Dial 911: Emergencies in Medical Writing (Open Session 21)

by Amy Karon

Nearly every seasoned medical writer can recall clients and contracts that evolved into the stuff of nightmares. Maybe endless requests for revisions are eating into your sleep time. Or perhaps you realize a high-profile faculty member is self-plagiarizing.

Stay in the profession long enough and scenarios like these are bound to make you hold your head at times. But there’s help. At the 2012 AMWA conference, Scott Kober, MBA, CCMEP,  and Anne Jacobson, MPH, CCMEP, reprised their popular open session on emergencies in medical writing.

Using digital keypads, attendees anonymously chose how they would handle a variety of problems. Lively discussion followed. Here we summarize those debates and dilemmas.

Scenario 1: Your work from long-term clients is drying up after more than 20 years of freelancing. Do you really need a web presence?

You do need a consistent and varied online presence, said Kober and Jacobson. But there are two ways to go about it—by dipping your toes, or going all out.

More cautious medical writers might start by creating their own simple website and LinkedIn profile. Others might hire a marketing and social media consultant to help develop a brand, website, detailed LinkedIn page, and professional Twitter account.

Whichever way you go, your website should include a resume and some sample writing or editing projects. If you’re under a nondisclosure agreement, keep that in mind. Some writers create pieces specifically for their online portfolios.

Scenario 2: Your last client burned you. How do you vet a new one to prevent this from happening again?

“My first-line approach is to e-mail people whom I trust,” Jacobson said. “Luckily, I know a lot of freelance medical writers whom I can vet clients through." She said she tends to avoid asking for feedback from members of AMWA's online discussion groups.

Kober and Jacobson also suggested crafting a checklist of the kinds of clients and projects you want. This will help you develop a broader perspective on whether prospective clients fit your business goals.

Scenario 3: You discover an author whose review article you’re editing is recycling chunks of text from a previous article. Whom do you tell, and how?

Make your client aware of this taboo practice and consider proposing a solution, said Jacobson and Kober. But don’t approach the faculty member yourself. Let the client handle it.

Be aware that copyright infractions can come back to haunt writers, they added. “Some faculty don’t even realize that self-plagiarism is a problem,” said Jacobson. “When this has happened to me, usually the remedy is just to rewrite (a piece) because it obviously can’t go out as it is.”

If a client tries to say self-plagiarizing is all right, rewrite the piece anyway and then don’t take any more work from the client, Kober said. Participants also suggested ensuring clients know that journals use software to detect plagiarism and copyright infringements and that such infractions can result in their being blacklisted.

As for red flags for plagiarism, watch out if a manuscript’s first draft is clean, with perfect punctuation, Kober said: “Plug it into Google and see what comes up.”

Scenario 4: You have a major deadline in three days and your father has been rushed to the emergency department. His physician thinks he’ll be okay, but has to run some more tests.

Do you go and bring your work? Tell your client you can’t make the deadline?

“Mild emergencies come up all the time and you find yourself schlepping your work all sorts of places,” said Jacobson. “The real question is whether to alert your client that there could be a problem. It depends on the client and the relationship.”

But from a client’s perspective, Kober said, “I would want to know as soon as possible. There is nothing worse than hearing on the day of the deadline, ‘Oh, I’m sorry, my dad has been in the hospital for a week and a half.’ I’m sympathetic, but I also wonder why you didn’t tell me before.”

Others recommended giving clients the names of three people they trust to get the work done.  Communication is critical, they agreed – let the hiring manager or the client know right away that you are working at a hospital. Most will appreciate the heads up and adjust their expectations accordingly.

Scenario 5: A client asks you to cover the cost of purchasing full-text references, which is not the norm. Do you renegotiate your contract?

Kober retrieves needed references for freelancers, but encourages them to get what they can on their own. “Ideally, from a client’s perspective, it would be great if we didn’t have to dig up references for you and find them.”

Said Jacobson, “When a client is nickel and diming you about project costs, they are unlikely to be willing to renegotiate a project fee.” She suggested searching on PubMed and restricting access to free, full-text articles. “Open access sources are now pretty good,” she added. “Every once in a while, I spring at the last minute for a $30 reference for a big project.”

