This paper examines the ethical violations committed by Wyeth Pharmaceuticals in its use of ghostwritten, fabricated research to promote Prempro, a menopausal hormone therapy. Drawing on Fugh-Berman's (2010) analysis of publication planning in the pharmaceutical industry, the paper outlines how falsified research placed in peer-reviewed medical journals misled physicians, contributed to breast cancer diagnoses among thousands of patients, and undermined public trust in medicine and regulatory institutions. The paper further analyzes the consequences for Wyeth, the victims, and society, and proposes legal and regulatory remedies — including aggressive punitive damages and stronger FDA oversight — as necessary deterrents against systemic research fraud.
The unethical research behavior examined here was conducted by Wyeth, and is symptomatic of systemic problems within the pharmaceutical industry. The case involves class action litigation against Wyeth and centers on the ethical issue of fraudulent research. The allegation is that Wyeth fabricated research by using vendors to produce ghostwritten manuscripts and place them into medical journals. The research was therefore entirely fraudulent, yet was passed off in peer-reviewed journals as legitimate science. The objective of placing this research in journals was to legitimize a new drug Wyeth was about to launch: Prempro, a menopausal hormone therapy.
The larger issue is publication planning, described by Fugh-Berman (2010) as "the process by which pharmaceutical, biotech and medical device companies produce and release articles in medical journals and posters at meetings to establish key marketing messages." These companies use academics to produce the articles, and for both parties the practice represents a significant breach of ethics.
The ghostwriters have a duty of care as academics to produce only research that meets genuine scholarly rigor; instead, they falsify results to match predetermined marketing messages. For the companies, there is an equivalent duty of care — to their customers and to the FDA — to sell only products that offer a tangible benefit, one the FDA determines outweighs the risks of using the drug. Both obligations are violated when publication planning drives research outcomes rather than evidence.
In the Prempro case, there were at least 14,000 injured parties, defined by the number of individuals who joined the class action suit. These individuals brought claims related to the development of breast cancer while taking Prempro. Had Wyeth and its ghostwriters conducted proper research rather than falsified it, they would have had a clearer understanding of the risks involved. That honest research would also have informed physicians, enabling them to make better prescribing decisions. As a result of the falsified research, far more women were prescribed this drug than otherwise would have been. While this brought financial benefit to Wyeth, it also produced significant negative health outcomes for the victims, specifically contributing to the development of breast cancer.
Society at large also suffers from this kind of unethical behavior. The drug and medical systems in the United States rely heavily on the compartmentalization of knowledge. Consumers often know little about their conditions or the treatments they are receiving; they trust the people treating them to be knowledgeable and to act in their best interests. When doctors and pharmacists are misled by falsified research, they are unable to serve those interests effectively. Because this particular ethical breach is systemic, public trust in the medical profession, academia, and regulators like the FDA is undermined. Eroding trust in those with the highest degree of knowledge and expertise is likely to have further repercussions, including patients making poor medical decisions for themselves because they no longer believe their providers are acting with knowledge and integrity. As noted in broader analyses of the pharmaceutical industry, this kind of institutional distrust is difficult to rebuild once it takes hold.
"Financial gains, class action damages, and reputational loss"
"Punitive damages and FDA oversight as deterrents"
Always verify citation format against your institution’s current style guide requirements.