many young physicians are looking for – rewarding work plus a ‘lifestyle.’

What she enjoys most about her chosen field is the broad view she can take on health issues, the shift to different perspectives, and the opportunity to look at end results “not just the here and now.” She’s also intrigued by the intersection of policy and science and sociology. Is there a down side? Well, Madhus admits, “I’m not especially numerate; I have trouble with dense statistics and computer programs.”

Would she recommend her line of work to her children? Probably, she says, if that’s what they want to do. The important thing about any type of work, she believes, is to enjoy it. For her, exploring how to deliver optimum patient care is especially fulfilling.
Soon, she’ll be taking up a new challenge: moving to California with her husband, a researcher into Alzheimer’s disease.

Oh, and what about HOC? It’s concise and helpful, she says.

Abstract submission deadlines

Please note that dates were correct at time of sending this email; HOC cannot be responsible for any amendments.

Drug approval agencies

By Mary Gabb

Health Outcomes Communicator is starting a regular series describing the major drug approval agencies and healthcare systems in countries across the world. In this first article, we’ll start with two of the largest drug approval agencies – the Food and Drug Administration in the United States (US FDA) and the European Medicines Evaluation Agency (EMEA).

US FDA

The main role of the US FDA is ensuring the safety and efficacy of human and veterinary drugs and medical devices, although it also regulates the safety and accurate representation to the public of foods, cosmetics, and electronic products that emit radiation. The FDA’s role in biological products includes product and manufacturing establishment licensing, safety of the nation's blood supply, and research to establish product standards and develop improved testing methods. With regard to drugs, its oversight includes product approvals, over-the-counter and prescription drug labelling, and drug manufacturing standards, through the Center for Drug Evaluation and Research (CDER, http://www.fda.gov/cder/). It is also involved in post-drug approval processes, such as post-marketing surveillance, prescription drug advertising and promotional labelling, pharmaceutical industry surveillance, medication errors, drug shortages, and therapeutic inequivalence reporting. It does not have oversight over drugs of abuse with no approved medical use.

According to the FDA’s website (www.fda.gov), “The agency grew from a single chemist in the US Department of Agriculture in 1862 to a staff of approximately 9100 employees and a budget of $1.294 billion in 2001”. The formal agency emerged from the passage of the Federal Food and Drugs Act of 1906.

EMEA

A newer body, the EMEA (www.emea.europa.eu) was developed in 1995. Like the FDA, its main role is “the protection and promotion of public and animal health by regulating medicines for human and veterinary research”. The EMEA is a decentralised body in the European Union (EU), with headquarters in London. As such, the EMEA uses scientific resources from the 25 EU member states. However, because it is a single agency, companies wishing to apply for a new drug approval file a single marketing authorisation application to the EMEA. Upon review and approval by the Committee for Medicinal Products for Human Use (CHMP), a positive opinion is sent to the Commission, ultimately resulting in a single market authorisation valid for the entire EU.

The CHMP also arbitrates disagreements among member states concerning the marketing authorisation of a particular medicinal product, and can issue an “urgent safety restriction” to inform healthcare professionals about changes in the way a medication can be used (similar to the “black box warning” by the FDA). Moreover, the EMEA is involved in post-authorisation evaluation of drugs for human consumption including pharmacovigilance. The EMEA also reviews applications regarding orphan drugs (ie, drugs for rare diseases) and provides scientific opinion on traditional herbal medicines via the Committee on Herbal Medicine (HMPC), established in 2004.

Another full and informative issue, including:

• The rewards of research
• A review of international drug approval agencies and how they work in each country – part 2
• Constraining the information balloon – information overload.