Participants noted that AMWA membership includes access to MD Consult. Alumni organizations also sometimes offer limited journal access, and entering the full title of the article in quotes in online search engines also sometimes yields a PDF.

DeepDyve also offers lets you “rent” full-text articles for small amounts of money, members added, although you can’t print or save them to your computer.

Be careful about downloading PDFs and giving to clients, participants added; that can be seen as illegally selling them.

Scenario 6: A client is asking for many more revisions than expected. You are being paid for the extra time, but you’ve taken on other scheduled projects and this one is now keeping you up nights and weekends.

Think about how much you want to keep this client, Kober and Jacobson advised. If you don’t want to work with him or her again, consider politely extracting yourself by explaining that your contract does not include project management. You can also try to renegotiate for more money per hour.

Another approach: Say that you have taken on other projects because the plan did not include this much extra time.

Attendees also suggested building milestone payments into bigger projects so that at the end of 6 months, you’re not crossing your fingers hoping the client doesn’t refuse to pay (because you finally drew the line at further revisions) or goes bankrupt.

Scenario 7: You are writing multiple needs assessments for the same client on the same topic. Can you reuse your work?

“If you’re not willing to turn a blind eye to a faculty self-plagiarizing his own work, how are you willing to turn a blind eye to yourself?” Kober said.

Added Jacobson, “Once you have already done the mental work of understanding the same disease states, it is easier to crank it out. You do have an obligation to submit original material.”

But try for a bit of wiggle room when working with the same client on certain projects, Jacobson suggested. For example, agree to write updated needs assessments for the same client, rather than reinventing the wheel each time.

Scenario 8: After 5 years of full-time freelancing, you’ve decided to take a job. You just interviewed for what seemed like a terrific position, but half the interviewers did not show and no one explained why or followed up. Do you give the company the benefit of the doubt?

Jacobson said she is working on noticing red flags and steering clear of clients and companies who raise them.

“There are far too many employers who think they are doing an employee a favor by giving them the time to talk to them,” added Kober. “It’s a slap in the face. It’s rude and disrespectful.”

One option: Write a courteous letter to human resources explaining what happened and your disappointment. HR departments often appreciate hearing this, participants said. But don’t address your letter to the people who didn’t show up to the interview!

Scenario 9: You (in a client’s role) hire a freelance who checks out and has great references and clips, but turns in awful work. What do you say?

Attendees said they definitely want to hear feedback. Kober said he makes it a personal rule to give it. Jacobson recommends asking for an edited version of a document. If a client is constantly changing a certain word, for example, you can modify your writing style for that client accordingly.

When hiring and applying for work, require and send raw copy, suggested participant Debra Gordon. She added that she plans to send clients an anonymous SurveyMonkey questionnaire so they can provide honest feedback on her work without worrying about jeopardizing their business relationship.

Should the Skull Be an Inviolable Zone of Privacy?

Keynote Speaker Focuses on Bioethics

by Faith Reidenbach

“We are becoming cyborgs,” one of the founders of neuroethics, Dr. Paul Root Wolpe, told the large audience assembled for his keynote address on Thursday morning. He wasn’t playing on the fact that AMWA’s conference falls near Halloween this year. As an increasing number of people use artificial organs to survive, prosthetic limbs to move, or brain waves to communicate, we are becoming “semicreated creatures,” Dr. Wolpe said, and the accelerating pace of these advances “may induce a phase change beyond which we can predict nothing.”

By juxtaposing photos, Dr. Wolpe demonstrated that a real-life woman who has a brain implant for a neurologic disorder looks remarkably like Star Trek Captain Jean-Luc Picard after he was assimilated by The Borg. And just as Picard discovered when he battled the Borg Queen, “our last great freedom”—the freedom not to reveal the contents of our minds—may someday be in jeopardy. Using functional MRI, scientists at Carnegie Mellon University have taken a baby step toward mind reading:  they have shown that they can identify the unique brain activation patterns generated when a person thinks of any one of dozens of nouns. Later, with about 75% accuracy, they determined what noun a person was thinking of, even nouns their computer model had not encountered.

