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WHAT'S THIS?
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FREELANCE SPOTLIGHT << Clement Weinberger
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An interview with Catherine Rees
Published 8 January
The practice of publication planning and freelance medical writing has come under growing attack in recent years, with claims that many of the medical articles published in peer-reviewed journals are not really objective reports of clinical trials, but sophisticated marketing exercises orchestrated by pharmaceutical companies in order to promote their products.
A particular practice deplored by critics is so-called ghost-writing, where pharmaceutical companies — usually via intermediary service providers called medical communication companies — pay freelance writers to produce papers for physicians, who simply add their name to the end product. These articles, claim critics, overstate the efficacy of the sponsoring company’s drugs, and downplay any negative aspects. Some estimate that as many as 12% of the medical papers published today have been ghost-written.
Medical writers respond by pointing out that many of the examples cited by critics date back 10 years or more. Since then the industry has cleaned up its act. Moreover, they add, allegations of ghost-writing don’t always stand up to scrutiny. In September 2009, for instance, Reuters published a story implying that freelance medical writer Catherine Rees had ghost-written a paper for a professor of clinical pharmacy at the Philadelphia College of Pharmacy. This, responds Rees, is simply not true. Her contribution was clearly acknowledged at the outset.
Below Rees, a freelance medical writer based in New Zealand, and proprietor of Rata Communications, explains how the Reuters story got it wrong. She suggests, however, that if the medical communications industry really wants to demonstrate that it is sincere about its new commitment to ethical standards and transparency it needs to become more media savvy, and end its culture of silence.
THE INTERVIEW BEGINS...
Q: As I understand it you started out studying medicine, took an English degree, after which you became a medical writer. You also provide marketing services to pharmaceutical companies, and worked for a number of years for the medical communication company ADIS Communications (now InScience Communications)?
A: That is correct.
Q: Can you briefly talk me through your career to date?
A: Essentially I developed a career in medical publishing because I had two quite disparate degrees and it seemed like the logical direction to take for someone who had studied both science and English. I started out working on a product that reviewed the current literature in particular areas, and then moved on to do medical communications for the same company.
Q: ADIS Communications?
A: Yes. I started my medcomms career in Australia, in the Sydney office of ADIS — where I worked for four years. Later I returned to New Zealand for family reasons and took a job doing medcomms there. This included work for South East Asian clients, so I travelled a lot to South East Asia. We principally did work for the regional offices of the pharma companies in Singapore and Hong Kong, working with a lot of regional advisory boards.
Q: And today you are freelance, and run Rata Communications. Effectively this is you and a colleague called Ruth Williams?
A: Right. While I was at ADIS I managed a team of writers who were based in New Zealand but did writing work for the US, the UK and the Japanese offices. They used us instead of freelancers as a way of saving money, and maintaining expertise within the company.
Then I worked in the US for a couple of years. During that period I found it quite difficult to find really good freelancers, so I thought I could use a similar kind of outsourced model as ADIS had used to provide writing services from New Zealand for overseas clients — providing high quality writing at a potentially lower cost than they would be able to access locally in the US. That was the objective of Rata Communications.
Q: What range of activities do you undertake at Rata Communications: writing obviously, but also perhaps marketing, publication planning etc.?
A: We don’t do a lot of publication planning — that is something medcomms companies tend to keep within their local offices — but I have written one or two plans while at Rata. Most of the work we do for our American clients is writing — the kinds of things you would do for a tactical plan, including primary research papers, abstracts and posters, and review articles.
But I do have Australian medcomms agencies as clients, and that work is a little different, more marketing work than publications. This is not so much advertising but working at the promotional end of the medcomms spectrum. For instance, we do detail aids, patient information leaflets, and I have just written some direct-to-consumer advertising copy.
I also have a Southeast Asian client, and I have been running training workshops up in Asia, teaching the local doctors how to write for publication.
Q: Medical writing appears to me to be surprisingly broad in scope. I have seen mention of congress abstracts, clinical papers, case reports, editorials, letters, comments, posters, slide kits, etc. etc. And then there are primary research and review papers. What do you mainly write?
