The line between scientific uncertainty and promotion of snake oilBMJ 2013; 347 doi: https://doi.org/10.1136/bmj.f5687 (Published 20 September 2013) Cite this as: BMJ 2013;347:f5687
- Ed Silverman, editor
- 1Pharmalot, Millburn, NJ, USA
What should physicians think when a press release boasts that a subanalysis of a clinical trial shows significant patient benefit, even though the primary outcome was not achieved? Should the emphasis be considered a ruse to bolster the company and its drug? Or might this be an instance in which there can be reasonable disagreement about statistical interpretations and results?
These are the questions that a former biotechnology executive is asking the United States Supreme Court to review as he attempts to overturn a conviction for wire fraud for allegedly skewing the results of a clinical trial in a press release about the drug.1 And the case is being closely watched because First Amendment and commercial speech rights have been raised.
Questions of interpretation
The press release in question was issued in 2002 by a small biotechnology company named InterMune and contained the results of a clinical trial of interferon gamma-1b (Actimmune) for treating idiopathic pulmonary fibrosis (IPF). The drug was already approved to treat chronic granulomatous disease and severe malignant osteopetrosis.
The trial failed to achieve significance on its primary endpoint of progression-free survival, but the press release played up a finding that a post-hoc subanalysis indicated that the drug helped patients live longer. The release, in fact, trumpeted this headline: “InterMune announces phase III data demonstrating survival benefit of Actimmune in IPF,” and the subheading boasted that the drug “Reduces mortality by 70% in patients with mild to moderate disease.”
However, the US Department of Justice charged that the release contained false and misleading statements that prompted doctors to write more prescriptions for interferon gamma-1b, even though it was not approved to treat idiopathic …