Dr. Wolpe explained that according to other studies, brain imaging can distinguish traits, such as extroversion versus introversion; whether a person has racist attitudes; what languages a prisoner of war can read; a person’s intentions on a very simple level—the intention to add or subtract; and whether a person is more likely than average to engage in violent behavior.

“Should the skull be an inviolable zone of privacy?” he asked. The emerging field of what he calls neuroprivacy exemplifies that ethics is much more than an inquiry into right and wrong. “Ethical consensus is a social, evolving process in which the media plays a primary role.”

Dr. Wolpe also discussed “cosmetic” neurology. Reporting that 20% of scientists acknowledge using a psychostimulant such as Ritalin, Adderall, or modafinil, he posed the question of whether use of this drug class should be required of professionals such as pilots and surgeons. Other examples of cosmetic neurology are the use of propranolol for memory suppression, research by Nobel Laureate Eric Kantel on memory enhancers, and, much more questionably, the use of oxytocin spray as a “trust inducer.” What are the ethical implications of spraying Liquid Trust on flowers given to a girlfriend?

Turning to the hot-button issue of prenatal genetic testing, Dr. Wolpe said he is not opposed, but that scientists should own up to the fact that “it’s eugenics” and talk about how to manage the consequences of the testing. For example, he pointed out, a disease such as cystic fibrosis might be cured by the time a child with the CFTR gene reaches reproductive age; should a fetus with the gene necessarily be aborted?

Medicine will become a “risk management system,” he predicted, with individuals receiving long printouts of their genetic profiles. Not all parts of the profiles will relate to disease; for example, some scientists believe there are genetic markers for criminal behavior. “What do we do with that information?”

In all of these areas, “the science is running way ahead of the ethics,” Dr. Wolpe said. The goal should not be to hurry to arrive at cut-and-dried decisions; rather, what’s needed are “robust ethical conversation with people representing different points of view.”

Dr. Wolpe encouraged listeners to visit the home page of the Center for Ethics at Emory University, which he currently directs. At Emory he is the Asa Griggs Candler Professor of Bioethics; Raymond Schinazi Distinguished Research Professor of Jewish Bioethics; and professor of medicine, pediatrics, psychiatry, neuroscience and biological behavior, and sociology. Dr. Wolpe also serves as the senior bioethicist at NASA (National Aeronautics and Space Administration). He is co-editor of the American Journal of Bioethics (AJOB) and editor-in-chief of AJOB‒Neuroscience. He sits on the editorial boards of more than a dozen professional journals in medicine and ethics. Dr. Wolpe is a past president of the American Society for Bioethics and Humanities, a fellow of the Hastings Center, and a fellow of the College of Physicians of Philadelphia, the country’s oldest medical society.

Related Links
Dr. Wolpe's Web page
Dr. Wolpe on "60 Minutes"

AMWA and Ethics

If you look through the AMWA annual conference program, you may notice one word appearing again and again.

Ethics.

It’s there on the very first page, where AMWA President Melanie Fridl Ross mentions the role of medical communicators in upholding the highest ethical principles

It’s there in the title of the keynote speech: Re-creation: Ethics and the Biotechnological Restructuring of Life, which is to be delivered by Paul Root Wolpe, PhD, a professor of bioethics at Emory University and director of Emory’s Center for Ethics.

There are the open sessions, “Clinical Trial Ethics: Placebos and Other Issues,” and “Publication Ethics: Moving Beyond Authorship.”

There are the workshops:

• Preparing CME Materials: Concepts, Strategies, and Ethical Issues
• Ethics of Communicating Regulated Drug Development Activities
• Ethics for Regulatory and Research Communicators
• Fundamentals of Ethics and Practical Application
• Ethics for Science and Medicine Communicators
• Ethical Standards in Medical Publication

A self-study course “Essential Ethics for Medical Communicators” is also being launched at this conference.

I had an opportunity recently to speak with Cindy Hamilton, a past president of AMWA, who teaches some of the ethics workshops and has been a driving force in AMWA’s increased emphasis on ethics.

Listen to the Audio Interview With Cindy Hamilton.

