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My freelance medical writing and editing work in 2017

A combination of work and domestic pressures has meant that it’s been several years since I last able to sit down in a timely fashion to write a review of my working year. I find that it is a useful thing to do, though: it helps me to take stock of what went well, what could have been done better, and what I might choose to concentrate on (or avoid doing) in the future. For anyone interested in freelancing in medcomms, it also provides a snapshot of a freelancer’s lot, and I hope that it will be useful in that respect.

At the beginning of 2017, I was in the position of having quite substantially expanded my business – in terms of the number of clients that I was working with, the types of work I was taking on, and the size and scope of the projects that I was working on – over the previous 2 years. Realistically, without changing the nature of my business (ie by subcontracting or taking on staff) that expansion could not continue, and 2017 has been a year of consolidation.

For many years now, medical writing has been the cornerstone of my business, with editing and proof reading making up an increasingly smaller part of my workload. I have always enjoyed these area of work, however, and I was delighted to be asked to proof read the annual report and updated resource materials for an international not-for-profit organisation that I have been working with now for 3 years. I also edited a good number of slides – primarily for symposia – during the year. Almost always, these projects also included fact checking the slides against cited references or finding references to back up claims made in the slides. This can be very challenging when the slide concerns the finer points of clinical practice that owe much to the expertise and experience of the faculty member, but which perhaps have never been completely captured in a peer-reviewed publication.

As in previous years, an important aspect of my medical writing work in 2017 was the creation of training materials for members of the pharma sales force. This work is interesting to do because it usually involves assembling multiple modules covering basic information about the disease in question, how it is diagnosed and treated, a competitor analysis and information about the new drug/class of drugs, including a review of the available clinical data. In the past, I have done a number of projects with different medcomms agencies in type 2 diabetes, multiple myeloma, and leukaemia; in 2017, I added chronic kidney disease and mucopolysaccharidosis Type I to this list.

One of my favourite medical writing activities is attending and writing up advisory board meetings, and I had several opportunities to do this in 2017. Each was different in terms of the therapy area (breast cancer, allergy and diabetes), the make-up of the board (one or more of consultants, academics, specialist nurses and pharmacists), and their purpose (two being reviews of the therapy landscape and one a discussion about the positioning of a new drug). While two of the meeting reports were simply for the attention of the board members and sponsors, one resulted in a paper which is currently making its way through peer review.

In a similar vein, I was asked to write summary reports of two symposia, one in haematology and one in psoriasis/psoriatic arthritis. Apart from the obvious difference, these were notable for the fact that in one case I received a very poor audio recording and a correspondingly poor transcript, and in the other case I received very high-quality video recordings of the meeting, along with the slides, which was almost as good as actually being there. Recording meetings is often fraught with difficulty, and bitter experience has taught me to make my own audio recording (with the permission of the participants, of course), also to accept a copy of the agency’s/sponsor’s recording (if there is one), and always to take handwritten notes just in case the belt and braces fail. Copies of the slides (or photographs) also help to ensure that the report is as accurate as possible.

My writing work in 2017 also included a few papers: in addition to the review paper based on an advisory board mentioned above, I was commissioned by a start-up medical device company to work with its lead investigators to publish data from trials of its new fertility device and towards the end of the year I worked up an outline for a paper on developments in aesthetic medicine that is currently back with the authors.

The medical device company was one of three brand new clients for me in 2017. That company and one other (a PR agency) found me through my website (www.freelancemedicalwriting.co.uk), while I found the other client through the MedComms Workbook (http://www.medcommsworkbook.com/) – a freelancer listing service that I thoroughly recommend to freelancers in medcomms. It was also good to work for existing contacts who have moved to new agencies. During the summer, I took a 3-month in-house contract with a medcomms agency in West London. Unhappily, that period coincided with the refurbishment of Waterloo station, which made my commute more difficult than I had expected. Clearly, I didn’t do enough background research there. Generally, I enjoy in-house contracts as opportunities to get out of my home office and interact with real, present, people. They also serve as reminders of the pressures that writers and account managers are under when they place work with freelancers.

