August 28, 2014

Being the Ghost in the Machine: A Medical Ghostwriter’s Personal View

pin it button Being the Ghost in the Machine: A Medical Ghostwriters Personal View

ghost writing medical journals 300x199 Being the Ghost in the Machine: A Medical Ghostwriters Personal View

by Linda Logdberg
www.plosmedicine.org

Introduction

Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.

For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship.

What I Did

In line with the description on the American Medical Writers’ Association Web site about what medical writers do [1], I wrote slide kits, monographs, executive summaries, journal articles, backgrounders, newsletters, competitive analyses, publication plans, video scripts, audio scripts, and continuing medical education (CME) programs for physicians and nurses. Each piece (“job”, in advertisingspeak) was born out of the publications planning strategy developed for a fee by the medical education (meded) company for the pharmaceutical corporation.

Medical writers are highly deadline-driven. For one hormone patch product I worked on, writers and “creatives” were asked to remain at work until close to midnight to await results from physician focus groups on the West Coast. After receiving the client’s (i.e., pharma’s) take on the focus group results for that day, we rewrote the messages for the next day’s groups and sent them to the West Coast. A slide rose or fell on subtleties: in one slide kit draft in my files, an account executive added “Importance of early intervention” to a slide titled “Chronic Pain.” The bullet does not help define chronic pain, but it plants the idea that treatment should be started ASAP in the mind of the listener. Clients admonished us to always distinguish between “adverse effects” (for competitors’ products: Drug X could have caused the heart attack) and adverse events (our product: some patients taking Drug X just happened to have a heart attack).

Ghostwriting was a small, but real, part of my duties. I have seen published pieces that are virtually identical to the final drafts I submitted. Regardless of what I wrote, though, for many years I considered my role to be similar to that of a highly paid technician and did not question its ethics.

Why I Did It

My background may not have been typical for a medical writer, but neither was it uncommon. I enjoyed a research career up to the point where I no longer enjoyed it, which came a few years after receiving my PhD. Several things about an academic career did not encourage me to continue, although I loved research and working in the lab. These included the difficulty of getting tenure and the possibility of finding myself unemployed in my mid-40s: there were 12 newly hired assistant professors in the department where I did my second postdoc, with an average time to tenure of more than 10 years.

Ironically, though, it was the ethics of authorship that sent me fleeing academia. I ran afoul of a colleague in my last research position, who assumed that postdocs would draft his grant renewal application. I commented offhandedly one day, “Well, I for one would never write something and have someone else sign his name to it—that would be unethical.” Dr. X told me that that was when he realized that it would not work out for me to continue there, as my attitude was unacceptably insubordinate. Faced with the need for a job, I resigned and answered an ad in The New York Times for a company that needed medical writers. This began a series of freelance and in-house jobs with a range of medical communications companies.

I believe that many of the factors that kept me in medical writing apply to most medical writers. First, I believed that I was helping people: sick people need drugs, and physicians need to know about those drugs to prescribe them appropriately. Second, I had young children and valued the flexibility of working at home, which most meded companies offered at least part of the time. Third, the work was interesting: I interacted with top researchers and was assured of an ease of access that I never would have had as an assistant professor. Fourth, the money was good. Really good, especially compared with the typical assistant professor salary. And perhaps most important in the longer run—it was fun. Traveling, eating in high-end restaurants, wearing fashionable clothes, and rushing to meet important deadlines—what’s not to like?

Why I Stopped Doing It

It turned out, there was quite a bit not to like. I’d started in smaller companies headed by PhDs or MD/PhDs who dealt directly with the primary researchers and the pharmaceutical companies. There were no advertising types in sight, and I had frequent, direct communication with the physician-authors. I saw my role as helping a busy researcher write up research results: he or she did the research (which I’d already decided I didn’t want to do), and I got to analyze and describe it.

But as my career developed, several of these smaller firms went out of business, and I began to get more work from larger meded companies that were part of large advertising agencies. The bigger the agency, the more likely it was that my contact person was someone without a science background. In the worst of these settings, I discussed projects only with the program manager and had limited—or no—access to the “author.”

The work itself began to lose its charm. My preferred area of interest was oncology, and the lighter-weight assignments that increasingly came my way were not as interesting. It was hard to muster up much enthusiasm for the importance of treating, say, subclinical hypothyroidism—indeed, subclinical anything. In addition, the ethical issues began to tap me on the shoulder: perhaps the most memorable example of this was a contraceptive product that caused severe, unpredictable vaginal bleeding in some women. My job was to draft a monograph that would profile the product’s benefits, one of which, according to the client, was that although the bleeding could be severe, it was at least something that women could anticipate. In other words—the bad news is that a meteorite will strike you, but the good news is—a meteorite will strike you!