Of Sin, Salvation, and the Relationship Between Physicians and Industry

by Faith Reidenbach

I sent Dr. Thomas Stossel, winner of this year’s McGovern Award, a telepathic message before his speech. “Talk about ACRE, talk about ACRE,” I chanted mentally. He didn’t disappoint—in fact, as it turns out, his entire speech concerned ACRE’s research and advocacy work.

Thomas P. Stossel, MD, is a co-founder of ACRE, the Association of Clinical Researchers and Educators, which is “dedicated to the advancement of patient care through productive collaboration with industry and its counterparts,” according to its Web site. “ACRE seeks to define and promote balanced policies at academic medical centers and within government that will enhance rather than interfere with our highly valued collaboration.”

One might say that the group is making waves by swimming against the incredibly strong current of disapproval for “conflicts of interest” (COI) in the pharmaceutical industry. That very term has become code for “corruption,” Dr. Stossel said. All commercial research and promotion is now suspected of being corrupt, investigators’ relationships with industry are considered to bias their research, other physicians’ relationships with industry are thought to cause them to become “hooked” and prescribe the company’s drugs more often, and all gifts and payments to physicians are considered fundamentally unethical.

In a luncheon speech provocatively entitled “Commercialism in Health Care--Sin or Salvation?” Dr. Stossel argued that these allegations are weak in substance or even false. He asserted that no relevant, valid evidence exists for commercial bias in continuing medical education (CME). In addition, he claimed, “Most citizens think physicians and industry should work together.”

The “toxic” policies on COI have costs, Dr. Stossel emphasized. Pharmaceutical companies that lose a lawsuit about off-label marketing, for instance, can be debarred—banned from doing business with Medicare and Medicaid. Rather than risk that devastating outcome, the companies pay huge sums to settle lawsuits, which diverts resources from research and development of new drugs. Other costs of COI policies include inhibition of collaboration between physicians and industry, elimination of physician training opportunities (due to elimination of unrestricted company grants for fellowships), compromised innovation, and decreased funding for CME.

Dr. Stossel’s speech was rapid-fire and contained some inflammatory words, such as his “demonization list” of practices that he said “confuse evidence with arbitrary preferences.” One item on that list was ghostwriting. “True ghostwriting doesn’t happen very often,” Dr. Stossel charged, faulting the “ghost police” for blurring the definitions of ghostwriting, enforcing overly rigid definitions of authorship, and adopting a romanticized concept of scientific publication as the sharing of new truths, neglecting more pragmatic motivations such as the need to get a job promotion or “get a signal out over the noise.”

Dr. Stossel is a distinguished hematologist who has served as president of the American Society for Clinical Investigation, editor in chief of Journal of Clinical Investigation, president of the American Society of Hematology. He is now editor-in-chief of Current Opinion in Hematology. Tom Gegeny, last year’s AMWA president, confirmed with me that Dr. Stossel received the McGovern Award for these contributions as well as for his work with ACRE. That award is presented in recognition of preeminent contributions to any of the various modes of medical communication.

Dr Stossel is founding scientist and a director of Critical Biologics Corporation, which is developing what may be a life-saving treatment for severe infections based on his patented discoveries. He is also a director of Velico (formerly Zymequest) Corporation, which is developing another of his research projects into an improved method for storing blood platelets for transfusion. He previously served on scientific advisory boards of the Biogen and Dyax Corporations.

Related links

Stossel TP. Has the hunt for conflicts of interest gone too far? Yes
BMJ 2008;336:476.

Lee K. Has the hunt for conflicts of interest gone too far? No. BMJ  2008;336:477.

Meeting the Needs of Tomorrow’s Medical Writers: AMWA’s Expanded Professional Education Program

by Victoria White

A shorthand way of describing members of AMWA is to say that we are either writers learning to become scientists or scientists learning to become writers. That is a great description, as far as it goes, but if you are involved in designing a professional education program to meet AMWA members needs, it doesn’t take long for things to become much more complicated.

Where are you in your career? Who is your audience? What is your therapeutic area (to use that two-word combo that seems so common at these meetings)? What skills are you lacking? Are you familiar with current ethical standards? And stats, what about stats?

AMWA’s workshop-based education program debuted in 1979. In the past year, AMWA has unveiled an updated program that is designed to offer a wide range of workshop options in key areas of interest to medical communicators. For existing members, there is a new lingo to learn. For new members, well, they also have a lingo to learn.