So that was 2017, what of 2018? Well, as far as work is concerned, I am off to a busy start. I am looking forward to two days at the European ISMPP meeting (http://www.ismpp.org/european-meeting) later this month and to a Medcomms Workbook networking meeting in March. Having missed both meetings last year, I’d also like to get to at least one of the EMWA meetings this year (https://www.emwa.org/conferences/future-conferences/). I am keen to understand how/if Brexit is going to affect medcomms – one of the topics for the ISMPP meeting – and I hope that this might become clearer during the year. I am trying very hard to keep open-minded about this, and I think that it is important to get out and listen and talk to people from agencies and pharma and device companies about their views and expectations. A particular regret about 2017 for me is that, having suggested them in the first place, I didn’t organise many local meetings for Kent freelancers last year. Hopefully, life in general will be a bit more settled this year and more of these events will happen.

To find out more about me and my medical writing work, please visit my website at www.freelancemedicalwriting.co.uk . You can also follow me on Twitter (@jytricker).

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SoMe and Me: Self-Promotion and Business Development

The second of my three articles describing how I use social media in my freelance business was published in the December 2013 issue of Medical Writing (©Maney Publishing; http://www.maneypublishing.com) – the quarterly journal of the European Medical Writers Association (EMWA). You can read it here:

Self promotion and business development

I was asked to write the articles by the joint editors of the ‘Out On Our Own’ section of the journal, which is aimed at freelancers, to encourage more freelance medical writers to participate in EMWA’s LinkedIn group and on Facebook and Twitter. These articles are not intended as ‘how to’ guides – I am no expert – I just describe my level of engagement with social media.

The final article in the series will be published in Medical Writing in Spring 2014, and I will post that on Trickerish Allsorts in due course.
To find out more about me and my medical writing work, please visit my website at http://www.freelancemedicalwriting.co.uk . You can also follow me on Twitter (@jytricker).

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My freelance medical writing and editing work in 2012

2012 was a good year! I signed with more new clients than in any year since I went freelance. These included individuals, small medcomms agencies, large multinational agencies, a publisher and, for the first time, an advertising agency. I also continued to work with existing clients – some that I have worked with for a number of years. This also brought a huge variety of work, which I always appreciate.

In contrast to 2011, most of the work that I did in 2012 was on a freelance basis, interspersed with three short contracts. My contacts with new clients were made through a variety of channels: recruitment agencies, LinkedIn, EMWA, my website and a new initiative, the Freelance Workbook. Most of these were in the UK, but I worked with new clients in France and Germany too.

Medical writing

By comparison with previous years, very little of the writing that I did in 2012 was on primary research papers.  Instead, from a writing viewpoint, 2012 was about PR and training. I wrote a number of articles (on biologics and HIV care) for business-to-business magazines, which felt a bit like coming home for me, and which I was particularly pleased to do. Among the training programmes I was involved with were three interactive courses for iPad and/or the web for healthcare professionals , two slide-based courses, and two more traditional booklets aimed at sales and marketing teams. HCPs were also the target for some web copy, a couple of drug monographs and a short series of adverts.

A new target audience for me in 2012 was payers. Demonstrating cost-effectiveness is an important part of bringing drugs to market and the challenge for me was to provide an engaging summary of the therapy area and technology concerned for readers who may not have a medical background, before going on to summarise the health economics data in a fairly short brochure. It’s been challenging, but it’s been absolutely fascinating too.

In terms of therapy areas, 2012 was primarily about diabetes (types 1 and 2), cardiovascular disease, eczema and rheumatoid arthritis. I wrote about Alzheimer’s disease for the first time, did a little bit more work on rare diseases – this time patient leaflets for the parents of babies with rare skin diseases – and revisited vaccines for the first time in a while.

Editing and proofreading

I did more editing and proofreading work in 2012 than I’ve done in recent years. As usual I’ve had a steady throughput of papers requiring editing for English – either from doctors that I work with directly or via med comms agencies – but I did a lot of slide deck edits too. Most excitingly, I have been taken on as a freelance copy editor for a quarterly magazine sponsored by one of the big medical device companies and as a freelance proofreader for a quarterly ophthalmology newsletter produced by the London School of Tropical Hygiene for HCPs and patients in emerging markets. In terms of editing and proofreading, medical devices in their various guises provided quite a lot of my work in 2012.

