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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For #raredisease day

February 29th is Rare Disease Day – an opportunity to celebrate steps forward in the understanding and treatment of rare diseases, to pay tribute the people who live with them – and their carers – and to draw attention to the pressing need for more research, more treatments, more recognition and more help to address the hundreds of diseases and disorders which are designated as ‘rare’.

Until a year ago, my understanding of rare diseases was, to say the least, limited. In the last 12 months, however, I have provided writing and editing support to a number of teams working on rare diseases. These have included several blood disorders (porphyria, haemophilia, idiopathic thrombocytopenic purpura [ITP]) and metabolic disorders (hyperammonaemia, chronic cholestasis), as well as hereditary angioedema (HAE) and ichthyosis.

Most of these have the potential to be life threatening. Most require prompt recognition in order for optimal treatment to be delivered before the situation becomes critical. Most are hereditary (although some also appear spontaneously – ie without a family history). All of these affect children.

In the work that I’ve done in the last year I’ve identified some common threads in communications about rare diseases, which I’ll share here.

1.Traditional media – traditional response

I have worked with two teams this year who have been trying to publish papers on the treatment of porphyria and HAE, respectively. My involvement – funded by drug companies in both cases – has been to edit for length and for English. Both papers were summarily rejected by the authors’ first choice of journal for being of limited interest to their readership. This is something of a brick wall, then, against which to bang your head. Most doctors will never see a case of porphyria or HAE (or any other rare disease), but if they don’t know about porphyria or HAE, how will they recognise it if they do? It is all very well to publish in journals that specialise in rare diseases, but you’re probably only reaching doctors who know all about those conditions anyway. This does not help patients, as the following two examples will hopefully help to illustrate.

A couple of the conditions that I have written about this year initially present with very general symptoms. Sadly the most obvious choices of therapy or procedure for those symptoms exacerbate rather than alleviate them, which, if doctors had been able to read case reports on patients with these disorders, could be a clue to the fact that something more unusual is going on.

Haemophilia, renowned as a hereditary disease in males, is now known to affect women and to arise as a result of spontaneous gene mutations. Doctors who are unaware of those facts could expend a lot of time, money and patient goodwill on exploring unexplained and/or heavy bleeding in a patient who could be easily helped by prescribing the appropriate clotting factor.

It would be great … if the general medicine journals could commit to taking a few papers on rare diseases each year. The planting of those seeds of knowledge could make a huge difference to those few patients whose quality of life (even life itself) may depend on it.

2. Social media: making contact and spreading the word

I don’t think that it is possible to underestimate the huge difference that widespread uptake of social media has made and continues to make, to patients with rare diseases, their carers and their doctors. Starting with websites providing news and information about the disease and its treatment, case histories that might prove useful in differential diagnosis, space for discussion and links to other useful sources of information, and moving on to Facebook and Twitter, which provide more natural environments for interaction with other patients, researchers, drug companies and healthcare professionals, social media is generally making the world a better place for people with rare diseases.

Here’s one example of how motivating social media can be, particularly for young people with a rare disease.

British professional cyclist Alex Dowsett has haemophilia – Google him (plus haemophilia) and you will see how social media allows him to reach out to young people with haemophilia (and the rest of us, of course) and let them know that not only can you lead an ordinary life with a rare disease, you can lead an extraordinary life if you are motivated to stay fit and healthy.

Haemophilia is a disorder that we know a lot about, and medication and diagnostics for checking clotting times have been available for some time and are being continuously improved. This is not the case for many rare diseases, however. Going forward, Twitter and Facebook are likely to become essential in the recruitment of patients into clinical trials for new drugs to treat rare diseases. With comparatively few patients being eligible for inclusion in these trials, it is really important to contact as many as possible at the outset and it is easier to do this through social media than through patient records.

France-based Eurordis (www.eurordis.org) – a non-governmental patient-driven alliance of patient organisations representing >500 rare (orphan) diseases in 46 countries – and the US-based National Organization for Rare Diseases (NORD; www.rarediseases.org) have created a portal (www.rarediseasecommunities.org), which links rare disease communities together, provides automatic translations of websites, and acts as a centre for the collection and dissemination of news on rare diseases. I was fortunate to meet Rob Pleticha of Eurordis last year at a meeting for representatives of ITP patient groups and he provided them with useful tips for staying safe online, reaching as large an audience as possible and ensuring the accuracy of information on their sites.

It would be great  … if everyone followed @eurordis and @NORD on Twitter and retweeted their news and requests for help. The more people they reach, the more people are likely to be helped.

The patient is king/queen

The chances are that if you are a patient with a rare disease, or the parent or the partner of a patient with a rare disease, you know at least as much about that condition as most of the healthcare professionals that you will come across. Patient groups play a vital role then in not just being a resource for patients, partners and parents, but also for healthcare professionals.