This kind of doublespeak became more and more troubling, and my career came to an end over a job involving revising a manuscript supporting the use of a drug for attention deficit-hyperactivity disorder (ADHD), with a duration of action that fell between that of shorter- and longer-acting formulations. However, I have two children with ADHD, and I failed to see the benefit of a drug that would wear off right at suppertime, rather than a few hours before or a few hours after. Suppertime is a time in ADHD households when tempers and homework arguments are often at their worst. So I questioned the account executive at the large agency that had hired me. In particular, I wanted to ask the physician author their view of the drug’s benefits. Attempts to discuss my misgivings with the meded contact met with the curt admonition to “just write it.” But perhaps because this particular disorder was so close to home, I was unwilling to turn this ugly duckling of a “me-too” drug into a marketable swan.

I decided it was time to burn my medical writing bridges and contacted The New York Times, which coincidentally had planned an investigative article on pharmaceutical marketing to physicians. I was interviewed for this article, written by Melody Petersen, by Ms. Petersen and Walt Bogdanich [2]. Shortly after its publication (November 22, 2002; page A1), I received a polite letter from an executive of the meded company asking for all the materials back and reminding me of my confidentiality agreement. I also received a direct threat of legal retaliation in a phone call from my former contact at that agency.

What I Think Now

Wordsmithing is ubiquitous in all promotional writing, not just ghostwriting: it’s the name of the game. Yet advertising masquerading as unbiased health information clearly threatens the fundamental assumptions of scientific research. Can pharma, clinicians, researchers, and consumer protection advocates work together without distortion?

I believe that they can. A system could be put in place that fortuitously addresses another critical problem—the underemployment of medical writers, who, possessing academic training and experience without opportunities to use them, are “all dressed up” intellectually with no place to go. All too often, people like me find themselves unemployed or in science-related positions such as teaching that offer little hope of advancement in a job market that has not added new jobs in biomedicine in 20 years despite a doubling in the number of PhDs in that field [3].

If research centers that employ people who serve as “guest authors” (often the same places that accredit CME programs funded by pharmaceutical money) were, in addition, to employ medical writers, much could be accomplished toward cleaning up the ethics of authorship. Funds to pay medical writers and editors could be given to these centers by pharmaceutical companies, allowing the writers to work directly with researchers. The pharmaceutical company’s role would be limited to factchecking the document and clarifying issues about dosage, adverse events, postmarketing developments, etc., and the final product would be submitted for peer review by the researcher personally. The incentive for the pharmaceutical company would be to educate and inform physicians and researchers, pure and simple. Drug promotion would still occur, but would be in the hands of advertising agencies.

This approach would eliminate the meded companies, currently “the middleman” between pharma and physician. It would reduce the need for journals to take on the entire responsibility of vetting submitted manuscripts for conflicts of interest related to authorship, because the academic institution that employed the researcher-author would have a stake in ensuring the paper’s accuracy as well as in exposing conflicts of interest. The increased visibility to the research community of the pharmaceutical company could reduce the likelihood of unfounded claims or egregious promotion of off-label use. This arrangement could shorten the interval between research and publication, and ensure a high quality of publications. Finally, one other stakeholder would surely be well pleased by such an arrangement—the medical writer, who would be glad to once again work in an academic environment.

Acknowledgments

This paper is based upon a presentation given by the author at a conference on the Ethics of Ghost Authorship in Biomedical Research: Concerns and Remedies, University of Toronto, May 4, 2011.

Author Contributions

Wrote the first draft of the manuscript: LL. Contributed to the writing of the manuscript: LL. ICMJE criteria for authorship read and met: LL. Agree with manuscript’s results and conclusions: LL.

References

  1. Alexander L, Vélez LF (2010) Medical communication: a branch of the technical communication tree. Intercom. Available: http://www.amwa.org/default/prof.devo/st​c.medicalcommunication.2010.05.pdf. Accessed 8 July 2011.
  2. Petersen M (22 November 2002) Madison Ave.has growing role in the business of drugresearch. The New York Times; A1. Available: http://www.nytimes.com/2002/11/22/busine​ss/madison-ave-has-growing-role-in-the-b​usiness-of-drug-research.html?src=pm. Accessed 13 July 2011.
  3. Monastersky R (21 September 2007) The real science crisis: bleak prospects for young researchers. The Chronicle of Higher Education 54(4): A1.

Full Article here: http://www.plosmedicine.org/article/info:doi%2F10.1371%2Fjournal.pmed.1001071

Copyright: © 2011 Linda Logdberg. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

0 commentsback to post

Other articlesgo to homepage

CDC Whistleblower: Mercury in Vaccines Given to Pregnant Women Linked to Autism

CDC Whistleblower: Mercury in Vaccines Given to Pregnant Women Linked to Autism

Pin It

Today, the Autism Media Channel released a short video where CDC whistle-blower Dr. William Thompson states, in a phone call to Dr. Brian Hooker, that injecting mercury into pregnant women creates a “clear and present danger” to the unborn child. Thimerosal, a form of mercury used as a preservative in vaccines, was removed from most childhood vaccines a few years ago, but is still in the annual flu shot, which is recommended for pregnant women.