Away from the keyboard

As in other years, I made sure to get out of my office and attend a few workshops and conferences. This helps to ensure that I keep abreast of changes in the pharma and medcomms industries, and enables me to find out about other things that are going on in the world that might prove useful  in my work. This year these included conferences on changes in the way that pharma delivers continuing medical education to doctors (InPharm), the growing influence of patients in healthcare management and treatment strategies (MedComms Networking), how to use Twitter in business (Digital Surrey) and the use of mobile technology to improve policing in the community (Digital Surrey). The Publication Plan’s annual publication planning workshop proved a great opportunity to learn about how open access publishing is evolving, what it can offer our clients and its customers and to get up to speed on how the requirements of the US Sunshine Act might affect the provision of medical writing/editing assistance to American doctors.

What about 2013?

Well it has started at a frenetic pace! I have been solidly booked since the beginning of the year and each project has been very different from the last – hopefully that is a trend that will continue throughout the year.

I’ve already attended the European ISMPP meeting as well as a workshop on social media for the pharma industry. I am looking forward to the annual EMWA meeting in the Spring, and am hoping to get to other events later in the year. I’m also looking forward to being a panellist at two workshops for new and would-be freelancers that are being held in March.

On the social media front, I feel that it is time to freshen up my website – it’s been up for a little over 2 years now, so a good time, I think, to have another look at the copy and the artwork. I’m still enjoying participating with Twitter and LinkedIn and, as I say every year, I will try to write more blogs!

To find out more about me and my medical writing work, please visit my website at www.freelancemedicalwriting.co.uk .

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My road to medcomms

I would say that, by comparison with most medical writers I know, I took the long way round into medical communications. By comparison with other freelance medical writers I am unusual (although by no means unique) in that I went freelance before I became a medical writer.

After graduating, rather than go on to a PhD, I went to work in the pharmaceutical industry as a process development chemist – taking on likely candidates from the initial safety and efficacy screens and finding and optimising work-arounds to the laboratory synthetic route to make it suitable for full-scale manufacturing.  Having gone on to do similar jobs with Tate & Lyle and then Zeneca Agrochemicals, I came to the realisation that I couldn’t progress my career in the lab without a PhD (which I still didn’t want to do), so I started to look around for a new career.

At about the same time, PJB Publications (whose business was later incorporated into Informa) was looking for an editor for a new competitor intelligence product (AGROProjects) for the agrochemicals industry. It seemed the perfect answer: I’d discovered an aptitude for and enjoyment of writing during my lab career and here was a job that would allow me to develop those skills without completely losing touch with my R&D roots. And I had the challenge and the fun of developing it pretty much from scratch, including making market research visits, working with the design team to come up with a ‘look’ for the product, working with the marketers to develop promotional materials, developing budgets and sales targets and, of course, gathering and validating the content. This was all experience that would prove useful later.

After 4–5 years of growing the AGROProjects portfolio of products I was offered the opportunity to take over the management of the editorial team for the business reports division of PJB. These provided insight into new products and technologies, changes in the regulatory and business environment and company profiles for the pharmaceuticals, medical devices and animal health sectors as well as agrochemicals. (I still find this ‘big picture’ stuff really interesting – and Twitter makes it really easy to stay in touch. I’d definitely encourage other medical writers to take an interest too.) The job came with opportunities to mentor new in-house writers and editors, to provide input into the content of the reports and to commission freelance writers.

At the end of 2002, a reorganisation of the business reports division eliminated the need for an editorial team. My job was made redundant and I took the decision to strike out on my own.  I had work right from the start – primarily editing and proofreading – thanks to the contacts that I’d made whilst Editorial Manager and through former colleagues from PJB who’d moved on to other organisations. Initially though, I couldn’t get work from med comms agencies – they only wanted to use people with agency experience.

