January2012

Editorial: What’s in a name? Guest authors, ghost authors, and plain ol’ writers

Jan 30, 2012
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‘Ghostwriting’ is a contentious issue among both medical practitioners and medical writers. Previously, this issue typically only surfaced when either a politician decided to get on a bandwagon or a pharmaceutical company was implicated. In more recent times, lawyers are putting their case forward for policing the issue. In this upheaval, all players are involved, as described in two older articles in the New York Times on the issue of using ghostwriters in the medical literature and one more recently in PLoS Medicine, a medical journal from the Public Library of Science.

The first article described the use of ghostwriters by Wyeth as part of their publication plan regarding Premarin and Prempro, two drugs to treat the symptoms of menopause, known as hormone replacement therapy, or HRT.

The article reveals that ghostwriters ‘played a major role in producing’ 26 scientific papers (published between 1998 and 2005 in 18 medical journals) backing the use of HRT. The article cites several areas of concern: the lack of disclosure of a ghostwriter, the selection and involvement of the named author, and the continued recommendation for HRT after evidence of significant health risks associated with its use emerged.

According to the article, the ghostwritten papers were typically review articles and did not disclose Wyeth’s role in initiating and paying for the work. One example described in the NYT piece included acknowledgements of several medical writers for ‘editorial assistance’, but neither the use of a medical communications company, nor Wyeth, were mentioned. Also at issue is the selection of the named authorafter a detailed outline for the article had been drafted. A spokesman for Wyeth noted that the articles were peer-reviewed by the journals. Adding to the concern was the stopping of a large federal study in 2002 after an increased risk of invasive breast cancer, heart disease and stroke (and in a later study, dementia) with the use of certain types of HRT was discovered. The article’s information is based on court documents from a lawsuit against Wyeth.

More interesting though is the original whistle-blowers (see paragraph six) and the third article we will be discussing.

The second NYT piece is based on a letter written by Senator Charles Grassley – a Republican from Iowa who helps oversee public funding, including for medical research, and has been a vocal opponent of the relationship between the pharmaceutical industry and the medical profession – to the Acting Director of the National Institutes of Health (NIH) asking about NIH policies on ghostwriting and recipients of NIH grant money. Of particular issue is the participation by faculty members at American medical schools as ‘guest authors’ on such ghostwritten articles. As the article notes, ‘Many of the nation’s top doctors depend on federal grants to support their work, and attaching fresh conditions to those grants could be a powerful lever for enforcing new ethical guidelines on the universities.’

The third and more recent piece published in PLoS Medicine has already had some exposure and attention, more so about the retribution of this issue as deterrent. In this article, the authors (one lawyer and two law consultants) argue that self-regulation has not produced results and the government has failed to have any significant impact on ghostwriting, and that the only remaining option is the legal system. The article then proceeds to illustrate the possible legal remedies that can help outlaw a practice that has “long tainted journal content and jeopardised patient safety”.

Our former editor, David Woods, PhD, offers a broad perspective on this topic, as a former journal editor himself and from other journal editors and leaders in medical publication.

He discusses an important point – the lack of clarity on what is an author, a ghost author, and a guest author. While we resolve those questions, full disclosure appears to be the best option for all involved: writer, investigator, editor, and reader.

Health economist, interrupted

Jan 25, 2012
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By Julie Stauffer (julie.stauffer@rxcomms.com)

The statistics are staggering. According to one study, the average office worker is interrupted every 11 minutes and takes 25 minutes to return to the original task. Another estimate is that distractions swallow up a whopping 28% of the typical workday.

In the face of a daily onslaught of email, phone calls, instant messages, text messages, beeping pagers, and colleagues poking their head around the door, how can a beleaguered health economist stay productive?

First of all, keep in mind that not all interruptions are bad news. Some bring essential information or provide a brief mental break that lets you return to the problem at hand with a fresh perspective. Others, like a co-worker with a question that urgently needs answering, contribute to the greater productivity of the organisation, even if it throws your own schedule awry.

There’s no doubt, though, that many interruptions wreak havoc, derailing your train of thought and distracting you from important tasks. Here’s how to sidestep as many as possible and minimise the impact of the ones you can’t avoid:

  1. Set your phone to voice mail, close your door (if you have one), and turn off your email alert. According to one study, ringing telephones and pinging emails can take 10 points of your functioning IQ – more than double the drop caused by smoking marijuana.
  2. Schedule concentration-heavy work – anything involving complex mental models, dozens of details, or the planning stages of a project – when or where you’re least likely to be disturbed. Come in early, stay late, or arrange to work from home.
  3. Make use of instant messaging. Although it may seem counterintuitive to give colleagues yet another way to contact you, researchers have found it offers a less disruptive way to communicate than phone calls, email, or face-to-face conversations, in part because it lets you signal when you are and aren’t available.
  4. The biggest cost of interruptions is the time it takes to reconstruct your earlier train of thought. Before you switch gears, take a moment to jot down what you’re doing. As you’re working, it’s also helpful to create project outlines, document your sources, and make a note of any assumptions: after a break, you’ll be able to pick up the threads more quickly.
  5. Recognise that the biggest culprit may be staring you in the mirror. According to one researcher, 44% of interruptions are self-initiated. Consider setting limits on how frequently you check email, send text messages, or peek at your favourite blog.
  6. Reduce the need for interruptions. Communicate clearly the first time round, so that people aren’t forced to bother you for additional details or clarifications.
  7. Remember that you can’t make yourself unavailable all the time. When you switch your phone to voice mail or hang that “do not disturb” sign on the office door, let your co-workers know when you will be free to answer questions, put out fires, or discuss that upcoming project.

Understanding the Literature Search Process

Jan 18, 2012
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At Rx Communications we have recently been developing proposals for a number of literature review projects – including one where an original review and analysis required updating before publication, and others that were designed to find answers to fairly obscure or unusual questions. We find, at the start of the year, many of our clients looking for vendors for these types of projects, and so we thought it might be useful to share our experiences. Rx has been performing literature searches and reviews since the company began; we are one of the few boutique medical communication agencies to have a dedicated information manager who specialises in this work. With all the literature benchmarking, systematic and comprehensive reviews we have undertaken over the years, we have developed a useful 4-step thought process that helps ensure our clients get the results they want. Here’s hoping they get you the results you want too.

Step One – Decide what the question REALLY is.

Although this seems fairly obvious, it is often the make or break point of success, and we find that clients often haven’t thought through what it is they really want. This can make a tremendous difference to the size and complexity of the project: for example – is this research going to inform future drug or device developments or in-licencing opportunities? With a large future investment riding on the results of the search, you would do well to spend a little more on the literature search and analysis to ensure that your future investments will be well spent.  Is this search (for example, of study methodologies) going to inform the way future clinical trials will be conducted, or perhaps establish the basis for an HTA submission? In this case inclusion and exclusion criteria need to be very clearly defined so that only the most robust data are collected. Are you looking to publish the results as a foundation or background to your own development research?  It must be very clear that data have not been ’cherry picked‘, and that the search has not been skewed to omit unfavourable results or a competitor’s pivotal study.

On the other hand, you don’t want to end up analysing every single citation that may be identified in a comprehensive search, if all you want to know is the most common study approach taken to determine the parameter you are interested in. Part of deciding what the question is, is the issue of budget – do you need to know absolutely everything about your chosen question, or is a general indication sufficient?

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