Dr. Thompson, in the video below, insists that this mercury in vaccines causes “tics” in children, and these tics are 4 times more prevalent in kids with autism. “Tics” are defined on the CDC website as: “Tics are sudden twitches, movements, or sounds that people do repeatedly. People who have tics cannot stop their body from doing these things. For example, a person with a motor tic might keep blinking over and over again. Or, a person with a vocal tic might make a grunting sound unwillingly.”

Watch the short 1 minute video.

CDC Responds: Admits Omitting Vaccine Data Linking Vaccines to Higher Rates of Autism

CDC Responds: Admits Omitting Vaccine Data Linking Vaccines to Higher Rates of Autism

Pin It

While the mainstream media continues to ignore what is becoming the biggest news event of the year, the CDC is scrambling to respond to damaging data that they were forced to release earlier this year clearly showing they had data linking vaccines to autism that they hid from the public. This issue can longer be hidden since one of the top researchers within the CDC, who co-authored several of the studies that supposedly showed no link between vaccines and autism, has decided to become a whistle-blower. He has yet to make an official statement, and it is thought that his attorney is seeking official whistle-blower status before he does so.

The CDC, on the other hand, has responded to Dr. Brian Hooker’s newly published study reanalyzing a 2004 CDC study that excluded data showing a significant increase in autism among African American boys who were vaccinated with the MMR vaccine. They supplied a response to the Next News Network, admitting they excluded certain data, and the reasons for doing so. Next News interviewed Dr. Hooker to discuss the CDC response. Dr. Hooker, through a 10-year legal battle with the CDC and hundreds of Freedom of Information requests, finally received the entire data sets from the CDC after Congressman Bill Posey stepped in to put pressure on them to release it. We also now know that Dr. Hooker was in contact for more than a year with an insider in the CDC who has become a whistle-blower, which undoubtedly applied pressure on the CDC to obey the law and release the data.

In this interview, Dr. Hooker states that the CDC is lying in their response, and the reason they are doing so is to protect the reputation of the MMR vaccine. He also points out that the CDC purchases $4 billion of vaccines from the vaccine industry every year, and are the last ones who should be trusted to do studies on vaccine safety due to their huge conflict of interest.

Social Workers Snatch Sick Kids Away from Parents on Fake Diagnosis

Social Workers Snatch Sick Kids Away from Parents on Fake Diagnosis

Pin It

The Homeschool Legal Defense Association (HSLDA) helps defend parents who chose to educate their children at home from medical tyranny and abuse. They are a non-profit organization that depends on contributions and membership fees to provide free legal representation. They have successfully litigated cases on parental rights all the way to the U.S. Supreme Court.

HSLDA recently announced they had taken on a case in Virginia where social workers removed two children from the home where they lived with their parents over a fake psychological diagnosis.

Is 16-Year-Old Boy Seized from Mother Being Used in Medical Research?

Is 16-Year-Old Boy Seized from Mother Being Used in Medical Research?

Pin It

It has been 4 months since Cook County officials and Lurie Children’s Hospital seized custody of 16-year-old Isaiah Rider from his mother Michelle Rider because she disagreed with his treatment and wanted to transfer him to another hospital.

Isaiah suffers from a condition called neurofibromatosis, and his mother originally brought him to Lurie Children’s Hospital in Chicago because they had specialists on staff trained to treat this disease. But when Isaiah’s condition, which includes severe pain, was not getting any better, she decided to transfer him to a different hospital. As a result, Lurie Children’s Hospital stepped in and seized custody. Isaiah has recorded a video in support of his mother, who he is not allowed to see anymore.

In the report blow by Fox4kc, Michelle explains why she thinks they may be holding Isaiah: to do medical research. The top researchers in the world for neurofibromatosis are at Lurie Children’s Hospital, and the specialists there have previously told her that Isaiah’s case is “very rare.”

Data on Serious Hospital Errors Will Now Be Withheld from the Public

Data on Serious Hospital Errors Will Now Be Withheld from the Public

Pin It

Preventable medical mistakes are the third leading cause of death in the US, right after heart disease and cancer, claiming the lives of 210,000 Americans each year. More than two million people are affected by hospital-acquired infections each year, and 75,000-100,000 people die as a result of those infections. The federal government has quietly decided to “solve” the problem of hospital acquired conditions by burying the data.

read more


Get the news right in your inbox!