In Open Session 3, moderated by Douglas Haneline, panelists Lawrence Liberti, Susan Aiello, and Dane Russo explained the new system.

In a nutshell: Members who have been working on core, science fundamentals, and advanced certificates under the old system can generally continue to do so. New members should look to the updated curriculum.

In the new system, the Essential Skills curriculum will be the place to start. Essential Skills courses will provide a basic grounding in editing, writing, communication, and bibliographic skills. An ethics workshop, which is being taught for the first time at this year’s conference and will be available toward the end of 2011 in the distance-learning format, is required for earning a certificate.

A visionary keynote address

Dr. Karen Woolley is the first AMWA keynote speaker in my experience who is one of us--a medical writer. And what a medical writer she is! In addition to running a large medical writing firm based in Australia, she is internationally engaged in advancing our profession through teaching, research, and advocacy for higher educational and ethical standards.

In her talk Thursday, Karen outlined 3 major problems facing medical writers, especially those of us who work on journal manuscripts:

• Lack of evidence that we add value to our projects and are ethical
• Lack of a truly international approach to training
• Isolation from other stakeholders, particularly journal editors

For each problem, she suggested actions that the profession can take and actions that individual members can take.

To address the first problem, Karen urged members to compete for the new award AMWA created for original research by AMWA members. The research must explore the value added by medical writers and editors and must be published in a peer-reviewed journal indexed by PubMed. The winner will receive a $2000 honorarium. (For more information, look under "What's New?" on the AMWA home page.) Aside from competing for that award and the new student research award, individuals can help by learning the rules of medical publishing, especially the AMWA Position Statement, Good Publication Practice for Pharmaceutical Companies (soon to be updated), and the Uniform Requirements for Manuscripts.

Even more emphatically, Karen called on us to reject ghostwriting assignments, because short-term financial gain for individuals is creating long-term professional pain for everyone in the profession. “That has got to stop,” she said. She urged us to use the PLoS Medicine checklist to document the specifics of our collaborations with authors.

As part of formal research, Karen and colleagues have investigated manuscript retraction rates to identify contributing factors. They presented some of this research at last month’s 6th International Congress on Peer Review and Biomedical Publication. One critical issue, Karen believes, is lack of training in medical writing. Effective training needs to be available globally, given that clinical trials are booming in sites such as China and India.

Ethics, ethics, and more ethics

A major theme coursing through the sessions at this year's conference is the importance of ethics in medical communication. That's not a surprise, given that there has been considerable media attention in recent months to the issue of ghostwriting of biomedical research papers.

AMWA has long advocated that contributions of medical writers should be acknowledged in scientific publications. The organization is seeking to spread the word about best practices.

AMWA's position statement
The American Medical Writers Association (AMWA) recognizes the valuable contributions of medical communicators to the publication team. Medical communicators who contribute substantially to the writing or editing of a manuscript should be acknowledged with their permission and with disclosure of any pertinent professional or financial relationships. In all aspects of the publication process, medical communicators should adhere to the AMWA Code of Ethics.

More information is available at the AMWA web site. On the home page, follow the links under the Ethics and Medical Communication heading.

R-E-S-P-E-C-T

Karen Woolley delivered an impressive keynote speech titled "Getting Respect--Two Steps Forward and?" She addressed head-on the challenges of banishing the practice of ghostwriting in medical communication and the critical importance of ethics in medical writing and editing.

Woolley is the CEO of ProScribe Communications, and an adjunct associate professor at the University of Queensland, University of the Sunshine Coast, Australia.

The blog will have more on the speech later. Full coverage will be available in the AMWA Journal. The speech was audiotaped and will be posted at a later date in the members-only section of the AMWA web site.

Articles referenced by Woolley in her talk:

Gøtzsche, PC et al. What Should Be Done To Tackle Ghostwriting in the Medical Literature? [Authors include Karen Woolley and Cindy Hamilton, 2008-09 AMWA president.]

Woolley, KL. Goodbye Ghostwriters! How To Work Ethically and Efficiently With Professional Medical Writers.^*