I was invited last year to act as a scribe for representatives of patient groups from across Europe at an international meeting for physicians and nurses who treat patients with ITP. The whole event – which happens annually – was sponsored by Amgen, who had included the patient group representatives for the first time in recognition of the important role that they play in supporting newly diagnosed patients. In addition to their own sessions, these groups took part in discussions of case studies with the HCPs and led a session on how patient groups can help HCPs in their work with patients.

I found this meeting at the same time profoundly moving and immensely uplifting. It is impossible not to be moved when you hear the how and why these people came to set up or be involved their groups. But it was truly uplifting to hear about their successes, to see how seriously they were taken by the HCPs at the meeting and to understand how deeply committed they were to sharing best practice and supporting other patients with ITP and their families.

It would be great … to see other formal opportunities for patient groups and HCPs to share best practice and learning, and to look at life from the other’s perspective – there were some real ‘lightbulb moments’ at the sessions I attended.

And finally …

The ITP meeting was a watershed for me, coming at the end of a year of closer contact with rare diseases. It inspired me to find out more about Eurordis and to do my bit in the social media that I use to promote its aims. Ultimately, it inspired this blog.

I realise that this is (another) long post – and there’s still plenty that I’d like to say (perhaps another time) – but before I finish I particularly want to mention @Rose_arr and @pjbjib, who follow me on Twitter (@jytricker). They have family members with rare diseases and they’ve been asking me to sign a petition (wh.gov/OMR) to improve state funding for treatments for rare diseases in the USA. I’m not a US citizen, so I don’t think that I can sign it. This, then, is my next best thing, using social media to be an extra voice for the cause – I hope that someone reading this will sign the petition.

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

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My freelance medical writing and editing work in 2011

Another year, another retrospective. I said at the start of last year’s retrospective that I tend to have a lot of variety in my work, and, as if to prove a point, 2011 was completely different from 2010!

The year started at a frantic pace. In the space of 9 weeks I did some consultancy work for an established client preparing for a big pitch, some more regulatory writing (patient narratives), assembled a core slide deck on photodynamic therapy, complete a position paper on the treatment of non-melanoma skin cancer with authors drawn from an advisory board, proofread an issue of Human Genomics, and edited an issue of a cardiovascular journal, a manuscript for my Italian clients, some web copy and a drug monograph (for a new client).

The major difference between 2011 and 2010 was that I spent 8 months working under contract for a local agency here in Kent. I was covering for an editorial team leader while she was on maternity leave – giving me the opportunity to manage a team for the first time since I went freelance. This was my first experience of working in a big agency with a formal structure, which was very different from the very small agencies that I usually work with.  It also provided an opportunity to help mentor some junior writers just starting on their careers, their enthusiasm was invigorating. The team had a wide portfolio of clients and products to support, providing a range of materials for publication and presentation in different media. There was some travel to attend advisory boards, conferences and client meetings and even some filming with a key opinion leader talking about a clinical trial he’d taken part in.  I wrote copy for three websites (two on acute lymphoblastic lymphoma [ALL] and one on haemophilia) and I also wrote a few apps – my first foray into that medium.  It was a very busy 8 months, and I had a great time and made lots of new friends and contacts.

Since finishing the contract I’ve been just as busy with an equally broad range of writing and editing work in urology, neurology, haematology and gastrointestinal cancers, adding two more clients to my roster in the process. This work will take me through to February, and after that – well I’m looking forward to finding out!

Social media

I’ve been very pleased with the performance of my website – www.freelancemedicalwriting.co.uk – it has generated a number of leads – from pharmaceutical companies to publishing companies to academics, mainly in the UK but also from across Europe. I’ve been particularly pleased with how it is performing for search engines, but a target for 2012 will be to find ways to improve its page ranking.

I have links in to and out of www.freelancemedicalwriting.co.uk to my Twitter account (@jytricker), to my LinkedIn profile (http://uk.linkedin.com/in/jytricker) and to my blog site, Trickerish Allsorts (https://trickerishallsorts.wordpress.com). I’ve significantly expanded my contacts/followers on LinkedIn and Twitter this year, but have not published as many blogs as I’d wanted to – although the reason for that was my workload, so I don’t feel too bad. More frequent blogging is another target for 2012, then.

Old-fashioned networking

I do enjoy getting together with fellow medcomms professionals and I went to a number of excellent events in 2010. These included several organised by Network Pharma (www.networkpharma.com) – a training session on the revised ABPI guidelines (since revised again!), a symposium on open access publishing and an evening with Guardian columnist  Ben Goldacre MD (see my Access all areas blog: http://wp.me/p15PpZ-1t and www.badscience.net) at which we discussed transparency in biomedical publishing. I went to my first European Medical Writers Association (EMWA) meeting in November and enjoyed getting together with fellow freelance writers from across Europe as well as catching up with some friends and acquaintances from the UK industry and undertaking some training in regulatory writing. December saw me at the European meeting of the International Society for Medical Publication Planning (ISMPP) – another great opportunity for training, catching up with old friends and meeting new contacts. One of the things I most like about ISMPP meetings is the high attendance from the pharmaceutical industry and publishers – it was good to talk to them directly.