A: There is no one thing that I write mostly. As we get more diverse clients, the variety of work increases. I have been in this business so long that I have done pretty much everything there is to do within the spectrum, so there is little I can’t turn my hand to, including electronic media.
What I like about this business is that there is such a broad range, so it is never boring and there is always something new coming along — a new type of writing to turn your hand to, or a different therapeutic area to work on.
Q: If a member of the public were to ask you what the aim and purpose of what you do is, how would you answer?
A: I usually say that we provide medical writing services to communications agencies that have pharmaceutical companies as their clients. At that point most people’s eyes glaze over and they don’t want to hear any more.
If they do want to delve, I just describe the spectrum of activities that we engage in, explaining what sort of material we receive from our clients and how our role is to turn that material into readable, accurate copy able to be published.
Q: If they were to ask why anyone needs to read this material, and who the audience is, how would you reply?
A: I would describe the different audiences we have, and stress that the ultimate audience, the end reader, is usually the physician. Essentially, our aim is to explain to physicians in an interesting way things that are relevant to their clinical practice, taking turgid scientific material and making it relevant and interesting to them.
Q: Why do they need to read this material?
A: For different reasons. Above all, they need to read it in order to keep their scientific knowledge up to date. All physicians would acknowledge the need to do this, and they read medical journals routinely in order to maintain their clinical knowledge. That would be the primary reason why they would read the papers we help to write.
The aim is also to inform them about particular products, how they work, and how they can be used in a doctor’s clinical practice — explaining, for instance, the risks and the potential benefits of those products.
TYPICAL DAY
Q: Talk me through a typical day for you.
A: During a typical day I will probably be writing a clinical paper or, if it is for a more local client, writing something marketing oriented.
I usually start work at about 8:30 in the morning and work through until 3 pm, when I get the kids from school. If things are hectic I will usually get up early and try to do some work first thing in morning before seeing the family off — maybe 5am.
But I always try to stop at 3pm. I can work in the evenings, but it is hard. I am not a night person, and I like to put my feet up after dinner.
Q: Who normally commissions you to writer papers? Who are your clients?
A: Mostly medical communications agencies. I have worked directly with a pharmaceutical company, but I work mostly for medcomms agencies. And from an outsourcing point of view I think that works best. It helps the pharma client to have somebody on the spot that they can pick up the phone and talk to when they have questions.
That allows us to work synergistically with the medical communications agencies: We can do the ground work, and they can then finesse it and make sure it has all the quirky things that their clients — the pharmaceutical companies — expect or like in a paper. And they can front to the clients.
Q: Can you explain to me the process of how a typical paper might get written: Who do you liaise with? How many steps are there in producing the paper? And
what happens in each stage?
A: As a freelancer I can enter the process at any stage. So I may not be the one who starts the article — the outline may already have been written and they just need somebody to incorporate the author’s feedback and put the first draft together. Other times I might simply be asked to incorporate some comments and move the article on to the next stage.
Q: How does it work if you are asked to start the process of writing an article?
A: If I start from scratch — which I quite often do — and it is a primary research paper I will usually be given a clinical trial report, or a protocol and the results as a statistical output. I will then usually have a conversation with the medical communications agency, and ideally the author as well.
Q: What do you discuss?
A: I will talk through with them the key results, and how they want to present them, plus what they see as the objective of the paper. I will then put together an outline with some key references and send a draft to them.
Once I have received the comments from the author on that I will put together the first draft of the article, which will include some figures, tables and references, plus all the other things required by the journal. The draft will then be sent out for review by the author and the clients, after which I will incorporate their comments. The same process will then be repeated during several rounds of reviews before the paper is ready for submission.
Q: How might the process differ if you were working in a medcomms office rather than sitting at home as a freelancer?
A: The role would be different but the job would be pretty much the same. When I am sitting here in New Zealand, for instance, I am thinking about all the things that I would have thought about when I was in the medcomms company. I think about good publication practice, and I think about following the publication guidelines, and the journal and author instructions — all of the elements that you have to bear in mind in preparing an article.
