The Biotech Ink Insider

February 27, 2009  |  Vol. 2 No. 6     Published by Biotech Ink, LLC

Inside the Insider

Medical Writers in the Crosshairs

by Brian Bass

 
Once again, the issue of the use of medical writers who work with physician authors to develop manuscripts for publication in medical journals rears its head in the media, in an article published in the December 12, 2008 issue of the New York Times and in an article published in the December 13, 2008 issue of Wall Street Journal.  
The articles cite an investigation by Senator Charles E. Grassley into whether pharmaceutical giant Wyeth recruited and paid physicians to put their names on journal manuscripts that were already written. This particular situation is just one part of an ongoing investigation by Senator Grassley, a member of the Senate Finance Committee who is trying to determine what, if any, influence the pharmaceutical industry has on physicians.   An unfortunate consequence of this article is the naming of a reputable medical communications firm, whom Wyeth hired to assist with the creation and placement of these journal manuscripts and, indirectly, the suggestion that such firms-and the medical writers they hire-inherently engage in unethical practices when crafting manuscripts.  

While pharmaceutical companies are in business to make money, the suggestion that medical writers and medical communications firms are inherently unethical couldn't be farther from the truth. Have questionable and possibly deceptive practices taken place in the past? I'm sure they have. Once upon a time, it was perfectly acceptable to keep the contribution of medical writers invisible. More recently, the contribution of medical writers has come out of the shadows and begun to be rightfully acknowledged. Of course, with this acknowledgement comes responsibility-including the responsibility of medical writers and others who contribute substantially to the content of a manuscript, to report any potential conflicts of interest. Today, medical writers and medical communications firms must adhere to strict guidelines when it comes to creating journal articles that report on the outcomes of clinical trials that will appear in reputable medical journals.
 
An unspoken issue here that has been overlooked relates to the skills needed to write an accurate yet readable manuscript. Writing is a skill, one that some folks have innately, but one that others must learn. Writers know how to write; physicians know how to diagnose and manage diseases. As writers, we must have a solid understanding of the science behind what we are writing, but we rely on the expertise of the physicians with whom we work to direct us and keep us on track. Likewise, physicians must have a solid understanding of what they want to communicate, but they rely on medical writers to construct informative and understandable prose. It can no more be assumed that a physician can write than that a teacher can cook. Medicine and writing are separate skills with separate prerequisites.
 
Every pharmaceutical company has a medical writing department with writers who create documents to very precise standards. Medical communications firms exist to assist pharmaceutical companies with those tasks. Such medical writers are skilled at organizing medical information and making complex scientific information readable and understandable. In the same vein, pharmaceutical companies hire statisticians to crunch the results of clinical trials and identify significant trends and outcomes. We've never understood why it's perfectly acceptable to use statisticians to assist physicians in the content of their manuscripts, but unacceptable to use a medical writer to assist physicians in putting their thoughts coherently on paper.
 
Let's not allow the valuable contributions of medical writers to be thrashed in this controversy. Instead, let's use this as an opportunity to advance the call for all medical writers who are involved in the development of manuscripts for publication in medical journals to be acknowledged for their contributions and held to the same standards of quality and ethics as physician authors.

Article Resources:
 
AMWA Position Statement on the Contributions of Medical Writers to Scientific Publications: http://www.amwa.org
New York Times article: http://www.nytimes.com/2008/12/13/business/13wyeth.html?_r=1
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About the Author
 
  Brian BassBrian Bass
Co-Author of The Accidental Medical Writer
Web: http://www.theaccidentalmedicalwriter.com
 
For more information on this subject, check out the AMWA Position Statement on the Contributions of Medical Writers to Scientific Publications (AMWAJ).

The Accidental Medical Writer is for everyone who is frustrated with working for someone else. For everyone who wants the freedom and security that freelance medical writing can help them achieve. Visit our website at the link above for information, inspiration, strategies, lessons, and tips to help you become a successful freelance medical writer, too.

What Makes a Good Medical Writer?

by Amr Y Eissa, MD, MPH 
 
In the field of technical writing, medical writing is a highly specialized subset that is currently in very high demand. The purpose of the medical writer is to efficiently and effectively communicate concepts in complex medical and scientific disciplines. While anyone can put a lot of data on a page, an accomplished medical writer can make those data relevant, concise, and easily understood. Medical writing is about successfully disseminating information to a varied audience in a wide diversity of formats. Such writers must use a combination of science and research skills to present information in a way that is most useful to the targeted reader.

