“The study had a bunch of flaws, pointed out in editorial and letters since,” Dr. Carlson noted. “The FDA has not changed its policy as a result.”
With a large study now underway aimed at replicating the data in that 2009 study, Dr. Carlson said, “I would surely hope that with an n of 100,000, we should get a good answer. So stay tuned.”
Dr. Carlson disclosed financial relationships with several pharmaceutical companies, including Eli Lilly & Co.; Janssen L.P.; Ortho-McNeil-Janssen Pharmaceuticals Inc.; Otsuka America Pharmaceutical Inc.; Bristol-Myers Squibb Co.; Cephalon Inc.; McNeil Pediatrics, a division of McNeil-PPC Inc.; and Shire U.S. Inc.