I signed with some of the primarily London-based recruitment agencies that handle freelance and interim contracts, and that led to some very interesting work outside of my usual area of expertise. Then in mid-2004 I had a call from a recruiter who was looking for a freelance editor who could also work in-house for a med comms agency not far from where we lived in Berkshire.  I got the job, and MedSense is still a client now – although since our move to Kent I no longer go and work in-house, and I do as much writing as I do editing these days. Over time, working with MedSense allowed me to build up some real experience of agency life beyond writing and editing – liaising with clients and KOLs, helping to run advisory boards, preparing  materials for conferences and symposia, working up designs with the studio and preparing and pitches.

Not long after I started at MedSense I got a call from an ex-PJB colleague who was working with Medical Action Communications (now Innovex) – again they wanted a freelance editor who could work in-house when they needed extra help. I’ve estimated that in the first year that I worked with them I edited and referenced around 1000 Powerpoint slides!

In 2006, my husband took up his dream job in Kent. As a freelancer, I was able to take that pretty much in my stride. Being primarily home-based it was no struggle to combine working and managing childcare in the initial months while he was away in Kent during the week, and then just move my office and client list once we had found a new home and schools for our children.  Since we’ve been in Kent I’ve continued to alternate between short-term and long-term contracts (primarily with med comms agencies) and purely freelance work.

Finally being able to say that I had some agency experience really opened up doors into other agencies, and I’ve gradually been able to add to my client list. Once or twice I’ve become aware that my (twice made) decision not to do a PhD has meant that I’ve been passed over for a job, but overall it doesn’t seem to be an issue. (Although I can point to 7 years in commercial R&D and a couple of peer-reviewed papers to strengthen my credentials as a scientist. )

In terms of sourcing new work, recruiters are still an important source of introductions for me, but just as important are my EMWA listing (http://www.emwa.org/Freelancer-listing.html), my listing on the MedComms Networking site (http://www.medcommsnetworking.co.uk/independents.html), LinkedIn (http://uk.linkedin.com/in/jytricker) and my own website (www.freelancemedicalwriting.co.uk). Just occasionally I think about a permanent position, but not usually too hard and not usually for too long. Freelancing has its downsides of course, but overall I relish the variety of work it brings me and the opportunities to ring the changes in how and where I work.

To find out more about me and my medical writing work, please visit  www.freelancemedicalwriting.co.uk .

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Communicating on non-communicable diseases

Last week, the World Health Organization (WHO) held its annual World Health Assembly (#WHA65) in Geneva, Switzerland. I was particularly interested to read the outcomes of the session on the prevention and control of non-communicable diseases (NCDs) – cardiovascular disease (CVD), cancers, chronic respiratory diseases (eg asthma and chronic obstructive pulmonary disease [COPD]) and diabetes mellitus (especially type 2 diabetes [T2DM] – which took place on 22nd May 2012. Most medical writers will work on one or more of these conditions at some point during their career because of their high prevalence and their correspondingly high levels of interest to the pharmaceutical and medical devices industries.

The background to the session is interesting.

In 2009, the leaders of the International Diabetes Foundation (IDF), World Heart Federation and the International Union Against Cancer (UICC) came together at WHO’s 62nd World Health Assembly to launch a campaign for a UN summit on NCDs to address the demographic-shifting levels of deaths from NCDs in low- and middle-income countries.1 This group highlighted the futility of spending millions of dollars every year to save people from infectious diseases only to lose them at a relatively early age to NCDs, particularly when efficacious drugs to address these conditions are readily available and cheap. In 2010, this group of three founded the NCD Alliance (www.ncdalliance.org), bringing together a network of 880 member organisations in 170 countries to continue to advocate for action against NCDs.

The UN duly held a high level Global Assembly Meeting in September 2011, to which >30 heads of state and government and ≥100 other senior ministers and experts were invited and which upheld the NCD Alliance’s call for NCDs to be added to the development agenda. As a result, the UN charged WHO with setting up a global surveillance programme and making recommendations for voluntary global targets for reducing deaths due to NCDs before the end of 2012.2 Perhaps surprisingly (and underlining the seriousness with which the UN regards these goals), this is only the second health-related campaign promoted by the UN – the first being the campaign to control the spread of HIV/AIDS.

