Public release date: 17-Aug-2008
Clinical studies that are designed by pharmaceutical companies to promote use of their drugs are called “seeding” trials. While much has been written about the marketing tactics of the pharmaceutical industry, seeding trials have not been characterized in depth. A new study finds strong documentary evidence of how a pharmaceutical company framed a marketing effort as a clinical trial. Researchers reviewed internal documents that became public during litigation against the drug manufacturer. The company’s marketing division designed the trial, and handled all collection, analysis, and dissemination of data. The company hid their motive for the trial from participants, investigators, and institutional review board members. Researchers concluded that seeding trials are harmful for three reasons:
First, because the company disguises its motives, informed consent is impossible; second, good quality research is at risk when marketers – rather than scientists – design a study; and third, the scientific question posed by a seeding trial often has little merit. An accompanying editorial warns institutional research review boards to avoid approving seeding trials and physicians to avoid enrolling their patients in them.