One thing that is a little different is that in order for the people who receive my work at the other end to better figure out why I have done what I have done I will add explanations and comments. So, for instance, if I have presented the data in a different order to how it is presented in the clinical trial report I will explain why. I do this because I am writing from a distance so they cannot just pop into the next door office and ask me. So I will try to add an explanation to anything I think might spark a question in their heads.
Q: One of the writers I spoke to previously — Clement Weinberger — told me that medical writing appears to be the only way in which freelance writers can earn a decent living today. Are you able to say how much you earn writing a paper?
A: I would rather not say what my hourly rate is, but when I went freelance I based it on what I knew was the going rate for a freelancer in the US, and then discounted it. While the cost of living is not necessarily any lower in New Zealand the cost of labour is. Essentially I wanted to make myself competitive with American-based freelancers.
That said, when those rates are converted into New Zealand dollars I find I am earning a lot less today than I was this time last year — because the American dollar is weak right now. I would estimate my income has gone down by about one third as a result of that.
Q: In a recent PLoS Medicine article Adriane J. Fugh-Berman reported that ten years ago Wyeth was paying $25,000 for the articles it sponsored. That is a lot of money. How are costs like that justified?
A: That will have been the price that the medcomms company charged. And the cost will be at that level because a medcomms company has to account for every moment of time spent on producing an article. They will have people working with clients on the account management side, and on the project management side, and they will have others fact checking, and providing editorial assistance to style manuscripts for submission. All in all, there will be a great many people working on a paper — and that time has to be accounted for on top of the cost of hiring medical writers.
Bear in mind also that a medcomms company will have overheads to pay for on office, including its power and phones etc. When a pharmaceutical company engages the services of a medcomms company it will have to fund some of these fixed costs.
BAD PRESS
Q: Publication planning and medcomms companies have had a lot of bad press in the past few years. Why do you think that is so?
A: Because in the 1980s and early 90s the industry didn’t have the same ethical standards as it has today, and I think there were some pretty dodgy practices in the past. And while the industry has really cleaned up its act, its reputation has unfortunately been damaged, and perception is reality in many ways. Essentially, we made ourselves an easy target by not being as upfront about our involvement in pharma-sponsored publications as we currently are.
This has led, for instance, to a lot of allegations about ghost writing. In the past many of these allegations may have been justified, so the industry is struggling to reverse the bad impression it acquired with the media.
Q: Indeed, as you say many of the allegations are about ghost-writing. Tell me, when you write a medical paper do you always know when and where it is published?
A: Sometimes clients are kind enough to let me know when the paper has been published, and perhaps they will send me a copy.
But that is the exception rather than the rule. Once you finish working on a paper you generally don’t hear again from your clients again in connection with that paper. That means that if I want to show an example of my work to another client I usually have to hunt it down myself.
But you have to bear in mind that medical writing is a collaborative process. So all the words in the paper are not your words, but words produced in collaboration with the authors and others. By the time that paper is published it is not necessarily the same article that you originally wrote.
As a freelance medical writer you don’t have control over the final text, and you don’t choose which journal it is published in or how your contribution is acknowledged.
Q: Presumably therefore you cannot always know if your name has been attached to the articles you work on?
A: Well I always assume that it has been. I would say that all of the clients I work with in America at least have some very clear policies about following ethical publication practices, and so acknowledging any contribution made by a medical writer. Certainly I always insert my name when I write the first draft of a paper.
However, if the paper is worked on extensively by a writer within the medcomms company, then it may be their name that appears in the acknowledgement.
Q: When you contacted me proposing this interview you referred me to a September 2009 Reuters article in which it was implied that you had been complicit in the ghost-writing of a paper published in the Journal of Managed Care Pharmacy (JMCP). The journalist who wrote the article, Brendan Borrell, had spoken to the editor of JMCP Frederick Curtiss, who seems to have alleged that there had been something untoward in the way your paper was submitted to JMCP: that your involvement had been hidden, and that you resisted his request that you be named. Citing Curtis, Borrell wrote: “Curtiss says Rees did not wish to be a co-author.” Is that accurate?
A: No. That is not accurate. Curtiss is wrong, and how could he know what I wanted anyway? I’ve never had any direct contact with Dr Curtiss so I just don’t know how he formed that impression.
