A report appearing today in the Archives of Internal Medicine uses court documents related to a product liability lawsuit to detail the running of a “seeding trial.” Such trials, which occur after a drug is approved, are primarily conducted to promote drugs and increase prescribing among physicians who partake in these studies rather than to advance scientific knowledge.
In an accompanying commentary, G. Caleb Alexander, MD, MS, of the University of Chicago, explains how the deception of investigators, physicians, and patients plays a key role in the success of seeding trials and suggests steps to take by the medical community to avoid such questionable studies.
In an interview, Dr. Alexander expands on his concerns and ideas.
news@JAMA: How common are seeding trials?
Dr. Alexander: It’s an important question, but we don’t know. One of the challenging aspects of studying this phenomenon is that in most cases, the types of documents we have in the Archives paper are not in the public domain. Remember that seeding trials are unethical but not illegal, and given this, it does pose challenges to the scientific community to uncover and prevent them.
news@JAMA: Should institutional review boards (IRBs), which approve and monitor clinical trials, do a better job identifying and rejecting seeding trials?
Dr. Alexander: IRBs should play in important role, but the primary focus of IRBs is the protection of human subjects. Assessing the scientific integrity of a trial is secondary. One of the important contributions the Archives paper makes is shedding light on a marketing phenomenon that often does not see the light of day, and with greater awareness among IRBs, academicians, and policy makers, it may help to limit their frequency.
news@JAMA: How do researchers, who often work at prestigious universities, come to put their names on seeding trials?
Dr. Alexander: It would be interesting to know what the authors’ roles are in the design, conduct, analysis, and interpretation of these studies. It’s not clear how much authors know about the role that marketing and promotion play in the design and conduct of these studies. One can only hope the authors fulfill the criteria for authorship that are espoused by medical journals.
news@JAMA: And how do journals come to publish seeding trials?
Dr. Alexander: First of all, every journal is capable of publishing a seeding trial. When journal editors considering phase 4 trials [studies performed following a drug’s approval, usually to examine real-world safety and effectiveness] they need to carefully scrutinize these studies to make sure they are not seeding trials in disguise.