“The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols. Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention,” the authors wrote.
In June, the American Medical Association endorsed the concept of clinical trial registration, and GlaxoSmithKline was sued by the state of New York for concealing negative information from clinical trials related to Paxil.
In August, GSK agreed to a settlement that required posting a summary on its corporate Web site of every company-sponsored drug trial completed after Dec. 27, 2000.
In September, Forest Laboratories, manufacturers of the antidepressants Lexapro (escitalopram) and Celexa (citalopram) in a separate agreement with the state of New York, said it would post clinical study results completed since Jan. 1, 2000, for its marketed drugs.
That same month, the International Committee of Medical Journal Editors issued a requirement that clinical trials be registered by July 1, 2005, for results to be published in member journals.
Problems with cyclooxygenase-2 (COX-2) drugs came to light, and Merck pulled Vioxx (rofecoxib) off the market after its own study revealed an association between the use of the drug and an increased the risk of cardiovascular events.
In October, bills were introduced (but not passed) in the U.S. Congress that would mandate registration of all clinical trials and provide penalties of up to $10,000 per day for noncompliance.
And in November 2004, the Medicines and Healthcare Products Regulatory Authority (the British version of the U.S. FDA) announced its intention to add members of the general public to its regulation of medicines committee, in part to limit industry influence.