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The Public Library of Science (PLOS) announced that it has launched a new website called PLOS Currents that is intended to serve as a vehicle for the rapid publication of scientific research and new ideas and themes. Not surprisingly, the first theme for PLOS Currents is influenza. On his Virology blog, Vincent Racaniello, a BioCrowd cofounder and prominent virologist, discusses why PLOS Currents is important and timely for scientist actively engaged in influenza research and vaccine development.  

The opening of PLoS Currents: Influenza was announced by Harold Varmus, Chairman and Co-Founder of PLoS. He wrote about the reasons for starting this website at The Official Google Blog:

The key goal of PLoS Currents is to accelerate scientific discovery by allowing researchers to share their latest findings and ideas immediately with the world’s scientific and medical communities. Google Knol’s features for community interaction, comment and discussion will enable commentary and conversations to develop around these findings. Given that the contributions to PLoS Currents are not peer-reviewed in detail, however, the results and conclusions must be regarded as preliminary. In time, it is therefore likely that PLoS Currents contributors will submit their work for publication in a formal journal, and the PLoS Journals will welcome these submissions.

Contributions that will be welcome at PLoS Currents: Influenza include research into influenza virology, genetics, immunity, structural biology, genomics, epidemiology, modeling, evolution, policy and control. The manuscripts will not be subject to peer-review, but unsuitable submissions will be screened out by a board of expert moderators. This policy will enable rapid publication of research.

The path to publishing original scientific research is often long and tortuous.  A manuscript describing the findings is prepared and submitted to a scientific journal (such as Nature, Cell, Journal of Virology). The manuscript is assigned to two or three expert reviewers, generally scientists involved in the same area of research. If their reviews are favorable, the paper is published. Usually additional experiments are called for, which may require additional time to complete. Many months to a year may pass before the paper is published, although some manuscripts (e.g. those on 2009 pandemic influenza) may be expedited. The point is that PLoS Currents: Influenza will allow everyone – including non-scientists – to read about research soon after the authors have prepared the paper.

PLoS Currents: Influenza is a terrific idea, and I welcome this venture with great enthusiasm. I hope that PLoS Currents will grow to include other areas of science. But Varmus warns:

Given that the contributions to PLoS Currents are not peer-reviewed in detail, however, the results and conclusions must be regarded as preliminary. In time, it is therefore likely that PLoS Currents contributors will submit their work for publication in a formal journal, and the PLoS Journals will welcome these submissions.

During peer review of submitted manuscripts, new experiments may be suggested that change some of the conclusions of the research. Hence, the papers that appear in PLoS Currents: Influenza may be different from final versions that are published elsewhere.

I wonder how other scientific journals will react to submissions of manuscripts that have appeared in PLoS Currents. Many journals do not accept manuscripts that have already appeared elsewhere. For example, the instructions to authors for the Journal of Virology state:

By submission of a manuscript to the journal, the authors guarantee that they have the authority to publish the work and that the manuscript, or one with substantially the same content, was not published previously, is not being considered or published elsewhere, and was not rejected on scientific grounds by another ASM journal.

It’s time for scientific journals to change this policy, and allow for preliminary publication at sites such as PLoS Currents.

Rapid and open-access publication will drive research forward and help inform and educate the public about science.

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People who become scientists spend many years learning how to design, conduct, collect and analyze data from the experiments that they conduct. The ultimate goal of this seemingly endless exercise is to craft peer-reviewed publications that either support or refute the underlying hypotheses used to initiate the experiments in the first place. As part of our training, we are repeatedly reminded that it is our obligation to fastidiously and accurately report the results of our experiments and to assume “full ownership of the manuscripts and publications" that we author. The idea of allowing a person who didn’t participate in the design or execution of the research, to craft a manuscript for peer review is something that is virtually unheard of in the scientific community and, in the minds of some scientists, tantamount to scientific misconduct or fraud.