Essentially, there are two types of medical writers: scientific and marketing. Scientific and marketing medical writing are divergent career paths.

Most often, scientific medical writers have a science background and learn to successfully write. These writers normally gravitate to doing serious scientific or technical writing for professional audiences.
Marketing medical writers often come from a background of journalism or English, and learn the intricacies of medicine on the job. The assignments characteristic of this type of writing are marketing oriented and target consumers or lay audiences.

Further, medical writing may also be classified as educational or regulatory.

Educational medical writing may involve documents about devices, drugs, vaccines, and genetic advances. These documents are intended for general information or specific audiences, such as healthcare workers. Examples include data presentations for conferences, drug benefits for sales representatives, articles for medical journals, or material for continuing education (CE) and continuing medical education (CME).
Regulatory medical writing is used to create documents destined to be submitted to regulatory agencies in support of drug, biologic, and/or medical device product development. Regulatory documents can be very large, and their content is rigidly controlled by local and international laws and guidelines. Information of this type may summarize data acquired in developing a new drug, a report on a clinical study, a patient informed consent form, or an investigator brochure.

During preparation for their careers, few plan to become medical writers. Those who are successful have several characteristics in common.

One of the foremost skills necessary to being an effective medical writer is having a good working knowledge of medicine and science, or an aptitude for quickly understanding medical and scientific principles. Many employers require a scientific degree (e.g., medicine, biology, or chemistry), or possibly a masters degree or doctorate. This educational requirement is of greater importance if the writing to be done is scientific medical writing. However, if the project is geared more toward marketing medical writing, a degree in English or journalism may suffice.

Another necessary asset is the ability to write. Although it is unnecessary to be the next F. Scott Fitzgerald, writing clearly and appropriately for the intended audience is essential. The quality of medical writing may have enormous bearing on the regulatory approval of a new drug or requirement for more clinical testing before approval. Poor-quality documentation can lead to substantial costs to companies through lost revenues and/or unnecessary duplication of efforts. Well-written medical documentation is instrumental in decreasing product approval times and lengthening the lifecycle of a product, as well as producing superior product labeling and promotion. Characteristics of good medical writing documents are accuracy, detailed research, sound methodology, readability, adherence to regulatory laws and guidelines, and concise and logical thought processes.

It is also essential to have good interpersonal skills. Whether working on a team or soliciting information outside the company, medical writers must be able to interact well with others to obtain timely and precise information. This ability is critical in producing quality work. Examples of these skills include diplomacy, the ability to motivate others, and cooperation with diverse personalities.

Although it is important to work well with others, it is equally important to be able to work autonomously. Having the initiative to foresee possible roadblocks or independently research ancillary information makes for a better document, and can be benefit the client or employer by saving time and money.

Equally vital is the need for the medical writer to be deadline oriented. Meeting project deadlines and deliverables, on time and on budget, is essential in fostering the employer's or client's confidence. This saves money and can prevent revenue loss due to unnecessary delays. Similarly, the medical writer should be able to work well under the pressure of tight deadlines and insufficient team member input.

In addition, effective medical writers must have good attention to detail. Whether reviewing and editing documents or spotting important points in raw data, the value of this skill is extremely high.

For today's writer, it is important to be current on computer skills. Chiefly, the ability to use a word processing program like Microsoft Word is critical. If a more detailed and complex document needs to be created, it may be helpful to be proficient in a program, such as Adobe FrameMaker. When it comes to research, familiarity with search engines (for example, Google and Yahoo), is indispensible. There are also specific web sites tailored for medical research, such as Healthline and Medical World Search. These and similar sites can be very valuable to the writer in finding information.

Finally, as with any successful career path, there must be a passion for medical writing work. Medical writing is a great career. The work can be very interesting and financially rewarding, and the demand for accomplished medical writers has never been higher. The healthcare field is virtually guaranteed to experience dynamic growth for the foreseeable future; those who can supply vital medical writing and editing support will always be in demand.

Many excellent resources for medical writers are available on the web. Here are just a few:
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About the Author
 
Amr Y. Eissa, MD, MPH
ICG Inc.
2021 The Alameda, Suite 220
San Jose, CA 95126
 
(408) 247-8000 x107  Direct
(408) 892-1000  Mobile
(408) 247-8000  General
(408) 247-8900  Fax
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