Q: So what did happen?
A: When the paper was submitted I was acknowledged as a contributor, so it was clear to the journal that a medical writer had been involved, and there was no way my contribution was not indicated. We also followed all the journal regulations in terms of financial disclosures.
My understanding from the correspondence I was copied into was that, after the paper had been submitted, the journal contacted Dr Spinler, the only listed author at the time of submission, and asked her to provide a quantitative analysis of my contribution. They then came back and said that under their authorship guidelines I should be listed as a co-author. We said, fine put me down as a co-author.
Q: That fits with what Curtiss told me when I emailed him. He said to me, “JMCP is diligent in determining the qualitative and quantitative contributions of all contributors to JMCP manuscripts in our attempt to assure full disclosure for your readers”. That is a reasonable objective isn’t it?
A: Yes it is.
Q: Curtiss also said: “The JMCP Author Guidelines and our policies regarding disclosure including our author attestation forms are available on the JMCP webpages on the AMCP web site.” If you read the author guidelines it does seem clear that the journal takes the view that anyone who has made a contribution of at least 25% to a paper should be listed as an author. I assume therefore that Curtiss was signalling to me that you did not follow those guidelines, and so you were being economical with the truth.
A: Ok, I see. But it was not me that put the submission package together. The medical communications company did. And I didn’t complete the authorship forms either.
Q: You had been commissioned by ADIS Communications; consequently it will have been ADIS that did that?
A: Yes, I think so. So I don’t know if there was a failure to submit an authorship form when the manuscript was submitted. I do know however that one was completed, and it was on the basis of that that the authorship attributions were changed after submission to include me. From my perspective I don’t think we did try to hide anything. However, I don’t know the order in which events occurred.
Q: As you say, the sole named author at the time of submission was Sarah Spinler, a Professor of Clinical Pharmacy at the Philadelphia College of Pharmacy. Dr Spinler faced some criticism after the Reuters article. (E.g. here). Was that criticism justified?
A: Well, I stopped reading some of the blogs after a while. From my perspective the criticism wasn’t justified. Dr Spinler was pretty frank with the journal when she was asked to specify my contribution.
Actually, during the course of our developing the paper she herself invited me to be a co-author with her — this was prior to submission. But at the time I turned her down.
Q: Why?
A: When you are a medical writer you never have the expectation of being a co-author, although you do expect that your contribution will be acknowledged. That is the basis on which your services are contracted. That is not to say that I wouldn’t want to be named as a co-author, but I didn’t feel it was my place as a freelancer to jump in and become an author. I also wasn’t sure that the client would approve of that course of events. I just said, “Thanks that’s very kind of you; but no thanks; I am happy to be acknowledged.”
So I was delighted that she asked me, but I felt it wasn’t the right thing to do.
Anyway, so far as your question as to whether the criticism of Dr Spinler was justified — from my perspective I don’t think so. She was a delight to work with, and we worked extremely collaboratively on the paper, and she was very, very thorough in her analysis of all the data. Her comments were also very thoughtful. In fact, it was one of the most rewarding and collaborative author relationships that I have had. For that reason I feel sad that she received a lot of criticism.
CONFLICT OF INTEREST?
Q: Which pharmaceutical company sponsored the production of the paper?
A: The client was Daiichi Sankyo.
Q: So let me get this clear: you were commissioned to write the article by ADIS, but it was paid for by Daiichi Sankyo?
A: That’s right. But I should stress that I was just contracted to write the article, so the financial relationship between ADIS and Daiichi Sankyo is not something I can really comment on.
Q: The article you were commissioned to write was what is called a literature review?
A: Yes.
Q: What is the purpose of a review article?
A: To provide an overview of the scientific literature on a particular subject. Essentially it is a synthesis of the science, and of a particular area — with the aim of giving doctors an overview and saving them the time of having to read every single paper themselves.
Q: Your task in that article was to synthesise multiple papers that had been written about a drug called prasugrel, which is an anti-clotting agent used to help people with heart trouble. Prasugrel was developed by Daiichi Sankyo, the company that paid for you to write the article?