Physicians, on the other hand, who don’t learn how to conduct research or write scientific papers during their medical training, are frequently poor writers and have a little or no time to spend on writing scientific or medical manuscripts. Because of this, it is not uncommon for physicians who conduct medical research on behalf of pharmaceutical, biotechnology and medical devices companies to hire medical writers to write manuscripts for them. In fact, many physicians who work with pharmaceutical and biotechnology companies prefer and expect this arrangement. So, why the recent commotion over medical “ghostwriting”?

Drug companies typically hire medical communication agencies to develop and craft manuscripts that showcase the results of clinical or research studies that they have conducted. These companies will usually provide an agency with background information about a study, a research summary, clinical study reports, ideas or titles for proposed manuscript and a list of prospective authors (usually physicians who performed the studies on behalf of the company).  Medical writers, who are either employed by the agency or work as freelancers use these materials to craft a detailed outline for the proposed manuscript. After the outline is completed, the agency usually shares the outline with physicians who were named on the list to determine who may be interested in authoring the publication. After an author is identified, the medical writer works closely with the author to develop a first draft of the manuscript. After the draft is reviewed by the author, changes are made to the draft, a revised version is circulated and the process is repeated until all stakeholders are satisfied with the manuscript. Once the publication has been copyedited and undergone legal and regulatory review it is submitted for peer review.

For the record, in my five years as a medical writer, I have never encountered a situation where the primary author doesn’t have final say over what will and won’t appear in a manuscript. When scientific, medical or business disagreements do arise, the author(s), medical writer and company representatives usually negotiate mutually-agreed upon solutions. Rarely, have I seen a company remove an author from a publication because his/her views or interpretations of the data were not consistent with those of the company that sponsored the research. The reason why drug companies and medical communication agencies have recently come under fire for their “ghostwriting” practices is because they have repeatedly failed to disclose that many of their publications were written by medical writers —whose names didn’t appear anywhere on the publications. Although this practice still exists, it is no longer as widespread or commonplace as it once was. These days, the names of medical writers who author manuscripts routinely appear in the acknowledgement sections of many scientific and medical publications. Moreover, in some instances, a medical writer may be able to garner co-author status on a publication —depending upon his/her level of involvement in the project. 

In my opinion, there is little difference between graduate students, postdoctoral fellows and medical writers when it comes to preparing manuscripts for publication. It is not uncommon for the names of PIs, supervisors and others to appear as authors on publications even though their contribution to a project (or preparation of a manuscript) has been limited or nominal at best. Consequently, I fail to see any credible legal or ethical arguments against hiring a medical writer to write manuscript on behalf of an “author” as long as the “author” can demonstrate that he/she actively participated or was intimately associated with study design, conduct or analysis. Finally, to maintain the integrity and transparency of the medical writing process, it is imperative that medical writers who prepare manuscripts on behalf of study authors should be acknowledged or credited with “authorship” somewhere in a publication.

Until next time….

Good Luck and Good Job Hunting!!!!!!

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Fellow blogger, Jacob Goldstein, over at the WSJ Health Blog posted a story today about a prominent hypertension researcher who was approached by a medical communications agency about  putting her name on an abstract (she did not participate in the research) that was being prepared by the agency for a pharmaceutical client. According to the Health Blog, the researcher was so outraged by the offer that she decided to go public about the alleged “ghost writing” incident. I have no doubt that the story is accurate.  That said,  I think that a comment posted to WSJ’s blog about the story sums it all up nicely:

 “So, this is some new revelation for the WSJ? There are plenty of studies in the medical literature which have been ghost written by an industry-sponsored medical writer, that was then submitted under the name of a highly-recognizable leader in the field–always at a steep price”.

As much as I hate to admit it, the person who posted the comment is right--sort of. Although ghost writing was commonplace in the medical communications industry as recently as a few years ago, the practice is no longer tolerated at most medcom agencies, and, perhaps more importantly, by the would-be authors whose names ultimately appear on the publications. That said, medcom agencies and their clients must remain vigilant in their attempts to eradicate ghost writing entirely so that all medical communications are written (and published) in the most scientifically-sound and ethical manner.

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