Ghostbusters

Much of the negative press surrounding ghostwriting predates the significant effort in recent years to ensure that professional medical writing is used in ways that are ethical and transparent and that can ultimately be of significant benefit to the healthcare community. In this virtual roundtable, Communiqué spoke with thought leaders in medical communications to get the whole story.

How would you define ghostwriting vs legitimate professional medical writing?
Julia Ralston, President and CEO, MedErgy HealthGroup, and president, The International Society for Medical Publication Professionals (ISMPP): “There is a very clear distinction. Professional medical writer support is provided in full consultation with the authors from the very beginning of the manuscript development process. Indeed, authors have full editorial control of the content, and medical writers provide assistance as required or directed by the authors. The other key element is that any professional medical writer support must be fully disclosed. Ghostwriting is typically characterized by situations in which ‘authors’ are added after a manuscript is developed and when medical writer support is not disclosed.”

Carolyn S. Clark, president, Peloton Advantage: “Ghostwriting is not involving the author. It’s rewriting the literature or the clinical data. It’s writing a manuscript and then looking for someone to put their name on it. Agencies today really don’t do ghostwriting. It’s something that keeps popping up in the press, but many of the cases that they refer to are old.”

Daniel J. Donovan, founder and president, UBC-Envision Group: “There is a huge difference between ghostwriting and legitimate medical writing. There has been a lot of negative publicity around the life-sciences industry and suggestions that they ghostwrite. It’s blown completely out of proportion and refers back to practices that took place 12 or 15 years ago. These old stories get picked up every so often and then hit the presses as if it’s some great new finding. Things have definitely changed for the better, but the lay press and even sometimes the medical press continuously refer back to the ‘same old, same old,’ trying to make it all sound new… The difference is ghostwriting is when an editor or writer is not identified as having contributed to the development of a manuscript. If we are being transparent in the development of manuscript or poster or abstracts, then there is no ghostwriting. We’re saying right upfront that this person contributed to the development of this manuscript and her participation was funded by whoever the client is. We’re very open and transparent about how we do our work.”

Thomas P. Stossel, MD, American Cancer Society Professor of Medicine, Harvard Medical School, and co-founder, Association of Clinical Researchers and Educators: “Ghostwriting is one of the slogans used by the industry-bashing industry. Do politicians write their own speeches? No. But they take responsibility for them. The only activity that I would concede is actually ghostwriting is if I put my name on something, whether I do it for pay or not, and I haven’t taken any responsibility. I haven’t done the work, I haven’t read the thing and I haven’t contributed anything.”

Bob Norris, Founder and President, Complete Healthcare Communications: “As long as there’s no ghost, it’s not ghostwriting. As long as you get rid of the secrecy part, then there’s no such thing as ghostwriting.”

What is the legitimate role of professional medical writing?
Clark: “A professional medical writer doesn’t start writing a draft until there’s been a full download by the author as to what should go into that manuscript. Once they develop that draft, there’s a fair amount of revising that goes on, with the author’s involvement from that first draft to submission. A lot of authors now, depending on where they are affiliated in terms of an academic institution, have to write their own draft, so the role of the medical communications agency is helping make sure it’s in the right style, has the right word-count, it’s got the right format for submission, and generally completes the checklist.”

Norris: “It’s our job to make sure that our client’s data gets into the New England Journal of Medicine, but also to make sure they stay off of the front page of the Wall Street Journal. Especially for the smaller or midsized companies that don’t have the staff or the people-power to make sure that they’re all on the right side of the issues and the guidelines, it’s very much part of our job to make sure that they and their authors are (in compliance). Our role as professional medical writers is to work on behalf of the authors to fully disclose the role that we had. Our role is to make sure that we portray in a balanced, appropriate, fully disclosed manner anything that we’re working on on behalf of an author, and as long as that happens, then there is no such thing as a ghost. Some people would take things to the extreme and say that we should get rid of professional medical writers, but I think that’s an improbable outcome. If you do that, then the data, which is most important, is not going to get out there as quickly or as well written. A lot of clinicians are great researchers but not great writers.”

Are there particular areas of confusion when it comes to the press’ and the public’s understanding of medical writing?
Norris: “Disclosure of who did what on a paper and the transparency of the data itself are two very, very different issues and sometimes people get confused. The true transparency of who made what contribution to a peer-reviewed manuscript is easy. It’s just making sure everyone knows who’s been involved, and then the journal decides what they want to publish and make available to their readers to make their own informed decision. That’s a very different issue from the transparency and the distribution of the data that comes from the study, and I think there have certainly been some egregious examples of where that has been an issue, but they are few and far-between. I think that at times people gather those two issues up into the same concept, and we’ve got to be careful to stress that those are two very different things. It’s certainly pharma and the investigators’ responsibility to make sure that all the data is available when the study is being analyzed and the manuscript is being written, but that’s a different issue from the transparency of who did what with the paper.”