CMPP

On the subject of ISMPP, a personal highlight for me was gaining that organisation’s accreditation as a certified medical publications professional – meeting an important standard for ethical publishing in the biomedical sector and achieving one of my goals for 2011 in the process.

2012

It’s going to be an extraordinary year in many ways – particularly here in SouthEast England – but in terms of work I will be happy to have more of the same in 2012. I am due to be attending the European Association of Urology meeting in Paris at the end of February – and I’m very much looking forward to that. Thereafter the year is a blank page. Fingers crossed for another good year though.

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#Womanspace – still a story of our time?

The British Sex Discrimination Act came into force in 1975. Sadly, it was not soon enough for my ‘A’ level chemistry teacher, who, despite her first class degree from a good university, had been unable to get a job in industry because she was a woman. The mere existence of the Act does not eradicate discrimination, of course. Over time, it has certainly proved useful in blatant cases of discrimination, but low level, almost unconscious, bias against women has proved more difficult to overcome, as Nature helped to demonstrate quite recently.

At the end of September 2011, Nature published a science fiction story entitled ‘Womanspace’ by Ed Rybicki in its ‘Futures’ section (http://www.nature.com/nature/journal/v477/n7366/full/477626a.html). This ‘story’ – which the section editor makes a point of saying is based at least in part on actual events – recounted an incident in which Dr Rybicki and a friend, who were discussing a book on virus structure at the time, were sent by his friend’s wife to the supermarket to buy knickers for their school-aged daughter, leaving her in peace and quiet to cook dinner. Dr Rybicki explained their subsequent failure to find the knickers on a difference in shopping strategy between men and women:

Men hunt: that is, they go into a complex environment with a few clear objectives, achieve those, and leave. Women, on the other hand, gather: such that any mission to buy just bread and milk could turn into an extended foraging expedition that also snares a to-die-for pair of discounted shoes; a useful new mop; three sorts of new cook-in sauces; and possibly a selection of frozen fish.’

As I read that, I was conscious of a sinking feeling in my stomach. The next paragraph did nothing to improve matters, by appearing to exclude a majority of women from its intended audience:

‘Have you never had the experience of talking to your significant female other as you wend your way through the complexity of a supermarket — only to suddenly find her 20 metres away with her back to you?’

I just want to remind you at this point, that this piece was approved by the editorial team at Nature.

Although subsequently Dr Rybicki was keen to establish that his wife is a professor of virology and vaccinology, and that his friend’s wife is an astrophysicist, in his story the only roles for women are parent, cook and shop assistant. Women play no obvious role in the formulation of a theory on the existence of parallel universes, which the two men arrive at based on their experiences in the supermarket.

Depressingly, as evidenced by his subsequent responses to outraged comments on the ‘story’ from men and women, Dr Rybicki genuinely seemed not to understand why anyone would find it offensive and/or upsetting. He intended it to be humorous. Women of his acquaintance, he said, found the story funny.

Had he been able to read a paper by Sharon Haynie and six fellow female chemists in Chemistry Central Journal (http://ow.ly/7mkNG) before he wrote his story, perhaps Dr Rybicki would have had second thoughts. Published in support of the International Year of Chemistry’s goal of celebrating the contribution of women to science, the paper described the path these women took as they pursued careers in chemistry through the second half of the 20th century and the early part of the 21st.

What Dr Rybicki would have learned from their stories is that his idea of humour is just a little too close to home for many women who have chosen to make a career in science. It was a little too close to home for me.

When I started my degree there were no female lecturers in the department of chemistry; our only female lecturer came from the maths department. At my first tutorial in inorganic chemistry the tutor provided the group (consisting of me and two male students) with some advice on writing essays: ‘They should be like a woman’s skirt’ he said ‘long enough to cover the bare essentials but short enough to be interesting.’ Humourous? Not when you’re a woman sitting opposite him.  Then there was the head of department at a blue chip chemical company who told me that one of the reasons he couldn’t give me a job there was that some of his team leaders (all men) would not have women on their teams. Later on, I apparently missed out on a chance of promotion because instead of sticking around at the end of the day to chew the fat with other senior members of staff, I dashed off to collect my daughter from day nursery.

I’m guessing that I’m of an age with the women who tell their stories in Chemistry Central Journal – there were many aspects of their journeys that seemed familiar to me. Not least the belief that things are better now than they were in the past.

Coming back to ‘Womanspace’, which, in my opinion (and aside from everything else) was not very well written and not very funny, there are a few positive comments after the story. One is from Dr Rybicki’s wife and the others are from young women. I have to take some hope from this, because I presume it means that they haven’t experienced a downside to being a woman in science – and I sincerely hope that they never do.

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

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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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Filed under Medical Writing