Mr. Krumholz and his coauthors clearly demonstrate that the true intent of seeding trials is to introduce a new product and induce clinicians to use it, according to Dr. G. Caleb Alexander.
"Perhaps the greatest cause for concern is that these trials deceive investigators, clinicians, and patients, subverting the scientific process and violating ethical norms."
As others have noted, "Deception is not just an incidental part of a seeding trial, but rather the very success of the trial depends on such deception, since few institutional review boards, investigators, clinicians, or patients would willfully participate in a study with marketing objectives and little or no scientific value," Dr. Alexander wrote in commentary accompanying the report (Arch. Intern. Med. 2011;171:1107-8).
Because "there will continue to be a need for well designed, rigorously conducted phase 4 clinical trials," he noted that institutional review boards, clinical investigators, practicing clinicians, and other important stakeholders must increase their vigilance in order to prevent and recognize future seeding studies.
This analysis of the STEPS study was not directly supported by any grants or funds. Mr. Krumholz and Dr. Egilman are paid consultants for plaintiffs in litigation related to gabapentin against Pfizer Inc., and Dr. Ross is an unpaid consultant in the same litigation. Dr. Egilman and Dr. Ross were previously paid consultants for plaintiffs in litigation against Merck related to rofecoxib. Dr. Ross is supported by the National Institute on Aging and the American Federation of Aging Research.
Dr. Alexander is in the department of medicine at MacLean Center for Clinical Medical Ethics, University of Chicago Hospitals, and the department of pharmacy practice at the University of Illinois at Chicago School of Pharmacy. He is supported by the U.S. Agency for Healthcare Research and Quality, and he reported being a consultant for IMS Health.