In 1994, a hormone drug was marketed in the US. It became widely used by women in the next eight years, both to relieve menopause symptoms and to prevent heart disease and osteoporosis. In 2002, the Women's Health Initiative turned the perception of the drug on its head when they terminated the trial; they'd found an increase in breast cancer in patients compared with control. Moreover, the claims about benefits for cardiovascular disease and osteoporosis turned out to be unsupported by research.
Use of the drug plummeted, and the following years showed a decline in breast cancer incidence, suggestive of a link. Many thousands of lawsuits followed. How was it possible the drug became marketed and widely used? Indeed, articles had supported the drug, but investigations proved these articles to be unscientific promotion material. The authors - who were indeed experts in the field - turned out to have had nothing to do with the actual research, nor with the writing of the article. They were guest authors for articles that were already written by ghostwriters, who weren't named.
Many more drugs beside this hormone therapy have been marketed with unscientific, ghostwritten articles (e.g. Merck's Vioxx and Pfizer's Neurontin). Journals fail to exclude them from publication, and it's their use in patients that brings to light diminished benefits or larger risks than what the literature promised. This makes ghostwriting in the scientific literature a danger to public health.
How does it work?
Pharma hire ghostwriters and hand them the outline and predetermined conclusions for the article. Once finished, it's common practice to offer academics in the appropriate medical field to be named author. Because of the huge pressure for them to get published, and because of added fees or other compensation pharma offer, many academics agree. The articles get published, even in the most prestigious journals, and are assumed to be reliable even though the expert authors are oblivious of the research and actual content.
Note: there's an important distinction to make between ethical medical writing and ghostwriting. A medical writer should work together with the medical experts. The experts should always take responsibility for factual correctness and completeness of the content. The medical writer or editor helps to comply with journals' guides and policies, and helps to put information on the page in the most clear, concise, and entertaining way.
Can we stop it?
Criticism towards scientific ghostwriting started over twenty years ago, yet it persists today. Several measures have been proposed to eliminate the practice.
- Creators disclose every part of each writer's contribution (e.g. with this checklist). This splits responsibility between pharma, ghostwriters, authors, and journals, but this also means none of them has sole responsibility.
- Researchers and writers work together directly and we remove pharma as the middleman. The scientists are responsible for the content, the writer(s) can save them time and improve their text. Good science, with all its doubts and disclaimers, will lead to a less promotional end product, and so making this legally mandatory may be necessary.
- Laws around the world already address authorship fraud. More fraud claims against guest authors and pharma (and possibly ghostwriters or journals) will help to discourage ghostwriting. Who should test publications and file these claims though? Is it desirable that government interferes, or should the sector solve it themselves? Will they be able to?
One thing is clear: ghostwriting persist, so the enforcement of regulations so far has been insufficient. It needs updating one way or another. Eliminating the practice effectively may require a combination of new measures, and a way to discipline violators.
When a medical product is recalled, trust in health care and science vaporizes, often on a scale that's impossible to reverse. Attempts to disprove doubts can backfire* even when you have the facts on your side. If you don't, you have no chance convincing people. Unreliable science, including products of ghostwriting, fuels the distrust of the public. Who can blame them, when they're put at risk of harmful medication for the financial gain of big companies?
Everyone involved in research - pharmaceutical companies, writers, authors, publicists - must become motivated to stop ghostwriting, and to make this change we might need more effective regulations.
To regain trust, science must earn it, over and over, with every press release, every marketed product, and every publication.
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