A: Yes. It was a systematic literature review. I put prasugrel into PubMed and pulled up a list of every paper that had been published on prasugrel. I then looked at them and selected the ones that I thought had the best quality research in them, and then I wrote about those.
I also reviewed the FDA report on the drug that the Cardiorenal Drugs Committee produced during their deliberations about registration.
Q: The paper also makes comparisons with a competing drug called clopidogrel — a drug marketed by Bristol-Myers Squibb and Sanofi-Aventis under the trade name Plavix. Is that right?
A: Correct. That was the current standard of care that prasugrel was compared with during phase III trials.
Q: The article concludes, “Available data suggest that prasugrel offers potential as an alternative to clopidogrel with greater efficacy but with increased bleeding risk in patients with ACS [acute coronary syndrome] who receive PCI [percutaneous coronary intervention]. Data are not yet available to define the efficacy and risk-benefit profile of prasugrel in patients not undergoing PCI.” Can you explain in layman’s language what you are saying in that conclusion?
A: Basically it is says that within a patient population that have undergone a PCI the key clinical data and primary efficacy outcomes for prasugrel come out in favour of prasugrel, but there was more bleeding in particular patient subgroups. From memory (I haven’t looked at the data for a while, and I am sure there have been further announcements since then) I think these patient subgroups were those who had had a stroke, elderly patients, and patients who had a low body weight. We pointed out that these subgroups have a particularly high risk of bleeding.
Essentially what we were saying was that if you have a patient who is not thin, not old, and who hasn’t had a previous stroke, and they are having a PCI, then prasugrel might offer better efficacy than clopidogrel. If, however, your patient hasn’t had PCI — if, say, they have had thrombolysis or some other intervention for their acute coronary syndrome — then there is no data available to enable you to make a determination as to whether prasugrel would be better.
Q: I wonder if a member of the public might not feel it to be odd for a pharmaceutical company to pay a freelance writer to produce a scientific paper that discusses its product in comparison with the product of a competitor; a paper moreover that concludes that the sponsoring company’s product is likely to be more effective that the competing product. I would think they would feel that a conflict of interest must inevitably arise from doing so. Would you agree that there might be a conflict of interest issue here?
A: Because I received payment?
Q: Because a pharmaceutical company paid you to produce an article that talks about its own product, compares it with a competitor’s product, and concludes that the sponsoring company’s produce may be more effective?
A: I can see that a layperson, or a member of the public, might feel it to be a little unethical. But I don’t see any conflict of interest for me per se. If anything, the conflict may lie with the journals that are willing to accept such a sponsored publication, while knowing that it may inform decision-makers.
With regard to the favourable conclusion, the comparison with clopidogrel was inevitable based on the fact that it is the current standard of care and the comparator in the clinical trials. There was no way to avoid making such comparisons when you review the data.
I also actually think the conclusion is careful not to overstate the benefits of prasugrel, or to oversell it. The benefit-risk is clearly spelled out and we (Dr Spinler and I) were careful to say that the data couldn’t be extrapolated to patients outside of those undergoing PCI.
So I think the conclusion is a fair representation of the data at the time, and someone reviewing the data and not being paid would probably draw the same conclusion.
Q: I’m not saying that there is an inevitable conflict of interest for you. I am, however, thinking that perhaps the reason why the industry has attracted a lot of criticism is because the public (and the media that report to the public on these issues) don’t understand what is going on, and inevitably find it hard to believe there is not some kind of conflict of interest.
A: I see that. And I think that is where our industry does really have an image problem. On the other hand, financial disclosures are made and it is stated quite clearly that the paper I wrote was a paid-for article. And since I am named as a co-author it is obviously not a ghost-written article.
In addition, we should note that medical papers all undergo the peer review process, and I think we have to have some faith in the ability of the peer review process to maintain scientific rigour and integrity in publications — even sponsored papers.
In the end, once the information about medical writer involvement and financial transactions has been disclosed, the journals must take some responsibility for choosing to publish sponsored articles.