The statistics3 that prompted the UN to act are shocking. NCDs account for 57 million deaths annually (63% of all deaths). Approximately 16% of all deaths due to NCDs occur in the under-60s. A disproportionate number of these occur in developing nations, where widespread death and debilitation among adults of working age could retard industrial development and where in any case the loss of a wage earner throws families back into poverty from where they are more susceptible to the effects of NCDs. Worse, WHO estimates that the proportion of deaths attributable to NCDs will increase by 17% worldwide in the next decade. The key messages to take from this are that NCDs are not conditions only associated with the developed world and not only associated with aging.

The burden of caring for people with NCDs is no less daunting. One in three people has raised blood pressure (a risk factor for CVD), rising to almost one in two in Africa, and one in ten people has diabetes mellitus.4 Moreover, in every region of the world the prevalence of obesity – which is a risk factor in T2DM, CVD and some cancers – doubled between 1980 and 2008.3 Today, half a billion people (12% of the world’s population) are considered obese. Worryingly, it is thought that there are hundreds of millions of people worldwide who are unaware that they have a NCD and whose first contact with the health service will only come when they develop complications associated with advanced disease. No wonder, then, that Margaret Chan – Director-General of WHO – referred to NCDs as ‘the diseases that break the bank’ at last week’s meeting.

It is generally recognised that the slowly progressive nature of most NCDs requires a quite different mindset at government/NGO level to that necessary for promoting control of infectious disease outbreaks. The NCD programme must be goal orientated and focussed on prevention (ie reducing exposure to risk factors such as tobacco use, harmful use of alcohol, unhealthy diet and physical inactivity) and universal access to treatment.1  WHO has announced its aim to work with its existing stakeholders in the education, agriculture, sports, transport, communications, urban planning, industry, employment and finance sectors, in addition to the health sector, to develop a global framework for the prevention and control of NCDs.5

De Maeseneer et al, in their commentary on the aims of the NCD Alliance, agree that a fundamentally different approach is required for preventing and controlling NCDs but disagree that the vertical, disease-orientated approach advocated by the Alliance is the best way to approach the problem.6 They note that altering patient perceptions and behaviours are key aims in preventing and treating NCDs and that this process requires more than just access to medicines. They believe that it is necessary to empower patients, reduce barriers to healthy lifestyles and care that reflects the needs of individual patients and that this is best achieved by global investment in local primary healthcare.

And the outcome of the session at the WHA65? A target to reduce premature deaths due to NCDs by 25% by 2025 – this is a massive target (and an incredible achievement for the NCD Alliance).

Speaking personally, though, I was struck by the lack of any reference to the need for innovation in the approach to the prevention and control of NCDs. We know what the causes are, we know how to prevent NCDs and, as the Alliance has pointed out, medicines are available – but still their prevalence is increasing in countries with well-funded healthcare services and in countries without.

De Maeseneer et al, whose paper was published before WHO assembly, say that: ‘We must fundamentally rethink the way that we address complexity in health problems, in both developed and developing countries.’ And I agree with them.

References

1. IDF, UICC, International Heart Federation. Time to act: The global emergency of non-communicable diseases (2009). Available at: http://www.world-heart-federation.org/fileadmin/user_upload/documents/Publications/Time%20to%20Act%20-%20High%20Res.pdf

2. UN News Center. UN launches global campaign to curb death toll from non-communicable diseases (19 September 2011). Available at: http://www.un.org/apps/news/story.asp?NewsID=39600&Cr=non+communicable+diseases

3. World Health Organization. World health statistics 2010 (2011). Available at: http://www.who.int/whosis/whostat/EN_WHS10_Full.pdf

4. World Health Organization. World health statistics 2012 (May 2012). Available at: http://www.who.int/gho/publications/world_health_statistics/EN_WHS2012_Brochure.pdf

5. World Health Organization. Sixty-fifth World Health Assembly: daily notes on proceedings. (Tuesday 22nd May, 2012). Available at: http://www.who.int/mediacentre/events/2012/wha65/journal/en/index4.html

6. De Maeseneer J, Roberts RG, Demarzo M et al. Tackling NCDs: a different approach is needed. Lancet 2012;379:1860–1. (Free registration.)