Stossel: “There’s a romanticized concept of writing motivation, which is that you only write a paper when you’ve made some great new discovery. If a company decides to hire a writer to help an opinion-leader write a review on the use of a certain product, there’s nothing wrong with that...The muddle gets caused by people who make pronouncements without understanding how research and writing get done. There’s a huge nuance of subtly and diversity in the way research gets done. In the real world, we have to be practical. Let’s restore common sense.”

What, if anything, has changed over the past 10 years in terms of ensuring transparency and high ethical standards in medical writing?
Donovan: “Have things changed in the past 10 years? Definitely. But that’s not to say that there was anything subversive going on 10 years ago. It just wasn’t necessarily general practice to identify everyone who had contributed to the process, and that’s different now. The industry is leading the charge. Since I started my company in 2001, I’ve been personally involved with the development of policies and processes for a dozen or maybe 15 life-science companies, and every single one of them has stipulations about who qualifies as an author, how you identify those who have contributed and how they are acknowledged, even down to the point where they require specific language to be used to identify who did what in the development of the manuscript.”

Ralston: “I don’t think it’s fair to say that medical writing was ever conducted unethically. Quite simply, there was not historically a requirement to disclose professional medical writer support. Now, the profession considers this standard, regardless of whether the journal requires such disclosure or not. ISMPP has joined other organizations, and also endorsed the June 2010 report from Senator Grassley’s office, calling for full transparency in medical publications.”

Clark: “There’s nothing like key messages anymore. It’s not a PR piece, it’s a scientific communication on the clinical data or a physician’s impression of what needs to be communicated in treating a disease. I’ve never worked with any client or any organization that engaged in PR. There are PR companies for that. There are many pharma companies that have taken leadership positions in ensuring good publications practice and that have been involved with the GPP1 and now GPP2 guidelines, which map out the process of using good medical writing from the very beginning to the final submission, as well as the role of the author in driving that manuscript...We were a founding member of ISMPP, which was created five years ago because there was a need for an organization that really drives the ethical creation of scientific publications. ISMPP involves pharma companies, agencies, journal editors and publishers and is looking to expand into academic institution authors. It’s really a collaboration between all those major parties and stakeholders that drives the true scientific quality of a manuscript.”

Norris: “I think the industry certainly has sinned in the past -- not nearly as much as folks perhaps believe, especially outside of the industry, but it’s our job to make sure that we’re cleaner than clean and that everything is fully disclosed. I think there wasn’t ever an intention to mislead, but I do believe that there is very much an intention now to fully disclose. I think that part has gotten better for everyone. The pendulum may now have swung, as it often does, way too far over to the other side, but at the end of the day it’s our job to make sure that what we’re doing is always accurate and fully disclosed.”

Are there ways in which the pendulum may have swung too far?
Stossel: “If you read the pronouncements that medical journals come up with, they’re way overblown, this idea that the author has to have conceived of the project or materially contributed to it. Another issue has to do with access to the data and control of the information. When Pfizer or Merck has done a trial in 27 countries that involves a vast number of different activities, there’s no way that everybody can have control of all the data. That’s an unrealistic view of responsibility for content...And the whole conflict-of-interest question has just gone way overboard. The onus should be on the skeptics to prove that what the writer writes is spun.”

What changes are still to come?
Ralston: “Changes still to come would involve universal acceptance of the need for disclosure of medical writing support. While we know that the core of the profession now routinely discloses involvement of professional writer support, we assume there are still those, perhaps less aware of today’s standards, who do not recognize this practice.  Likewise, it would be good to see a change whereby critics acknowledge that progress has been made, and that guidance and standards are now in place that represent best practices today.”

Norris: “Things are moving toward more standardization between journals’ requirements. The ICMJE (International Committee of Medical Journal Editors) has certainly helped to make the guidelines from journals more consistent, but there’s still an awful lot of difference between journals. Some journals want certain information disclosed, while others do not. Our stand as a company and ISMPP’s stand has been to provide all the information that anyone might want to know, and let the journal decide what they want to use or not...Getting the journals to take the responsibility to ensure that their authors and readers know and can follow clearly their guidelines is one aspect. I think helping all investigators to know what the rules are is another important part of the puzzle. Certainly, investigators who are very well published are cognizant of what’s going on, but those who maybe do an occasional study here or there or a secondary author might not be as aware as others.”

Clark: “ISMPP is probably still a little bit more heavy on the agency side, but not much. It’s becoming more of a 50-50 split between agencies and companies. We’re doing a big push now to look at every pharma company that we have a business card from or have heard about, making sure they get an email blast to encourage them to be a member of ISMAPP. If you’re not a member of ISMPP, you should become a member. If you’re working with an agency, check to see that the agency is a member of ISMPP.”

What can be done to ensure a more balanced portrayal of medical writing in the press?
Stossel: “There’s only one side of the story being told, and this is to a large extent the fault of the industry, and even the writers. The industry should say, ‘We want to continue to work with academics to improve communications, and we have to rebut the accusation that this is somehow corrupt.’ Writers have to be willing to say, ‘Yeah, I got paid to do this, because I’m good.’ Not everybody writes well, not everybody writes promptly, so if people who are good writers and will do it in a timely manner are getting paid, that’s social benefit.”

The Author
Kate Fodor, Editor, Communiqué