Q: To go back to the Reuter’s story for a minute: as I understood it, the gist of the story is that medical journal editors are increasingly trying to stop ghost-writing, but they are often frustrated in their attempts to identify it. To help in this process Curtiss has been using what he calls “forensics” — examining the metadata in papers sent to him for instance. Borrell described the issue in this way: “Readers of his [Curtiss’] journal will primarily be determining which drugs are most cost-effective for inclusion in managed care plans, which means articles can have a significant influence on pharmaceutical profits. However, he cannot always count on authors to provide accurate disclosures, which is why he is often checking for authorship clues in the metadata.” You would agree that this is an important issue?
A: Yes, it is if you are trying to identify ghost writing. But how prevalent is it really? I have been reading a report on ghost-writing written by US Senator Charles Grassley where he suggests that ghost-writing is as prevalent now as it was 10 or 15 years ago. That is not my anecdotal experience. I think it is far less prevalent, and I think medical communications agencies are far more upfront about that kind of thing now.
I would like to have seen Brendan Borrell ask Dr Curtiss how often authors provide inaccurate disclosure information. Many authors who work with medical writers do not receive payment for their work, so Dr Curtiss may be assuming closer financial ties between the authors and company than there really are.
Of course the metadata will identify whether the paper has been reviewed by anyone at the pharmaceutical company, but these reviewers are often from the legal and regulatory teams, and their purpose is to ensure that the article does not make claims outside of what is scientifically or legally correct. So the presence of pharmaceutical company review of a paper (via the metadata) does not necessarily indicate promotional intent.
Of course the aim of a medcomms company is to ensure that the products of the pharmaceutical companies they represent are positioned positively within the literature — but only within the limits of what is scientifically possible. I mean, as a freelance writer I can’t make claims outside what has been found by research. We can’t change the clinical results.
Q: In the PLoS Medicine article I referred to earlier the author states that medical freelance writers are routinely asked to insert “marketing messages” into the papers they write. I think, at its most basic, that implies interpreting the data in a way that casts the sponsoring pharmaceutical company’s products in a favourable light, and downplaying any negative aspects. Have you ever been asked to include such marketing messages in a paper? Were you asked to do so in the paper on prasugrel?
A: Not marketing messages, but scientific communication messages (although I accept that in some ways these are similar beasts). A pharmaceutical company will want to highlight certain scientific features in their publications. Yes, it’s true that I have been asked to do that. And I assume that that will continue to be the case with any paper that has been developed by means of a publication plan.
Q: One thing that is strange to me is that, apart from a brief, somewhat cryptic, response to my enquiries, Curtiss has proved very reticent to talk further about the incident. When I emailed him he said, “Brendon Borrell wrote the news release independently, and it contains inaccuracies.” However, despite several attempts — both by email and telephone — I have been unable to persuade Curtiss to elaborate on this statement, or specify the inaccuracies he says the article contains. Why do you think he is so reticent to say more?
A: I really don’t know why he would be reticent. It could be any number of reasons: he might just want the whole thing to go away for instance.
Q: As I understand it, you believe that your decision not to speak to Borrell when he contacted you about the paper was a mistake. You said: “Looking back, I think the medical communication agencies’ fear of the press (and talking to the press) means that we do not communicate our position effectively, and our industry continues to struggle with perceptions of poor ethics left over from how we conducted business 10-20 years ago. Personally, I think we need to have our say, even at the risk of being misquoted. After all, ‘no comment’ is a blank slate on which a journalist can write their own interpretation of events, as happened to me.” So based on your experience you have concluded that medical communication companies and medical writers should be more open about what they do, and more prepared to talk to the press?
A: I do. I would certainly like to think that if I had talked to Brendan Borrell he would have seen that my paper wasn’t an example of the successful used of forensics, and so didn’t make the point he was trying to make in his article. Clearly it wasn’t an example of ghost writing because I ended up being a co-author. As I say, that’s what I like to think. I can’t be sure, of course, because you just don’t know how something is going to come out once it has gone through the journalist’s story development.
Nevertheless, I do believe that medical communications agencies and pharmaceutical companies should all have a spokesperson willing to stand up and say: “We don’t condone ghost writing, and we conduct ourselves ethically — in line with the standards established by international organisations.”