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Blog on blogs

On Thursday October 13th, listening to the Today programme on BBC’s Radio 4, I nearly choked on my Special K. ‘What  if’, the business editor laughed ‘in the same week that RIM has had all its problems, the Apple iPhone 4S failed to take off, would we have a Blackberry and Apple crumble?’ I thought that it was a good line too – I used it in my blog about choosing good keywords for headlines 9 months ago (Apple and blackberry crumble and other stories). By coincidence, two other subjects that I’ve written about previously have also been back in the news again this week.

Earlier in the week I tweeted (@jytricker) that Reuter’s were reporting another paper that described cardiovascular benefits in older women who eat chocolate – this time in reducing the risk of stroke. This added to data published at the end of last year that indicated that Australian women in their 70s who ate chocolate no more than once a week had healthier hearts than women who didn’t (see Eating and  drinking for old age: Hints and tips from Twitter and reference 1). This new study followed more than 30,000 Swedish women for 10 years. The authors stratified the incidence of stroke by the weight of chocolate consumed each week2 and, perhaps surprisingly, women in the study who ate more chocolate (>45g per week, mean 66.5g per week) had the lowest risk of stroke. I estimate that this is roughly equivalent to one bar of chocolate per week, which if I am correct, would tie in with Lewis et al’s findings. Like Lewis and colleagues, Larsson et al suggest that the anti-oxidant properties of flavenoids present in chocolate are likely to be responsible for its protective effect. The authors noted that during the study period the most popular form of chocolate in Sweden was milk chocolate and that dark chocolate, which has higher concentrations of flavenoids would likely be more beneficial. Larsson also told Reuters that while she believed that chocolate had health benefits, over-consumption could be counterproductive because of its high sugar and fat content – which neatly brings me to my third update.

Obesity – and its sequelae – is never far from the headlines, and this week the UK government attracted some scathing headlines when it announced that to combat obesity we ‘must eat less’ (doh!!) and that ‘individuals must be responsible for what they eat and drink’. While I was reading the BBC’s version of this story (http://bbc.in/owiJeJ) a related story caught my eye – one that  announced that Denmark had introduced a ‘fat tax’ at the beginning of October. This was a subject that I mulled over in a blog that I osted at the end of March 2011 (Obesity: will we put our money where our mouth is?). As I scrolled through readers’ comments on that story, I found that many of them rehearsed the same sort of arguments that I set out in my blog (it’s always a relief to find that you are on the same wavelength as other people) – in particular the regressive nature of the tax and a general feeling that people need to be incentivised to eat healthily not just penalised for eating (and living) unhealthily. The World Health Organization recently announced a global AIDS-style campaign to highlight the explosion in non-communicable diseases, particularly those associated with over-eating, drinking too much alcohol and smoking tobacco, because of the effect that treating these diseases is having on healthcare spending. It’s something that I will be coming back to in future blogs.

To find out more about me and my medical writing and editing work, please visit my website at  www.freelancemedicalwriting.co.uk .

15th October 2011

References

1. Lewis JR et al. Habitual chocolate intake and vascular disease: A prospective study of clinical outcomes in older women. Arch Intern Med 2010;170(20):1857–58.

2. Larsson SC et al. Chocolate consumption and risk of strokein women. J Am Coll Cardiol 2011;58:1828–29.

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Access all areas

I’ve been to two meetings recently on the general theme of access in biomedical publishing. One was an in-house meeting to share some thoughts and learning points on open access (OA) publishing and the other a Medcomms Networking meeting to hear Guardian columnist Ben Goldacre’s views on how clinical trials results are published. That meeting has prompted a discussion thread on The Publication Plan’s LinkedIn page that has been running ever since and which seems to have pulled those two ideas together.

Open access publishing, particularly in the biomedical sector, is undergoing steady growth.1 Beyond the laudable concept of allowing everyone (including patients) to read and study the research, the ‘online only’ nature of OA publishing has other benefits, not least the facility to publish (sometimes extensive) data tables for which there would never be room in a print journal and the potential for more rapid publication. The editorial boards of OA journals also seem to be more open in their approach to content, needing primarily to satisfy themselves that studies are scientifically robust rather than making an additional judgement call on whether the work would be of interest to their subscribers.

