The medical profession in America faces complex challenges in the 21st century. Medical Ghostwriting is a challenge that threatens the credibility and integrity of professional medical publications and highly trained medical providers.
HISTORY OF GHOSTWRITING
The phenomenon of ghostwriting is not new. Fiction writers and autobiographers often enlist the services of a ghostwriter to enhance the quality of their writing. In fiction writing, the plot, characters, and setting of a story may be written by an author and completed with the help of a ghostwriter to ‘flesh it out’ and perfect the manuscript.
Politicians hire ghostwriters to compose their speeches and to create advertisements for campaign purposes.
The first known for-profit ghostwriting began in the 1960s. Medical research was proving that cigarette smoking could cause cancer and ‘big tobacco’ was eager to bury the information.
In the 1980s and 1990s, ghostwriting services rallied to try and cover up mounting evidence that inhaling second-hand smoke could be as deadly as actually smoking (http://www.slate.com/articles/health_and_science/medical_examiner/2017/09/big_pharma_s_ghostwriting_problem.html).
In both examples above, presumably independent scientists wrote articles reassuring the public that smoking was, indeed, relatively harmless. Consumers accepted the veracity of these ‘experts’, ghostwriters padded their bank accounts and the tobacco industry continued to amass a fortune.
MEDICAL GHOSTWRITING IN THE AGE OF TECHNOLOGY
Medical ghostwriting has served a legitimate purpose to medical researchers. Busy researchers can devote more time to their studies if they do not have to take time to write all the results and compose findings into a publishable article.
Often researchers will write a preliminary version of findings and hire an accomplished medical writer to convert this to an academic-quality article for publication. Other researchers have retained ghostwriters for proofreading purposes to free up their time for their studies.
The above-described ghostwriters could be described as writing assistants, purely for research and reporting purposes. Ghostwriting has taken on a new and more dubious role of providing professionally written documents to be ‘sold’ to pharmaceutical companies or research organizations.
These articles differ from advertisements because they are not signed by the writer. The completed article is turned over to the client, the writer is paid and disappears.
The client then makes revisions and adds information beneficial to their profit-making purpose. Negative realities of their product are rewritten to their advantage.
Members of the media and others concerned with the efficacy of medical ethics have become irate over the corruption in medicine involving ‘doctored’ ghostwritten medical articles.
Much is at stake in publishing articles in reputable medical journals. The information contained will influence doctors’ decision making processes in treating patients. Policy makers such as state and federal legislators use information contained in these articles to shape policies involving life-and-death decisions for millions of people
GHOSTWRITING AND CORRUPTION IN MEDICAL PRACTICE AND LITERATURE
As crucial as medical research is, medical writers have a responsibility to maintain the integrity of the research findings. Pharmaceutical companies have abandoned this responsibility and changed content to maximize profit and minimize negative aspects of their products and services.
A paper recently composed and published by three researchers highlights the way big drug companies manipulate scientific research findings to their advantage. Jay Amsterdam, M.D., Jon Jureidini, M.D. and Leemon McHenry, Ph.D. explored the mishandling of ghostwritten articles, the recruitment of KOLs (key opinion leaders), and the failure of reputable medical journals to protect the scientific and ethical integrity of publications.
KOLs (key opinion leaders) are physicians who are influential in their medical community, who exercise a degree of leadership over other physicians, including what medications they routinely prescribe.
Pharmaceutical companies pretend to solicit the consultative advice of these physicians to receive expert feedback on how best to develop and market their product. The actual role of the key opinion leaders is to cooperate with the company to champion and promote their product.
The KOLs often become ‘authors’ of the drug company’s ghostwritten articles, providing the facade of expertise behind manipulated data that helps create a burgeoning market for their product.
Fraudulent articles with faulty information are submitted to publications, which are required to subject the articles to peer review before publication. When peer reviewers recommend against publication, the journal (or its lawyers) can override the recommendation and publish anyway.
This overriding may be done because of threats of libel lawsuits from the pharmaceutical manufacturers.
In an effort to expose the corruption of big pharmaceutical companies, Amsterdam, McHenry, and Jureidini exposed corrupt practices of three major pharmaceutical giants and published their findings.
1. “SmithKline Beecham Paroxetine Study 329” was the first study exposed for unethical and corrupt actions.
The use of imipramine and paroxetine were compared to determine the safety of each in treating adolescent and childhood depression. This case was deconstructed by presenting a number of court documents that divulged ghostwriting and manipulation of research data to allow them to market off-label SSRI medications to adolescents and children.
2. Forest Laboratory Citalopram Study CIT-MD-18 also promoted and printed false claims regarding the safety of using SSRI antidepressants in children and adolescents. The deconstructing of this printed claim revealed that symptoms of agitation, akathisia, and hypomania had been observed in young patients taking citalopram.
3. SmithKline Beecham Paroxetine Study 352 highlighted the manipulation of data and presentation of false outcomes regarding adult patients with a diagnosis of a bipolar affective disorder.
In this study, the author credited with writing the article was discovered to have had little to no participation in any phase of the drug study or article composition.
These three deconstructed studies confirmed that any study released by a major pharmaceutical company needs to be questioned and carefully inspected. The public needs to demand transparency and accountability from these pharmaceutical giants to protect the health and welfare of all patients.