That said, the problem — and this is an issue that was discussed at the ISMPP [the International Society for Medical Publication Professionals] meeting this year — is that it is very hard to get a story out to the media that says the industry has cleaned itself up, that it now has clear guidelines in place, and that it is now almost universally conducting itself in a straightforward way because that is not a particularly newsworthy story. Certainly it is not as exciting as uncovering scandalous practices by pharmaceutical companies.
CULTURE OF SECRECY?
Q: Why do you think there is such a culture of secrecy in the industry — assuming you accept that there is such a culture?
A: I don’t know if it is a culture of secrecy. It’s more a reluctance to speak to the press based on the fact that there has been so much bad publicity in the past, and because there is potential for comments to be taken out of context, or misinterpreted by a journalist. That means that there is always the danger that even if you do explain your position it could still come out sounding bad.
So perhaps it is fear rather than a culture of silence. I know that ISMPP and AMWA [the American Medical Writers Association] and other organisations have tried to put our position forward, but they have not managed to get a lot of traction with the media. Meanwhile the pharmaceutical companies are probably just worried that they will become the next target.
Q: Nevertheless you personally think that there ought to be more transparency and openness in the industry?
A: I think we should be more open with the media yes. I would hope that those agencies that do conduct themselves ethically, and are not ashamed of how they run their business (which, as I say, is the vast majority today), will become more willing to speak to the press. In doing so they should be frank and open about what they do, and explain what is going on.
Q: You work in an industry comprised of freelance writers, physicians, medical education companies, journal publishers and pharmaceutical companies. Who do you think really drives the process of medical writing, and the way in which it is organised and practised?
A: Obviously at the end of the day it is the pharmaceutical companies that fund the industry, and the medical education companies are only able to exist because of the money they get from pharma companies. And the journals make money from pharma and from the medical education companies.
I haven’t worked on the journals side of the business, but from my experience working in a publishing company I would hazard to say that it is probably not the journals that are driving the industry. What really drives it is the synergism between the medical education companies and the pharmaceutical companies.
Q: I assume that one problem for anyone wanting to improve ethical standards is that it is very hard to police the industry from outside. In the case of ghost writing, for example, no one outside the small group of people that produces a paper will know whether a medical writer has been used unless an acknowledgement is attached to the paper. Likewise, it is not easy to know whether marketing messages have been inserted into a paper that are not entirely supported by the data. This is presumably exacerbated by the fact that, as you make clear, even some of those involved in the production of a paper will not know exactly what’s gone on. You say, for instance, that you assume but do not know that your name has been attached to all the papers you have produced?
A: Sure. But I don’t know how you would go about solving that problem. As a freelancer, I have no control over how the medcomms agency presents (or hides) my involvement to the pharma company or the journal. Journals could start demanding that all scientific messages are submitted along with the financial disclosures but, as I say, I don’t know what the solution is.
I would add, however, that I don’t think writers and medcomms agencies are inserting marketing messages that can’t be supported by the data.
Q: One of the other medal writers I interviewed for this series — Caitlin Rothermel — told me that horror stories like the one described in the PLoS Medicine article (concerning Wyeth) are historical events, and things have changed. That is also what you are saying. I note, however, that in the same interview Caitlin described a recent event where she had been, as she put it, asked to “shill” for a new product. I note also that in his article Borrell says, “A survey presented this week at the Sixth International Congress of Peer Review and Biomedical Publication in Vancouver found that 12 per cent of research articles in top medical journal studies failed to disclose authors who contributed substantially to the work. Those additional authors sometimes have financial ties to pharmaceutical companies, and critics say the resulting papers often interpret data about those companies' drugs more favourably.” What are your views on this kind of claim?
A: Personally I would think 12% sounds rather high. I know that Senator Grassley’s report estimates the figure at around 11%, and he quotes another report claiming that the figure hasn’t changed much over the years. But you know I can only speak about what I am doing, and I am somewhat removed from the agency environment and so not in a position to be able to guess. From my personal experience, however, I would say there isn’t a lot — if any — ghost writing, or the hiding of medical writer involvement, today.
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