The expansion in OA publishing has pretty much coincided with increasing requirements for the pharmaceutical industry to be more open and transparent about its funding and reporting of clinical trials including its relationships with trial investigators who author papers and the medical communications and medical education agencies who provide medical writing and other support for the preparation of manuscripts in which trial results are reported. This followed the disclosure in a number of class actions involving patients who had suffered drug-related adverse events that data about the drug’s safety and efficacy had not been fully reported in papers that had not been written by the study investigators but by un-named and unacknowledged medical writers (ghost writers) working for med comms agencies and paid for by pharma companies.

These requirements, which largely have been driven by the International Committee of Medical Journal Editors (ICMJE) in its Uniform Requirements for Manuscripts Submitted to Biomedical Journals, and the International Society for Medical Publication Professionals (ISMPP) – authors of Good Publication Practice, aim to make it possible for editorial staff, reviewers and readers to know when trials have been funded by pharmaceutical companies and to scrutinise the reporting of trial results against the study protocol to make it easier to see if data are being withheld or misused. They also require the involvement of medical writers to be disclosed along with the source of funding for this involvement. Authors must declare how much involvement they have had in preparing the manuscript, any financial arrangements with pharmaceutical companies, and their willingness to take responsibility for the content of the paper.

Dr Goldacre, whose passion is evidence-based medicine, charges that, even now, too many clinical trial reports distort the evidence-base for drug safety and efficacy and that medical communications companies and the medical writers that work for them are complicit in this distortion. See his website for some specific examples. You might imagine that this was not easy for a group of medical writers to hear – perhaps particularly so because Dr Goldacre is not a typical pharma industry ‘basher’. He readily acknowledges the role of drugs in healthcare (‘no medicine without medicines’) but wants doctors and healthcare funders to have access to all the trial data.  He singled out the dearth of reports of negative findings (ie where the test drug fails to demonstrate superiority over other drugs or placebo) as a particular source of bias. I think that this point was generally accepted by people at the meeting – certainly from the point of view of transparency. Where opinions diverged was on whether it could be achieved.

Going forward, pharmaceutical companies will be posting all raw clinical trials data on the clinical trials.gov and EudraCT websites. But in terms of providing useful information to physicians, if this is the only way that negative data get published, is that either sufficient or appropriate?

The usual answer to the question ‘Why don’t negative results get published?’ is that journals won’t accept papers that don’t advance the understanding of medicine. But I don’t know how many people are trying to ‘push the envelope’ and convince journals that understanding might be advanced by publishing negative results in some circumstances. A published study report would allow some context to be added to the results and some reasoned speculation about why the study hypothesis wasn’t proved, which might open up avenues to further research (I, of course, as a medical writer, should declare a vested interest at this point).

Going back to where we came in, in OA journals we have a broader forum for publication. If even a negative study meets the requirement for robustness, there is perhaps a greater chance of it being accepted. Moreover, where allowed by the journal, readers may have the opportunity to comment on and ‘discuss’ the paper online, and in real time, adding to the scientific interest in the paper. In theory at least though, OA journals should not be the only option open to teams wishing to publish negative results. The ICMJE’s position statement on publishing negative studies says that: ‘Editors should seriously consider for publication any carefully done study of an important question, relevant to their readers, whether the results for the primary or any additional outcome are statistically significant. Failure to submit or publish findings because of lack of statistical significance is an important cause of publication bias’.2

At the current time, the pharmaceutical industry has much to do regain the confidence of the people who use its products. Granting access to data for all studies, in tandem with complete disclosure of the nature of its relationships with the study investigators and the people who write up the study, may go some way to achieving this aim.

To find out more about me and my medical writing work, please visit my website at www.freelancemedicalwriting.co.uk .

References

1. Laakso M et al. PLoS One 2011;6:e20961.

2. www.icmje.org.publishing_1negative.html

Useful websites

International Society of Medical Publication Professionals www.ismpp.org

International Committee of Medical Journal Editors www.icmje.org

European Medical Writers Association www.emwa.org

MedComms Networking www.medcommsnetworking.co.uk (for links to the LinkedIn page of The Publications Plan)

Ben Goldacre www.badscience.net

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